Half Year 2025 Innovent Biologics Inc Earnings Call
Speaker #2: Good evening and good morning, everyone. This is Jan, head of China healthcare research at JP Morgan. Thank you for joining Innovent Biologics 2024 interim results webinar and call.
Yang Huang: Good evening and good morning, everyone. This is Yang, Head of China Healthcare Research at JPMorgan. Thank you for joining Innovent Biologics 2025 interim results webinar and call. Today, we have a full suite of Innovent Management team joining today's call. It is my great pleasure and honor to present the Innovent Management team to you, who include Dr. Michael Yu, founder, chairman, and the CEO; Mr. Ronnie Add, Executive Director; Ms. Vivian Zhang, Executive Director, Chief People Officer, and Chief Commercial Officer; Ms. Rachel Yu, Chief Financial Officer; Dr. Hui Zhou, Chief R&D Officer of Oncology Pipeline; Dr. Lei Qian, Chief R&D Officer of General Biomedicine Pipeline; and other management attendees with IR team. A few hours ago, Innovent released its 2025 entry results with significant revenue growth and a pretty large positive profit for the period.
Speaker #2: Today, we have a full suite of innovative management teams joining today's call. It is my great pleasure and honor to present the innovative management team to you, which includes Dr. Michael Yu, founder, chairman, and CEO.
Speaker #2: Mr. Ronnie Ed, Executive Director. Ms. Vivian Zhang, Executive Director, Chief People Officer, and Chief Commercial Officer. Ms. Rachel Yo, Chief Financial Officer. Dr. Hui Zhou, Chief R&D Officer of the oncology pipeline.
Speaker #2: Dr. Lei Chen, Chief R&D Officer of the General Biomedicine Pipeline, and other management attendees, along with the Investor Relations (IR) team. A few hours ago, Innovent released its 2024 interim results, showing significant revenue growth and a substantial positive profit for the period.
Speaker #2: So, during today's call, the Innovent management team will first present the results and company updates. After the management presentation, there will be a Q&A session. Audience members can raise their hands in Zoom to ask questions at that time.
Yang Huang: So, during today's call, Innovent Management team will first present results and company updates. After the management presentation, there will be a Q&A session. Audience can raise your hands in the Zoom to ask questions at that time. Without further ado, I will pass the microphone to the Innovent team.
Speaker #2: Without further ado, I will pass the microphone to the Innovent team.
Speaker #3: Thank you, Dr. Huang. To their investors and analysts, thank you for joining Innovent Biologics' conference call for the first half of 2025. We're very delighted to share with you our strong financial results and excellent execution under a clear strategy.
Rachel Yu: Thank you, Dr. Huang. So, dear investors and analysts, thank you for joining Innovent Biologics conference call for the first half of 2025. We are very delighted to share with you our strong financial results and excellent execution under a clear strategy. So, today's agenda will be as follows. So, Dr. Michael Yu will provide an overview of our first half achievements and outline the business outlook, followed by Dr. Hui Zhou and Dr. Lei Qian will dive into details of the key pipeline updates. And Ms. Rachel Yu will then review the financial performance, followed by the Q&A. So, before we begin, I'd just like to remind you that the result presentation has been uploaded to our official website under the Investors and Media section for you to download.
Speaker #3: So, today's agenda will be as follows: Dr. Michael Yu will provide an overview of our first half achievements and outline the business outlook, followed by Dr. Hui Zhou and Dr. Lei Chen, who will dive into the details of the key pipeline updates.
Speaker #3: And Dr. and Ms. Rachel Yo will then review the financial performance, followed by the Q&A. So, before we begin, I'd just like to remind you that the results presentation has been uploaded to our official website under the Investors and Media section for you to download.
Speaker #3: And unless otherwise stated, during this conference, all the financial numbers we discussed today will refer to the non-IFRS measures, which exclude the non-cash items, including the foreign exchange loss and the share-based compensation expenses.
Rachel Yu: And, as otherwise stated, during this conference, all the financial numbers we discussed today will refer to the non-IFRS measures, which exclude the non-cash items, including the foreign exchange loss again and the share-based compensation expenses. This adjustment will provide a clearer view of our core operational performance. So, with that, I will hand over the call to Dr. Michael Yu, please.
Speaker #3: These adjustments will provide a clearer view of our core operational performance. So, with that, I will hand over the call to Dr. Michael Yu. Please.
Speaker #2: Thank you. Thank you, Wendy. Dear investors, good evening and good morning. This is Michael Yu. As you may recall from our Q4 annual results, we delivered positive EBITDA and net profit for the first time in our history.
Yang Huang: Thank you. Thank you, Wendy. Dear investors, good evening and good morning. This is Michael Yu. As you may recall from our 2024 annual results, we delivered positive EBITDA and net profit for the first time in our history. Innovent has now entered a new phase of a dual-engine growth and a global innovation. We are expanding our portfolio beyond oncology into general biomedicine and extending our R&D footprint from China to international markets. 2025 is pivotal for us. In the first half, guided by a clear strategy, our team effectively executed and delivered robust results. We achieved robust revenue growth and substantial profit improvement, launched five new products, and rolled out innovative commercial models led by our launch team for Mesotide.
Speaker #2: Innovent has now entered a new phase of due diligence growth and global innovation. We are expanding our portfolio beyond oncology into general biomedicine and have extended our R&D footprint from China to international markets.
Speaker #2: Q2 is pivotal for us. In the first half, guided by a clear strategy, our team effectively executed and delivered a robust result. We achieved robust revenue growth and a substantial profit improvement.
Speaker #2: Round five new products and the rollout of innovative commercial models were led by our round team of four mesotypes. We also obtained a series of positive proof-of-concept data for our next-generation programs.
Yang Huang: We also obtained a series of positive proof of concept data for our next-generation programs to support legislation studies, which include IBI-363, the very first global phase III studies in patients with lung cancer who failed PD-1 treatment. In the following pages, I will review our first half performance and outline our outlook going forward. Next slide, which is slide 3. Revenue for the first half reached R&B 5.95 billion, an increase of 50.6% year-over-year. This was driven by the continued robust oncology performance, expansion of the general biomedicine portfolio, and increased licensing fee income. Our commercial portfolio expanded to 16 approval products, and it will be 18 around the end of this year, as we expect two additional approvals: IBI-112, which is IL-23 p19 antibody, PICCARN TBOT, and IBI-310, ipilimumab CTLA4 antibody. Next slide.
Speaker #2: To support legislation studies, which include IBI 363: the very first global Phase III studies in patients with lung cancer who failed PD-1 treatment. In the following pages, I will review our first half performance and outline our outlook going forward.
Speaker #2: Next slide, which is slide three: revenue for the first half reached $5.95 billion, an increase of 50.6% year-over-year. This was driven by the continued robust oncology performance, expansion of the general biomedicine portfolio, and increased licensing fee income.
Speaker #2: Our commercial portfolio expanded to 16 approved products, and it will be 18 around the end of this year. As we expect two additional approvals, IBI 112, which is our 2023 P19 antibody, will become key, and IBI 310, a Believer MAP CTR4 antibody.
Speaker #2: Next slides. During the first half, net profit rose substantially to R&D $1.2 billion, and EBITDA rose to R&D $1.4 billion. This was driven by robust top-line growth and operational efficiency as shown in ongoing improvements in gross profit margin and SG&A expenses, rate expense ratios.
Yang Huang: During the first half, net profit rose substantially to R&B 1.2 billion, and EBITDA rose to R&B 1.4 billion. This was driven by robust top-line growth and operational efficiency, as shown in ongoing improvements in gross profit margin and ST&A expense ratios. Our CFO Rachel will provide further details on the financials in the next couple of slides. Also, we are the only biotech in China, one of three globally, to hold AAA MSCI ESG rating, which is, you know, the highest ESG rank. It's a great recognition of our commitment to sustainable development and corporate responsibilities. Next slide, which is slide 5. Our leadership in oncology remains strong. Over 3,000 new patients receive treatment with our cancer drugs every day. Major products, including Cinqlimab and Tyver, maintain strong growth momentum. Meanwhile, three new products launched further enrich our franchise.
Speaker #2: Our CFO ratio will provide further details on the financials in the next couple of slides. Also, we are the only biotech in China and one of three globally to hold a triple A MSGI ESG rating.
Speaker #2: Which, as you know, is the highest ESG rank. It's a great recognition of our commitment to substantial development and corporate responsibilities. Next slide.
Speaker #2: Our leadership in oncology remains strong. Over 3,000 new patients receive treatment with our cancer drugs every day. Major products, including SintelliMab and Tyver, maintain strong growth momentum.
Speaker #2: Meanwhile, three new products further enrich our franchise: Round One, an EGFR inhibitor; Double Two; and Japigo, which is a BTK inhibitor. Looking forward, we will continue to broaden indications for core products and introduce new assets.
Yang Huang: Dabordir ROS1 inhibitor, Rematinevab EGFR inhibitor, and Japico, which is BTK inhibitor. Looking forward, we will continue to broaden indications for core products and introduce new assets. Tyver currently is under NDA review for 9 and 10 indications, including renal cell carcinoma and a new adjuvant treatment of colorectal cancer. Then later, in combination with IBI-310, ipilimumab, which is CTLA4 antibody, we also expect readouts in the early next year from a phase III trial of Tyver in the patient with non-small cell lung carcinoma for preoperative treatment, which could support a new NDA submission. Together, these steps will reinforce our leadership and the momentum in the oncology space. Next slide. In the first half of this year, Cymbalo, which is PCSK9 antibody, was listed on the NADL. Tecumab, which is IGF1R for thyroid eye disease, was successfully launched, and Mesotide received approval as the original plant.
Speaker #2: Tyver is currently under NDA review for nine and ten indications, including renal cell carcinoma and a new adjuvant treatment of colorectal cancer. The latter is in combination with IBI-310, a belimumab, which is a CTLA-4 antibody.
Speaker #2: We also expect readouts in early next year from a Phase III trial of Tyver in patients with small cell lung carcinoma, specifically for preoperative treatment.
Speaker #2: Which could support a new NDA submission. Together, this step will reinforce our leadership and the momentum in the oncology space. Next slides. In the first half of this year, seen below, the PCSK9 antibody was listed on the NRDL.
Speaker #2: Thickened, which is IGF1R for thyroid eye disease, was successfully launched, and a mesotype received approval as an original plant. An innovative portfolio of robust blockbusters is taking shape.
Yang Huang: An innovative portfolio of robust blockbusters is taking shape. We are also open-minded and creative in general biomedicine commercialization. We have implemented a multiple-channel strategy supported by a scalable, full-functioning team of more than 1,000 people. We are strengthening our academia presence and coverage in public hospitals while expanding access through retail pharmacy chains, online healthcare platforms, and private clinic networks. Those channels are essential for widespread patient populations looking for chronic disease medicines. At the same time, we are integrating digital marketing and patient support tools to improve disease education, disease awareness, and adherence of therapeutics. Within a short period, we have seen a good outcome from our innovative commercial strategy and a successful launch and ramp-up of our CVM products. As we expand into general biomedicine, including areas such as CVM, autoimmune, and ophthalmology, our goal is to establish Innovent as innovative leaders in those areas. Next slide.
Speaker #2: We are also open-minded and creative in general biomedicine commercialization. We have implemented multiple channel strategies, supported by a scalable full-function team of more than 1,000 people.
Speaker #2: We are strengthening our academic presence and the coverage in public hospitals while expanding access through retail pharmacy chains, online healthcare platforms, and private clinic networks.
Speaker #2: Those channels that are essential for widespread patient populations looking for chronic disease medicines. At the same time, we are integrating digital marketing and patient support tools to improve disease education, disease awareness, and adherence to therapeutics.
Speaker #2: Raising a short period, we have seen a good outcome from our innovative commercial strategy and a successful round and wrapped ramp-up of our CVM products.
Speaker #2: As we expand into general biomedicine, including areas such as cardiovascular medicine (CVM), autoimmune diseases, and ophthalmology, our goal is to establish Innovent as an innovative leader in those areas.
Speaker #2: Next slide. Slide seven. Looking ahead to the middle term, ongoing launch and a strong pipeline in both oncology and general medicine will support the sustainable growth of our business.
Yang Huang: Slide 7. Looking ahead to the middle term, ongoing launch and a strong pipeline in both oncology and general medicine will support our sustainable growth of our business. In oncology, our next-generation immuno-oncology and ADC pipelines are progressing into late-stage development, serving as important further growth drivers. This includes IBI-363, IBI-343, and IBI-354, which is HER2 ADC assets. Currently, all of them are under legislation studies across a few different major cancer indications. In general biomedicine, the lineup of high-potential products will strengthen our position, including continued lifecycle management of Mesotide, Cinqlimab, which is IGF1R antibody, and PICO-CYBORT, which is IL-23 antibody. Dr. Lei Qian will provide you with more detail in the next couple of slides. Next slide.
Speaker #2: In oncology, our next-generation immune oncology and ADC pipelines are progressing into late-stage development, serving as important further growth drivers. This includes IBI 363, IBI 343, and IBI 354, which are HER2 ADC assets.
Speaker #2: All currently, all of them are under registration studies across a few different major cancer indications. In general biomedicine, the lineup of high-potential products will strengthen our position, including continued lifecycle management of mesotypes.
Speaker #2: Synchromer, which is a PCS IGF1R antibody, and Kybert, which is an IL-23 antibody. Dr. Lei Chen will provide you with more details in the next couple of slides.
Speaker #2: Next slides. Now we are entering a new chapter focused on global innovation, powered by a robust pipeline and strengthening antibody and ADC technology platforms.
Yang Huang: Now we are entering a new chapter focused on global innovation, powered by a robust pipeline and a stringing of antibody and ADC technology platforms from our cornerstone research institute we call Innovent Academy. Next slide. Slide 9. We have built a highly competitive pipeline aligned with our global vision. Specifically, this year, we have achieved several key milestones. Number one, we announced the robust proof of concept data for our leading assets, including IBI-363 and IBI-343, and moved them to the first wave of legislation studies accordingly. Number two, we also accelerate global R&D efforts for the next wave of novel pipelines. We are currently conducting an MRCT trial, phase I, for our novel bispecific ADC, dual-payload ADC, and T-cell engaged pipeline in oncology, as well as the next-generation immunology and CVM pipelines in general biomedicine, as indicated in these slides.
Speaker #2: From our cornerstone research institute, we call Innovent Academy. Next slide. Slide nine. We have built a highly competitive pipeline aligned with our global vision.
Speaker #2: Specifically, this year, we have achieved several key milestones. Number one, we announced the robust proof of concept data for our leading assets, including IBI 363 and IBI 343, and moved them to the first wave of legislative studies.
Speaker #2: Accordingly, number two, we also accelerate global R&D efforts for the next wave of novel pipelines. We are currently conducting an MRCT trial Phase One for our novel bispecific ADC to payload ADC and T cell engaged pipeline in oncology.
Speaker #2: As well as the next-generation immunology and the CVM pipelines. In general, biomedicine, as indicated in this slide. Number three: going forward, global R&D remains our top priority.
Yang Huang: Number three, going forward, global R&D remains our top priority. We will continue to advance assets into global clinical studies, supporting our goals of reaching five assets in MRCT studies by 2030. Slide 10. At this year's ASCO, IBI-363 presented excellent phase IB and II proof of concept data across IL-resistant lung cancer and the colder tumors such as melanoma and MSS colorectal cancer, highlighting its unique dual immunoactivation by PD-1 and IL-2 and the therapeutic potential as the next-generation IL therapy. As we just announced earlier this week, we have received the R&D approval from FDA to initiate its first global MRCT phase III studies for this asset, which is in patients with IL-resistant squamous non-small cell lung carcinoma. This marks a significant milestone for our next-generation IL therapy and also evidence to support Innovent's long-term globalization strategy.
Speaker #2: We will continue to advance assets into global clinical studies supporting our goals of reaching five assets in MRCT studies by 2030. Slide ten. At this year's article, IBI 363 presented excellent Phase IB and two proof of concept data across IL-resistant lung cancer and cold tumors such as melanoma and MSI colorectal cancer.
Speaker #2: Highlighting its unique dual immunoactivation by PD-1 and IL-2, and the therapeutic potential as the next generation IL therapy. As we just announced earlier this week, we have received the R&D approval from the FDA to initiate its first global MRCT Phase III studies for this asset.
Speaker #2: Which is in patients with IL-resistant squamous small cell lung carcinoma. This marks a significant milestone for our next-generation IL therapy and also provides evidence to support Innovent's long-term globalization strategy.
Speaker #2: Following the article POC data, IBI 343, which is clotting 18.2 ADC, also launched its Phase III study in certain lines of pancreatic cancer. Dr. Hui Zhou will share more in detail in the next part of the presentation.
Yang Huang: Following the ASCO POC data, IBI-343, which is clotting 18.2 ADC, also launched its phase III study in certain line pancreatic cancer. Dr. Hui Zhou will share more in detail in the next part of the presentation. Next slide. To support our global strategy, we are accelerating the development of overseas organizations and specialized teams. This involves establishing robust clinical operation and development teams in key markets such as the US and Europe, ensuring efficient execution and long-term global growth. Next slide. We are also expanding global presence through collaborations and broadening market access. Earlier this year, we entered an exclusive our license agreement with Roche for DLL3 ADC to advance our pipeline globally.
Speaker #2: Next slide. To support our global strategy, we are accelerating the development of overseas organizations and specialized teams. This involves establishing robust clinical operations and development teams.
Speaker #2: In key markets such as the U.S. and Europe, we are ensuring efficient execution and long-term global growth. Next slide. We are also expanding our global presence through collaboration and broadening market access.
Speaker #2: Earlier this year, we entered an exclusive out-licensed agreement with Roche for DLL3 ADC to advance our pipeline globally. Meanwhile, several of our commercial products have secured approval in Hong Kong, in the Macau market, as well as in the legislative process of a few products in Southeast Asia and Latin America, to bring our therapeutic products to more patients worldwide.
Yang Huang: Meanwhile, several of our commercial products have secured approval in Hong Kong, in Macau markets, as well as in the legislation process of few products in Southeast Asia, Latin America, to bring our therapeutic products to more patients worldwide. Next slide. To conclude my presentation, the first half of 2025 has been highly successful under the strategy of dual-engine growth and global innovation. Looking ahead, we will focus on two key priorities for the rest of the year. First, to sustain robust revenue growth. This includes three tasks: maintain leadership in the oncology area, ensure the successful launch of CVM products specifically for Mesotide, and prepare for the upcoming launch of our autoimmune product, PICO-CYBORT, IL-23 p19 antibody, around the year's end. Secondly, we will continue prioritizing our global innovation strategy. This involves advancing IBI-363 and IBI-343 through legislation studies and initiating new POC studies for additional indications.
Speaker #2: Next slide. To conclude my presentation, the first half of 2025 has been highly successful under the strategy of dual engine growth and global innovation.
Speaker #2: Looking ahead, we will focus on two key priorities for the rest of the year. First, to sustain robust revenue growth. This includes three tasks.
Speaker #2: Maintain leadership in the oncology area. Ensure the successful launch of CVM products specifically for mesotypes. And prepare for the upcoming launch of our autoimmune product.
Speaker #2: Take a keeper bet. IL-23. P19 antibody. Around the year-end. Secondly, we will continue prioritizing our global innovation strategy. This involves advancing IBI 363 and IBI 343 through registration studies and initiating new POC studies for additional indications.
Speaker #2: We have also observed preliminary positive phase I results in next wave next-generation autoimmune pipeline such as OX-40 lichen, IL-4, TSLP bispecific asset, and could potentially move to POC studies.
Yang Huang: We have also observed preliminary positive phase I results in the next wave, next-generation autoimmune pipelines such as OX40 ligand, IL4R TSLP bispecific asset, and could potentially move to POC studies. Furthermore, we will accumulate more phase I data internationally on bispecific and dual-payload ADCs, as well as next-generation GLP-1 molecules to support further development globally. We are confident. Next slide. We are confident in our five-year strategic plan, as shown in these slides. Our goals are to deliver consecutive EBITDA and profits in 2025, achieve R&B target, the sale target 20 billion R&B in product revenue by 2027, and have five assets in the global phase III trials by 2030. All while establishing Innovent as a premier global biopharmaceutical company. Now I will hand over to Dr. Zhou and Dr. Qian, who will provide you with more details, insights into our product pipelines. Zhou Hui, please.
Speaker #2: Furthermore, we will accumulate more Phase I data internationally on bispecific and dual payload ADCs, as well as next-generation GLP-1 molecules to support further development globally.
Speaker #2: We are confident next slide. We are confident in our five-year strategic plan as shown in this slide. Our goals are to deliver consecutive EBITDA and profits in 2025.
Speaker #2: Achieve R&D targets: the sale target is $20 billion in product revenue by 2027. Additionally, we aim to have five assets in global Phase III trials by 2030.
Speaker #2: All well, establishing Innovent as a premier global biopharmaceutical company. Now, I will hand over to Dr. Zhou and Dr. Chen, who will provide you with more details and insights into our product pipelines.
Speaker #2: So Hui, please. Okay. Yeah, thanks, Dr. Yu. I will talk about our oncology strategy and the pipeline. As we optimized at the Oncology R&D Day in June, supported by deep insight in cancer biology and advanced technology platforms.
Hui Zhou: Thank you. Yeah, thanks, Dr. Yu. I will talk about our oncology strategy and pipelines. As we authorized at the Oncology R&D Day in June, supported by deep insight in cancer biology, advanced technology platforms, our strategy focuses on innovation in next-generation IL-plus, next-generation ADC to transform cancer treatment worldwide. Next. IBI-363, our global first in class PD-1 IL-2 alpha biosubfusion protein. It features a novel molecule designed with dual immune activation. The IL-2 is engineered to retain its affinity for IL-2 alpha receptor and while reduced binding to receptor beta and gamma, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This dual mechanism targets and activates tumor-specific T cell co-expression PD-1 and IL-2 alpha, enabling more precise and effective stimulation of this T cell sub-population. Next, please. IBI-363 has demonstrated robust anti-tumor activity across multiple tumor types.
Speaker #2: Our strategy focuses on innovation in next-generation IO, plus next-generation ADC, to transform cancer treatment worldwide. Next, the IBI 363, our global first-in-class PD-1 IL-2 alpha bio-diffusion protein.
Speaker #2: It diffused novel molecular design with dual immune activation. The IL-2 is engineered to retain its affinity for the IL-2 alpha receptor while reducing binding to the beta and gamma receptors.
Speaker #2: Thereby, minimize toxicity. The PD-1 binding not only blocks PD-1 but also selectively delivers IL-2. This dual mechanism targets and activates tumor-specific T cells co-expressing PD-1 and IL-2 alpha.
Speaker #2: Enabling more precise and effective stimulation of this T cell subpopulation. Next phase, IBI 363 has demonstrated robust anti-tumor activity across multiple tumor types. At the article this year, IBI 363 had three oral presentations demonstrating breakthrough potential with remarkable response and prolonged survival benefits in hard-to-treat tumor types, including IL-resistant non-small cell lung cancer, typical cold tumors such as acral melanoma, and also the late line of MSI colorectal cancer.
Hui Zhou: At ASCO this year, IBI-363 had three oral presentations demonstrating breakthrough potential with remarkable response and prolonged survival benefits in hard-to-treat tumor types, including IL-resistant non-small cell lung cancer, typical co-tumor such as acromucosal melanoma, and also the late line of MSS colorectal cancer. Next, please. We are adopting a stepwise development strategy to validate IBI-363's potential as the next-generation IL therapy. We are launching a registration study for the first wave of indication. The phase II pivotal trial in melanoma is already underway. This week, we announced that both US, FDA, and China NAB already approved the R&D. We will soon initiate the first global phase III study in IL-resistant squamous non-small cell lung cancer. The phase III in third-line treatment of MSS CRC is also in preparation.
Speaker #2: Next, please. We are adopting a stepwise developed strategy to validate IBI 363's potential as the next-generation IL therapy. We are launching a registration study for the first wave of indication; the Phase II pivotal trial in melanoma is already underway.
Speaker #2: This week, we announced that both the US FDA and China NAP have already approved the R&D. We will soon initiate the first global Phase III study in IL-resistant squamous non-small cell lung cancer. The Phase III study in third-line treatment of MSCRC is also in preparation.
Speaker #2: Meanwhile, a phase IB, phase II proof-of-concept study of IBI 363 in first-line non-small cell lung cancer and first-line colorectal cancer (CRC) was ongoing, with data readout planned for 2026.
Hui Zhou: Meanwhile, phase IB phase II proves our concept study of IBI-363 in first-line non-small cell lung cancer and the first-line CRC was ongoing with data readout planned in 2026. We also plan to explore signals in additional more indications, including late line in ovarian cancer and EGF mutant non-small cell lung cancer, as well as new adjuvant setting for non-squamous non-small cell lung cancer. Next. As mentioned, this is truly exciting news for us. The US FDA has approved us to initiate a global phase III study in squamous non-small cell lung cancer, following positive feedback from the recent end-of-phase II meeting on the study protocol. Canada NAB also has approved this program, so we expect to enroll the patients and start the first patient enrollment by the end of this year.
Speaker #2: We also plan to explore signals in additional indications, including late-line ovarian cancer and EGFR-mutant non-small cell lung cancer, as well as the neoadjuvant setting for non-squamous non-small cell lung cancer.
Speaker #2: Next. As mentioned, this is truly exciting news for us. The U.S. FDA has approved us to initiate a global Phase III study in squamous non-small cell lung cancer, following positive feedback from a recent end-of-Phase II meeting on the study protocol.
Speaker #2: China's NAP has also approved this program. Therefore, we expect to enroll the patients and start the first patient enrollment by the end of this year.
Speaker #2: The Phase III trial will be a global MRCT enrolling about 600 patients across China, Japan, the US, Canada, the EU, the UK, and other countries. It will evaluate IBI 363 in clinical practice as a monotherapy versus docetaxel, the standard of care for patients with squamous non-small cell lung cancer who have progressed after PD-1 or PD-L1 treatment.
Hui Zhou: This phase III trial will be a global MRCT enrolling about 600 patients across China, Japan, US, Canada, EU, and the UK, and other countries. It will evaluate IBI-363 as a swimming pathway as a monotherapy versus docetaxel, the current standard of care for patients with squamous non-small cell lung cancer who have progressed after PD-1 or PD-L1 treatment. The primary endpoint is overall survival. This milestone marks IBI-363's first global phase III study. If successful, it has the potential to deliver transformative treatment to patients with squamous non-small cell lung cancer worldwide. It also represents a significant achievement in Innovent's global innovation strategy. Next, please. Next, I want to highlight IBI-343, our novel TOPO-1 inhibitor clotting 18.2 ADC. The phase III study in gastric cancer has been ongoing since 2024. Importantly, IBI-343 has demonstrated a distinct advantage in treating pancreatic cancer.
Speaker #2: The primary endpoint is overall survival. This milestone marks IBI 363 as the first global Phase III study. If successful, it has the potential to deliver transformative treatment to patients with squamous non-small cell lung cancer worldwide.
Speaker #2: It also represents a significant achievement in Innovent's global innovation strategy. Next, I want to highlight IBI 363 and IBI 343, our novel topo II inhibitor, and Clotting 18.2 ADC.
Speaker #2: The Phase III study in gastric cancer has been ongoing since 2024. Importantly, IBI 343 has demonstrated a distinct advantage in treating pancreatic cancer. Following the article POC data release, we initiated a Phase III trial in third-line PDAC.
Hui Zhou: Following the ASCO POC data release, we initiated a phase III trial in third-line PDAC, marking it the first ADC globally to enter into registration in this challenging indication. We also plan a global phase III study in second-line PDAC, pending regulatory discussion with FDA later this year. Additionally, we are exploring its combination therapy in a phase IB trial for first-line PDAC treatment. Next, please. IBI-354 is our novel HER2 ADC, developing using our in-house SOLOTEC platform. Previously with higher potency and low toxicity, this year, we began a phase III trial in plasma-resistant ovarian cancer for this molecule. It's also under phase IB development for HER2 positive breast cancer. Next, please. This page highlights our next-generation bispecific ADC, IBI-3001, a global first-in-class EGFR B7H3 bispecific ADC, leveraging dual-targeted signage to cover multiple high-potential tumor types.
Speaker #2: We are proud to mark it as the first ADC globally to enter into registration in this challenging indication. We also plan a global Phase III study in second-line PDAC.
Speaker #2: Pending regulatory discussion with the FDA later this year. Additionally, we are exploring its combination therapy in a Phase IB trial for first-line PDAC treatment.
Speaker #2: Next, please. IBI 354 is our novel HER2 ADC, developed using our in-house Solo tech platform. It demonstrates higher potency and low toxicity. This year, we began a Phase III trial in platinum-resistant ovarian cancer for this molecule.
Speaker #2: It is also in phase IB development for HER2-positive breast cancer. Next, please. This page highlights our next-generation bispecific ADC, IBI 301, a global first-in-class EGFR B73 bispecific ADC.
Speaker #2: Leveraging dual target 17 to cover multiple high-potential tumor types, IBI 301 is currently in dose escalation in a global MRCT Phase I study.
Hui Zhou: IBI-3001 is currently in dose escalation in a global MRCT phase I study, with patient recruitment in the US also underway since early this year. Preliminary signals have already been observed, and we will continue to gather more data. Next. This page shows our next-generation dual-payload ADC. IBI-3020 is our first dual-payload ADC developed from a dual-tax platform designed with two types of payload aiming to overcome the resistance and prolong the duration of benefits while maintaining low toxicity with optimized linker stability. IBI-3020 is in dose escalation stage in an MRCT phase I study. It's observed some preliminary encouraging signals. We will continue to gather more data. Next. Next is about IBI-303, is a global potential best-in-class tri-specific ADC targeting GPIC 5D B7A CD3. It is also in dose escalation stage in an MRCT phase I study in China and Australia.
Speaker #2: With patient recruitment in the U.S. also underway since early this year, a preliminary signal has already been observed. We will continue to gather more data.
Speaker #2: Next. This page shows our next-generation dual payload ADC. IBI 3020 is our first dual payload ADC developed from a dual tech platform designed with two types of payloads aiming to overcome resistance and prolong the duration of benefits.
Speaker #2: While maintaining low toxicity with optimized linker stability, IBI 3020 is in the dose escalation stage in a MRCT Phase I study. We've observed some preliminary encouraging signals.
Speaker #2: We will continue to gather more data. Next is about IBI 303, a global potential best-in-class trial-specific ADC targeting GPRC5D, B7A, and CD3. It is also in the dose escalation stage in an MRCT phase I study in China and Australia.
Speaker #2: As shown here, patient case achieved very good partial response within short circle of treatment. Next. To summarize oncology pipeline upcoming milestone this year, we will continue to broaden indication for PD-1, cornerstone target.
Hui Zhou: As shown here, patient cases achieve very good partial response within a short circle of treatment. Next. To summarize, oncology pipeline upcoming milestone this year, we will continue to broaden indication for PD-1, cornerstone, and Tyver. Our IL-plus ADC strategy is taking shape with the delivering of differentiated value and advantage as we launch registration studies for IBI-363, IBI-343, and others to support global launch and sustainable growth. Furthermore, we will focus on gathering more POC studies for IBI-363 and IBI-343's new indication as listed here. We will also advance the novel bispecific ADC, dual-payload ADC, and the CD3-based therapies through phase I MRCT study. Moving forward, we will prioritize global R&D by conducting MRCT trials in China, US, and other regions. Our ongoing pipeline will support our goal of having five assets in MRCT stage by 2030. Next, I will hand over to Dr.
Speaker #2: Our IL plus ADC strategy is taking shape with the delivery of differential value and advantage as we launch the registration study for IBI 363 and IBI 343, along with others to support the global launch and September growth.
Speaker #2: Furthermore, we will focus on gathering more POC study for IBI 363 and IBI 343 for the new indication as listed here. We will also advance novel bispecific ADC, dual-payload ADC, and the CD3-based therapies, along with the slow phase I MRCT study.
Speaker #2: Moving forward, we will prioritize global R&D by conducting MRCT trials in China, the U.S., and other regions. Our ongoing pipeline will support our goal of five assets in MRCT stage by 2023.
Speaker #2: Next, I will hand over to Dr. Chen, who will talk about the general biomedicine pipeline.
Hui Zhou: Qian, who will talk about the general biomedicine pipeline.
Speaker #4: Okay. Thank you, Hui. In the next part, I will introduce the progression of general biomedicine. And next slide, please. In this slide, it's an overview of the strategy of our general biomedicine portfolio.
Lei Qian: Okay. Thank you, Hui Zhou. And in the next part, I will introduce the progression of general biomedicine. And next slide, please. Yeah. In this slide, it's a highly overview of the strategy of our general biomedicine portfolio. Our CVM pipeline is designed to target the most prevalent cardiovascular diseases and also obesity-related conditions. It consists of several cornerstone assets like Mesotide P6K9 inhibitor for hyperlipidemia, or excise for hyperuricemia, and ADT SRNA for hypertension, and also next-generation of GLP-1-based assets for obesity-related conditions. Our autoimmune pipeline focuses on addressing unmet medical needs in dermatology and rheumatology areas, anchored by the best-in-class IL-23 p19 monoclonal antibody counterpart, and also followed by the next wave of innovation exploring global development opportunities such as OX40 ligand, CD40 ligand, and TSLP IL-4 receptor bispecific antibody, etc.
Speaker #4: Our CVM pipeline is designed to target the most prevalent cardiovascular diseases and also obesity-related conditions. It consists of several cornerstone assets like mesotype, a PCSK9 inhibitor for hyperlipidemia, Excite for hyperuricemia, and ADT SNA for hypertension.
Speaker #4: And also the next generation of GLP-1-based assets for obesity-related conditions. Our autoimmune pipeline focuses on addressing unmet medical needs in dermatology and rheumatology areas, anchored by the best-in-class IL-23 P19 monoclonal antibody. This is a concrete part, followed by the next wave of innovation exploring global development opportunities such as OX-40 ligand, CD40 ligand, and TSLP IL-4 receptor bispecific antibody.
Speaker #4: Of the knowledge pipeline still is built on specific antibodies with differentiated modes of action, including VEGF complement protein alongside other bispecific antibodies in clinical and preclinical stages.
Lei Qian: Our ophthalmology pipeline still is built on specific antibodies with differentiated mode of action, including VEGF complement protein alongside with other bispecific antibodies in clinical and preclinical stages. Next slide, please. Mesotide stands as the cornerstone product in CVM. It has already entered seven phase III studies and a series of new phase II studies covering some segmented indications such as heart failure, MAFUD, OSA, and MASH. In the second half of this year, we expect Mesotide to receive approval for a second indication in type 2 diabetes. Dream Street, the head-to-head study phase III trial for Mesotide with semaglutide assets without results, potentially demonstrating Mesotide's superiority on dual benefits in weight loss and blood glucose control. Another phase III trial, GLORY-2, will not make dose Mesotide, but also without support long-term weight management evidence for moderate to severe obesity.
Speaker #4: Next slide, please. Mesotypes stands as the cornerstone product in CVM. It has already entered seven Phase III studies and a series of new Phase II studies.
Speaker #4: Covering segmented indications such as heart failure, matured OSA, and MASH. In the second half of this year, we expect mesotypes to receive approval for a second indication in type 2 diabetes.
Speaker #4: Dream 3. The head-to-head study phase III trial for mesotypes with semaglutide assets is ongoing, without results. It potentially demonstrates mesotypes' superiority in terms of dual benefits in weight loss and blood glucose control.
Speaker #4: Another Phase III trial, GLORY2, for the NAMIC dose mesotypes will also support long-term weight management evidence for moderate to severe obesity. We will also gather data for a Phase I study in adolescents with obesity and initiate new Phase III studies in this population.
Lei Qian: We will also reroute data for phase I study in adolescents with obesity and initiate new phase III studies in this population, where currently no GLP-1 medicine is approved in China. Next slide, please. This slide shows our best-in-class exoI inhibitor TIPSTAT. Different than URAD inhibitors, exoI prevents the production of uric acid at upstream so that there won't be any cost-safety concerns in vitro. This first half, we have finished the phase II studies seeing excellent results for the hyperuricemia associated with GOT, with early onset, superior efficacy over PEPSTAT, and clean safety profiles and good tolerability. The phase II study will be presented in the coming academic conferences APILA in September. We will advance this promising pipeline into phase III stage, making it the only new exoI medicine in registration studies in China. Next slide, please.
Speaker #4: We are currently no GLP-1 medicine approved in China. Next slide, please. This slide shows our best-in-class Exo I inhibitor, TxTAT. Different from URED inhibitors, Exo I prevents the production of uric acid upstream.
Speaker #4: So that there won't be any false safety concerns in renal. This first half, we have finished the Phase II studies, and we have excellent results for the hyperuricemia.
Speaker #4: Associated with GOT, with early onset, superior efficacy over PEFSTAT, and clean safety profiles, as well as good tolerability. The phase II study will be presented at the upcoming academic conferences in September.
Speaker #4: We will advance this promising pipeline into Phase III stage, making it the only new exo I medicine in registration studies in China. Next slide, please.
Speaker #4: IBI 3032 is our in-house oral small molecule GLP-1 receptor agonist, with a bias for the CMP signaling pathway. Preclinical data demonstrate its superior pharmacokinetic and physicochemical properties compared with peer compounds.
Lei Qian: IBI-3032 is our in-house ROS1 molecule GLP-1 receptor agonist with bias for CAMP signaling pathway. Preclinical data demonstrates its superior decay and physicochemical properties compared with peer compounds. In animal models, this asset achieved 5 to 10 times higher ROS exposure at the equivalent dosage, with improved efficacy and good tolerability in both mice and obese monkey models, achieving comparable therapeutic effects at lower doses. We have received US FDA R&D approval for the phase I study, and we'll start the trial in China and the US soon. We plan to get initial data from phase I study around the end of this year. Next slide, please. In the autoimmune field, the counterpart is unexpected to receive its first indication approval for cirrhosis indication around the end of this year.
Speaker #4: In animal models, this asset achieved 5 to 10 times higher oral exposure at the equivalent dosage, with improved efficacy and good tolerability in both mice and obese monkey models.
Speaker #4: Achieving comparable therapeutic effects at a lower dosage. We have received U.S. FDA R&D approval for the Phase I study and will start the trial in China and the U.S. soon.
Speaker #4: We plan to get initial data from the Phase I study around the end of this year. Next slide, please. In the autoimmune field, Concrete is expected to receive its first indication approval for the thyrosis indication around the end of this year.
Speaker #4: As outlined in this slide, we have developed a series of clinical studies to generate robust evidence supporting Concrete's distinct advantage in thyrosis.
Lei Qian: As outlined in these slides, we have developed a series of clinical studies to generate robust evidence supporting counterpart's distinct advantage in cirrhosis. The first phase III study, CLIER-1, demonstrated the counterpart is the only IL-23 p19 monoclonal antibody that achieves over 80% of pathogen negative response at week 16. This data underscores its key benefits: rapid onset of action, durable efficacy, and convenient quarterly dosing. Results from our recently completed phase III study, CLIER-2, further highlight its strength. 63% of patients maintained an SPGA score of 0 or 1 even after six months of treatment withdrawal. In contrast, the IL-17 inhibitor class only achieved around a 15% maintenance rate in comparable settings. These significant differences confirm counterpart's superiority performance in enabling durable remission and reducing relapse rate.
Speaker #4: The first Phase III study, CLEAR ONE, demonstrated that Concretin is the only IL-23 P19 monoclonal antibody that achieves over 80% PASI 90 response at week 16.
Speaker #4: This data underscores its key benefits: rapid onset of action, durable efficacy, and convenient quarterly dosing. Results from our recently completed Phase III study, CLEAR 2, support these findings.
Speaker #4: Further highlights its strength: 63% of patients maintained an SPGA score of zero or one even after six months of treatment withdrawal. In contrast, the IL-17 inhibitor class only achieved around a 15% maintenance rate.
Speaker #4: In a comparable setting, these significant differences confirm the concrete part's superiority in enabling durable remission and reducing the relapse rate. Another Phase II study shows the concrete part still has a 65% response rate.
Lei Qian: Another phase II study shows counterpart still has a 65% response rate in cirrhosis patients who have been treated with IL-17 inhibitors but experienced inadequate response. These findings indicate that the drug's potential to address unmet needs in the IL-17 refractory population, and we also initiate a phase III trial in this population. Furthermore, new studies for PSA and adolescents with cirrhosis are planned to start in the near future, building a pipeline in a product like counterpart. These slides show our novel immunology assets as the next generation. IBI-356 targets OX40 ligand, which is the key driver for type 2 inflammation. Based on the preliminary phase I studies resulting in a potted dermatitis, IBI-356 has shown robust efficacy with an extended dosing interval of every four weeks, compared with current treatment DUPIXENT, which is dosed every only two weeks.
Speaker #4: In thyrosis patients who have been treated with IL-17 inhibitors but experienced inadequate response, this finding indicated the drug's potential to address unmet needs in the IL-17 refractory population. We will also initiate a Phase III trial.
Speaker #4: In this population. Furthermore, new studies for PSA and adolescents with thyrosis are planned to start in the near future. Building a pipeline in a product like concrete part.
Speaker #4: This slide shows our novel immunology assets as the next generation. IBI-356 targets OX-40 ligand, which is a key driver for type 2 inflammation.
Speaker #4: Based on the preliminary Phase I study results in positive dermatitis, IBI 356 has shown robust efficacy with an extended dosing interval of every four weeks compared with the current treatment Dupixent, which is dosed every two weeks.
Speaker #4: We plan to explore every eight-week or twelve-week sub-Q dosing interval in the coming Phase II studies to further investigate its differentiated potential in a positive dermatitis indication, etc.
Lei Qian: We plan to explore every eight weeks or q.12 weeks sub-q dosing interval in the coming phase II studies to further explore its differentiated potential in a potted dermatitis indication, etc. We are also fighting R&D with the US FDA to initiate development in the US later this year. IBI-3002 is another first-in-class immunology molecule that simultaneously inhibits IL-4 receptor alpha and TSLP. It potentially offers deeper remission for type 2 inflammation-driven diseases like asthma or COPD. In the coming phase I study, we have observed preliminary efficacy signals in terms of significant and sustainable phenol reduction and substantial and durable peripheral blood COC neutrophil level reduction and lung function improvement. We will continue gathering data from phase I studies. In these slides, I want to summarize the general biomedicine pipeline's coming milestones.
Speaker #4: We are also fighting R&D to the U.S. FDA to initiate development in the U.S. later this year. IBI 302 is another best-in-class immunology molecule that simultaneously inhibits the IL-4 receptor alpha and TSLP.
Speaker #4: It potentially offers deeper remission for type 2 inflammation-driven diseases like asthma or COPD. In the coming phase I study, we have observed a preliminary efficacy signal in terms of significant and sustainable phenol reduction, substantial and durable peripheral blood ELC neutrophil level reduction, and lung function improvements.
Speaker #4: We will continue gathering data from the Phase I study. In this slide, I want to summarize the general biomedicine pipeline and coming milestones. We will continue to advance our cornerstone assets mesotypes.
Lei Qian: We will continue to advance our cornerstone assets Mesotide, ZYCUMI, and the counterpart across their therapeutic areas through indication expansion. With additional phase III and new studies planned to reroute or start later this year, we will also reroute positive phase II data for TIPSTAT and will enter phase III in hyperuricemia in GOT later this year. Meanwhile, our next wave of novel assets is beginning to generate clinical data for further development, including global opportunities. We could potentially move new molecules into proof of concept platforms such as OX40 ligand for AD and TSLP IL-4 for asthma. We are continuing to gather more phase I data for programs such as CD40 ligand for TSS and also ROS GLP-1 for weight loss. With that, I will hand it over to our CFO, Rui Zhou.
Speaker #4: The coming and the concrete part across their therapeutic areas through indication expansion, with additional Phase III and new studies planned to start later this year.
Speaker #4: We will also have positive Phase II data for TxTAT and will enter Phase III in hyperuricemia in GOT later this year. Meanwhile, our next wave of novel assets is beginning to generate clinical data for further development.
Speaker #4: Including global opportunities. We could potentially move new molecules into proof of concept such as OX-40 ligand for AD and TSLP IL-4 for asthma. We are continuing to gather more phase I data for programs such as CD40 ligand for TSS and also oral GLP-1 for weight loss.
Speaker #4: With that, I will hand it over to our CFO, Rachel Yu.
Speaker #3: Thank you, Dr. Chen. I will now review our company's key financial results for the first half of 2025. Total revenue increased by 50.6% year over year to $6 billion.
Speaker 6: Thank you, Dr. Qian. I will now review our company's key financial results for the first half of 2025. Total revenue increased by 50.6% year-over-year to R&B 6 billion, including strong product revenue growth of 37.3%, reaching R&B 5.2 billion. During the first half, the oncology portfolio sustained its leadership and strong growth momentum with consistent performance of major products and the rising contributions from new products. General biomedicine emerged as a new growth engine. New products such as our IGF1R ramped up very quickly through enhanced channel access and comprehensive marketing strategies. TSLK9 also ramped up very quickly after being included in the national reimbursement list. In the first half, the licensing fee income was mainly attributable to the upfront payment we received from our licensing deal with Roche.
Speaker #3: Including strong product revenue growth of 37.3%, reaching R&D spending of $5.2 billion. During the first half, the oncology portfolio sustained its leadership and demonstrated strong growth momentum.
Speaker #3: With consistent performance of major products and the rising contributions from new products, general biomedicine emerged as a new growth engine. New products such as our IGF1R ramp up very quickly through enhanced channel access and comprehensive marketing strategies.
Speaker #3: PCSK9 also ramped up very quickly after being included in the national reimbursement list. In the first half, the licensing fee income was mainly attributable to the upfront payment we received from the licensing deal with Roche.
Speaker #3: Driven by robust revenue growth and the continuously enhanced operational efficiency. In the first half, we achieved a positive and a substantial improved profitability. And an IFRS measures net profit reached R&D 1.2 billion and EBITDA reached R&D 1.4 billion.
Speaker 6: Driven by robust revenue growth and continuously enhanced operational efficiency, in the first half, we achieved a positive and substantially improved profitability. Under NIFRS measures, net profit reached R&B 1.2 billion and EBITDA reached R&B 1.4 billion. Next slide. During the year, the key financial ratios have been continuously improved. Gross profit margin increased by 2.7% to 86.8%, benefiting from product volume increase and manufacturing cost optimization. Combined sales marketing and the GNA expense ratio decreased by 7.9% to 50.9%. This is mainly driven by rapid revenue growth and the productivity improvement within the oncology portfolio. I would like to mention that in the second half, as we are launching new products including Mesotide, we anticipate additional investment for new product launches in the general biomedicine sector to take place. In the first half, R&D expenses were R&B 903 million.
Speaker #3: Next slide. During the year, the key financial ratios have been continuously improved. Gross profit margin increased by 2.7% to 86.8%, benefiting from product volume increase and manufacturing cost optimization.
Speaker #3: Combined sales, marketing, and the G&A expense ratio decreased by 7.9% to 50.9%. This is mainly driven by rapid revenue growth and productivity improvements within the oncology portfolio.
Speaker #3: I would like to mention that in the second half, as we are launching new products, including Master Type, we anticipate additional investment for new product launches in the general biomedicine sector to take place.
Speaker #3: In the first half, R&D expenses were $93 million. During the first half, we maintained our advantage of high capital efficiency and demonstrated strong execution in our R&D activities.
Speaker 6: During the first half, we maintained our advantage of high capital efficiency and demonstrated strong execution in our R&D activities. In the second half, we anticipate R&D costs could be higher as we advance our pipeline in China and internationally for more registrational studies and early-stage clinical studies. The full-year R&D budget is still within the range of US dollar 300 to 400 million this year. Lastly, as the latest date, we had a cash position of US dollar 2 billion. The strong cash position will provide a solid foundation for our long-term growth and the globalization strategy. Next slide. To summarize, the year 2025 marks a pivotal year as we transition into a new phase of dual-engine growth and global innovation, and the first half was very successful. Moving forward, Innovent will leverage our unique strengths in industry insight, strategic planning, execution, and corporate culture.
Speaker #3: In the second half, we anticipate R&D costs could be higher as we advance our pipeline in China and internationally for more registrational studies and early-stage clinical studies.
Speaker #3: The fully R&D budget is still within the range of $300 million to $400 million this year. Lastly, as of the latest date, we had a catch position of $2 billion.
Speaker #3: The strong catch position will provide a solid foundation for our long-term growth and globalization strategy. Next slide. To summarize, the year 2025 marks a pivotal year as we transition into a new phase of dual-engine growth and global innovation.
Speaker #3: And the first half was very successful. Moving forward, Innovent will leverage our unique strengths in industry insight, strategic planning, execution, and corporate culture.
Speaker #3: We will continue to reinforce our core business in China without expanding our global presence, and to become a world-class biopharmaceutical company delivering innovative therapies that are accessible and affordable to patients worldwide.
Speaker 6: We will continue to reinforce our core business in China, while expanding our global presence and to become a world-class biopharmaceutical company delivering innovative therapies that are accessible and affordable to patients worldwide. Thank you for your continuous support of Innovent. This concludes our presentation today. Now I will hand it over to Dr. Huang to open the Q&A session. Dr. Huang, please.
Speaker #3: Thank you for your continuous support of Innovent. This concludes our presentation today. Now, I will hand it over to Dr. Huang to open the Q&A session.
Speaker #3: Dr. Huang, please.
Speaker #2: Yeah, thank you very much for the excellent presentation and the results. And so, before I invite our audience to raise questions, I have kind of two questions for management.
Yang Huang: Yeah, thank you very much for the excellent presentation and the results. And so before I invite our audience to raise questions, I have kind of two questions for management. Maybe I will go ahead first. The first question is for Dr. Michael Yu. It's on the company's overall global strategy. Given we're now seeing the company's domestic business is going well, and the company has initiated a global trial for IBI-363 and is going to enroll patients soon. And I understand you already briefly mentioned the global development policy, but will you spend a little bit more time to give us a more concrete, extensive overview of your globalization plan for the next few years?
Speaker #2: Maybe I will go ahead first. First question is for Dr. Michael Yu. Is the company's overall global strategy given we're now seeing companies' domestic business is going well and the company has initiated a global trial for IBI 363 and is going to enroll patients soon.
Speaker #2: And I understand you already briefly mentioned global development policy, but will you spend a little bit more time to give us a more concrete, tangible overview of your globalization plan for the next few years?
Speaker #4: Great. Thank you. Thank you, Dr. Huang. Just as you pointed out, we currently have a total of six assets. Has there been approval for clinical study in the U.S.?
Michael Yu: Right. Thank you. Thank you, Dr. Huang. As you pointed out, we currently have a total of six assets that have been approved for clinical studies in the US, including assets for Australia and Japan and Europe. So accordingly, we need to build an experienced and capable product development team for those regions. Starting with our organization development in the US. So some of you may notice that we do have a lab in the San Francisco Bay Area. But at the same time, we are actively piloting and building the team for clinical development from medical science to clinical operations, a full range of product development. And currently, in some of the regions, including Australia and Japan, we're still using CIO.
Speaker #4: And including assets for Australia, Japan, and Europe. Accordingly, we need to build an experienced and capable product development team for those regions, starting with our organizational development in the U.S.
Speaker #4: So, some of you may notice that we do have a lab in the San Francisco Bay Area. But at the same time, we are actively piloting and building the team for clinical development.
Speaker #4: From medical science to clinical operations, we cover the full range of product development. Currently, in some regions, including Australia and Japan, we are still using CIO.
Speaker #4: But for the major market like the U.S., we are likely going to reference what we did in China, which heavily relies on in-house organization instead of CIOs.
Michael Yu: But for the major markets like the US, we likely are going to reference what we did in China, which is heavily relying on in-house organizations instead of CIOs. So Dr. Zhou Hui is going to spend lots of time in the US. And at the same time, we are building an experienced team to fulfill our goal by carrying out the clinical development for those assets already approved for clinical studies in the US. So that's the overall plan we have. But internally, for the organization we have in China, some of them will involve in the management of studies outside of China. So we recently just reorganized our clinical operations team to cover some of the countries, including those I mentioned to you earlier. Yeah. That's our current plan.
Speaker #4: So, Dr. Zhou Hui is going to spend a lot of time in the U.S. At the same time, we are building an experienced team to fulfill our goal by carrying out the clinical development for those assets already approved for clinical study in the U.S.
Speaker #4: So, that's the overall plan we have. But internally, for that, the organization we have in China, and some of them will be involved in the management of studies outside of China.
Speaker #4: So we recently reorganized our clinical operation team to cover some of the countries, including those I mentioned to you earlier. Yeah, that's our current plan.
Speaker #2: Thank you. Thank you, Dr. Yu. That's great to hear. And my next question is for Dr. Zhou Hui. We understand IBI 363 is one of the most important assets right now for the company.
Yang Huang: Thank you. Thank you, Dr. Yu. That's great to hear. And my next question is for Dr. Zhou Hui. And we understand IBI-363 is one of the most important assets right now for the company. So can you quickly remind us the most updated clinical development strategy for 363? And maybe more importantly, what's the next data reroute plan for this asset for the next six to 12 months?
Speaker #2: So, can you quickly remind us of the most updated clinical development strategy for 363? And maybe more importantly, what's the next data readout plan for this asset for the next six to twelve months?
Speaker #4: Thanks for the question. Yeah. Okay. So, as you may recall from our R&D Day and today, we presented the overall strategy for IBI 363. So, the first wave for us focused on the IL-resistant population and cold tumors.
Hui Zhou: Thanks for the question. Yeah. Okay. So as you may recall from our R&D day, and today also we presented the overall strategy for IBI-363. So the first wave for us focuses on IL-resistant population and co-tumor. So this is our first wave. So that's why we have three oral presentations at this ASCO. And we already initiated two pivotal studies: one in melanoma, the other IL-resistant squamous non-small cell lung cancer. And then followed by the third, the pivotal study, which will be in third line above colorectal cancer. So this is our first wave, followed by actually the positive POC results. And then you may also care about the second wave and above. So we also share with you. So now we are focusing from late line to front line. So we already initiated the evaluation for first-line lung and the first-line CRC.
Speaker #4: So this is our first wave. That's why we have three oral presentations on this article, and we have already initiated two pivotal studies: one in melanoma and the other in IL-resistant squamous non-small cell lung cancer. This will be followed by the third pivotal study, which will be in third-line treatment for colorectal cancer.
Speaker #4: So this is our first wave, followed by actually the positive POC results. And then you may also care about the second wave and above.
Speaker #4: So we also share with you, so now we are focusing from late line to front line. We have already initiated the evaluation for first-line lung and the first-line CRC.
Speaker #4: But as you know, IBI 363 is a first-in-class. So we are facing a different population from PD-1. That means PD-1 only has the IL-9 population, but from the beginning, we actually started with the IL-resistant and cold tumor or the late-line population.
Hui Zhou: But as you know, IBI-363 is a first-in-class. So we are facing different populations from PD-1. So that means PD-1 only IL-9 populations. But from the beginning, actually, we started from IL-resistant and co-tumor or the late line population. And then when we move into the first line, we also needed to evaluate the dose, because of the different potential mechanisms. So that means we need to take some time to identify the dose first in first line. And then we will have the, actually, we have ongoing the POC study. So anticipated will be reroute next year. And in the meantime, also, we are moving forward for other indications, as we mentioned or announced, for ovarian cancer, EGF mutant non-small cell lung cancer. And even in the meantime, we evaluate the potential in new adjuvant settings.
Speaker #4: And then when we move into the first line, we also needed to evaluate the dose. So because of the different potential mechanisms, that means we need to take some time to identify the dose first in the first line, and then we will have the ongoing POC study.
Speaker #4: So, anticipated will be laid out next year. In the meantime, we are also moving forward for other indications. As we mentioned or announced, this includes ovarian cancer, EGFR mutant non-small cell lung cancer, and we are even evaluating the potential in the new adjuvant setting.
Speaker #4: So all those we are moving forward and will be read out if we have mature data and share with you later. Thank you.
Hui Zhou: So all those, we are moving forward and will be reroute if we have mature data and share with you later. Thank you.
Speaker #2: Thank you, Dr. Zhou Hui. And now I will see and we'll see we can I can see we have a lot of people raising hands.
Yang Huang: Thank you, Dr. Zhou Hui. And now I will see, I can see we have a lot of people raising hands. So first, I will get to maybe to Yi Chen. Can you unmute yourself or we'll unmute you?
Speaker #2: So, first I will get to maybe Zhichen. Can you unmute yourself, or will I unmute you?
Speaker #5: Yeah, sure. Thank you, Dr. Huang, and thank you, management, for giving me the opportunity to raise questions. Just to follow up on what Dr. Zhou just mentioned about the two new Phase II studies the company initiated on IBI 363.
Speaker 8: Yeah, sure. Thank you, Dr. Huang, and thank you, management, for giving me the opportunity to raise questions. Just to follow up to what Dr. Zhou just mentioned about the two new phase II studies our company has initiated on IBI-363. One is on ovarian cancer, primary peritoneal, and also fallopian tube cancers. And the other one, we are moving to a new adjuvant setting for non-squamous non-small cell lung cancer. And also, you come up with a pretty interesting dose, right? For the new adjuvant, you have a 1.5 milligram per kilo. But for the second line, I think you're using a 3 milligram per kilogram. So I'm thinking about, number one, is what kind of data coming from the phase I study that gives you confidence to move the route into the new adjuvant before you get meaningful data from the first-line setting?
Speaker #5: One is on ovarian cancer, primary peritoneal, and also fallopian tube cancers. The other one is moving to a new adjuvant setting for non-squamous, non-small cell lung cancer.
Speaker #5: And also, you came up with a pretty interesting dose, right? For the new adjuvant, you have 1.5 milligrams per kilogram. But for the second line, I think you’re using 3 milligrams per kilogram.
Speaker #5: So I'm thinking about number one: what kind of data coming from the Phase I study gives you confidence to move the route into the new adjuvant?
Speaker #5: Before you can you get meaningful data from the first line setting. And also any signal that you observed in the phase I study that give you the confidence to move into ovarian cancer and particularly this later line PARP treated GBRITE communication patients and also the FR alpha ADC treated population.
Speaker 8: And also, any signal that you observed in the phase I study that gives you the confidence to move into ovarian cancer, and particularly this later line, PARP-treated GBRCA mutation patients and also the FR-alpha ADC-treated population. So we're trying to get a sense on that. My second question is regarding another very important asset for you, Mesotide. And we understand that we have already seen, I believe, a lot of investors are also seeing a lot of the user-facing marketing events from news and social media. And also, if you're walking in some of the major cities, you're going to see some advertisements. So I think this is very differentiated compared to semaglutide compared to tadalafil in their marketing strategy in China. We're trying to understand what has been the initial feedback for this kind of very extensive marketing events.
Speaker #5: So, you know we're trying to get a sense on that. My second question is regarding another very important asset for you as a mesotype. We understand that we have already seen, I believe, a lot of investors are also seeing a lot of the user-facing marketing events.
Speaker #5: You know from news, social media, and also if you're walking in some of the major cities, you're going to see some of the enticements.
Speaker #5: So, I think this is very differentiated compared to semaglutide and tezepatide, particularly concerning their marketing strategy in China. We're trying to understand what has been the initial feedback for this kind of very extensive marketing events.
Speaker #5: And also, since the launch, what has been the sales performance, and is there any full-year expectation that the company can potentially provide to the investors?
Speaker 8: And also, since the launch, what has been the sales performance? And is there any full-year expectation that the company can potentially give to the investors? Thank you.
Speaker #5: Thank you.
Speaker #4: Thank you, Zhi. So, yeah, the first question goes to Zhou Hui.
Yang Huang: Thank you, Zi. So yeah, first question goes to Zhou Hui. And the second one is going to be Rui Zhou, right? Yeah.
Speaker #2: And the second one is going to be Rachel, right? Yeah.
Speaker #4: Okay.
Hui Zhou: Okay. Okay. Thank you, Zi. You bring a great question for us. So mainly focus on the dose selection. So as I mentioned that for IL-resistant and late line, so we believe that this is a different population with bronchial. So we have a separate dose optimization study for different populations. For IL-resistant, we can compare two different dose levels. And then finally, based on the benefit and risk justification, so we pick up three mixed packets. And also, we present all the data with FDA and get endorsement for three mixed packets as a pivotal study dose level. And you mentioned that so for new adjuvants, so that means that actually we already generate safety run-in data in first-line lung and first-line CRC. And based on what our understanding and also the data that we already observed, that I share with you, so the mechanism is totally different.
Speaker #2: Okay, thank you, Zhi. You bring up a great question for us. So, mainly focusing on the dose selection. As I mentioned, for IL-resistant and the late line, we believe that this is a different population from the front line.
Speaker #2: So we have a separate dose optimization study for different populations for IL-resistant. We compare different dose levels and then, finally, based on the benefit and risk justification.
Speaker #2: So we picked up three meat pockets, and we also presented all the data to the FDA and received endorsement for three meat pockets as a pivotal study dose level.
Speaker #2: And you mentioned that. So for new adjuvant, that means we have already generated safety-running data in first-line lung and the first-line CRC.
Speaker #2: Based on our understanding and the data we have already observed, as I shared with you, the mechanisms are totally different.
Speaker #2: And that means we may not need the high dose level for front line. And so that's why we picked the lower dose for the front line, as well as for the new adjuvant setting.
Hui Zhou: And that means we don't need the high dose level for our front line. And so that's why.We
Speaker 1: pick up the lower dose for the front line and, as well as new adjuvant setting. So, everything is based on the data generated and moved ahead. So, for new adjuvant, because of the potential landscape change, so for especially for checkmate ATC-16, so new adjuvant alone can, generate all the long-term EFS, even survival benefit for the patients. And our, the benefits, we already observed in monotherapy and also already we have generated the CT data. So, put together, we want to also, generate a POC data new in new adjuvant setting. And regarding ovarian cancer, yes, we also, based on the data, we generated in monotherapy for ovarian cancer, we observed, quite encouraging signal for ovarian cancer, which actually is the co-tumor.
Speaker #2: So everything is based on the data generated and we move ahead. So for the new adjuvant, because of the potential landscape change, especially for Checkmate HC16.
Speaker #2: So, new adjuvant alone can generate long-term EFS and even survival benefits for the patients. The benefits we have already observed in monotherapy, and we have also generated the safety data.
Speaker 1: So, based on, the monotherapy data for ovarian cancer and also, the, the landscape potential change, so, we, combined with Bavsumab for this setting to see the combo if they have more synergy, just like as CRC. Actually, CRC data, we already also disclosed that the benefit additional, to mono, when we combo with Bavsumab, there will be more additional benefit. So, put all information together, so we move forward for combo for ovarian cancer. So, thank you.
Yang Huang: Let me show.
Rachel Yu: Yes. Yes, thanks, Michael. And thanks for your questions about mesotide's commercialization strategy and also, you know, the initial launch performance. so, mesotide was approved in late June, and we start our commercialization activities in early July. You know, so the time period is still pretty short, you know, to provide a more holistic view. but, we would provide you two important strategic imperatives, you know, when we plan for the mesotide launch. the first one is really to raise the awareness of weight management in the society and to build our brand equity through a very strong clinical profile. Mesotide's fuel mechanism delivers not only significant weight loss, but also a more than 80% reduction in liver fat and also offers very comprehensive metabolic benefits.
Rachel Yu: And these are the key things that we would like to emphasize, you know, in front of our key customers to really demonstrate the uniqueness of mesotide. And meanwhile, we also hope to build a very positive customer perceptions, recognition, and experience when they use this product. So, this is the first thing that we would really focus to do, you know, at the initial launch. And the second thing is we really want to ensure, a really good product accessibility, you know, by a very holistic channel coverage. we have a dedicated team, covering hospital channels, and we actually have another team, to cover retail channels. We are actively expanding into some innovative channels like online platforms and retail pharmacies and also some private hospitals and clinics. through some of the strategic partnerships that you may already be aware of.
Rachel Yu: all these partners will help us extend the reach of the product and improve the patient experience. So, the aim is to jointly create a healthy ecosystem, you know, for the Chinese patient to manage their weight. So, although it's still in a pretty early stage, of our launch, the market and also the initial user feedback so far has been very positive. it actually confirmed that our initial brand positioning and also the channel strategy really worked. the initial sales trend actually is very in line with our internal expectation. So, going forward, we will continue strengthening the brand equity. And in addition to our current strategy, we expect some new indications and also strong data readouts in the next couple of months. The evidence will further reinforce mesotide's strong clinical profile as an innovative and trusted treatment option in weight management. Thank you.
Yang Huang: Thank you, Rachel, and thank you, Dr. Zhou. Thank you.
Hui Zhou: Next, we'll have a Lomping Zhou. Please unmute yourself.
Speaker 1: Thank you. Thank you for taking my question and congratulate on the good results. So, maybe I have two questions. First one for Rachel, and do we have 2025 guidance for the four-year sales and earnings given the very strong first half results? And yeah, and this is the first one. Thank you.
Yang Huang: Rachel, please.
Rachel Yu: Okay, thank you, Michael. Thank you, Lomping, for your question. You know, we have not provided specific guidance, but you can see we actually, you know, achieved a very strong first half performance. So, with that, I think we're very confident to achieve our full-year revenue targets. And also, we maintain our 2027 revenue target in China of 20 billion RMB. If you look at our cost and expense side, you can see, you know, we actually manage our R&D spending and the sales marketing spending on an annual basis. So, looking at the first half, you know, the R&D expense was about like 900 million RMB, but we anticipate the R&D expense in the second half will be higher compared to the first half. There are a couple of reasons.
Rachel Yu: First one, you know, we are planning to advance our leading pipeline assets, including 363 and the 343, into the registrational trial in China and in the global market. And secondly, we do have a few ongoing phase three studies for MaxDuTai, AgF1R, and IL-23. And we're also planning to advance our XOI into phase three trial in the second half this year. And the third one is that for a few early-stage molecules, we're also planning to start patient enrollment in the US in the second half this year. So, that's why, you know, the second half R&D expense could be higher compared to the first half. But overall, I think the full-year R&D budget will remain within the range of US dollar 300 to 400 million.
Rachel Yu: And looking at the sales marketing and the GNA expense ratio, I think the lower ratio in the first half was primarily attributable to the continued efficiency improvement within our oncology portfolio. In the second half, I think we anticipate increasing our investment to support our multi-channel strategy following the launch of MaxDuTai. And also, we will have pre-launch investment related to our IL-23 in the second half. So, overall, I think the sales GNA ratio in the second half could be higher compared to the first half. So, overall, if you look at the profitability, I think, you know, earlier this year, we anticipate, you know, even excluding the US dollar 80 million absorbent from Roche, we should be able to achieve NIFRS EBITDA break even.
Rachel Yu: But with the very strong first half performance, we are very confident to achieve better than expected profitability as compared to the goal we set at the beginning of this year.
Speaker 1: Thank you. And maybe I had another question for Dr. Chen Lei and on our Orajio Q1. We're very glad to see our candidate to enter into clinical stage and we know that ofagliptom demonstrated a very good safety profile but not that good efficacy, which leaves room for us to be a better product. And you mentioned the drug exposure is around five to ten times compared to ofagliptom. So, could you please give us more details of your profile of the Orajio Q1 and its clinical development plan? Thank you.
Lei Qian: Thank you. Thank you for your question. So, besides the higher exposure compared with ofagliptom, actually, it's T half life. It's almost doubled compared with ofagliptom in our animal models, which gives us more confidence and actually more space to optimize the penetration algorithm in clinical stage. And we have confidence that which will help us generate more robust efficacy data. And also, the ofagliptom scaffold will help us to keep our privilege from the safety perspective. And for this, I think actually it's a good fit for complementary injectables like the maintenance, what we call it a sequence maintenance therapy after injection introduction. And also, we observe there's potentially differentiated indications such as hypertension and OSOM, especially when considering it could be makeup as a fixed dose combination with other oral agents. So, it highlights its huge potential.
Lei Qian: Currently, we have received the US IND approval, and we will quickly start the phase one studies in parallel both in US and China in the second half of this year. And we are quite optimistic that at the end of this year, we will have some preliminary observations in clinical stage. Thank you.
Yang Huang: Thank you. Thank you. Thank you for the details. Thank you.
Hui Zhou: Thank you. Next, let's have Chen Chen.
Speaker 6: Thanks, Dr. Huang. Thanks, management, for taking my questions. My first question, I think, is for Dr. Zhou. So, regarding your oncology pipeline, in addition to the promising late stage candidates such as 363 and 343, we also see multiple phase one and preclinical candidates in the pipeline such as ADC, bispecific ADC, dual-payload ADC, and bispecific dual-payload ADC, and trispecific antibody. Well, may we know which assets have the highest priority and what clinical data can we expect in the next 6 to 12 months? Secondly, we also noticed that, well, there are multiple products successfully passing the formality review for NRDL negotiation. So, can management please elaborate a bit more on your NRDL strategy, your expectation for their price cut, and also a commercial strategy for this product post their NRDL inclusion? Thank you.
My first question I think is for Dr. Joe so regarding your oncology pipeline, in addition to the promising late stage candidates such as 363 and 343. We also see multiple fifth 1 and pre-clinical candidates in the pipeline uh, such as ADC by specific ADC. A dual payload ADC and by specific deal, period, ADC and the choice specific antibody.
Well, may we know which assets have the highest priority and what clinical data can we expect in the next 6 to 12 months?
Products successfully passing the format should we view the negotiation. So can management. Please elaborate a bit more on your the al strategy your expectation for the price cuts and also the commercial strategy for this product posted at the elite pollution.
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Yang Huang: Okay. The first one goes to Zhou Hui, right? And the second one, Rachel.
Right and the second one ratio.
Okay.
Speaker 1: Okay. Thank you, Chen Chen, for the question. So, yes, actually, we have several ongoing phase one studies for the ADC, what you mentioned. So, currently, our key focus is bispecific ADC and dual-payload ADC. And the bispecific ADC, EGFR B73, actually is our first bispecific ADC, which shares the same platform with IBS 343, so the same platform. And we already also introduced the status. We have already observed encouraging signal for this molecule. And now, we are more quickly currently in the potential dose optimization as a next stage. And this study also includes US, Australia, and China in one phase one study. And the other will be the dual-payload. So, the key focus is more quickly to validate the dual-payload platform. So, that's why 30, 20, as you know, we completed the first phase one within only two weeks after we got IND in China.
Thank you for the question so yes.
Hi.
We have several ongoing phase one study for the ADC.
You mentioned.
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Speaker 1: And now, the overall dose escalation is smoothly. Now, we are already at the higher dose level. So, everything is within our expectation. So, we will share with you more about the status once we have completed the dose escalation and when we have such kind of data. And the other I also would like to highlight is our trispecific. So, this trispecific, we position it as we want to achieve even similar efficacy as CAR-T. So, as you know, CAR-T almost have 50% of C, almost 90% of response rate. So, this actually will set a similar bar as CAR-T. And also, currently globally only in Jianjin, actually, they disclosed very encouraging data. But also, we compare our data with Jianjin's data, especially for the patients post the BCMA and the GPRC5D for these highly unmet medical needs patients.
So.
Everything is within our expectation so we will share with you more.
More about that state tests once we have completed.
Those excitation and Huawei have such kind of data.
And the other I would also like to highlight is our <unk> specific so as they try specific till we position it.
Yes.
We want to achieve even similar efficacy as Scott so as you'll know catchy almost of that.
50% of almost 90% of our response rate. So this actually was set has seen similar by car T and also kind of globally on a gen James actually the discos.
In kinds of data, but also a way I can pair our data with Tianjin data, especially for the patient posted a visa and they ended <unk> for this highly unmet medical needs patients and also at <unk> for this kind of patient potential weekend.
Speaker 1: And also, actually, for this kind of patient, potentially, we can have a fast launch opportunity. So, currently, also more quickly now, we are in dose optimization stage for this molecule. So, also, we will share with you more data in later, so in the academic conference. Okay, I think this is a brief introduction about our the other encouraging molecules with you. Thank you.
Faster larger opportunity. So currently also more quickly now we are in dose optimization stage for this monitor. So also we will share with you more data in later so in the academic conference. Okay. I think they see a brief introduction.
You asked about our the other encourage you monetize whether you've sent to you.
Is that.
Rachel Yu: And thank you, Chen Chen, for your question about NRDL. So, this year actually is a pretty busy year for our market access team to prepare for the reimbursement negotiation. We totally already have six products already passing the first round of formal review, you know, for this year's NRDL negotiation, including the Cycomet, the TED product, Retevmo, RET inhibitor, KRAS inhibitor, ROS1 inhibitor, and also the EGFR TKI inhibitor, AUGEN. And also, we need to add one more indication, the second line endometrial cancer photype. We are actually actively preparing for all the dose submitting to the government. and although we cannot really predict the final outcome, we will always, you know, think about how to balance, you know, the patient need, price, and also company profit, you know, to make, you know, a source for decision, you know, about the final NRDL negotiation. Thank you.
Thank you Tien tsin for a question about audio.
This year actually is a pretty busy year for our market access team to put capital.
Reinvestment negotiation.
We currently already have six products already passing their first round of Bob will review both the CSN.
Jason.
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Your line endometrial cancer.
We are actively preparing for all of those you're submitting to the government.
And although we cannot really predict the final outcome.
We will always thinking about how to balance you know the patient need.
Price and also company profit to make.
<unk> decision in about the final ideal negotiation.
Okay. Okay. Thank you, Dr Joe and Rachel for your insights.
Speaker 6: Okay, thank you, Dr. Zhou and Rachel, for your insights. That's very clear. Appreciate it.
With me here I appreciate it.
Thank you Max and I have checked Lang.
Hui Zhou: Thank you. Next, let's have Jack Lang.
Uh huh.
Hi can you hear me.
Yang Huang: Hi, can you hear me?
Hui Zhou: Yes, we can.
Yes.
Yang Huang: Okay, thank you, Dr. Huang and management for giving me the chance to have a question. I have two quick questions. I think the first one is to kind of follow up on the earlier question on mesotype. So, I understand that we are anticipating launch for the drug to also be approved in type 2 diabetes. So, in terms of the commercialization of this opportunity, I'm curious in terms of management's thoughts on, you know, things like branding and pricing and potentially NRDL strategies and how we would look to position this differently for this indication compared to the obesity indication. That's the first question. And I think the second question is, so in terms of the overall globalization and out-licensing trend from China, we've seen a lot of oncology assets that's been going up.
Okay. Thank you, Dr Kwan and management for.
Giving me the chance you have a question or two.
Two quick questions I think first one is kind of a follow up on the earlier question on Mastercard. So understanding that we are anticipating launch for the Trump <unk> approved in type two diabetes. So in terms of the commercialization of this opportunity.
I am curious in terms of management.
What song you know things like branding and pricing and potentially on RTL strategies, and how we will look to position. This differently for this indication compared to the PCB indication.
That's the first question and I think the second questions.
So in terms of overall global globalization all license in China from China that we've seen a lot of oncology asset thats been going on but I think what has been kind of a potential opportunity areas in autoimmune diseases. So curious to see.
Yang Huang: But I think what has been kind of a potential opportunity area is in the autoimmune diseases. So, curious to see, you know, I think earlier also the management has shared, you know, some thoughts on the autoimmune space. But just wondering in terms of kind of more overall strategy, in terms of how management is thinking of the opportunities in autoimmune and how we are approaching it. We already have a couple of promising assets, you know, OX-40L, the bispecific, and just curious in terms of overall strategy. Thank you.
I think earlier also the management has shared some thoughts on the autoimmune space, but just wondering in terms of kind of more overall strategy in terms of how management's thinking about the opportunities in autoimmune and how we are approaching it and we have already have a couple of promising assets ox 40.
The bi specific and just curious in terms of the overall strategy. Thank you.
Thank you Jack first led to mess with diabetes.
Hui Zhou: Thank you, Jack. First, related to mesotype, diabetes ratio, and the immunology link.
Diabetes.
Our ratio.
The immunology.
Thank you Jack for questions Yes.
Rachel Yu: Thank you, Jack, for your question. Yes, the diabetes indication will be approved soon. We anticipate in a couple of months. And based on the approval timeline, definitely for 2026, we are going to play in the self-pay market. It's not eligible for the reimbursement negotiation for this year. So, we will, based on the pricing mechanism in China and design some of the programs to really support patients who need our product. And more importantly, we will also observe this year's NRDL negotiation result, you see, to see how our key competitor, you know, will potentially what's their landing, you know, pricing and reimbursement situation and see what our next year's strategy will be. Thank you.
Diabetes indication will be approved as soon we anticipate a couple of months.
And based on the approval timeline that's necessary.
So we are going to play in the self pay market.
At <unk>, Florida reimbursement negotiation for this year.
So we will based on the.
Pricing in Canada, China, and the design some of the program to the east.
Patients who need it.
In our products.
And more importantly, it will also offer the <unk>, yes, and ASEAN negotiations result in eight years.
See to see how our key competitor you know well.
Essentially what's their lending pricing and reimbursement situation and see whats our next year's strategy work. Thank.
Thank you.
Okay.
Lei Qian: Okay. So, to your question about the immunology pipeline, I think, first of all, the immunology disease areas suddenly become, I mean, kind of hot in recent years. I think the main reason is due to the breakthrough of the, technology and the science that, for some molecules, emerged. And also, due to the, economic growth. So, the, the patients and also the, the general, population, they need more, I mean, higher quality of life requirements, which give us a very optimistic view about the market overall. But for our strategies, the clinical development and also the targeted nomination, we will follow a very simple role. That is, we want to address unmet medical needs and, based on our know-how and also our strengths. So, for our two molecules, I think for LBS356 and LBS3002, I think we play very well about our strategy.
Hello, a question about the immunology pipeline I think.
First of all by the immunology business areas.
Following comps on mechanical heart in recent years as you know.
The main reason is due to the breakthrough of the.
Technology and science.
For some molecules.
And also due to the.
Economic growth so the.
Patients and also the.
The general population they need more higher quality of life requirements, which should give us a very optimistic view about the market overall.
For our strategies.
Clinical development, but also the target of nomination will follow a very simple.
So we want to address unmet medical needs.
Based on our know how and also our strengths.
<unk> two molecules I think for <unk>.
Thanks.
Zero zero to refi.
<unk> strategy for example, grocery pharmacy this.
Lei Qian: For example, for 356, this molecule we have in our preliminary data, we have observed a lower loading dose compared with Dupixent and with comparable efficacy but a much longer dosing interval. And, in our phase two studies, we will explore every two months or three months dosing, in the proof of concept trial. And, we have observed sustainable remission even after treatment discontinuation. And, all this together, we will explore more competitive treatment regimes to create a more favorable option for the coming, potentially phase three trials. And for LBS3002, this is a global first-in-class molecule with, two targets. And, in our phase one study, we have observed, that, substantial and sustainable signal reduction and substantial and durable, peripheral blood, SNO fail level reduction suggesting its bispecific design may avoid Dupixent-associated, risks. Clinical meaningful and durable lung function improvement are also expected.
This molecule we have in our preliminary data we have observed lower lower loading dose comparison Dixon and with comparable efficacy umbrella are much longer dosing interval.
Our phase two studies, we will explore every two months or three months dosing.
In the proof of concept trial.
We have observed sustainable remission, even after discontinuation.
And all this together we will explore in more competitive trade amongst regime will create a more favorable option for becoming a potential phase III trials and before <unk> does the global first in class molecule.
Two targets and.
In our phase one study we have.
Reserved.
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Reduction in substantial and durable.
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Risks clinical meaningful and durable lung function improvement also expected.
Lei Qian: So, based on all this, observations, we believe our pipelines reflect the, most advanced, progression, even in the mainstream, globally. And, we will, move these molecules based on our next, wave of, clinical data results and explore, more, indications venture. Thank you.
Based on these observations.
Believes our headlines with regard to the year on most of the Boston progression.
Ministry.
Globally.
We will move this molecule based on a whole lot.
A wave of.
Clinical data Readouts and explore more indication expansion. Thank you.
Yes.
Understood. Thank you guys. So much for the insightful answers and congratulations congratulations again on the sale of the first half performance.
Yang Huang: Understood. Thank you guys so much for the insightful answers. And congratulations again on the still the first half performance. Thank you.
Thanks.
Hui Zhou: Thanks. I can see we still have quite a few questions here, but unfortunately, I think we can only accommodate one more analyst question. So, next, I will get to Linda Xu. You can unmute yourself, Linda.
It was to have a quite a few questions here, but unfortunately, I think we're kind of OLED.
Commented, so far more autonomous cluster.
So next hour.
Industrial.
Okay Amir yourself Linda Thank you that's helpful and.
Speaker 6: Thank you, Dr. Huang, and thanks, management, for taking my question. I'm Linda Xu from HSBC. I have one question regarding the globalization. We've seen Innovem has entered into a new era by initiating the MRCDs as the IBS 363 and IBS 343. And I would like to know, could you give us some colors on the R&D expenses in the next three years? And also, as mentioned by Dr. Zhou, we're also expecting more global trials, including Orajio Q1. Have any other pipelines initiated in the next six months that can be shared? Thank you.
Thanks Nathan.
No my question on industrial from HSBC.
One question regarding the globalization with sea <unk> has entered into a new era.
EMEA shrinking.
Mercedes S D Ibs C.
Three and I've asked me for three and I would like to know could you give us some color on the R&D expenses in the next three years and also estimation biotech shall we also if any more color about global trials, including all of our accounting one.
Have any other pipeline to initiate in next six.
Six months and that can be shared thank you.
Yang Huang: The financial part is Rachel. And the GLP-1 or GLP-2, the second? Yeah, for the laser pipeline, all the new GLP-related. Okay.
Financial parties ratio.
And it's <unk>.
The second quarter.
Okay.
Great for the laser pipeline.
So the new geopolitically related.
Okay.
Thank you all enough other question.
Rachel Yu: Thank you, Linda, for the question. I think in terms of the overall R&D spending in global trial, you can see now we have 2 billion cash reserves on our balance sheet. So, it actually provides a solid foundation to advance our pipeline into global trial. And our domestic business reached EBITDA break even last year. Our cash is mainly reserved for global development. Our R&D budget for China is around 300 to 400 million US dollars every year. For the global R&D budget, I think we will advance into registrational trial until we have generated positive POS data, which will help us balance our risk and reward. So, if we have multiple trials entering into registrational trial globally, I think the value of our pipeline will also go up. And the last thing is that I think we're also open with, you know, BD collaborations.
In terms of the overall R&D spending in global trial, you can see now we have 2 billion cash reserve.
Our balance sheet. So it's actually provide a solid foundation.
Our pipeline into global trial, and our domestic business reached the EBITDA breakeven last year, our cash is mainly reserved for global development.
R&D budgets or China, it's around the 300 $400 million every year.
Global R&D budget, I think will advance into Registrational trial until we have generated a positive PFS data, which will help us balance our risk and the reward.
So if we have multiple trials entering into a registrational trial globally I think the value of our pipeline will also go up and a lots of things that I think will also open Wayne BD collaborations.
Rachel Yu: You know, we can also leverage external resources to maximize the value of our global pipeline.
We can also leverage external resources to maximize the value of our global pipeline.
Okay.
Lei Qian: Okay. I guess your question is about, well, what will be the next pivotal study plan for MaxDuTai? I think currently we have all seven pivotal studies ongoing. And for the next planned pivotal study, I think it's the obesity, the adolescents with obesity. We are planning to have the patient first patient first dose at the end of this year or early next year. And also for the other metabolic disease areas and our molecule IBI-128, we'll plan to enter into a pivotal study stage in the indication of GOT. Thank you.
<unk> will be the next to pivotal study planned for.
Four months into time, Inc.
Currently.
We have seven.
Seven pivotal studies ongoing and.
For the next one pivotal study I think there is.
The obesity adolescence resolve easily we are planning to have all patients first patient first dose.
End of this year or early next year and also for the other.
For the.
Cobalt disease areas and our molecule Abi.
<unk>, two H well plan to inherit to our pivotal study stage and an indication of our costs.
Thank you.
Thank you Mark here.
Speaker 6: Thank you. Very clear.
Yeah. Thanks again.
Hui Zhou: Yeah, thanks again. I will give a microphone to the Innovem team to see if the Innovem team has any concluding remarks to make.
Do you have a microphone to you know vantiv.
To see if you know what the team has done.
A N a concluding remarks to make.
Thank you I think of it that <unk> filed for hosting the call us and thank you Dear analysts and investors for joining US today, we really appreciate your continuous support to end of our biologics I think <unk>.
Rachel Yu: Thank you. Thank you, Dr. Huang, for hosting the call for us. And thank you, dear analysts and investors, for joining us today. We really appreciate your continuous support to Innovem Biologics. I see through there are quite a few questions that haven't been answered. Please feel free to reach out to our AI team after the call, and we'll be more than happy to answer the rest of your questions. And thank you very much for your support. And then we'll conclude our call today. Thank you.
<unk> that are that have.
Being answered please feel free to reach out to all of our team after the call and will be more than happy to answer the rest of your question Alright. Thank you very much for support and that will conclude our call today. Thank you.
Yes. Thank you everyone. Thank you you know when the management team. Thank you audience.
Hui Zhou: Yeah, thank you, everyone. Thank you, Innovem management team. And thank you, audience. And have a good night.
And I have a good night.
Lei Qian: Thank you.
Okay.
Okay.
[music].