Kelun-Biotech Announces Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-™T) in Combination With Tagitanlimab in China for Certain Types of Non-Small Cell Lung Cancer

Sichuan Kelun-Biotech's sacituzumab tirumotecan (sac-™T) in combination with tagitanlimab has received Breakthrough Therapy Designation from China's NMPA for first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. This designation, the fifth for sac-™T, is based on Phase II OptiTROP-Lung01 study data demonstrating significant clinical advantages over existing treatments. Kelun-Biotech's CEO, Dr. Michael Ge, highlighted the potential of TROP2 ADC-immunotherapy combinations for NSCLC subtypes, with MSD holding exclusive rights to develop and commercialize sac-™T outside of Greater China.

Analysis

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has received a significant regulatory endorsement for its core product, sacituzumab tirumotecan (sac-™T), a TROP2-directed antibody-drug conjugate (ADC). The combination of sac-™T with the PD-L1 monoclonal antibody tagitanlimab was granted Breakthrough Therapy Designation by China's National Medical Products Administration (NMPA) for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. This marks the fifth such designation for sac-™T, underscoring its potential and the NMPA's recognition of its significant clinical advantages, based on efficacy and safety data from the Phase II OptiTROP-Lung01 study. Sac-™T, which features proprietary intellectual property, a novel linker, a belotecan-derivative topoisomerase I inhibitor payload with a drug-to-antibody-ratio (DAR) of 7.4, and a bystander effect mechanism, has already achieved two marketing approvals in China for TNBC and EGFR-mutant NSCLC, establishing it as the first domestic ADC with global IP rights fully approved and the world's first TROP2 ADC approved for a lung cancer indication. The company has two additional new drug applications (NDAs) for sac-™T under priority review and 8 registrational clinical studies ongoing in China. Furthermore, Kelun-Biotech's strategic partner, MSD (Merck & Co., Inc.), holds exclusive rights to sac-™T outside Greater China and is actively advancing its development with 14 ongoing Phase 3 global clinical studies. This progress, combined with the existing approvals and global development efforts, positions sac-™T as a potentially transformative therapy and a key value driver for Kelun-Biotech, supported by its innovative OptiDC™ ADC platform.

Key Decisions for Investors

• The repeated Breakthrough Therapy Designations for sac-™T, particularly this fifth one for first-line NSCLC, significantly de-risk its development pathway and enhance its commercial prospects, suggesting a strengthened positive outlook for Kelun-Biotech (6990.HK) and its parent, Kelun Pharmaceutical (002422.SZ).
• Investors should closely monitor upcoming catalysts, including data from Kelun-Biotech's 8 Chinese registrational studies, NMPA decisions on the two NDAs under priority review, and interim results from MSD's 14 global Phase 3 trials, as these will be critical for valuation.
• The extensive global Phase 3 program led by MSD (MRK) not only validates the potential of sac-™T but also significantly expands its addressable market beyond China, representing substantial long-term revenue and royalty potential for Kelun-Biotech.