Kelun-Biotech Secures Fourth China Approval for Sacituzumab Tirumotecan
Event summary
- Kelun-Biotech’s sacituzumab tirumotecan (sac-TMT) received NMPA approval for HR+/HER2- breast cancer patients who have received prior endocrine therapy and at least one line of chemotherapy.
- The approval is based on Phase III OptiTROP-Breast02 study data, presented as a Late-Breaking Abstract at the 2025 ESMO Congress.
- The study demonstrated a statistically significant increase in progression-free survival (PFS) with sac-TMT (8.3 vs. 4.1 months, HR=0.35).
- This marks the fourth indication for sac-TMT approved for marketing in China.
The big picture
The approval underscores the growing importance of China’s biopharmaceutical market and the increasing acceptance of ADCs in cancer treatment. Kelun-Biotech’s strategy of licensing out ex-China rights to MSD suggests a focus on domestic market penetration while leveraging MSD’s global commercial infrastructure. The consistent PFS benefits across subgroups in the OptiTROP-Breast02 study strengthens sac-TMT’s position as a valuable treatment option for a significant patient population with limited therapeutic alternatives.
What we're watching
- Clinical Trials
- The ongoing Phase III trials combining sac-TMT with pembrolizumab will be crucial in expanding its clinical utility and potentially broadening its market reach, particularly in earlier lines of therapy.
- Commercialization
- The impact of sac-TMT’s inclusion on China’s National Reimbursement Drug List (NRDL) will determine the pace of adoption and revenue generation within the Chinese market.
- Global Expansion
- How MSD leverages its exclusive rights outside of Greater China will dictate sac-TMT’s overall commercial success and Kelun-Biotech’s revenue diversification.
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