By Fineline Cube 
China‑listed Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the National Medical Products Administration (NMPA) approved the trophoblast cell‑surface antigen 2 (TROP2)‑directed antibody‑drug conjugate (ADC) sacituzumab tirumotecan (sac‑TMT, SKB264/MK‑2870) for its third indication: treatment of adult patients with EGFR‑mutant‑positive locally advanced or metastatic non‑squamous non‑small cell lung cancer (NSCLC) who have progressed after EGFR‑tyrosine kinase inhibitor (TKI) therapy.
Clinical Evidence
| Study | Design | Key Outcomes |
|---|---|---|
| OptiTROPLung04 | Randomized, open‑label, multi‑center Phase III | Progression‑free survival (PFS): 8.2 months (sac‑TMT) vs 5.1 months (platinum‑based doublet). Overall survival (OS): 20.4 months vs 14.6 months. Both differences were statistically significant (p < 0.01). |
The interim analysis demonstrated a clinically meaningful benefit over the current standard of care, providing a new therapeutic option for a heavily pre‑treated patient population.
Current Indication Portfolio
- Triple‑negative breast cancer (TNBC) – unresectable locally advanced or metastatic disease after ≥ 2 prior systemic therapies.
- EGFR‑mutant NSCLC – locally advanced or metastatic, progressed after EGFR‑TKI and platinum‑based chemotherapy.
- EGFR‑mutant NSCLC – locally advanced or metastatic, progressed after EGFR‑TKI therapy only.
With the latest NMPA approval, sac‑TMT now covers a fourth indication, further expanding its market footprint in China.
Global Development Strategy
In May 2022, Kelun granted Merck Sharp & Dohme (MSD) exclusive rights to develop, manufacture, and commercialize sac‑TMT in all territories outside Greater China. The partnership positions Kelun to leverage MSD’s extensive oncology pipeline and global sales network while retaining full control over the product in the Chinese market.-Fineline Info & Tech