Kelun-Biotech says China regulator accepts sac-TMT filing for first-line metastatic TNBC use

• Sichuan Kelun-Biotech’s NMPA drug review center accepted a China filing for sac-TMT (SKB264/MK-2870), its TROP2 ADC.
• The application targets first-line treatment of recurrent or metastatic triple-negative breast cancer with PD-L1 CPS < 10 or prior early-stage PD-1/PD-L1 therapy.
• The filing entered China’s priority review track, supported by positive phase 3 OptiTROP-Breast03 results versus investigator-choice chemotherapy.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. published the original content used to generate this news brief via IIS, the regulatory disclosure system operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260730-12261794), on July 30, 2026, and is solely responsible for the information contained therein.