SKB BIO (06990.HK): NMPA Accepts sNDA for Core Product Sac-TMT in First-Line TNBC Treatment

NewTimeSpace News: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (06990.HK) issued a voluntary announcement on July 30, 2026, disclosing that the NMPA has accepted a supplemental New Drug Application for its core product, the TROP2-targeted ADC sacituzumab tirumotecan (sac-TMT, JIATAILEI®), for a new indication: the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC) in patients with PD-L1 CPS < 10 or those who have previously received PD-1/PD-L1 inhibitors at an early stage. This marks the sixth NMPA-accepted indication application for the drug and has been included in the priority review and approval procedure.

The acceptance was based on results from the randomized, multicenter Phase 3 registrational OptiTROP-Breast03 study, which demonstrated statistically significant and clinically meaningful improvements across key efficacy endpoints compared with investigator's choice of chemotherapy. To date, the drug has secured four approved indications in China, two of which have been included in the National Reimbursement Drug List (NRDL). The Company has granted Merck Sharp & Dohme (MSD) exclusive global rights outside Greater China, and MSD has initiated 17 global Phase 3 clinical studies. The Company cautions that there is no guarantee the drug will ultimately be successfully developed and commercialized for additional indications.

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