NMPA Accepts New Indication Application for Sacituzumab Tirumotecan (sac-TMT) as First-Line Treatment for Advanced TNBC

CHENGDU, China, July 30, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that a new indication application of its trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the first-line treatment of patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have a programmed death ligand 1 (PD-L1) combined positive score (CPS) <10, or have recurred after prior programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy in the early stage. This marks the sixth indication application accepted by the NMPA for sac-TMT.

The acceptance for review is based on the positive results from the randomized, open-label, multicenter Phase III registrational OptiTROP-Breast03 study evaluating the efficacy and safety of sac-TMT versus investigator's choice of chemotherapy in patients with unresectable recurrent or metastatic TNBC who have not received prior systemic therapy for advanced disease. The enrolled population included patients with PD-L1 CPS <10, as well as those who have recurred after prior PD-1/PD-L1 inhibitor therapy in the early stage. The study demonstrated that sac-TMT achieved statistically significant and clinically meaningful improvements in key efficacy profile compared with investigator's choice of chemotherapy, showing a clear clinical benefit.

Previously, sac-TMT was granted Breakthrough Therapy Designation (BTD) by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1-negative TNBC. This new indication application has also been included in the priority review and approval process, becoming the sixth application for sac-TMT to enter this process. Inclusion in this process is expected to further expedite the review and approval, allowing this innovative treatment to benefit patients sooner.

Dr. Michael Ge, CEO of Kelun-Biotech, said, "Following the approval of sac-TMT for second-line or later treatment of TNBC based on results from the Phase III OptiTROP-Breast01 study, we are delighted to see another important milestone in the same disease area. For patients with PD-L1-negative advanced TNBC, the efficacy of traditional chemotherapy is limited, and there is an urgent clinical need for more effective and safer first-line treatment options. The positive results from the OptiTROP-Breast03 study demonstrate a clear and clinically meaningful improvement in efficacy with sac-TMT compared to chemotherapy and support the continued evaluation of sac-TMT as the first-line treatment for TNBC. We look forward to the early approval of this indication to bring a new and more effective first‑line treatment option to a broader population with advanced TNBC."