The marketing application for new indications of the core product TROP2 ADC Lucan Satuzumab (Sac-TMT) of Collumbotai Biotech (06990) was accepted by the State Drug Administration

Zhitong Finance App News, Columbotai Biotech (06990) announced that the marketing application for a new indication of the company's antibody-conjugated drug (ADC) lucan satuzumab (SAC-TMT, also known as SKB264/MK-2870) (Cathay Lai®) targeting human trophic cell surface antigen 2 (TROP2) has been accepted by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) for procedural cell death ligand 1 (PD-L1) comprehensive positive score (CPS) <10 Accepted the procedure First-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC) with sex cell death protein-1 (PD-1) /PD-L1 inhibitors. This is the sixth application for marketing of lucansastuzumab (sAC-TMT) accepted by the NMPA.

This acceptance was based on the positive results of the randomized, open, multi-center Phase 3 registered OptiTrop-Breast03 study. The purpose of this study was to evaluate the efficacy and safety of lucansatuzumab (sAC-TMT) compared to chemotherapy selected by the investigators for patients with recurrent or metastatic TNBC that had not received systematic treatment at an advanced stage. The enrolment population included PD-L1CPS<10 and patients who had previously relapsed after receiving PD-1/PD-L1 inhibitors in the early stages. The study results showed that compared with the chemotherapy selected by the researchers, lucansatuzumab (sAC-TMT) achieved statistically significant and clinically significant improvements in key efficacy indicators, showing clear clinical benefits.

Previously, lucan satuzumab (sAC-TMT) for first-line treatment of locally advanced, recurrent, or metastatic PD-L1 negative TNBC that cannot be surgically resected was granted breakthrough therapy (BTD) by the NMPA. The marketing application for this new indication has also been included in the priority review and approval process, making it the sixth marketing application for lukansastuzumab (sAC-TMT) to be included in this procedure. Inclusion in the priority review and approval process is expected to further speed up the review and marketing process, so that this innovative treatment plan can benefit patients sooner.