Colon Pharmaceuticals (002422.SZ): TROP2 ADC lucansastuzumab (sac-TMT) marketing application accepted for new indications

Zhitong Finance App News, Colon Pharmaceutical (002422.SZ) issued an announcement that the marketing application for a new indication of Collenbotai's antibody-conjugated drug (ADC) targeting human trophic cell surface antigen 2 (TROP2), lukansatuzumab (SAC-TMT, also known as SKB264/MK-2870) (Cathay Lai®) has been accepted by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) for programmed cell death ligand 1 (PD-L1) comprehensive positive score (CPS) 10 or early stage First-line treatment for recurrent or metastatic triple-negative breast cancer (TNBC) who has received programmed cell death protein-1 (PD-1) /PD-L1 inhibitors. This is the sixth application for marketing of lucansastuzumab (sAC-TMT) accepted by the NMPA.

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.