Securities Code: 002422
Securities Abbreviation: Kelun Pharmaceutical
Announcement No.: 2026-059
Sichuan Kelun Pharmaceutical Co., Ltd.
Announcement on the Acceptance of the New Indication Marketing Application for TROP2 ADC Patritumab Deruxtecan (sac-TMT) by the National Medical Products Administration
The Company and all members of the Board of Directors guarantee the truthfulness, accuracy, and completeness of the information disclosed, and that there are no false statements, misleading statements, or material omissions.
Sichuan Kelun Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") recently learned that its holding subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd. (hereinafter referred to as "Kelun Botai"), has received acceptance from the China National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) for a new indication marketing application for its antibody-drug conjugate (ADC) targeting Trop-2 trophoblast cell surface antigen 2 (TROP2), Patritumab Deruxtecan (sac-TMT, also known as SKB264/MK-2870) (JiaTailai®). This application is for first-line treatment of locally advanced, unresectable, recurrent or metastatic triple-negative breast cancer (TNBC) with programmed cell death-ligand 1 (PD-L1) composite positive score (CPS) <10, or who have received prior treatment with programmed cell death protein-1 (PD-1)/PD-L1 inhibitors in the early stages. This is the sixth marketing application for a new indication of Patritumab Deruxtecan (sac-TMT) accepted by the NMPA. The core content is summarized as follows:
I. Basic Information