Sichuan Kelun Pharmaceutical Co.,Ltd. (002422.SZ) has announced that its subsidiary, Kelun-Bio, has received approval from the China National Medical Products Administration (NMPA) for a new indication of its antibody-drug conjugate (ADC) targeting trophoblast cell surface antigen 2 (TROP2), known as Locusantuzumab (sac-TMT, also referred to as SKB264/MK-2870, branded as Jiatailia).

The new indication is for first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC) in patients with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) <10 or those who have received prior treatment with PD-1/PD-L1 inhibitors in early-stage disease. This marks the sixth regulatory submission for Locusantuzumab (sac-TMT) under the NMPA's review process.

Previously, Locusantuzumab (sac-TMT) had been granted breakthrough therapy designation (BTD) by the NMPA for first-line treatment of unresectable, locally advanced, or recurrent/metastatic PD-L1-negative TNBC. The latest submission has also been included in the priority review and approval program, becoming the sixth such application for Locusantuzumab (sac-TMT) under this fast-track pathway. Priority review is expected to expedite the review and approval process, potentially bringing this innovative therapy to patients sooner.