Hengrui Pharmaceuticals has received marketing approval from its China homeland's National Medical Products Administration (NMPA) for retlirafusp alfa, a bifunctional fusion protein targeting both PD-L1 and TGF-βRII. The drug is approved for use in combination with fluoropyrimidine and platinum-based chemotherapy for the first-line treatment of locally advanced unresectable, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. This marks the first global approval for a drug of this class.

The approval is based on positive results from the Phase III SHR-1701-III-307 trial involving 737 patients. The study met its primary endpoint, demonstrating that retlirafusp alfa combined with chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone, with an acceptable safety profile.

PharmCube's NextBiopharm® database lists a total of 37 drug candidates targeting PD-1/L1 and TGF-β, incluidng in Phase III trials. Click here to request a free trial for NextBiopharm®.