Suzhou Suncadia Biopharmaceuticals Co Ltd, a company in SIP, recently announced that its self-developed Retlirafusp alfa Injection has received marketing approval from the National Medical Products Administration of China. This new drug is this year’s first approved Class 1 innovative drug from SIP.

The drug is used in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of fully validated PD-L1 positive (CPS≥1), locally advanced, unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma.

Unlike first-generation programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors, this new drug features a dual-target design, simultaneously blocking the PD-L1 and Transforming Growth Factor-beta (TGF-β) pathways to enhance anti-tumor efficacy.

SIP Market Supervision Bureau and Drug Administration Center provided full support for the company in the process of applying for the approval.

January 9, 2026