CNSTOCK News (Reporter: He Xinyi) – On the evening of January 7, Hengrui Pharma announced that its subsidiary, Suzhou Suncadia Biopharmaceuticals Co., Ltd., received notification from the National Medical Products Administration (NMPA) regarding the approval of its self-developed Class 1 innovative drug, Relafusp α Injection (Trade name: Aizerli), for market launch.
The drug is indicated for use in combination with fluoropyrimidines and platinum-based chemotherapy as a first-line treatment for patients with locally advanced unresectable, recurrent, or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, specifically those with PD-L1 expression (CPS ≥ 1) confirmed by validated testing. Notably, Relafusp α is the world's first anti-PD-L1/TGF-βRII bispecific antibody fusion protein to be approved for marketing.
Hengrui Pharma stated that Relafusp α is a bifunctional fusion protein developed independently with proprietary intellectual property rights. It exerts anti-tumor effects by specifically blocking the PD-1/PD-L1 interaction while simultaneously neutralizing TGF-β within the tumor microenvironment. According to current data, no similar products have been approved for marketing globally. As of now, the cumulative R&D investment for the Relafusp α project totals approximately 711 million yuan.
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