Jiangsu Hengrui Pharmaceuticals (01276): Rilafupu Injection Solution Obtains Drug Registration Approval

Jiangsu Hengrui Pharmaceuticals (01276) announced recently that its subsidiary, Suzhou Sendia Biopharmaceutical Co., Ltd., has received notification from the National Medical Products Administration approving the marketing of the company's self-developed innovative drug, Relafop injection. There are nearly one million new cases of gastric cancer worldwide each year, with over 655,000 deaths. In China, the proportion of late-stage gastric cancer patients is high, with poor prognosis, making the disease diagnosis and treatment situation more severe. Immunotherapy is one of the first-line standard treatment measures for late-stage gastric cancer currently. However, the current use of immune checkpoint inhibitors has limited long-term survival improvement for patients, especially in difficult-to-treat populations such as those with gastric cancer liver metastases. Patients are in urgent need of innovative treatment options to improve their prognosis. Relafop injection is a self-developed and proprietary anti-PD-L1/TGF-RII dual-functional fusion protein by the company. This product can specifically block the interaction of PD-1/PD-L1, and neutralize TGF- in the tumor microenvironment, exerting anti-tumor effects. As of now, there is no similar product approved for marketing domestically or internationally. As of now, the total R&D investment for the Relafop injection project is approximately 711.3 million yuan.