March 18, 2024 Source: drugdu 118
SHANGHAI RAAS and Boehringer Ingelheim, one of the world's leading biopharmaceutical companies, announced today that they have entered into a major collaboration: Boehringer Ingelheim BioPharmaceuticals (China) Ltd. will provide process transfer and clinical manufacturing services for SHANGHAI RAAS's innovative hemophilia drug, SR604 injection. Boehringer Ingelheim China Biopharmaceutical ("Boehringer Ingelheim China Biopharmaceutical") will provide process transfer and clinical manufacturing services for SR604 injection, an innovative hemophilia drug under Shanghai Lacey, which will be transformed into a high-quality end-product through the international first-class CDMO platform, helping Chinese innovations to go overseas to benefit patients worldwide.
SR604 injection is a humanized monoclonal antibody that binds human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. Recently, the State Drug Administration (SDA) has officially approved SR604 injection. Recently, the State Drug Administration formally approved an application for a clinical phase I trial of SR604 injection, to be administered by subcutaneous injection every 4 weeks, for the prophylactic treatment of bleeding in patients with hemophilia and congenital coagulation factor VII deficiency. Up to now, there is no product with the same target as this drug on the market worldwide.
In the development cooperation, Boehringer Ingelheim China Biopharmaceuticals will provide production process transfer, cGMP production of stock solution and formulation, and CMC declaration document writing services for SHANGHAI RAAS' SR604 injection project.
In recent years, the domestic biopharmaceutical industry has entered the "fast lane" of development, and innovative achievements represented by domestic innovative drugs have been emerging continuously. As a veteran blood product enterprise in China, SHANGHAI RAAS has always been committed to "making good and innovative drugs" and benefiting the society with "safe, high-quality and efficient" products.
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