Shanghai RAAS and Boehringer-Ingelheim reached a major cooperation：Boehringer-Ingelheim Biopharmaceuticals (China) Co., Ltd. (hereinafter referred to as "Boehringer Ingelheim China Biopharmaceuticals") will provide Shanghai RAAS process transfer and clinical production and manufacturing services for it’s hemophilia innovative drug -SR 604 injection, committed to transforming it into a high-quality ternimal product through a world-class CDMO platform, helping Chinese innovation go overseas and benefit patients worldwide.
SR604 injection is a monoclonal antibody preparation that binds to human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. Recently, the National Medical Products Administration officially approved an application for Phase I clinical trial of SR604 injection, administered subcutaneously once every 4 weeks and is intended for the prophylactic treatment of bleeding in patients with hemophilia and congenital factor VII deficiency. Up to now, no products with the same target as this drug have been marketed in the world.
Dr. Xu Jun
Chairman and General Manager of Shanghai RAAS
"Shanghai RAAS is very pleased to cooperate with Boehringer Ingelheim, a leading German pharmaceutical company in the world, Relying on Boehringer Ingelheim's globally renowned technology platform and mature production base, we will jointly promote the subsequent process transfer and manufacturing of SR604 injection so as to bring benefits to Chinese hemophiliacs as soon as possible and meet the huge clinical needs. 'Making good and innovative drugs' has always been the foundation of Shanghai RAASs' growth. Shanghai RAAS will continue to adhere to the quality policy of 'safety, quality and efficacy', fulfill the brand commitment of 'Shanghai RAAS , Guardian of Health', make more and better innovative drugs, and benefit the society."
Dr. Zang Yuhuo
General Manager of Boehringer-Ingelheim
"I am very glad to have reached cooperation with Shanghai RAAS, a local innovative pharmaceutical company, and also congratulate the successful approval of the clinical research of the new antibody drug-SR604 injection, . We hope that the top-class professional teams of both sides will work closely to bring this innovative drug to the market as soon as possible and bring more benefits to hemophiliacs. Bollinger Ingelheim will empower and accelerate product development to maximize value through it’s leading project management processes, experienced execution teams, excellent drug registration services, and a rigorous intellectual property protection system. In the future, we are willing to work with all partners to actively empower the innovation ecosystem of China's biopharmaceutical industry, to help achieve a full chain upgrade from research and development, production to commercialization and overseas, benefiting patients worldwide.
In the bilateral development cooperation, Boehringer-Ingelheim China Biopharmaceuticals will provide Shanghai RAAS with full-process services for production process transfer, stock solution and preparation cGMP production, and CMC filing document writing for the SR604 injection project.
In recent years, the domestic biomedical industry has developed rapidly with innovative achievements represented by domestic innovative drugs emerging continuously. As a domestic veteran blood product enterprise, Shanghai RAAS has also been committed to "making good medications and innovative medications" and benefiting society with "safety, quality and efficacy" products.