The reporter learned from the Shanghai Municipal Commission of Science and Technology that China's first hemophilia B gene therapy drug developed by Shanghai enterprises has been approved for market. The China National Medical Products Administration recently approved the listing of Shanghai Xinzhi Pharmaceutical Technology Co., Ltd.'s application for the injection of Bopida Ke Ji (trade name: Xinjiuning) through a priority review and approval process, for the treatment of adult patients with moderate to severe hemophilia B (congenital factor IX deficiency). Hemophilia B is a hemorrhagic disease caused by a deficiency of coagulation factor IX (FIX). Popadaki injection is a recombinant adeno-associated virus (rAAV) vector gene therapy product, which introduces the FIX gene into target cells (mainly liver cells) through the rAAV vector to express FIX. The launch of this product provides a new treatment option for adult patients with moderate to severe hemophilia B. It is reported that Xinjiuning was developed and launched in less than seven years, reflecting the "Shanghai speed" and "China speed". Since the beginning of this year, a total of 3 domestically produced Class 1 innovative drugs and 6 Class 3 innovative medical devices have been approved for listing in Shanghai. In response to the new situation of global biopharmaceutical industry development, relevant departments in Shanghai have continuously strengthened their innovation and sourcing capabilities, and made every effort to accelerate the entire process of "basic research, incubation and transformation, clinical trials, review and approval, landing production, and promotion and application" and empower the entire chain. In the past three years, Shanghai has successively released the "Action Plan for Promoting Technological Innovation and Industrial Development of Cell Therapy in Shanghai (2022-2024)" and the "Action Plan for Promoting Technological Innovation and Industrial Development of Gene Therapy in Shanghai (2023-2025)", systematically promoting the high-quality development of the cell and gene therapy industry and achieving a number of innovative results. At the same time, the implementation of policies such as the "Several Opinions on Supporting the Innovative Development of the Whole Chain of the Biomedical Industry" has also provided high-quality services for the innovative development and industrial upgrading of Shanghai's biopharmaceutical enterprises, optimizing the ecological development of industrial innovation. Shanghai is the birthplace of China's modern pharmaceutical industry and the innovation hub of China's biopharmaceutical industry. Currently, it is committed to accelerating the formation of a world-class biopharmaceutical industry cluster. In July 2024, Shanghai launched three leading industry parent funds with a total scale of 100 billion yuan, including integrated circuits, biomedicine, artificial intelligence parent funds, and future industry funds. (New Society)
Edit:Ou Xiaoling Responsible editor:Shu Hua
Source:People Net
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