一款创新药诞生在杭州并获批上市

Core Insights - The approval of the IL-23p19 monoclonal antibody, Xinmeiyue (Pikangqibai Injection), marks a significant milestone in the treatment of autoimmune diseases in China, specifically for moderate to severe plaque psoriasis in adults, providing a new treatment option for over 7 million patients [1][2] - Hangzhou is emerging as a new hub for pharmaceutical innovation, with all four class 1 innovative drugs approved in the province by the third quarter of 2025 originating from the city, which accounts for 75% of the province's total class 1 innovative drug applications [1] - The Hangzhou Municipal Market Supervision Administration has implemented various measures to accelerate the transformation of innovative results, including a "green channel" for innovative drugs, significantly reducing the time for production licensing and inspections [1][2] Group 1 - The IL-23p19 monoclonal antibody is the first domestically developed drug of its kind approved in China, filling a gap in the drug development landscape [1] - The city of Hangzhou has become a focal point for pharmaceutical innovation, with a notable concentration of new drug approvals [1] - The local government has introduced practical measures to support the pharmaceutical industry, including expedited licensing processes and tailored solutions for individual company challenges [1][2] Group 2 - The market supervision department has actively addressed common industry challenges, resulting in a 37.5% decrease in consultation requests related to production issues [2] - The collaboration between the market supervision department and companies has been highlighted as crucial in navigating key regulatory milestones from research to market approval [2] - In 2025, it is expected that approximately 320 million yuan will be allocated to assist companies in applying for provincial and municipal industrial special funds, further driving pharmaceutical innovation [2]

一款创新药诞生在杭州并获批上市 - Reportify