35家药企抢首仿！石家庄四药仿制乌帕替尼获受理，60亿美元市场引爆仿制大战

Core Viewpoint - The approval of the Upaftin sustained-release tablet application by Shijiazhuang Four Medicines adds to the competitive landscape of the JAK1 inhibitor market, which is rapidly growing and attracting local pharmaceutical companies [1]. Group 1: Market Potential - Upaftin sustained-release tablets, developed by AbbVie, are projected to reach nearly $6 billion in global sales by 2024, with a significant presence in the Chinese market after being included in the national medical insurance list [1][2]. - The sales of Upaftin in the Chinese hospital market are expected to exceed 300 million yuan in 2024, marking a year-on-year growth of 278.02%. By the first three quarters of 2025, sales are anticipated to surpass 400 million yuan, reflecting a staggering year-on-year increase of 104.03% [1][2]. Group 2: Patent Challenges - The core compound and composition patents for Upaftin were originally set to expire in 2030. However, a significant turning point occurred at the end of 2022 when Sichuan Guowei initiated a patent challenge targeting the compound patent [4][7]. - In July 2023, the National Intellectual Property Administration declared the compound patent invalid, significantly opening the pathway for generic manufacturers six years earlier than expected [7]. Group 3: Competitive Landscape - Over 35 companies, including Shijiazhuang Four Medicines, have submitted applications for the generic version of Upaftin, indicating intense competition among leading generic drug manufacturers [8]. - Despite early submissions by companies like Sichuan Guowei and Tiandi Hengyi, no local company has yet successfully launched a generic version, with AbbVie still holding a dominant position in the market [10][12].