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百济神州“首盈”背后:大单品突围,却面临仿制药潮涌与技术迭代双重夹击|创新药观察
Hua Xia Shi Bao·2025-10-23 09:31

Core Viewpoint - BeiGene has reached a profitability turning point, reporting a net profit of 450 million yuan for the first half of 2025, marking a significant recovery from previous losses exceeding 57 billion yuan over seven years. However, the company's revenue structure raises concerns due to its heavy reliance on core products and a single market, making it vulnerable to external fluctuations [3][4]. Revenue Structure - In the first half of 2025, BeiGene achieved total revenue of 17.518 billion yuan, with its core product, Brukinsa (Zebutinib), contributing significantly to this figure. The global sales totaled 12.527 billion yuan, reflecting a year-on-year growth of 56.2% [4][5]. - The U.S. market accounted for 51.2% of the total revenue, with sales reaching 8.958 billion yuan, a 51.7% increase year-on-year. European sales grew by 81.4% to 1.918 billion yuan, while sales in China increased by 36.5% to 1.192 billion yuan [5]. Market Challenges - The company's reliance on a "single product + single market" model poses risks, particularly from potential changes in U.S. healthcare policies and increasing market competition. The company has not responded to inquiries regarding how it would maintain profitability if U.S. healthcare negotiations require price reductions [5][6]. - The competitive landscape is intensifying, especially for Brukinsa, which faces threats from new generation competitors like Eli Lilly's Pirtobrutinib, which has shown advantages in clinical trials [7][8]. Patent Expiration Risks - The first-generation BTK inhibitor, Ibrutinib, is set to have its core patent expire in the U.S. by 2027, with some extensions possible until 2028. This will likely lead to an influx of low-cost generics in the market, which could significantly impact Brukinsa's pricing and market share, especially in price-sensitive segments [9][10]. - The approval of generic versions of Ibrutinib in China further complicates the competitive landscape, as these generics may lower prices and increase accessibility for patients, potentially affecting Brukinsa's performance [10].