Guotou Securities·2025-11-09 14:32Investment Rating - The report maintains an investment rating of "Outperform" [5] Core Insights - The report highlights that the global sales of the BTK inhibitor Zebutini reached $1 billion in Q3 2025, with a quarter-on-quarter growth of 5% and a year-on-year growth of 56% [2][3] - Zebutini's market share in the global market reached 28.9% in Q3 2025, surpassing Ibrutinib in the U.S. market for the first time with a share of 33.8% [3][21] Summary by Sections Weekly New Drug Market Review - From November 3 to November 9, 2025, the top five gainers in the new drug sector were: Zhongsheng Pharmaceutical (+8.13%), Yongtai Biological (+7.35%), Hansoh Pharmaceutical (+3.31%), Hehuang Pharmaceutical (+1.55%), and Youzhiyou (0.00%); the top five losers were: Saint Nor Pharmaceutical (-24.42%), Kedi (-17.80%), Yifang Biological (-17.76%), Kangning Jere (-17.65%), and Zai Ding Pharmaceutical (-14.08%) [1][16] Weekly Focused Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty: PD-1 upgraded products from Sanofi, GLP-1 assets from Lianbang Pharmaceutical, and ADC assets from Kelun-Botai [2][20] 2. Potential heavyweights for overseas authorization: PD-1 upgraded products from Kangfang Biotech and Innovent Biologics, breakthroughs in autoimmune fields from Yifang Biological and China Antibody, and innovative target ADCs from Fuhong Hanlin and Shiyao Group [2][20] 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: Heng Rui Pharmaceutical, Kangnuo Pharmaceutical, Maiwei Biological, Zhixiang Jintai, and Haichuang Pharmaceutical [2][20] Key Analysis of the New Drug Industry - BeiGene disclosed its Q3 2025 financial performance, reporting global sales of Zebutini at $1 billion, with U.S. sales of $739 million and European sales of $163 million [2][3][20] - The report notes that Zebutini's market share is continuously increasing, indicating a strong growth trend [3][21] New Drug Approval and Acceptance Status - No new drug or new indication approvals were reported this week, but 10 new drug or new indication applications were accepted [9][25] - A total of 37 new drug clinical applications were approved, and 43 new drug clinical applications were accepted this week [10][28]