新药周观点：国产创新药出海进展不断

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [8]. Core Insights - Recent advancements in the overseas expansion of domestic innovative drugs have been noted, including overseas sales, NDA approvals, and product licensing [2]. - The report highlights significant sales figures for BeiGene's BTK inhibitor, Zebrutinib, with global sales reaching $1.816 billion in the first three quarters of 2024, and $690 million in Q3 2024 alone [2][30]. - The report emphasizes the increasing market share of Zebrutinib, which reached 21.8% globally and 24.9% in the U.S. market in Q3 2024 [30]. Summary by Sections Weekly New Drug Market Review - From November 11 to November 15, 2024, the top five companies in the new drug sector by stock price increase were: - CStone Pharmaceuticals (15.98%) - Ascletis Pharma (5.04%) - Zai Lab (4.51%) - LianBio (4.11%) - Eternity Bioscience (3.89%) - The top five companies with the largest declines were: - Kintor Pharmaceutical (-19.31%) - Eucure Biopharma (-16.06%) - Junshi Biosciences (-14.63%) - Sihuan Pharmaceutical (-14.52%) - ZhiXiang JinTai (-14.39%) [1][25]. Key Analysis of the New Drug Industry - Recent progress in the overseas expansion of domestic innovative drugs includes: 1. NDA submissions: Dicerna Pharmaceuticals submitted an NDA for the drug Suvoritide to the FDA, and Betta Pharmaceuticals is expected to receive final review results for its ALK-positive NSCLC NDA by December 28, 2024 [2][30]. 2. Overseas sales: BeiGene reported global sales of Zebrutinib reaching $1.816 billion in the first three quarters of 2024, with Q3 sales of $690 million, including $504 million in the U.S. (up 87% year-on-year) and $97 million in Europe (up 217% year-on-year) [2][30]. 3. Overseas licensing: Recent collaborations include BioNTech's acquisition of Promis and Merck's licensing agreement for the PD-1/VEGF bispecific antibody LM-299 from LianBio, with an upfront payment of $588 million [2][37]. New Drug Approvals and Applications - This week, four new drugs or new indications were approved for market entry, with 46 new drugs receiving IND approvals, 38 IND applications accepted, and 7 NDA applications accepted [38]. - Notable approvals include: - Merck's global exclusive license for LianBio's PD-1/VEGF bispecific antibody [38]. - BioNTech's acquisition of Promis for $800 million [38].