新药周观点：首药控股二代ALK抑制剂NDA获受理，三代ALK抑制剂快速推进

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [2]. Core Insights - The biopharmaceutical sector is experiencing significant growth, particularly in the ALK inhibitor market, which reached a scale of 4.2 billion yuan in 2023, reflecting an 11% year-on-year increase. The approval of new drugs, such as the second-generation ALK inhibitor CT-707, is expected to further drive market expansion [3][21]. - Recent performance in the new drug sector shows a strong upward trend, with top-performing companies like Yiming Oncology and CloudTop New Drug achieving substantial gains [2][18]. Summary by Sections New Drug Market Overview - From October 21 to October 25, 2024, the new drug sector saw significant price movements, with the top five gainers being Yiming Oncology (36.86%), CloudTop New Drug (19.79%), and others, while the top five losers included Beihai Kangcheng (-31.14%) and others [2][18]. Key Analysis of New Drugs - The report highlights the acceptance of the NDA for CT-707, a second-generation ALK inhibitor developed by Shouyao Holdings, aimed at treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) [3][21]. - The market for ALK inhibitors in China is projected to continue growing with the anticipated approval of CT-3505, a third-generation ALK inhibitor currently in critical clinical phases [21]. New Drug Approvals and Applications - This week, five new drugs or new indications were approved for market entry, with 57 new drugs receiving IND approvals and 37 IND applications accepted [4][25]. - Notable approvals include CT-707 for ALK-positive NSCLC and the exclusive commercialization rights for an oral paclitaxel solution granted to Sanofi by 3SBio [5][35]. Focus on Domestic New Drug Developments - Key developments include the acceptance of the NDA for CT-707 by Shouyao Holdings and the ongoing clinical trials for various new drugs, indicating a robust pipeline in the domestic market [5][35]. - The report also notes the collaboration between Haihe Pharmaceutical and 3SBio for the commercialization of an oral paclitaxel solution, enhancing market dynamics [5][35]. International New Drug Highlights - Internationally, Precision BioSciences received approval for its in vivo gene editing therapy targeting HBV, marking a significant advancement in the field [7]. - Pfizer's RSV vaccine Abrysvo has been approved by the FDA for high-risk individuals, showcasing the ongoing innovation in vaccine development [7].