生物医药Ⅱ新药周观点：首药控股二代ALK抑制剂NDA获受理，三代ALK抑制剂快速推进中

Industry Rating - The investment rating for the industry is Leading the Market-A, with a Maintained Rating [2] Core Views - The domestic ALK inhibitor market is substantial and still in a growth phase, with the market size reaching 4.2 billion yuan in 2023, an increase of 11% year-on-year [3][22] - The approval of second-generation ALK inhibitor Kangtaitinib and the future approval of third-generation ALK inhibitor CT-3505 are expected to drive further growth in the domestic ALK inhibitor market [3][22] - The new drug sector saw significant gains, with Yiming Angke leading at 36.86%, followed by Yunding Xinyao at 19.79%, and Jishi Pharmaceutical at 18.75% [2][18] Key Highlights by Section New Drug Market Performance - Top gainers in the new drug sector for the week of October 21-25, 2024, include Yiming Angke (36.86%), Yunding Xiyao (19.79%), and Jishi Pharmaceutical (18.75%) [2][18] - Top decliners include Beihai Kangcheng (-31.14%), Oukang Weishi (-10.19%), and Kaituo Pharmaceutical (-7.83%) [2][18] Key Developments in New Drug Industry - Shouyao Holdings received NDA acceptance for Kangtaitinib, a second-generation ALK inhibitor, with a third-generation ALK inhibitor CT-3505 in advanced clinical stages [3][21] - The domestic ALK inhibitor market is projected to grow further with the approval of Kangtaitinib and CT-3505 [3][22] New Drug Approvals & Applications - During the week, 5 new drugs or new indications were approved for marketing, 57 new drugs were approved for IND, and 37 new drugs had IND applications accepted [4][25] Domestic New Drug Industry Focus - Shouyao Holdings' Kangtaitinib NDA was accepted for the treatment of ALK-positive NSCLC [5][35] - Haihe Pharmaceuticals and Sansheng Pharmaceutical announced a commercialization agreement for Paclitaxel Oral Solution [5][35] - Zai Lab presented Phase 1a clinical data for ZL-1310, a DLL3-targeting ADC, at the EORTC-NCI-AACR conference [5][35] Overseas New Drug Industry Focus - Precision BioSciences received regulatory approval in Moldova for PBGENE-HBV, a gene-editing therapy targeting HBV [7][40] - Pfizer's RSV vaccine Abrysvo was approved by the FDA for preventing lower respiratory tract disease in high-risk individuals aged 18-59 [7][40] - LENZ Therapeutics' LNZ100 eye drops for presbyopia received FDA acceptance for NDA [7][40] Market Performance Charts - The biopharmaceutical sector showed significant volatility, with Beihai Kangcheng declining by 31.14% and Yiming Angke gaining 36.86% [18][19] - Market capitalization rankings for new drug companies were led by Hengrui Pharmaceuticals and BeiGene, with Hengrui topping the list [20]