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新药周观点:创新药2月进院数据更新,多个新纳入医保创新药快速进院-2025-03-30
Guotou Securities·2025-03-30 07:40

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [7]. Core Insights - The report highlights that several newly included innovative drugs in the medical insurance directory are rapidly entering hospitals, with some drugs exceeding 100 hospital entries [2][19]. - The report notes a significant increase in the number of new drug approvals and applications, with 103 new drug INDs approved and 43 new drug INDs accepted this week [3][21]. Summary by Sections Weekly New Drug Market Review - From March 24 to March 28, 2025, the top five companies in the new drug sector by stock price increase were Youzhiyou (37.30%), Maibo Pharmaceutical (33.33%), Keji Pharmaceutical (26.44%), Yiming Anke (18.68%), and Zhixiang Jintai (18.34%). The top five companies with the largest declines were Kaituo Pharmaceutical (-23.84%), Tengshengbo Pharmaceutical (-16.32%), WuXi AppTec (-15.17%), Yongtai Biological (-12.56%), and Yunding Xinyao (-11.41%) [1][15]. Key Analysis of the New Drug Industry - The National Medical Insurance Administration updated the hospital entry data for innovative drugs included in the medical insurance directory as of the end of February 2025. Notable drugs that have entered over 100 hospitals include: - Cardunilumab from Kangfang Biopharmaceutical - Budesonide enteric-coated capsules from Yunding Xinyao - Goserelin microspheres from BeiGene/Green Leaf - Tolebrutinib from Innovent Biologics - Cangrelor and Clopidogrel from Haishi Pharmaceutical - Benzyl benzoate from Xinlitai - Dazatinib from Jingxin Pharmaceutical [2][19]. New Drug Approval & Acceptance Status - This week, 103 new drugs were approved for IND, 43 new drug INDs were accepted, and 5 new drug NDAs were accepted [3][21]. Domestic New Drug Industry Focus - Key developments include: - On March 21, Heptares Therapeutics announced a global strategic collaboration with AstraZeneca for the development of next-generation multispecific antibody therapies targeting immune diseases and tumors. - On March 24, Federated Pharmaceutical announced an exclusive licensing agreement with Novo Nordisk for the global development, production, and commercialization rights of the long-acting GLP-1R/GIPR/GCGR triple agonist UBT251. - On March 25, Heng Rui Medicine announced an exclusive licensing agreement with Merck for the development, production, and commercialization rights of the Lp(a) oral small molecule project (including the lead compound HRS-5346) outside Greater China [4][12]. Overseas New Drug Industry Focus - Key developments include: - On March 27, Daiichi Sankyo registered a phase III clinical trial for DS-8201 (T-DXd) in combination with Keytruda for first-line treatment of HER2-overexpressing non-small cell lung cancer (NSCLC). - On March 27, AstraZeneca registered a phase 1/2 clinical trial for AZD0120 for the treatment of recurrent systemic lupus erythematosus, with an expected enrollment of 150 patients. - On March 28, Lexicon Pharmaceuticals entered into an exclusive licensing agreement with Novo Nordisk for the global development, production, and commercialization rights of the oral small molecule inhibitor LX9851 [12].