Guotou Securities·2025-03-09 10:25Investment Rating - The report maintains an "Outperform" rating for the industry [2]. Core Insights - AstraZeneca's oral selective estrogen receptor degrader (SERD) camizestrant has shown significant clinical improvement in progression-free survival (PFS) for HR+/HER2- breast cancer patients in the SERENA-6 trial, indicating potential market expansion for oral SERDs [4][17]. - Currently, only Menarini's elacestrant is approved for HR+/HER2- breast cancer treatment, while several other oral SERDs, including camizestrant, are in phase 3 trials, suggesting a promising future for this drug class in the domestic market [18]. Summary by Sections New Drug Market Review - From March 3 to March 9, 2025, the top five companies in the new drug sector by stock performance were: Maibo Pharmaceutical (78.79%), Hengrui Medicine (30.19%), CloudTop New Drug (29.49%), Heyu Biotech (26.04%), and Deqi Medicine (24.90%). The bottom five were: Youzhiyou (-23.28%), Beihai Kangcheng (-13.33%), Junshengtai (-12.17%), Baili Tianheng (-9.44%), and Maiwei Biotech (-7.96%) [3][14]. Key Industry Analysis - AstraZeneca's camizestrant, in combination with CDK4/6 inhibitors, has demonstrated statistically significant improvements in PFS for HR+/HER2- breast cancer patients, marking a breakthrough in first-line treatment options [4][17]. - The report highlights that the oral SERD market is currently underdeveloped in China, with no approved products, but several candidates are in advanced clinical stages, indicating a potential for market growth [18]. New Drug Approval & Acceptance - This week, 64 new drugs received IND approval in China, 39 new drug IND applications were accepted, and 3 new drug NDA applications were accepted [5][21]. Domestic New Drug Industry Highlights - On March 4, BeiGene's anti-PD-1 monoclonal antibody, Tislelizumab, received FDA approval for a new indication in combination with platinum-based chemotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma expressing PD-L1 [6][30]. - On March 4, the new PD-1, VEGF, and CTLA-4 tri-specific antibody CS2009 from CStone Pharmaceuticals completed its first patient dosing in a global phase 1 clinical trial [6][30]. - On March 7, the siRNA drug SGB-9768 targeting complement C3 from Saintin Biopharma initiated a phase 2 clinical trial in China [10][30].