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荣昌生物(09995):泰它西普gMGIII期数据公布,差异化竞争优势明显,维持买入
09995REMEGEN(09995) 交银国际·2025-04-10 05:39

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 35.20, indicating a potential upside of 37.0% from the current price of HKD 25.70 [6]. Core Insights - The report highlights the competitive advantage of 泰它西普 (Taitasip) in treating generalized Myasthenia Gravis (gMG), with III phase trial results showing significant improvement compared to existing competitors like VYVGART [1][2]. - The company has a clear commercialization strategy for 泰它西普, which includes increasing specialized representatives in the neuroimmunology field and enhancing physician education on its advantages over competitors [1][2]. - The report anticipates that the approval of 泰它西普 for gMG will drive long-term sales growth, supported by strong clinical data and a well-defined marketing strategy [1][2]. Summary by Sections - Clinical Trial Results: The III phase study involved 114 gMG patients, showing an average improvement of 5.74 points in MG-ADL scores for the 泰它西普 group compared to 0.91 points for the placebo group. The improvement in QMG scores was 8.66 points versus 2.27 points for the placebo [1]. - Safety Profile: 泰它西普 demonstrated a better safety profile with a lower incidence of infection-related adverse events compared to VYVGART, which has limitations due to its safety concerns [1][2]. - Regulatory and Commercialization Timeline: The application for 泰它西普's gMG indication was accepted for priority review in October 2024, with expectations for approval within the year. Additional new indications and products are also in the pipeline [1][2].