抗ST2单抗

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迈威生物接待100家机构调研,包括国泰海通、希瓦资产、民生加银等
Jin Rong Jie· 2025-06-30 10:43
Core Viewpoint - Maiwei Biotech is focusing on its innovative drug business development (BD) in 2025, aiming for breakthroughs in key pipeline projects such as Nectin-4 ADC, while acknowledging uncertainties in the BD business [1][2]. Group 1: Business Development (BD) Focus - 2025 is a critical year for the company's innovative drug BD business, with a focus on achieving substantial project outcomes [2]. - The company plans to expand its BD pipeline in 2026 to include new generation TCE platform-based projects, which are expected to have global differentiation advantages [2]. - The Nectin-4 ADC is currently in clinical research for multiple indications, with over 800 patients enrolled, and is leading in development progress globally for several indications [1][2]. Group 2: Clinical Research Progress - Three key Phase III clinical trials are ongoing: UC monotherapy, UC combination therapy, and CC monotherapy, with plans for interim analysis in 2026 and 2027 [3]. - The TNBC ADC therapy is in Phase II, with plans to initiate a small sample clinical trial in the U.S. in 2025 [3][4]. - The company is also advancing clinical trials for UC perioperative combination therapy and CC combination therapy, both of which have received approval [3]. Group 3: Product Advantages and Market Potential - The MW282 (Nectin-4 ADC) utilizes a new conjugation technology and has shown significant safety and efficacy, with a large patient population in need of new therapies for TNBC [4][5]. - The MW19 (anti-ST2 monoclonal antibody) is the second globally in clinical development for its target and is expected to read out Phase II data in late 2025 [5]. - The 9MW3011 (for polycythemia vera) is the first targeted TMPRSS6 monoclonal antibody in China, with a clinical trial planned for 2025, and is expected to offer better safety and convenience compared to existing treatments [6]. Group 4: Stock Lock-up and Shareholder Commitments - The company will not have any lock-up stock releases in July 2025, as shareholders have committed to not reducing their holdings until the company achieves profitability [7][8].