9MW1911(MW19)
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迈威生物接待127家机构调研,包括安信基金、岙夏投资、保银投资等
Jin Rong Jie· 2025-08-01 11:27
Core Viewpoint - Maiwei Biotech is actively advancing multiple innovative drug candidates, with significant clinical developments and partnerships expected in the coming years, particularly in the fields of oncology and fibrosis treatment [1][2][3]. Group 1: Clinical Development Progress - The IL-11 monoclonal antibody 9MW3811 has completed Phase I clinical trials in China and Australia, and has received approval to initiate Phase I trials in the U.S. It is expected to start Phase II trials for hypertrophic scars and keloids by the end of this year [1][3]. - The anti-ST2 monoclonal antibody 9MW1911 is currently in Phase II clinical trials, with 80 patients enrolled, aiming to complete follow-ups by the second half of 2025 [6]. - The CDH17 ADC innovative drug 7MW4911 has had its clinical trial application accepted by both NMPA and FDA, with preclinical studies showing significant advantages in terms of efficacy and safety [6][7]. Group 2: Market Opportunities and Strategic Focus - The company is focusing on the TNBC indication for its 9MW2821 ADC, targeting a large patient population with limited treatment options, and plans to initiate small-sample clinical trials in the U.S. by 2025 [2][9]. - The TCE platform aims to develop multiple innovative pipelines by 2026, leveraging differentiated features of modified CD3 antibodies to enhance T-cell activation and specificity against tumor antigens [10]. - The company has identified significant unmet clinical needs in the treatment of hypertrophic scars and keloids, positioning MW38 as a potential first-in-class therapy in this area [3][4]. Group 3: Business Development and Collaborations - 2025 is deemed a critical year for the company's business development (BD) efforts, with ongoing collaborations for several pipelines including Nectin-4 ADC, B7-H3 ADC, and ST2 monoclonal antibody [10][11]. - The company has successfully established a partnership for IL-11 monoclonal antibody, with plans to advance other pipelines in the near future [2][10]. - The BD strategy will increasingly focus on pipelines developed from the new generation TCE platform starting in 2026, reflecting the company's commitment to innovation and market differentiation [10].