迈威生物:Nectin-4ADC展现泛瘤种潜力,快速推进注册临床

Investment Rating - Maintains "Outperform" rating [1][3] Core Views - The core product 9MW2821, a Nectin-4 ADC, is advancing rapidly in multiple indications, including urothelial carcinoma (UC) and cervical cancer (CC), with Phase 3 registration trials underway [1] - 9MW2821 is also being tested in esophageal cancer (EC) and breast cancer (BC), with clinical data disclosed for CC, EC, and TNBC, aiming to compete with PADCEV through differentiated indications [1] - The company plans to conduct overseas clinical trials for 9MW2821, leveraging comprehensive domestic clinical data to potentially expand into international markets through licensing [1] - The ST2 monoclonal antibody 9MW1911 is in Phase 2 trials for COPD, leading among domestic companies [1] - Other pipeline products, including 7MW3711 (B7-H3 ADC) and 9MW2921 (TROP2 ADC), are in Phase 1/2 trials, while 8MW0511 (long-acting leukocyte booster) has had its marketing application accepted [1] - The company has demonstrated strong commercialization capabilities, with further product approvals and clinical progress expected to drive sales growth [1] Financial Performance - H1 sales reached RMB 116 million (+28.4%), driven by drug sales of RMB 66 million (+371.9%) and significant technology licensing income from the 9MW3011 project [5] - H1 net loss was RMB 445 million (+7.6%), with R&D expenses of RMB 322 million (-5.4%), sales expenses of RMB 113 million (+29.8%), and administrative expenses of RMB 112 million (+18.3%) [5] - Shipments of Maikang exceeded 20,000 units, while Maikang and Maijian completed commercial shipments [5] Revenue and Profit Forecast - Revenue for 2024-26 is projected to be RMB 417 million, RMB 887 million, and RMB 1.431 billion, representing year-on-year growth of 226%, 113%, and 61%, respectively [1] - Net profit attributable to shareholders for 2024-26 is forecasted to be RMB -749 million, RMB -516 million, and RMB -126 million, respectively [1] Pipeline Progress - 9MW1911 (ST2 monoclonal antibody) is in Phase 2 trials for COPD [1] - 7MW3711 (B7-H3 ADC) and 9MW2921 (TROP2 ADC) are in Phase 1/2 trials [1] - 8MW0511 (long-acting leukocyte booster) has had its marketing application accepted [1] Commercialization - The company has shown strong commercialization capabilities, with further product approvals and clinical progress expected to drive sales growth [1]