Nectin-4 ADC rapidly advances clinical practice in multiple indications. Maiwei Biotech's core product, 9mW2821, is a domestically produced Nectin-4 ADC with the fastest development progress. It has entered phase 3 registered clinical trials for urothelial cancer (UC) and cervical cancer (CC). In addition, 9MW2821 has also carried out multiple clinical trials for indications such as esophageal cancer (EC) and breast cancer (BC). In addition to UC indications, 9MW2821 also revealed clinical data in CC, EC, and TNBC, hoping to compete with PADCEV with differentiated indications.

The company will develop 9MW2821 clinical trials overseas. Combined with comprehensive domestic clinical data support, it is expected to expand overseas markets through authorized overseas travel.

Subsequent pipeline products have made positive progress. The company's ST2 monoclonal antibody 9MW1911 is currently undergoing phase 2 COPD clinical trials, leading the way among domestic companies. 7MW3711 (B7-H3 ADC), 9MW2921 (TROP2ADC) are undergoing Phase 1/2 clinical trials. The marketing application for 8MW0511 (Long-acting Whitening Needle) has been accepted.

The company already has good commercialization capabilities, and subsequent product approval and clinical progress will drive the company's sales growth further.

The commercialization of biosimilar drugs is progressing smoothly. Maiwei Biotech achieved sales of 0.116 billion yuan (+28.4%) in the first half of the year, mainly pharmaceutical sales revenue of 0.066 billion yuan (+371.9%); at the same time, the 9MW3011 project confirmed that technology licensing revenue was high. The company's net loss in the first half of the year was 0.445 billion yuan (+7.6%), R&D expenses 0.322 billion yuan (-5.4%), sales expenses 0.113 billion yuan (+29.8%), and management expenses 0.112 billion yuan (+18.3%).

In the first half of the year, Milishu added shipments of about 0.117 million units. My Health was approved for listing and completed commercial delivery, and Junmaikang added more than 0.02 million units.

Investment advice: Maintain an “better than the market” rating.

The company's core product, 9MW2821, has entered phase 3 clinical trials, and data has been read out in multiple indications; positive progress has been made in subsequent pipelines, and commercialization of existing products is progressing smoothly. We maintain the company's profit forecast. We expect revenue for 2024-26 to be 0.417/0.887/1.431 billion yuan, up 226%/113%/61% year-on-year, and net profit to mother of -0.749/ -0.516/-0.126 billion yuan, respectively, maintaining the “superior to the market” rating.

Risk warning: Innovative drug development has failed or is progressing below expectations; innovative drug sales fall short of expectations.