Lepu Medical (300003.SZ) subsidiary MWN110 injection clinical trial application approved

Zhitong Finance App News, Lepu Healthcare (300003.SZ) issued an announcement. The company learned today that the company's holding subsidiary Shanghai Minwei Biotechnology Co., Ltd. (“Shanghai Minwei Biotech”) has received the “Drug Clinical Trial Approval Notice” approved and issued by the State Drug Administration, and the MWN110 injection clinical trial application declared by Shanghai Minwei Biology has been approved.

According to reports, MWN110 injection is a monoclonal antibody targeting ActriIA/b independently developed by Shanghai Minwei Biotech. It has global intellectual property rights and submitted a clinical trial application to the CDE in May 2026. The indication is adult weight control. Non-clinical study results showed that in pharmacodynamics studies on spontaneous obesity rhesus monkeys, MWN110 alone can significantly reduce body fat percentage, body weight, and increase muscle mass in animals. After MWN110 is used in combination with simeglutide, it can significantly inhibit muscle loss caused by simeglutide alone. Compared with the positive control Bimagrumab, it can achieve equivalent efficacy at 1/3 dose, and the half-life of MWN110 after multiple doses was more than 3 times that of positive control. In planned clinical practice, subcutaneous administration was used. At the same time, safety evaluation tests showed that MWN110 has good safety. MWN110 is expected to provide patients with clinical effects that are different from traditional GLP-1 drugs, such as loss of body fat, muscle maintenance, and smaller weight rebound. According to inquiries, there are currently no similar drugs approved for marketing at home or abroad.