Lepu Medical Technology (300003.SZ) subsidiary receives U.S. FDA approval for clinical trial of MWN117 injection.

Lepu Medical Technology (300003.SZ) announced that today the company learned that its controlling subsidiary Shanghai Minwei Biotechnology Co., Ltd. (hereinafter referred to as "Shanghai Minwei Biotechnology") received a notice from the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA") approving the conduct of clinical trials for MWN117 Injection (Study May Proceed Letter, IND No.: 182860). MWN117 Injection is an siRNA drug independently developed by Shanghai Minwei Biotechnology that targets and inhibits INHBE, with global intellectual property rights. It received CDE clinical trial approval in August 2026, with the indication being overweight or obesity. INHBE is a member of the TGF- superfamily and is specifically expressed in hepatocytes. The INHBE protein forms Activin E through dimerization. After being released by the liver, Activin E reaches adipose tissue through the bloodstream, binds to the ALK7 receptor on the surface of adipocytes, and thereby activates downstream Smad2/3 signaling, ultimately inhibiting lipolysis, promoting fat storage, and inducing insulin resistance. The drug can effectively reduce lipid accumulation by downregulating the level of the INHBE gene and its encoded protein Activin E, thereby reducing activation of the lipid metabolism pathway Activin E-ALK7. Nonclinical study results showed that in a pharmacodynamic study in spontaneously obese rhesus monkeys, MWN117 Injection alone significantly reduced animal body fat percentage and visceral fat while increasing muscle mass. After MWN117 Injection was combined with a GLP-1 receptor agonist, it synergistically reduced animal body weight, body fat, and visceral fat, with the magnitude of weight loss significantly exceeding that of the GLP-1 receptor agonist alone, while also significantly inhibiting the muscle loss caused by the GLP-1 receptor agonist alone. The pharmacodynamic effect of a single injection of MWN117 lasted up to 12 weeks. At the same time, safety evaluation trials showed that MWN117 Injection has good safety. MWN117 Injection is expected to bring patients clinical effects that differ from traditional GLP-1 receptor agonists, such as reduced body fat and maintained muscle, while also requiring less frequent administration. According to searches, there are currently no similar drugs approved for marketing domestically or internationally.