Lepu Medical Technology (Beijing) Co., Ltd. (300003.SZ) announced today that its controlling subsidiary, Shanghai Minwei Biotechnology Co., Ltd., has received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) regarding the clinical trial of MWN117 Injection (IND number: 182860).

The MWN117 Injection is a siRNA drug independently developed by Shanghai Minwei Biotechnology that targets and inhibits INHBE, with global intellectual property rights. It received clinical trial approval from China's CDE in August 2026, with the indication being overweight or obesity.

INHBE is a member of the TGF-beta 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 blood circulation, binds to the ALK7 receptor on the surface of adipocytes, and activates downstream Smad2/3 signaling, ultimately inhibiting fat breakdown, promoting fat storage, and inducing insulin resistance. The drug can effectively reduce lipid accumulation by downregulating the INHBE gene and its encoded protein Activin E, thereby decreasing the activation of the Activin E-ALK7 lipid metabolism pathway.

Non-clinical study results showed that in a pharmacodynamic study on spontaneously obese rhesus monkeys, MWN117 Injection alone significantly reduced body fat percentage and visceral fat in the animals while increasing muscle mass. When MWN117 Injection was combined with a GLP-1 receptor agonist, it synergistically reduced body weight, body fat, and visceral fat in the animals, with the weight reduction significantly exceeding that of the GLP-1 receptor agonist alone. It also significantly inhibited the muscle loss caused by GLP-1 receptor agonist monotherapy. A single injection of MWN117 sustained its pharmacodynamic effect for up to 12 weeks. Meanwhile, safety evaluation studies showed that MWN117 Injection has a favorable safety profile.

MWN117 Injection is expected to offer patients clinical benefits that differ from traditional GLP-1 receptor agonists, such as reduced body fat and maintained muscle mass, along with a lower dosing frequency. According to searches, there are currently no similar drugs approved for marketing both domestically and internationally.