Lepu Medical: Announcement on voluntary disclosure of three clinical phase I data and latest progress of MWN109 injection and oral tablets in China
Securities code: 300003 Securities abbreviation: Lepu Medical Announcement number: 2026-017
Lepu (Beijing) Medical Equipment Co., Ltd.
Regarding Voluntary Disclosure of MWN109 Injection and Oral Tablets China Three
Announcement of clinical phase I data and latest progress
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and contains no false records, misleading statements or major omissions.
Three phase I clinical trials of MWN109 injection and oral tablets independently developed by Shanghai Minwei Biotechnology Co., Ltd. (hereinafter referred to as "Minwei Biotechnology"), a holding subsidiary of Lepu (Beijing) Medical Devices Co., Ltd. (hereinafter referred to as the "Company"), were recently completed in China with the consent of the State Food and Drug Administration, and clinical research reports were recently received. The relevant information is now announced as follows:
1. Product information
MWN109 injection and oral tablets are GLP-1/GIP/GCG receptor triple agonists independently developed by the holding subsidiary Minwei Biotech and have global intellectual property rights. Its mechanism of action is to effectively control blood sugar by stimulating the secretion of insulin by pancreatic beta cells, increasing satiety and reducing energy intake by suppressing appetite and gastric emptying. At the same time, it promotes lipolysis and increases basal metabolic rate to increase energy consumption and effectively reduce weight.
2. Related information and main results of clinical research
- MWN109 injection phase Ia trial in China
The China Phase Ia trial of MWN109 Injection is a randomized, double-blind, placebo-controlled, single-dose/multiple-dose dose-escalation study conducted in Chinese participants, aiming to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of MWN109 Injection in healthy participants.
Safety: A total of 48 healthy participants were enrolled in this study, and all participants completed the study. There were no serious adverse events and no withdrawal from the study due to adverse events. MWN109 injection is safe and well tolerated in the dose range of 0.041.5mg for single administration and 3.04.5mg for multiple administrations.
Pharmacokinetics: Following subcutaneous injection of MWN109 injection, the PK profile supports a once-weekly dosing frequency of MWN109 injection.
Pharmacodynamics: After a single administration in the dose range of 0.041.5mg, the maximum mean reduction in body weight relative to the baseline is 3.49%; after 3 weeks of dose escalation, in the dose range of 3.04.5mg, the maximum mean reduction in body weight relative to the baseline is 8.37%.
- MWN109 injection phase Ib trial in China
The MWN109 Injection China Phase Ib trial is a randomized, double-blind, placebo-controlled, continuous dosing study for 14 weeks in non-diabetic overweight/obese participants in China, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of MWN109 injection in non-diabetic overweight/obese participants.
Safety: A total of 40 participants were dosed. Only 1 participant who received MWN109 injection withdrew due to adverse events related to MWN109 injection (3.1%, 1/32); the most common adverse events of MWN109 injection were gastrointestinal reactions, all of which were mild to moderate; MWN109 injection was safe and well tolerated within the target dose range of 3.0~9.0mg.
Pharmacokinetics: After subcutaneous injection of MWN109 injection, the PK profile supports a once-weekly dosing frequency of MWN109 injection.
Pharmacodynamics: Within the target dose range of 3.0 to 9.0 mg, and administered continuously for 14 weeks (including titration), the maximum mean weight reduction of the MWN109 injection treatment group relative to the baseline reached 16.67%, which was significantly better than the 0.99% reduction in the placebo group.
- MWN109 Oral Tablets Phase I Trial in China
The MWN109 oral tablet China Phase I trial is a randomized, double-blind, placebo-controlled, single-dose/multiple-dose dose-escalation study in Chinese participants designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of MWN109 oral tablet in healthy participants.
Safety: The single-dose study enrolled 58 healthy participants, and all participants completed the study. There were no serious adverse events and no withdrawal from the study due to adverse events. The multiple-dose study enrolled 40 healthy participants, and 1 participant withdrew early due to adverse events (3.1%, 1/32). There were no serious adverse events. Most adverse events that occurred during treatment were mild to moderate, mainly gastrointestinal-related events. MWN109 oral tablets are safe and well tolerated in the dosage range of 7.545mg for single administration and 7.545mg for multiple administrations.
Pharmacodynamics: MWN109 oral tablet is administered once daily for 4 weeks (including titration), at 7.5,
In the 15, 30, and 45 mg dose groups, the mean reductions in body weight relative to baseline were 4.18%, 5.72%, 6.99%, and 7.82% respectively, showing a dose-effect relationship, and were significantly better than the 0.84% decrease in the placebo group.
3. Risk warning
Pharmaceutical products are characterized by high technology, high risk, and high added value. The early stage of drug research and development and the product development, clinical trial approval, and production cycles are long, and are easily affected by factors such as technology, approval, and policies. There are many uncertainties in the progress and results of clinical trials, as well as the future product market competition. At present, the above-mentioned products under development are still in the clinical trial stage. There is uncertainty about whether the clinical trial results can support the drug's submission for marketing application, whether it can finally obtain marketing approval and when it will be approved. There is also a certain degree of uncertainty about whether the product can ultimately achieve its commercial purpose after approval. Investors are kindly requested to pay attention to potential investment risks.
Announcement is hereby made.
Board of Directors of Lepu (Beijing) Medical Devices Co., Ltd.
April 13, 2026