Lepu Medical (300003.SZ): MWX401 injection received approval for clinical drug trials

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Tongxin Finance APP News, Lepu Medical (300003.SZ) announced that today the company’s wholly owned subsidiary, Shanghai Minwei Biotechnology Co., Ltd. (hereinafter referred to as “Minwei Biotech”), received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA) (Notification No.: 2026LP00519), approving the clinical trial application for MWX401 injection submitted by Minwei Biotech.

MWX401 injection is an independently developed small interfering RNA (siRNA) drug by Shanghai Minwei Biotech, with global intellectual property rights. It was submitted to the CDE for clinical trial application in December 2025, indicated for the treatment of primary hypertension. Non-clinical studies show that MWX401 can significantly reduce serum target protein levels, mRNA levels, systolic and diastolic blood pressure in humanized hypertensive mice; in spontaneously hypertensive rhesus monkeys, a single subcutaneous injection of different doses of MWX401 significantly lowered AGT levels, as well as systolic and diastolic blood pressure, demonstrating a good dose-response relationship, superior to the positive control valsartan. The blood pressure reduction can be maintained until the end of the trial, with pharmacological effects lasting at least 12 weeks in animals. Safety evaluation tests indicate that MWX401 has good safety profile.

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