On November 10, Maiwei Biotechnology (688062) issued an announcement stating that the company recently received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, which approved the application for Phase II clinical trial of 9MW3811 injection for the indication of pathological scars.
The clinical trial notification number for this drug is 2025LP02967. The approval conclusion shows that it meets the relevant requirements for drug registration and allows clinical trials to be conducted. 9MW3811 is a humanized monoclonal antibody targeting human IL-11 independently developed by the company. It has high target affinity and signal blocking ability and is expected to demonstrate efficacy in various diseases such as pathological scars and pulmonary fibrosis.
The company plans to launch its Phase II clinical trial for pathological scars by the end of 2025 and has entered into an exclusive licensing agreement with CALICO LIFE SCIENCES LLC. CALICO has already paid the company an upfront payment of $25 million, and the company will also receive milestone payments and royalties of up to $571 million.
In the first three quarters of 2025, Maiwei Bio achieved revenue of 566 million yuan and net profit attributable to the parent company of -598 million yuan.

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