Core Viewpoint - Maiwei Biotech has received approval from the National Medical Products Administration for the clinical trial application of 9MW3811 injection for the treatment of pathological scars, marking a significant step in its drug development process [2][4]. Drug Basic Information - Drug Name: 9MW3811 Injection - Application: Clinical trial for domestic drug registration - Applicant: Maiwei Biotech - Clinical Trial Notification Number: 2025LP02967 - Approval Conclusion: The application meets the requirements for drug registration and is approved to proceed with clinical trials [2]. Drug Mechanism and Potential - IL-11 is a cytokine involved in chronic inflammation and fibrosis-related diseases, playing a crucial role in the fibrotic processes of various organs [3]. - Pathological scars include hypertrophic scars, keloids, and contracture scars, with IL-11 being particularly significant in their formation [3]. - 9MW3811 is a humanized monoclonal antibody targeting IL-11, designed to inhibit the abnormal activation of the IL-11/IL-11Rα signaling pathway, thus intervening in the pathological progression of fibrosis-related diseases [4]. Clinical Development and Market Potential - 9MW3811 has shown significant efficacy in preclinical studies for pulmonary fibrosis and other fibrosis-related diseases, with a global patient population of approximately 25 million for pathological scars, including about 7.4 million in China [4]. - The company plans to initiate Phase II clinical trials for 9MW3811 targeting pathological scars by the end of 2025, positioning it as the first IL-11 targeted drug to enter clinical stages for this indication [5]. - Maiwei Biotech has entered into an exclusive licensing agreement with CALICO LIFE SCIENCES LLC, which includes an upfront payment of $25 million and potential milestone payments totaling up to $571 million, indicating strong commercial prospects for 9MW3811 [5].