Core Viewpoint - Maiwei (Shanghai) Biotechnology Co., Ltd. has received acceptance from the National Medical Products Administration (NMPA) for the clinical trial application of 9MW3811 injection for the treatment of pathological scars, marking a significant step in the drug's development process [1][2]. Drug Information - Drug Name: 9MW3811 Injection - Application: Clinical trial registration for domestic production - Acceptance Number: CXSL2500751 - Applicant: Maiwei (Shanghai) Biotechnology Co., Ltd. - Approval Conclusion: The application has been accepted according to the Administrative Licensing Law of the People's Republic of China [1]. Mechanism and Efficacy - IL-11 is a cytokine that plays a crucial role in chronic inflammation and fibrosis-related diseases, significantly involved in the fibrotic processes of various organs [1]. - 9MW3811 effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, which is critical in the progression of fibrosis-related diseases [1]. - Preclinical studies have shown that 9MW3811 exhibits significant efficacy in models of pulmonary fibrosis and has potential applications in other fibrosis-related diseases [2]. Market Potential - The global patient population for pathological scars is approximately 25 million, with around 7.4 million in China, and the incidence is on the rise, expected to exceed 10 million in China by 2030 [2]. - Targeted therapy against IL-11 presents significant clinical value and market prospects [2]. Development Progress - The company has completed Phase I trials in Australia and China, demonstrating good safety and a half-life exceeding one month, positioning it as a leader in the global development of similar targeted therapies [2]. - The company plans to initiate Phase II clinical trials for pathological scars by the end of 2025, aiming to be among the first IL-11 targeted drugs in this indication [2]. Licensing Agreement - The company has entered into an exclusive licensing agreement with CALICO LIFE SCIENCES LLC, granting CALICO global rights outside Greater China, with an upfront payment of $25 million and potential milestone payments up to $571 million [3]. - CALICO, a subsidiary of Alphabet, focuses on anti-aging therapies, indicating a broad application potential for 9MW3811 in various fibrotic diseases and aging-related conditions [3][4].