Core Viewpoint - Maiwei Biotech has received the acceptance notice from the National Medical Products Administration (NMPA) for the Phase II clinical trial application of 9MW3811 injection for pathological scars, marking a significant step in its development pipeline [1][2] Group 1: Product Development - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The drug effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, intervening in the pathological progression of fibrotic diseases [1] - Preclinical studies have shown significant efficacy of 9MW3811 in various models, including pulmonary fibrosis, and potential applications in fibrotic diseases such as hypertrophic scars and abnormal uterine bleeding [1] Group 2: Clinical Trials and Market Position - 9MW3811 has been approved globally for clinical research in advanced malignant tumors and idiopathic pulmonary fibrosis, with Phase I trials completed in Australia and China showing good safety and a half-life exceeding one month [2] - The company plans to initiate Phase II clinical trials for pathological scars by the end of 2025, positioning itself as one of the first IL-11 targeted drugs to enter clinical stages in this indication [2]

Core Viewpoint - Maiwei Biotech (688062.SH) has received registration approval from the Drug Regulatory Authority of Pakistan (DRAP) for its two biosimilar products, 9MW0311 and 9MW0321, marking a significant milestone in the company's global commercialization strategy [1] Group 1: Product Approval - The two biosimilar products, known domestically as Mai Li Shu® and Mai Wei Jian®, are the first biosimilars of de-sumumab approved by the DRAP [1] - This approval represents the company's first overseas registration for its products, enhancing its competitive edge in the global market [1] Group 2: Market Potential - Pakistan, with a population of 240 million, is identified as a key emerging market with growing pharmaceutical demand, aligning with the company's strategic focus on expanding in such regions [1] - The approval is expected to positively impact the company's efforts to expand into new markets and improve its core competitiveness [1] Group 3: Global Strategy - As of the announcement date, the company has signed formal cooperation agreements covering dozens of countries in overseas markets [1] - The company aims to continue promoting the commercialization of its products in more countries, further enhancing the global accessibility of its de-sumumab injection [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received the acceptance notice from the National Medical Products Administration (NMPA) for the Phase II clinical trial application of 9MW3811 injection for pathological scar indications [1] Company Summary - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, developed independently by Maiwei Biotech, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The mechanism of 9MW3811 involves high-affinity binding to IL-11, effectively inhibiting the abnormal activation of the IL-11/IL-11Rα signaling pathway, thereby intervening in the pathological progression of fibrotic diseases [1] - Key advantages of 9MW3811 include higher target affinity and signaling blockade capability, as well as a half-life exceeding one month, making it suitable for the treatment of chronic diseases requiring long-term administration [1]

Core Viewpoint - The company, Maiwei Biotech (688062.SH), has submitted an application for issuing H-shares and listing on the Hong Kong Stock Exchange on August 29, 2025 [1] Group 1 - The application was submitted to the Hong Kong Stock Exchange and the relevant materials were published on the same day [1] - The application materials were prepared in accordance with the requirements of the Hong Kong Securities and Futures Commission and the Hong Kong Stock Exchange [1] - The published materials are in draft form and may be updated or revised as necessary [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received the acceptance notice from the National Medical Products Administration (NMPA) for the Phase II clinical trial application of 9MW3811 injection for pathological scar indications [1] Group 1: Product Information - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The mechanism of 9MW3811 involves high-affinity binding to IL-11, effectively inhibiting the abnormal activation of the IL-11/IL-11Rα signaling pathway, thereby intervening in the pathological progression of fibrotic diseases [1] Group 2: Competitive Advantages - The product boasts higher target affinity and signaling blockade capability [1] - It has a half-life of over one month, making it suitable for long-term administration in chronic disease treatment [1]

迈威生物(688062.SH)发布公告，公司已于2025年8月29日向香港联合交易所有限公司(简称"香港联交 所")重新递交了发行H股股票并在香港联交所主板挂牌上市的申请，并于同日在香港联交所网站刊登了 本次发行的申请资料。该申请材料为公司按照香港证券及期货事务监察委员会(简称"香港证监会")及香 港联交所的要求编制和刊发，为草拟版本，其所载资料可能会适时作出更新及修订，投资者不应根据其 中的资料作出任何投资决定。 ...

Core Viewpoint - The company, Maiwei Biotech, has received formal acceptance from the National Medical Products Administration for its clinical trial application of 9MW3811 injection for the indication of pathological scars [1] Group 1 - The clinical trial application for 9MW3811 has been officially accepted for Phase II trials [1] - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, developed independently by the company [1] - The product is classified as a Class 1 therapeutic biological product and holds independent intellectual property rights [1]

Core Viewpoint - The company, Maiwei Biotech, has re-submitted its application for issuing H-shares and listing on the Hong Kong Stock Exchange on August 29, 2025, indicating a strategic move to attract foreign investment and comply with regulatory requirements [1] Group 1 - The application materials were prepared and published in accordance with the requirements of the Hong Kong Securities and Futures Commission and the Hong Kong Stock Exchange [1] - The submitted documents are in draft form and may be updated and revised as necessary [1] - If the issuance is implemented, the target investors will be limited to qualified foreign investors and domestic qualified investors who are authorized to conduct overseas securities investments under Chinese laws and regulations [1]

Core Viewpoint - The company, Maiwei Biotech (688062.SH), has submitted an application for issuing H-shares and listing on the Hong Kong Stock Exchange on August 29, 2025 [1] Group 1 - The application was made in compliance with the requirements of the Hong Kong Securities and Futures Commission and the Hong Kong Stock Exchange [1] - The submitted materials are in draft form and may be updated or revised as necessary [1] - Investors are advised not to make investment decisions based solely on the information contained in the application materials [1]

每经AI快讯，迈威生物公告，公司已于2025年8月29日向香港联合交易所有限公司重新递交了发行H股 股票并在香港联交所主板挂牌上市的申请，并于同日在香港联交所网站刊登了本次发行的申请资料。 ...