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。 ...

来源：第一财经 迈威生物公告，公司近日收到合作客户The Searle Company Limited的通知，公司两款地舒单抗注射液 9MW0311和9MW0321（国内商品名：迈利舒®和迈卫健®）已获得巴基斯坦药品监管局的注册批准。 这是巴基斯坦药品监管局首次批准的地舒单抗生物类似药，也是公司首个获得海外注册批件的产品。 (本文来自第一财经) ...

Core Viewpoint - Maiwei Biotech (688062) has received regulatory approval for two biosimilar products in Pakistan, marking a significant milestone for the company and the biosimilar market in the region [1] Group 1: Regulatory Approvals - The Searle Company Limited has notified Maiwei Biotech that its two biosimilar injections, 9MW0311 and 9MW0321, have been approved by the Pakistan Drug Regulatory Authority [1] - This approval represents the first registration of a biosimilar drug for de-sulfanil in Pakistan [1] - The products are marketed under the names Mai Li Shu and Mai Wei Jian in China [1] Group 2: Clinical Trials - Maiwei Biotech has also received an acceptance notice from the National Medical Products Administration for the Phase II clinical trial application of 9MW3811 injection, which is intended for the treatment of pathological scars [1]

Core Viewpoint - The company 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 access international capital markets [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 - Maiwei Biotech has received the acceptance notice from the National Medical Products Administration for the Phase II clinical trial application of 9MW3811 injection for pathological scars, marking a significant step in its development pipeline [1] Group 1: Product Development - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, developed independently by Maiwei Biotech and holds proprietary intellectual property [1] - Preclinical studies have demonstrated significant efficacy of 9MW3811 in various models, including pulmonary fibrosis, and it shows potential application value in fibrosis-related diseases such as scar hyperplasia and abnormal uterine bleeding [1] - The company plans to initiate the Phase II clinical trial for 9MW3811 targeting pathological scars by the end of 2025, positioning it as one of the first IL-11 targeted drugs to enter clinical stages in this indication area [1]

Core Viewpoint - The company has received regulatory approval for two biosimilar products in Pakistan, marking a significant milestone in its international expansion efforts [1] Group 1: Product Approval - The Searle Company Limited has notified the company that its two biosimilar injections, 9MW0311 and 9MW0321, have been approved by the Drug Regulatory Authority of Pakistan (DRAP) [1] - This approval represents the first registration of a biosimilar drug for denosumab by the DRAP [1] - The products are the company's first to receive overseas registration, indicating a successful entry into the international market [1] Group 2: Product Details - 9MW0311, marketed as "迈利舒" in China, is indicated for osteoporosis in postmenopausal women at high risk of fractures [1] - 9MW0321, marketed as "迈卫健" in China, is used for the treatment of giant cell tumor of bone (GCTB) that cannot be surgically removed or where surgery may lead to severe functional impairment [1]