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迈威生物(688062.SH)重新向香港联交所递交H股发行上市申请并刊发申请资料
智通财经网· 2025-08-31 08:33
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]
迈威生物:9MW3811注射液临床试验申请获得国家药品监督管理局受理
Zhi Tong Cai Jing· 2025-08-31 08:30
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]
迈威生物重新向香港联交所递交H股发行上市申请并刊发申请资料
Zhi Tong Cai Jing· 2025-08-31 08:30
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。 ...
迈威生物:9MW3811注射液临床试验申请获国家药监局受理
Xin Lang Cai Jing· 2025-08-31 08:28
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]
迈威生物:重新向香港联交所递交H股发行并上市申请
Xin Lang Cai Jing· 2025-08-31 08:28
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]
迈威生物(688062.SH):重新向香港联交所递交H股发行并上市的申请并刊发申请资料
Ge Long Hui A P P· 2025-08-31 08:28
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]
迈威生物:重新向香港联交所递交H股发行上市申请并刊发申请资料
Mei Ri Jing Ji Xin Wen· 2025-08-31 08:20
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。 ...
迈威生物:地舒单抗注射液获得巴基斯坦上市许可
Xin Lang Cai Jing· 2025-08-31 08:20
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) ...
迈威生物:两款地舒单抗注射液获得巴基斯坦上市许可
Zheng Quan Shi Bao Wang· 2025-08-31 08:13
人民财讯8月31日电,迈威生物(688062)8月31日晚间公告,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。迈威生物同日公告,公司近日收到国家药品监督管理局签发的《受理通 知书》,9MW3811注射液用于病理性瘢痕适应症的II期临床试验申请已获正式受理。 ...
迈威生物:重新向香港联交所递交H股发行并上市的申请
Xin Lang Cai Jing· 2025-08-31 08:09
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]