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| Thursday, December 11, 2025 |
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CMS (867/8A8): NDA of Innovative Drug Y-3 for Injection for Acute Ischemic Stroke Accepted in China |
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CMS (867/8A8): NDA of Innovative Drug Y-3 for Injection for Acute Ischemic Stroke Accepted in China |
| China Medical System Holdings Limited (the "Group" or "CMS") is pleased to announce that on 11 December 2025, the New Drug Application (NDA) of Class 1 Innovative Drug Y-3 for Injection (proposed English generic name: Loberamisal for Injection) ("Y-3 for Injection" or the "Product") has been accepted by National Medical Products Administration of the People's Republic of China (NMPA). The Product is a brain cytoprotectant indicated for the treatment of acute ischemic stroke. more info >> |
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康哲藥業（0867）抗急性缺血性卒中創新藥注射用Y-3中國NDA獲受理 |
| 康哲藥業控股有限公司（"康哲藥業"）欣然宣佈，1類新藥注射用Y-3（擬定中文通用名：注射用洛貝米柳）（"注射用Y-3"或"產品"）新藥上市許可申請（NDA）已於2025年12月11日獲得中國國家藥品監督管理局（NMPA）受理。 more info >> |
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康哲药业（0867）抗急性缺血性卒中创新药注射用Y-3中国NDA获受理 |
| 康哲药业控股有限公司（"康哲药业"）欣然宣布，1类新药注射用Y-3（拟定中文通用名：注射用洛贝米柳）（"注射用Y-3"或"产品"）新药上市许可申请（NDA）已于2025年12月11日获得中国国家药品监督管理局（NMPA）受理。 more info >> |
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| Thursday, October 30, 2025 |
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CMS (867.HK; 8A8.SG) NDA for AD Indication of Long-acting Anti-IL-4Ra Humanized Monoclonal Antibody Injection MG-K10 Accepted in China |
| China Medical System Holdings Limited ("CMS") is pleased to announce that its subsidiary, Dermavon Holdings Limited ("Dermavon", an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited, please refer to the announcement of CMS on 22 April 2025 for details) together with its subsidiaries, holds co-development rights (except for atopic dermatitis (AD)) and exclusive commercialization rights for the Class 1 innovative drug anti-IL-4Rα MG-K10 humanized monoclonal antibody injection ("MG-K10" or the "Product"). more info >> |
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CMS (867.HK; 8A8.SG) NDA for AD Indication of Long-acting Anti-IL-4Ra Humanized Monoclonal Antibody Injection MG-K10 Accepted in China |
| China Medical System Holdings Limited ("CMS") is pleased to announce that its subsidiary, Dermavon Holdings Limited ("Dermavon", an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited, please refer to the announcement of CMS on 22 April 2025 for details) together with its subsidiaries, holds co-development rights (except for atopic dermatitis (AD)) and exclusive commercialization rights for the Class 1 innovative drug anti-IL-4Rα MG-K10 humanized monoclonal antibody injection ("MG-K10" or the "Product"). more info >> |
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康哲藥業（867.HK;8A8.SG）長效抗IL-4Rα人源化單抗注射液MG-K10特應性皮炎適應症中國NDA已獲受理 |
| 康哲藥業控股有限公司（「康哲藥業」）欣然宣佈，旗下德鎂醫藥有限公司（「德鎂醫藥」，專業聚焦皮膚健康的創新型醫藥企業，正申請於香港聯合交易所有限公司主板獨立上市，詳見康哲藥業2025年4月22日發佈的公告）連同其附屬公司擁有共同開發權（除特應性皮炎（AD）外）和獨家商業化權利的1類新藥抗IL-4Rα MG-K10人源化單抗注射液（「MG-K10」或「產品」）中國上市許可申請（「NDA」）於2025年10月30日獲得中國國家藥品監督管理局（NMPA）受理。 more info >> |
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康哲药业（867.HK;8A8.SG）长效抗IL-4Rα人源化单抗注射液MG-K10特应性皮炎适应症中国NDA已获受理 |
| 康哲药业控股有限公司（"康哲药业"）欣然宣布，旗下德镁医药有限公司（"德镁医药"，专业聚焦皮肤健康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市，详见康哲药业2025年4月22日发布的公告）连同其附属公司拥有共同开发权（除特应性皮炎（AD）外）和独家商业化权利的1类新药抗IL-4Rα MG-K10人源化单抗注射液（"MG-K10"或"产品"）中国上市许可申请（"NDA"）于2025年10月30日获得中国国家药品监督管理局（NMPA）受理。产品拟用于治疗外用药控制不佳或不适用外用药治疗的成人中重度特应性皮炎。 more info >> |
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| Monday, October 27, 2025 |
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CMS (867.HK; 8A8.SG) Signed A Distribution Agreement for Ophthalmic Drugs Lucentis(R) and Beovu(R) |
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CMS (867.HK; 8A8.SG) Signed A Distribution Agreement for Ophthalmic Drugs Lucentis(R) and Beovu(R) |
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