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| Monday, December 15, 2025 |
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CMS (867.HK/8A8.SG): Innovative Drug Oral JAK1 Inhibitor Povorcitinib Has Been Included in the List of Breakthrough Therapeutic Drugs in China |
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CMS (867.HK/8A8.SG): Innovative Drug Oral JAK1 Inhibitor Povorcitinib Has Been Included in the List of Breakthrough Therapeutic Drugs in China |
| more info >> |
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| Tuesday, December 16, 2025 |
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康哲藥業（867.HK/8A8.SG）：創新藥口服JAK1抑制劑Povorcitinib在中國獲納入「突破性治療品種」 |
| 12月15日，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，詳見康哲藥業日期為2025年4月22日發佈的公告）擁有相關許可權利的創新口服JAK1抑制劑povorcitinib（擬定中文通用名：磷酸泊沃昔替尼片）（「povorcitinib」或「產品」）已獲中國國家藥品監督管理局（「NMPA」）藥品評審中心批准納入突破性治療品種名單，擬定適應症為成人患者非節段型白癜風。此次認定有望加快該產品的研發與審評進程。 more info >> |
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康哲药业（867.HK/8A8.SG）：创新药口服JAK1抑制剂Povorcitinib在中国获纳入"突破性治疗品种" |
| 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，详见康哲药业日期为2025年4月22日发布的公告）拥有相关许可权利的创新口服JAK1抑制剂povorcitinib（拟定中文通用名：磷酸泊沃昔替尼片）（"povorcitinib"或"产品"）已获中国国家药品监督管理局（"NMPA"）药品评审中心批准纳入突破性治疗品种名单，拟定适应症为成人患者非节段型白癜风。此次认定有望加快该产品的研发与审评进程。 more info >> |
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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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