JAK1抑制剂

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康哲药业(00867) - 自愿性及业务进展公告 创新药口服小分子JAK1抑制剂Povorcitin...
2025-08-28 12:04
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其 準確性或完整性亦不發表任何聲明,並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 *僅供識別 自願性及業務進展公告 創新藥口服小分子JAK1抑制劑Povorcitinib 獲得白癜風、化膿性汗腺炎適應症藥物臨床試驗批准通知書 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本集團」) 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,詳見本公司日期為二零二五年四 月二十二日發佈的公告)連同其附屬公司於二零二五年八月二十七日獲中國國家藥品監 督管理局(NMPA)簽發的藥物臨床試驗批准通知書,於八月二十八日收到藥物臨床試 驗批准通知書。NMPA同意開展povorcitinib(擬定中文通用名:磷酸泊沃昔替尼片) (「povorcitinib」或「產品」)用於非節段型白癜風和中重度化膿性汗腺炎(HS)的臨 床試驗。 Povorcitinib 是一種選擇性口服小 ...
华东医药获得江苏威凯尔VC005口服剂型于中国大陆的独家商业化许可权利
Zhi Tong Cai Jing· 2025-08-11 14:29
Core Viewpoint - Huadong Medicine (000963.SZ) has entered into an exclusive commercialization agreement with Jiangsu Weikail Pharmaceutical Technology Co., Ltd. for the oral formulation VC005, which is a second-generation JAK1 inhibitor aimed at treating autoimmune diseases in China [1][2]. Group 1: Agreement Details - Huadong Medicine's subsidiary, Huadong Medicine (Hangzhou) Co., Ltd., will pay an initial payment of 50 million RMB and up to 180 million RMB in milestone payments to Jiangsu Weikail for the exclusive rights to commercialize VC005 in mainland China [1]. - VC005 is designed to selectively inhibit JAK1 while reducing the inhibitory activity on JAK2, potentially addressing safety concerns associated with excessive JAK2 inhibition [1]. Group 2: Clinical Development Status - VC005 has completed Phase II clinical trials for moderate to severe atopic dermatitis, showing comparable efficacy to Upadacitinib, with itch relief observed on the day of administration; it is currently in Phase III trials for this indication [2]. - The clinical trials for active ankylosing spondylitis have completed Phase II, with preparations for Phase III underway [2]. - For rheumatoid arthritis, VC005 has completed Phase Ib clinical trials, and for non-segmental vitiligo, it received IND approval in May 2025 and is set to initiate Phase II clinical trials [2]. - A sustained-release formulation of VC005 is also under simultaneous development [2].
恒生港股通创新药指数即将修订;恒瑞医药斑秃药物获批上市丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-06-30 23:31
Group 1: Index and Market Trends - The Hang Seng Hong Kong Stock Connect Innovative Drug Index will be revised to exclude CXO companies, focusing solely on innovative drug firms, achieving a 100% purity in its index composition [1] - This adjustment is expected to increase the weight of Hong Kong innovative drug companies in the index, better reflecting the core trends and valuation logic of the innovative drug industry [1] Group 2: Company Developments - Heng Rui Medicine received approval from the National Medical Products Administration for its innovative drug SHR0302 for treating severe alopecia areata, marking a significant advancement in domestic JAK1 inhibitors [2] - The approval addresses a substantial patient population in China, with approximately 3.49 million alopecia areata patients reported in 2021, highlighting the unmet medical need in this area [2] - Huiyu Pharmaceutical's TCE tri-antibody drug HY05350 has received clinical trial approval for treating advanced solid tumors, showcasing the company's capabilities in innovative drug development [3] - Han Yu Pharmaceutical expects a net profit of 142 to 162 million yuan for the first half of 2025, driven by strong global market demand and successful product approvals, indicating a recovery from previous losses [4] - The company's performance is significantly influenced by a few products in overseas markets, raising questions about future sustainability [4]