Core Viewpoint - 康哲药业's stock rose over 4% following the approval of its innovative oral small molecule JAK1 inhibitor, Povorcitinib, to commence clinical trials for treating non-segmental vitiligo and moderate to severe hidradenitis suppurativa [1] Group 1: Company Developments - 康哲药业's subsidiary, 德镁医药有限公司, received a clinical trial approval notice from the National Medical Products Administration (NMPA) of China on August 27, 2025, and officially received the notice on August 28, 2025 [1] - The approved clinical trials for Povorcitinib will focus on non-segmental vitiligo and moderate to severe hidradenitis suppurativa [1] Group 2: Product Information - Povorcitinib is a selective oral small molecule JAK1 inhibitor, which holds substance and use patents in specific countries/regions [1] - Currently, Povorcitinib is undergoing Phase 3 clinical trials for non-segmental vitiligo, hidradenitis suppurativa, and nodular prurigo in several overseas countries, along with Phase 2 trials for asthma and chronic spontaneous urticaria [1]

Core Viewpoint - 康哲药业's stock price increased by over 4% in the morning session, currently trading at 13.59 HKD with a transaction volume of 66.4 million HKD, following the announcement of clinical trial approvals for its drug povorcitinib [1] Group 1: Company Developments - 康哲药业's subsidiary, 德镁医药有限公司, is applying for an independent listing on the Hong Kong Stock Exchange [1] - The company received a clinical trial approval notice from the National Medical Products Administration (NMPA) of China for povorcitinib on August 28, 2025 [1] - NMPA has approved clinical trials for povorcitinib targeting non-segmental vitiligo and moderate to severe hidradenitis suppurativa (HS) [1] Group 2: Product Information - Povorcitinib is a selective oral small molecule JAK1 inhibitor, with substance and use patents in specific countries/regions [1] - The drug is currently undergoing Phase 3 clinical trials for non-segmental vitiligo, HS, and nodular prurigo in several overseas countries [1] - Additionally, Phase 2 clinical trials for asthma and chronic spontaneous urticaria are also in progress [1]

Core Viewpoint - 康哲药业's subsidiary 德镁医药 is seeking independent listing on the Hong Kong Stock Exchange and has received clinical trial approval for povorcitinib from the NMPA for treating non-segmental vitiligo and moderate to severe hidradenitis suppurativa [1] Group 1 - 德镁医药 has been granted a drug clinical trial approval notice by the NMPA on August 28, 2025, for povorcitinib [1] - Povorcitinib is a selective oral small molecule JAK1 inhibitor with substance and use patents in specific countries/regions [1] - The drug is currently undergoing phase 3 clinical trials for non-segmental vitiligo, hidradenitis suppurativa, and nodular prurigo in several overseas countries, along with phase 2 trials for asthma and chronic spontaneous urticaria [1]

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 ...