Core Viewpoint - 康哲药业's subsidiary 德镁医药 has received approval from the NMPA for its innovative oral JAK1 inhibitor povorcitinib, aimed at treating non-segmental vitiligo in adults, which is expected to accelerate the product's development and review process in China [1][2] Group 1 - The product povorcitinib has been included in the list of breakthrough therapeutic drugs, which is anticipated to expedite its research and review process in mainland China [2] - If approved for sale in China, povorcitinib is expected to synergize with 德镁医药's existing innovative drugs, enhancing clinical and commercial value for skin disease patients [2] - The product will provide differentiated and comprehensive treatment options for vitiligo patients alongside the topical formulation of phosphoric acid alfacalcidol [2] Group 2 - On March 31, 2024, the company entered into a collaboration and licensing agreement with Incyte for povorcitinib, securing exclusive rights for research, development, registration, and commercialization in mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries [2] - The subsidiary has sublicensed rights for povorcitinib in regions outside mainland China back to the company, excluding 德镁医药 and its subsidiaries [2]

Core Viewpoint - 康哲药业's subsidiary 德镁医药 has received approval from the NMPA for its innovative oral JAK1 inhibitor povorcitinib, which is expected to accelerate the drug's development and review process in China for treating non-segmental vitiligo [1][2] Group 1: Product Development - 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, moderate to severe hidradenitis suppurativa, and nodular prurigo in several overseas countries, along with a Phase 2 trial for asthma [1] Group 2: Market Potential - The inclusion of povorcitinib in the breakthrough therapy list is expected to expedite its research and review process in mainland China, potentially leading to a faster market launch [2] - If approved, povorcitinib will complement 德镁医药's existing innovative drugs, enhancing clinical and commercial value for skin disease patients [2] - The product will provide differentiated and comprehensive treatment options for vitiligo patients alongside the topical formulation of phosphoric acid lukotinin ointment [2] Group 3: Licensing and Collaboration - On March 31, 2024, 德镁医药 entered into a collaboration and licensing agreement with Incyte for povorcitinib, securing exclusive rights for research, development, registration, and commercialization in mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries [2] - The subsidiary has sublicensed rights for regions outside mainland China, excluding 德镁医药 and its subsidiaries [2]

Core Viewpoint - 康哲药业's subsidiary, 德镁医药, is applying for an independent listing on the Hong Kong Stock Exchange, focusing on innovative pharmaceuticals for skin health [1] Group 1: Company Developments - 德镁医药 has received approval from the National Medical Products Administration (NMPA) for its innovative oral JAK1 inhibitor, povorcitinib, to be included in the list of breakthrough therapies [1] - The proposed indication for povorcitinib is for adult patients with non-segmental vitiligo, which is expected to accelerate the product's research and review process [1] Group 2: Market Implications - The listing on the Hong Kong Stock Exchange is scheduled for April 22, 2025, indicating a strategic move to enhance capital and visibility in the market [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。 二零二五年八月，德鎂醫藥獲NMPA簽發的藥物臨床試驗批准通知書，同意開展 povorcitinib用於治療非節段型白癜風等適應症的臨床試驗。德鎂醫藥已啓動產品在中國 的臨床開發工作，並考慮擇機在中國推動其治療HS和結節性癢疹等皮膚相關疾病的臨 *僅供識別 1 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （香港股份代號：867） （新加坡股份代號：8A8） 自願性及業務進展公告 創新藥口服小分子JAK1抑制劑Povorcitinib 納入突破性治療品種名單 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 ...

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 ...