本集团于2024年3月31日，通过德镁医药的附属公司与Incyte就povorcitinib订立合作和许可协议，获得在 中国大陆、香港特别行政区、澳门特别行政区、臺湾地区及东南亚十一国(区域)研究、开发、注册及商 业化产品的独家许可权利，以及在区域内生产产品的非独家许可权利。德镁医药的附属公司已将 povorcitinib除中国大陆外的其他区域的相关权利再许可予本集团(不包括德镁医药及其附属公司)。 本次该产品获纳入突破性治疗药物品种名单，有望加速其在中国大陆的研发与审评进程。若于中国获批 上市，该产品将有望与德镁医药在售创新药益路取(替瑞奇珠单抗注射液)、在售独家药喜辽妥(多磺酸粘 多糖乳膏)及正处于新药上市申请(NDA)阶段的创新药磷酸芦可替尼乳膏形成协同，推动产品快速实现 临床和商业价值，惠及更多皮肤疾病患者。此外，该产品还将与外用磷酸芦可替尼乳膏共同为白癜风患 者提供差异化、全面的治疗选择。 康哲药业(00867)发布公告，集团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)拥有相关许可权利的创新口服JAK1抑制剂 povorcitini ...

本次该产品获纳入突破性治疗药物品种名单，有望加速其在中国大陆的研发与审评进程。若于中国获批 上市，该产品将有望与德镁医药在售创新药益路取(替瑞奇珠单抗注射液)、在售独家药喜辽妥(多磺酸粘 多糖乳膏)及正处于新药上市申请(NDA)阶段的创新药磷酸芦可替尼乳膏形成协同，推动产品快速实现 临床和商业价值，惠及更多皮肤疾病患者。此外，该产品还将与外用磷酸芦可替尼乳膏共同为白癜风患 者提供差异化、全面的治疗选择。 本集团于2024年3月31日，通过德镁医药的附属公司与Incyte就povorcitinib订立合作和许可协议，获得在 中国大陆、香港特别行政区、澳门特别行政区、臺湾地区及东南亚十一国(区域)研究、开发、注册及商 业化产品的独家许可权利，以及在区域内生产产品的非独家许可权利。德镁医药的附属公司已将 povorcitinib除中国大陆外的其他区域的相关权利再许可予本集团(不包括德镁医药及其附属公司)。 智通财经APP讯，康哲药业(00867)发布公告，集团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)拥有相关许可权利的创新口服 JAK1抑制剂po ...

Core Viewpoint - 康哲药业's subsidiary, 德镁医药, has submitted a listing application to the Hong Kong Stock Exchange, aiming for a spin-off listing without financing, reflecting a trend of pharmaceutical companies pursuing independent growth [1][6] Company Overview - 德镁医药, established in 2020, has been operating as an independent unit since 2021, focusing on skin health and ranking first among Chinese innovative pharmaceutical companies in skin prescription drug revenue in 2024 [2] - The skin disease treatment and care market in China is projected to reach a scale of 899 billion yuan in 2024, with a compound annual growth rate of 10.4% from 2024 to 2035 [2] Financial Performance - 德镁医药's revenue from 2022 to the first half of 2025 is reported as follows: 384 million yuan, 473 million yuan, 618 million yuan, and 498 million yuan, respectively, while the company has not yet achieved profitability, with net losses of 55.17 million yuan, 4.70 million yuan, 106 million yuan, and 31.08 million yuan during the same period [2][5] - The revenue structure is primarily composed of skin prescription drugs and dermatological skincare products, with prescription drugs accounting for nearly 90% of total revenue [2] Product Portfolio - The main products include益路取 (替瑞奇珠单抗注射液), 喜辽妥 (多磺酸粘多糖乳膏), and 安束喜 (聚多卡醇注射液), along with four candidates in clinical stages, targeting diseases like psoriasis and vitiligo [3] - The candidate product, 芦可替尼乳膏, is expected to be a new growth point, with its new drug application accepted by the National Medical Products Administration in September 2024 [3] Challenges Ahead - 德镁医药 faces challenges in original research capabilities, as its main products are primarily licensed or acquired, necessitating upfront licensing fees [4] - The company has incurred high sales and marketing expenses, attributing its losses to costs associated with promoting newly acquired or launched products [4][5] - The transition to an independent entity requires enhancing operational capabilities, as evidenced by the significant reduction in procurement from 康哲药业 over the years [5] Industry Context - The trend of pharmaceutical companies pursuing spin-off listings is gaining momentum, with several companies, including 三生制药 and 复星医药, also planning similar moves [6] - The rationale for these spin-offs includes expanding financing channels, accelerating internationalization, and enabling strategic transformation [6]

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 ...