自願性及業務進展公告 創新藥磷酸蘆可替尼乳膏中國上市許可申請獲批 為中國批准的首款且唯一用於白癜風治療的靶向藥 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。 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） 在產品正式獲得NDA批准之前，本集團受益於國家賦予海南自由貿易港及樂城先行區 （「樂城先行區」）「先行先試」政策、「港澳藥械通」政策、北京市及天津自貿試驗 區的臨床急需進口藥品政策，已啟動磷酸蘆可替尼乳膏的試點應用。目前博鰲超級醫院 已為超7,000名非節段型白癜風患者開具磷酸蘆可替尼乳膏處方，且廣州、深圳、東莞、 佛山、中山、珠海、江門、惠州、北京及天津共二十餘家醫院已提供該藥品處方服務。 磷酸蘆可替尼乳膏在境外開展的兩項相同設計的III期雙盲、隨機、安慰劑對照研究 （TRuE-V1和TRuE-V2）中，產品治療 ...

Core Viewpoint - The article discusses the emergence of Demy Pharmaceutical, a subsidiary of Kangzhe Pharmaceutical, focusing on the development and market potential of the drug "Ruxolitinib Cream" for treating vitiligo, amidst a growing demand for effective skin health products in China [1][2]. Company Overview - Demy Pharmaceutical is set to independently list in Hong Kong, having submitted its prospectus in April 2023, and is positioned to capitalize on the skin health market, which is projected to be worth billions [1][2]. - The company has a strong product pipeline, including Ruxolitinib Cream, which is the only FDA-approved JAK inhibitor for vitiligo, and other skin-related products [3][5]. Market Potential - There are over 10 million vitiligo patients in China, and the market for effective treatments is largely untapped, with Ruxolitinib Cream expected to generate significant revenue, projected at $340 million in its first full sales year [4][10]. - The skin health market is characterized by a high demand for unique and effective treatments, with Demy focusing on products that have a strong market need and limited competition [7][11]. Financial Performance - Demy Pharmaceutical has shown promising financials, with revenues expected to exceed 600 million yuan in 2024, reflecting a growth trend in the skin health segment [2][7]. - The company has maintained a positive cash flow despite not yet being profitable, indicating strong market interest and potential for future growth [2][10]. Product Pipeline - The product pipeline includes several other skin prescription drugs, with a focus on unique and differentiated products that address significant medical needs [5][7]. - The company has successfully introduced products that are the only approved treatments for specific conditions in China, enhancing its competitive edge [7][11]. Sales Strategy - Demy Pharmaceutical's sales strategy emphasizes leveraging its parent company's marketing expertise and established distribution channels, with a focus on hospital and retail pharmacy coverage [10][12]. - The company has a strong commercial team, with over 85% of its workforce dedicated to sales, which is crucial for its growth in the competitive biopharmaceutical market [10][12].