中金主要观点如下： NMPA获批首款且唯一用于白癜风治疗的靶向药，具有较大临床潜力 芦可替尼乳膏是Incyte开发的JAK1/JAK2抑制剂，也是经FDA批准的首款且唯一用于非节段型白癜风复 色药物。根据公告公司估算，中国约1030万人患有白癜风(820万人患有非节段性白癜风)，现有 TCS/TCIs治疗存在临床缺陷，长期用药具有不良反应或疗效有限，该行认为芦可替尼乳膏国内获批有 望填补白癜风靶向治疗空白，满足临床未被满足需求。 智通财经APP获悉，中金发布研报称，维持康哲药业(00867)"跑赢行业"评级，考虑板块中枢上行上调目 标价7%至16.50港元。该行维持25年盈利预测17.35亿元，考虑新品上市带来收入增量上调26年盈利预测 5%至19.84亿元，引入27年盈利预测24.18亿元。公司公告旗下德镁医药的磷酸芦可替尼乳膏已于2026年 1月30日经NMPA获批上市，用于治疗12岁及以上儿童和成人患者伴面部受累的非节段型白癜风。 芦可替尼乳膏在境外开展的III期(TRuE-V1和TRuE-V2)临床中，治疗24周后达到F-VASI75患者比例均为 29.9%，显著高于安慰剂组的7.5%和12.9%，持 ...

中金发布研报称，维持康哲药业(00867)"跑赢行业"评级，考虑板块中枢上行上调目标价7%至16.50港 元。该行维持25年盈利预测17.35亿元，考虑新品上市带来收入增量上调26年盈利预测5%至19.84亿元， 引入27年盈利预测24.18亿元。公司公告旗下德镁医药的磷酸芦可替尼乳膏已于2026年1月30日经NMPA 获批上市，用于治疗12岁及以上儿童和成人患者伴面部受累的非节段型白癜风。 芦可替尼乳膏在境外开展的III期(TRuE-V1和TRuE-V2)临床中，治疗24周后达到F-VASI75患者比例均为 29.9%，显著高于安慰剂组的7.5%和12.9%，持续使用至52周复色效果持续。目前博鳌超级医院已为超 过7000名非节段型白癜风患者开具处方，且广州、深圳等20余家医院已提供该药品处方服务。 德镁医药皮肤治疗产品矩阵进一步丰富，有望贡献更多收入弹性 该行认为，芦可替尼有望和其正处于商业化阶段创新药益路取(替瑞奇珠单抗)、独家药喜辽妥(多磺酸粘 多糖乳膏)发挥皮肤科协同效应，同时芦可替尼AD适应症国内III期已取得阳性结果，公司正积极推进 AD适应症NDA申请工作。此外，德镁医药已授权公司在港澳台以及 ...

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, 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 ...