Investment Rating - The investment rating for the company is "Buy" [2][10] Core Insights - The company is a leading domestic specialized commercialization enterprise, and its innovative transformation has initiated a new growth cycle [5][18] - The company has excellent commercialization capabilities and a comprehensive research, production, and sales layout in the Southeast Asian market [6][20] - The company has four major business segments that are progressing in synergy, with stable contributions from cardiovascular and digestive health, and new growth momentum from skin health and ophthalmology [7][19] - The innovative pipeline is entering a harvest period, with multiple innovative products nearing commercialization [8][19] - The company has strong profitability and cash flow, providing a solid safety net for its innovative transformation and maintaining a stable high dividend policy [21] Summary by Sections 1. Company Overview - Founded in 1992, the company has evolved from a pharmaceutical agency to an innovative comprehensive pharmaceutical enterprise [22] - The company has a clear shareholding structure, with the actual controller being Mr. Lin Gang [28] - The negative impact of centralized procurement has been largely digested, with revenue and profit growth turning positive in the first half of 2025 [30] 2. Commercialization Capabilities - The company has a robust commercialization system, covering over 50,000 hospitals and 300,000 retail pharmacies, supported by a professional team of approximately 4,700 academic promoters [39] - The company has established a complete strategic layout in Southeast Asia, integrating research, registration, commercialization, and manufacturing [47] 3. Business Segments - The cardiovascular segment contributes approximately 48% of revenue, with the impact of centralized procurement clearing up and new products gaining traction [54] - The digestive and autoimmune segment accounts for about 30% of revenue, with stable growth from exclusive products and significant potential from innovative products [7] - The skin health segment, operated independently by a subsidiary, has high growth potential, with plans for a separate listing to reassess its value [7] - The ophthalmology segment contributes around 8% of revenue, with a competitive product portfolio including exclusive products and newly introduced drugs [7] 4. Innovative Pipeline - The company has nearly 40 innovative products in its pipeline, with six already commercialized and several others nearing NDA submission [8][19] - Key innovative products include Y-3 for acute ischemic stroke, Dexamethasone for chronic kidney disease, and ZUNVEYL for Alzheimer's disease, with peak sales potential exceeding 10 billion [8][19] 5. Financial Forecasts - Revenue projections for 2025-2027 are estimated at 82.16 billion, 98.59 billion, and 120.28 billion respectively, with year-on-year growth rates of 10%, 20%, and 22% [9] - Net profit forecasts for the same period are 16.15 billion, 18.50 billion, and 22.38 billion, with growth rates of 0%, 15%, and 21% [9]

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） 磷酸蘆可替尼乳膏已在輕中度AD的一項隨機、雙盲、安慰劑對照中國三期藥物臨床研 究成功達到主要終點，即使用產品治療8周，達到研究者整體評估（IGA）評分為0或1 分，且較基線改善≥2分的受試者比例，顯著高於安慰劑（63.0% vs 9.2%，P<0.001）。 關鍵次要終點，磷酸蘆可替尼乳膏治療8周達到濕疹面積及嚴重程度指數評分較基線至 少改善75%（EASI 75）的受試者比例亦顯著優於安慰劑（78.0% vs 15.4%，P<0.001）。 安全性方面，治療期出現的不良事件（TEAE）的嚴重程度大多數為輕度或中度，未發 生導致研究藥物用藥終止的TEAE，整體安全耐受性良好。 （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 創新藥磷酸蘆可替尼乳膏增加 ...

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]

Core Viewpoint - In 2024, Kangzhe Pharmaceutical's core cardiovascular business faced revenue and profit declines due to unsuccessful bidding in centralized procurement, prompting its subsidiary Dermavon to apply for an IPO on the Hong Kong Stock Exchange despite ongoing losses in its skin care segment [3][4]. Group 1: Company Overview - Dermavon, established in 2020 and spun off from Kangzhe in 2021, focuses on skin prescription drugs and skin care products, holding three marketed drugs and a developing skin care brand [4][6]. - Kangzhe Pharmaceutical's revenue in 2024 was 7.469 billion yuan, a decrease of 6.8% year-on-year, with net profit dropping by 32.3% to 1.613 billion yuan [4]. Group 2: Financial Performance - Dermavon reported revenue growth from 384 million yuan in 2022 to 618 million yuan in 2024, but net losses increased from 55.17 million yuan to 106 million yuan during the same period [8][9]. - Sales expenses for Dermavon rose from 246 million yuan in 2022 to 388 million yuan in 2024, consistently accounting for around 60% of revenue [9][10]. Group 3: Market Position and Challenges - Dermavon's core product, Yilvqu (for psoriasis), lacks price competitiveness compared to established competitors, which impacts market penetration and necessitates high marketing expenditures [11][12]. - The skin care segment, particularly the He Ling series targeting sensitive skin, faces intense competition from established brands like Winona, which reported revenue of 4.91 billion yuan in 2024, significantly overshadowing Dermavon's performance [13][14]. Group 4: Future Outlook and Strategic Goals - Dermavon aims for a compound annual growth rate of over 50% over the next five years, targeting sales exceeding 10 billion yuan by 2029, although achieving this goal poses significant challenges given the current market dynamics [14][18]. - The company's reliance on Kangzhe for resources and sales channels raises concerns about its independence and long-term viability, as it struggles to establish a self-sustaining business model [16][17].

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 ...