Investment Rating - The report maintains an "Outperform" rating for China Medical System Holdings (867 HK) with a target price of HK$18.63, reflecting a potential upside from the current price of HK$12.96 [2][8]. Core Insights - The company achieved a revenue of CNY8.2 billion in FY25, representing a 10% year-on-year increase, with pharmaceutical sales revenue reaching CNY9.4 billion. The gross profit margin was 71.5%, down 1.1 percentage points year-on-year. Net profit was CNY1.4 billion, a decrease of 11% year-on-year, primarily due to one-off tax impacts [3][14]. - Exclusive and innovative products drove steady sales growth, with revenue from these products increasing by 44% year-on-year. Key products contributing to this growth include Velphoro, Metoject, Ilumya, Valtoco, and Mucopolysaccharide Polysulfate Cream [4][15]. - The approval and launch of Ruxolitinib cream for vitiligo in January 2026 is expected to generate significant sales, with management projecting revenue of at least CNY500 million in 2026 and peak sales of no less than CNY6 billion [5][16]. Financial Performance - Revenue projections for FY26 and FY27 have been revised to CNY9.6 billion and CNY11.4 billion, respectively, reflecting the expected contribution from innovative product launches. Attributable net profit forecasts for FY26 and FY27 have been adjusted to CNY1.7 billion and CNY1.9 billion, respectively, due to increased R&D spending [8][18]. - The breakdown of revenue by segment for FY25 shows: Cardiovascular and cerebrovascular segment at CNY4.2 billion (+2.3% YoY), Gastroenterology/autoimmune segment at CNY3.0 billion (+3.3% YoY), Skin health segment at CNY1.1 billion (+73.2% YoY), Ophthalmology segment at CNY0.7 billion (+12.9% YoY), and Other products at CNY0.46 billion (+10.3% YoY) [20].

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 ...

Company Updates - The company announced that its subsidiary, Dermira, has received NMPA approval for the launch of ruxolitinib cream on January 30, 2026, for the treatment of non-segmental vitiligo in patients aged 12 and above with facial involvement [1] - Ruxolitinib cream is the first and only targeted drug approved for vitiligo treatment in China, indicating significant clinical potential [1] Clinical Efficacy - In overseas Phase III clinical trials (TRuE-V1 and TRuE-V2), after 24 weeks of treatment, the proportion of patients achieving F-VASI75 was 29.9%, significantly higher than the placebo group at 7.5% and 12.9%, with sustained repigmentation effects observed at 52 weeks [1] - The Boao Super Hospital has prescribed the drug to over 7,000 patients with non-segmental vitiligo, and more than 20 hospitals in cities like Guangzhou and Shenzhen are providing prescription services for this medication [1] Revenue Potential - The company believes that ruxolitinib can synergize with its other dermatology products, including the innovative drug, Ilaris (canakinumab), and the exclusive drug, Hyaluronic Acid (multi-sulfated glycosaminoglycan cream), to enhance revenue [2] - The company is actively advancing the NDA application for the AD indication of ruxolitinib, which has shown positive results in domestic Phase III trials [2] - Dermira has licensed the rights for ruxolitinib in Hong Kong, Macau, Taiwan, and 11 Southeast Asian countries, which is expected to further contribute to revenue and profit growth [2] Profit Forecast and Valuation - The company maintains a profit forecast of 1.735 billion yuan for 2025 and has adjusted the 2026 profit forecast upward by 5% to 1.984 billion yuan due to the revenue increase from new product launches [2] - The introduction of the 2027 profit forecast is set at 2.418 billion yuan, with current prices corresponding to P/E ratios of 15.6 and 12.4 for 2026 and 2027, respectively [2] - The target price has been raised by 7% to 16.50 HKD, implying a potential upside of 17.6% based on P/E ratios of 18.3 and 14.6 for 2026 and 2027 [2]

Core Viewpoint - CICC maintains a "outperform" rating for Kangzheng Pharmaceutical (00867) and raises the target price by 7% to HKD 16.50, considering the upward adjustment of the sector's central tendency [1] Group 1: Financial Projections - The company maintains a 2025 profit forecast of CNY 1.735 billion and raises the 2026 profit forecast by 5% to CNY 1.984 billion due to revenue growth from new product launches, while introducing a 2027 profit forecast of CNY 2.418 billion [1] Group 2: Product Approval and Market Potential - The phosphoric acid ruxolitinib cream developed by Demy Pharmaceutical has been approved by NMPA for the treatment of non-segmental vitiligo in patients aged 12 and above, marking it as the first and only targeted drug for vitiligo treatment in China, indicating significant clinical potential [1] - Approximately 10.3 million people in China suffer from vitiligo, with 8.2 million having non-segmental vitiligo, and existing treatments have clinical deficiencies, suggesting that ruxolitinib cream could fill a gap in targeted treatment [1] Group 3: Clinical Efficacy and Commercialization - In overseas Phase III clinical trials (TRuE-V1 and TRuE-V2), the proportion of patients achieving F-VASI75 after 24 weeks of treatment was 29.9%, significantly higher than the placebo group [2] - Over 7,000 prescriptions for non-segmental vitiligo patients have been issued at the Boao Super Hospital, with over 20 hospitals in cities like Guangzhou and Shenzhen providing prescription services for this drug [2] Group 4: Product Portfolio and Revenue Contribution - The company believes that ruxolitinib can synergize with its other innovative skin treatment products, such as Yiluqi (trilaciclib) and the exclusive drug Xiliao (multi-sulfated glycosaminoglycan cream), to enhance revenue elasticity [3] - The company is actively advancing the NDA application for the AD indication of ruxolitinib, which has shown positive results in domestic Phase III trials [3] - Demy Pharmaceutical has authorized the company to hold rights for ruxolitinib in Hong Kong, Macau, Taiwan, and 11 Southeast Asian countries, which is expected to further contribute to revenue and profit growth [3]

Group 1 - The core viewpoint is that CICC maintains a "outperforming the industry" rating for Kangzheng Pharmaceutical (00867) and raises the target price by 7% to HKD 16.50, considering the upward adjustment of the sector's central tendency [1] - The company maintains a profit forecast of RMB 1.735 billion for 2025 and adjusts the 2026 profit forecast upward by 5% to RMB 1.984 billion due to revenue increments from new product launches, while introducing a profit forecast of RMB 2.418 billion for 2027 [1] Group 2 - The approval of the first and only targeted drug for vitiligo treatment by NMPA has significant clinical potential, with the drug being a JAK1/JAK2 inhibitor developed by Incyte and the first approved drug for non-segmental vitiligo [2] - The company estimates that approximately 10.3 million people in China suffer from vitiligo, with 8.2 million having non-segmental vitiligo, and existing treatments have clinical deficiencies, indicating that the new drug may fill a gap in targeted treatment [2] Group 3 - Clinical efficacy is notable, with preliminary commercial potential shown in Hainan's pilot application, where the drug achieved a 29.9% patient response rate after 24 weeks, significantly higher than the placebo group [3] - Over 7,000 prescriptions have been issued for non-segmental vitiligo patients at the Boao Super Hospital, with over 20 hospitals in cities like Guangzhou and Shenzhen providing prescription services for the drug [3] Group 4 - The product matrix for dermatological treatments at Demy Pharmaceutical is further enriched, with the potential for increased revenue elasticity from the new drug, which is expected to synergize with other innovative drugs in the commercialization phase [4] - The company is actively advancing the NDA application for the AD indication, which has shown positive results in domestic Phase III trials, and has licensed rights for the drug in Hong Kong, Macau, Taiwan, and 11 Southeast Asian countries, which may further contribute to revenue and profit growth [4]

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 ...