Core Viewpoint - 康哲药业's subsidiary 德镁医药 is seeking independent listing on the Hong Kong Stock Exchange and has received clinical trial approval for povorcitinib from the NMPA for treating non-segmental vitiligo and moderate to severe hidradenitis suppurativa [1] Group 1 - 德镁医药 has been granted a drug clinical trial approval notice by the NMPA on August 28, 2025, for povorcitinib [1] - 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, hidradenitis suppurativa, and nodular prurigo in several overseas countries, along with phase 2 trials for asthma and chronic spontaneous urticaria [1]

Core Viewpoint - 康哲药业's subsidiary 德镁医药 is seeking independent listing on the Hong Kong Stock Exchange and has received approval for clinical trials of povorcitinib for specific skin conditions [1] Group 1: Company Developments - 德镁医药 has been granted a clinical trial approval notice by the National Medical Products Administration (NMPA) of China on August 27, 2025, for povorcitinib [1] - The clinical trials will focus on the treatment of non-segmental vitiligo and moderate to severe hidradenitis suppurativa (HS) [1] Group 2: Product Information - 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, HS, and nodular prurigo in several overseas countries, along with Phase 2 trials for asthma and chronic spontaneous urticaria [1]

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 ...

Core Viewpoint - The company reported a stable revenue growth in the first half of 2025, driven by the recovery from previous negative impacts and the strong performance of innovative products Group 1: Financial Performance - In the first half of 2025, the company achieved a revenue of 4.002 billion yuan, representing a year-on-year increase of 10.8% [1] - The net profit attributable to shareholders was 941 million yuan, reflecting a growth of 3.38% [1] Group 2: Product Development and Innovation - The sales of exclusive/brand and innovative products increased by 20.6% year-on-year, accounting for 62.1% of total revenue, up from 56.1% in the same period last year [2] - The company is advancing its innovative drug pipeline, with several products in various stages of clinical trials, including NDA reviews and Phase III trials [2] - The company has recently acquired rights for new products targeting Alzheimer's disease and asthma, enhancing its product matrix in cardiovascular, central nervous system, digestive, and renal fields [2] Group 3: Segment Performance - The dermatology segment (Demey Pharmaceutical) showed significant growth, with revenue reaching 498 million yuan, a remarkable increase of 104.3% [3] - Demey Pharmaceutical has a strong pipeline with three marketed products and four in clinical stages, indicating potential for continued high growth [3] - The company plans to spin off Demey Pharmaceutical for independent listing, which is expected to help in the revaluation of its dermatology products and pipeline [3] Group 4: Revenue and Profit Forecast - Revenue projections for 2025 to 2027 are 8.053 billion yuan, 9.439 billion yuan, and 11.651 billion yuan, with year-on-year growth rates of 7.8%, 17.2%, and 23.4% respectively [4] - Net profit forecasts for the same period are 1.685 billion yuan, 1.956 billion yuan, and 2.465 billion yuan, with growth rates of 4.0%, 16.1%, and 26.1% respectively [4] - The company is rated with a "buy" recommendation based on its projected PE ratios of 17.7, 15.3, and 12.1 for the years 2025, 2026, and 2027 respectively [4]

Core Viewpoint - 康哲药业 reported a revenue of 40.02 billion yuan for the first half of 2025, representing a year-on-year increase of 10.83%, and a net profit of 9.41 billion yuan, up 3.38% year-on-year, indicating positive growth in both revenue and profit [1] Financial Performance - The company's expense ratio was 56.75%, an increase of 1.52 percentage points year-on-year; gross margin was 72.26%, down 2.41 percentage points year-on-year; R&D expenses reached 2.02 billion yuan, up 91.79% year-on-year, with an R&D expense ratio of 5.06%, up 2.14 percentage points year-on-year [1] - Sales expense ratio was 35.59%, down 3.19 percentage points year-on-year; management expense ratio was 15.82%, up 2.89 percentage points year-on-year; financial expense ratio was 0.28%, down 0.32 percentage points year-on-year [1] Business Segments - Traditional business in cerebrovascular disease generated sales of 22.16 billion yuan, up 0.6% year-on-year, accounting for 47.5% of total sales; sales from digestive and autoimmune disease lines were 14.11 billion yuan, up 4.9% year-on-year, accounting for 30.2% [1] - New business in dermatology and aesthetics (德镁医药) achieved sales of 4.98 billion yuan, up 104.3% year-on-year, accounting for 10.7%; ophthalmology sales were 3.58 billion yuan, up 17.7% year-on-year, accounting for 7.7% [1] - The company has five innovative drugs commercialized, including 莱芙兰, 美泰彤, 维福瑞, 益路取, and 维图可, with rapid commercialization progress [1] Product Development - Three products are currently under NDA review: 德昔度司他片 for anemia treatment in CKD patients, 芦可替尼乳膏 for vitiligo, and ZUNVEYL for Alzheimer's disease [2] - Two self-developed innovative drugs have received IND approval and are set to begin clinical trials: CMS-D001片 for psoriasis and CMS-D003胶囊 for obstructive hypertrophic cardiomyopathy [2] International Expansion - The company is in the process of splitting 德镁健康 for independent listing on the Hong Kong Stock Exchange, enhancing its position in the dermatology sector [3] - 康哲药业 is advancing its international commercial system, with a focus on Singapore as a regional hub, and has submitted product registration applications in several Southeast Asian countries [3] Investment Outlook - Revenue projections for 康哲药业 from 2025 to 2027 are 83.20 billion yuan, 94.54 billion yuan, and 110.43 billion yuan, with year-on-year growth rates of 11%, 14%, and 17% respectively; net profit estimates are 16.28 billion yuan, 18.92 billion yuan, and 22.52 billion yuan, with growth rates of 0%, 16%, and 19% respectively [3]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company reported a revenue of 4.002 billion HKD for the first half of 2025, representing a year-on-year increase of 10.83%, and a net profit attributable to shareholders of 941 million HKD, up 3.38% year-on-year, indicating a recovery in profits after two years of stagnation [4][10] - The sales of exclusive/brand and innovative products continued to grow, accounting for 62.1% of total revenue, up from 56.1% in the same period last year [4] Summary by Sections Financial Performance - The company’s total revenue for the reporting period was 4.002 billion HKD, with a year-on-year growth of 10.83% - The net profit attributable to shareholders was 941 million HKD, reflecting a year-on-year increase of 3.38% - The gross profit margin was 72.26%, down 2.41 percentage points year-on-year, primarily due to changes in product mix and increased investment in R&D [5][10] R&D and Innovation - R&D expenses increased significantly by 91.79% to 202 million HKD, with an R&D expense ratio of 5.06%, up 2.14 percentage points year-on-year [5] - The company has five innovative drugs that have entered commercialization, with rapid progress in their commercialization [6] Business Segments - Traditional business lines, such as cerebrovascular disease, generated sales of 2.216 billion HKD, up 0.6%, while the digestive and autoimmune disease lines saw sales of 1.411 billion HKD, up 4.9% [6] - New business segments, particularly the dermatology and aesthetic line (De Mei Health), reported sales of 498 million HKD, a remarkable increase of 104.3% [6] Future Catalysts - Several products are in the NDA/IND review stage, with two self-developed innovative drugs having received IND approval and set to begin clinical trials [7][8] - The company is in the process of splitting De Mei Health for independent listing, which is expected to enhance its market position [9] Financial Projections - Revenue projections for 2025-2027 are 8.32 billion HKD, 9.454 billion HKD, and 11.043 billion HKD, with expected year-on-year growth rates of 11%, 14%, and 17% respectively [10] - Net profit projections for the same period are 1.628 billion HKD, 1.892 billion HKD, and 2.252 billion HKD, with expected growth rates of 0%, 16%, and 19% respectively [10]

Group 1 - The company approved an investment in a joint venture, PharmaGend Global Medical Services Pte. Ltd., located in Singapore, with partners CMS Medical Venture Pte. Ltd., Rxilient Health Pte. Ltd., and Healthy Goal Limited [1][4] - The joint venture aims to raise $30 million through the issuance of 30 million Class A preferred shares, primarily for infrastructure and operational expenses [3][8] - The company plans to invest $10.5 million, corresponding to its 35% ownership in the joint venture, as part of the additional investment [2][8] Group 2 - The ownership structure of the joint venture post-investment will be as follows: the company will hold 32.38%, CMS Medical Venture will hold 31.27%, Rxilient Health will hold 10.36%, and Healthy Goal Limited will hold 18.50% [3][7] - The joint venture's financial data indicates total assets of $98.48 million and total liabilities of $40.32 million as of the latest reporting period [7][8] - The investment is expected to enhance the joint venture's capabilities in the Southeast Asian CDMO service market, contributing to the company's global and sustainable development [10][12] Group 3 - The investment transaction is classified as a related party transaction, with necessary approvals obtained from the board, excluding related directors from voting [4][10] - The company emphasizes that the additional investment will not alter its control over the joint venture or significantly impact its financial results [10][12] - The independent directors have reviewed the transaction and concluded that it will not harm the interests of the company or its shareholders, particularly minority shareholders [12]

另外，该行重申对翰森制药"跑赢大市"评级，目标价由27.8港元升至43.1港元，上调2025至27年收入预 测19%至29%，净利润预测10%至29%，基于创新药增长有机会好过预期，以及较高BD业务收入。 同时，该行重申对康哲药业"跑赢大市"评级，目标价由10港元升至15.6港元，上调2025至27年收入预测 0%至2%，净利润预测3%至6%，因今年上半年业绩胜预期。 里昂发布研报称，3间内地药企包括中国生物制药(01177)、翰森制药(03692)及康哲药业(00867)，上半年 均录得稳健业绩，2024年下半年及2025年上半年均实现双位数收入增长。该行预期势头将于2025年下半 年延续，推动因素包括更多创新药物上市及新产品销售增加、内地医疗保险支出环境更有利、以及潜在 的商业拓展(BD)收入。 股份方面，该行重申对中生制药"跑赢大市"评级，目标价维持9.2港元，料公司收入增长加速，2025至 27年分别升12%、15%及16%;基于创新药收入贡献增加，预期利润率亦有增长。 ...

另外，该行重申对翰森制药"跑赢大市"评级，目标价由27.8港元升至43.1港元，上调2025至27年收入预 测19%至29%，净利润预测10%至29%，基于创新药增长有机会好过预期，以及较高BD业务收入。 同时，该行重申对康哲药业"跑赢大市"评级，目标价由10港元升至15.6港元，上调2025至27年收入预测 0%至2%，净利润预测3%至6%，因今年上半年业绩胜预期。 智通财经APP获悉，里昂发布研报称，3间内地药企包括中国生物制药(01177)、翰森制药(03692)及康哲 药业(00867)，上半年均录得稳健业绩，2024年下半年及2025年上半年均实现双位数收入增长。该行预 期势头将于2025年下半年延续，推动因素包括更多创新药物上市及新产品销售增加、内地医疗保险支出 环境更有利、以及潜在的商业拓展(BD)收入。 股份方面，该行重申对中生制药"跑赢大市"评级，目标价维持9.2港元，料公司收入增长加速，2025至 27年分别升12%、15%及16%;基于创新药收入贡献增加，预期利润率亦有增长。 ...

Core Viewpoint - 康哲药业's performance in the first half of the year slightly exceeded market expectations, driven by strong sales of exclusive and innovative products [1] Financial Performance - Revenue reached 40.02 billion yuan, representing a year-on-year growth of 10.8% [1] - Pharmaceutical sales revenue was 46.7 billion yuan, with a year-on-year increase of 8.9% [1] - Net profit amounted to 9.41 billion yuan, reflecting a year-on-year growth of 3.4% [1] Strategic Developments - In April, the company announced plans to spin off 德镁医药 through a physical distribution method for listing, which is expected to unlock the independent value of its rapidly growing skin health business [1] - In July, 康哲药业 achieved a secondary listing on the main board of the Singapore Exchange, which is anticipated to help capture growth opportunities in emerging markets and create a new multi-regional growth pattern [1] Analyst Outlook - 中金 maintains its profit forecasts for 康哲药业 for 2025 and 2026, keeping the "outperforming the industry" rating [1] - The target price has been raised by 40% to 15.4 Hong Kong dollars, considering the upward adjustment of sector valuation and positive progress in the 德镁 business [1]