[Table_Title] 研究报告 Research Report 2 Feb 2026 康哲药业 China Medical System Holdings (867 HK) [Table_yemei1] 热点速评 Flash Analysis [Table_summary] (Please see APPENDIX 1 for English summary) 事件 1 月 30 日，康哲药业子公司德镁医药，获得中国国家药品监督管理局（NMPA）批准磷酸芦可替尼乳膏新药上市许 可申请，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（Opzelura®）是 Incyte 开发的选择性 JAK1/JAK2 抑制剂芦可替尼制成的一种创新型乳膏。2022 年 12 月，德镁医药与 Incyte 就芦可 替尼乳膏订立许可协议，获得在中国大陆、香港特别行政区、澳门特别行政区、台湾地区及东南亚十一国研发、 注册及商业化产品的独家许可权利，以及生产产品的非独家许可权利。 重磅品种芦可替尼获批上市，未来增长可期 Blockbuster Drug Ruxolitinib Cream Appr ...

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: China Medical System Holdings Limited 康哲藥業控股有限公司*（*僅供識別） 呈交日期: 2026年2月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00867 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 20,000,000,000 | USD | USD | 0.005 | | 100,000,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 20,000,000,000 | USD | ...

Market Performance - The Hong Kong stock market indices experienced a collective decline, with the Hang Seng Index falling by 2.23% to 26,775.57 points, the Hang Seng Tech Index dropping by 3.36% to 5,526.31 points, and the China Enterprises Index decreasing by 2.54% to 9,080.19 points [2]. Sector Analysis - The recent market adjustment is attributed to a technical pullback following a rapid rise in indices, compounded by hawkish comments from Fed Chair nominee Waller, which stirred market sentiment. This is not seen as a trend reversal signal [5]. - Key focus remains on the sustainability of volatility, with three main supportive drivers for the first quarter identified: improved liquidity environment, resonance of domestic and foreign capital, and upward revisions in corporate earnings expectations due to economic recovery [6][7]. Investment Strategy - Analysts suggest adopting a mid-term perspective, emphasizing opportunities in small and mid-cap sectors with clear catalysts, such as education, AI applications, and specialty consumption [8]. Sector-Specific Movements - Gold and related stocks saw significant declines, with Shandong Gold dropping by 12.56% and Chifeng Jilong Gold falling by 12.18%, influenced by a broader downturn in commodity prices [10][12]. - The cement and building materials sector also faced losses, with Western Cement declining by 15.47% and China National Building Material falling by 10.14%. The latter is projected to report a loss of approximately RMB 2.3 billion to RMB 4 billion for the year ending December 31, 2025 [13]. - Semiconductor stocks were affected by industry demand fluctuations, with Huahong Semiconductor down by 11.24% and Zhaoyi Innovation down by 9.25%. Reports indicate tightening order reviews by major manufacturers in response to market volatility [15]. Resilient Sectors - Some gaming stocks performed well, with Yabo Technology Holdings increasing by 8.79% and Sands China rising by 4.05%. Yabo announced a technical service agreement with the Hong Kong Gold Exchange [17]. - The liquor sector also showed resilience, with Yiyuan Liquor rising by 8.33% and Qingdao Beer increasing by 1.46%. Analysts expect the liquor industry to hit bottom by 2026, with a potential investment opportunity arising around the Chinese New Year [19]. Notable Stock Movements - Cloud Wisdom saw a rise of 5.49%, with expectations of significant revenue growth from its large model-related business, projected to reach approximately RMB 600 million to RMB 620 million in 2025, marking a year-on-year increase of about 1057% to 1095% [20]. - Kangzheng Pharmaceutical increased by 7.77% following the approval of clinical trials for its complement factor B inhibitor, indicating potential for new product launches [21].

消息面上，近日，康哲药业发布公告，旗下德镁医药有限公司("德镁医药"，专业聚焦皮肤健康的创新 型医药企业，正申请于香港联合交易所有限公司主板独立上市，)已于2026年1月30日获得中国国家药品 监督管理局(NMPA)批准磷酸芦可替尼乳膏(白癜风适应症)新药上市许可申请(NDA)。产品用于治疗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，是中国批准的首款且唯一用于白癜风治疗的靶向 药，满足巨大未被满足的临床需求。 中金指出，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。 康哲药业(00867)涨超3%，截至发稿，涨3.14%，报14.47港元，成交1838.61万港元。 ...

中金指出，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。 消息面上，近日，康哲药业发布公告，旗下德镁医药有限公司("德镁医药"，专业聚焦皮肤健康的创新 型医药企业，正申请于香港联合交易所有限公司主板独立上市，)已于2026年1月30日获得中国国家药品 监督管理局(NMPA)批准磷酸芦可替尼乳膏(白癜风适应症)新药上市许可申请(NDA)。产品用于治疗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，是中国批准的首款且唯一用于白癜风治疗的靶向 药，满足巨大未被满足的临床需求。 智通财经APP获悉，康哲药业(00867)涨超3%，截至发稿，涨3.14%，报14.47港元，成交1838.61万港 元。 ...

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 ...

Major Events - Lanke Technology (06809) will conduct an IPO from January 30 to February 4, with an expected listing on February 9 [1] - Aixin Yuanzhi (00600) will conduct an IPO from January 30 to February 5, with an expected listing on February 10 [1] - Lexin Outdoor (02720) will conduct an IPO from January 31 to February 5, raising HKD 130 million from Horizon Capital and Huangshan Dejun [1] - Dongpeng Beverage (09980) sets the offer price at HKD 248 per share [1] - Zhonghui Biotech-B (02627) received approval from the National Medical Products Administration for a trivalent influenza virus subunit vaccine [1] - Kangzheng Pharmaceutical (00867) received approval for the first and only targeted drug for vitiligo treatment in China [1] - Shishi Pharmaceutical Group (02005) received production registration for Propafenone Hydrochloride Injection from the National Medical Products Administration [1] - China Aluminum (02600) plans to jointly acquire 68.6% of Brazilian Aluminum from Rio Tinto and will initiate a mandatory offer [1] - Yanzhou Coal Mining (01171) plans to transfer 100% equity of Inner Mongolia Xintai Coal [1] - Botai Car Union (02889) plans to collaborate with Ping An Property & Casualty to reconstruct the smart travel insurance ecosystem [1] - Jin Jing New Energy (01783) signed a strategic framework agreement with Tianqi Grand for lithium battery recycling and precious metal extraction [1] - Guangdong-Hong Kong-Macau Holdings (01396) subsidiary Hongce Data introduces Fudian Capital as a strategic investor for 40% equity [1] - China Mobile (00941), China Unicom (00762), and China Telecom (00728) will adjust the applicable scope of value-added tax for telecom services [1] Operating Performance - BYD Company (01211) sold approximately 210,000 new energy vehicles in January [2] - Geely Automobile (00175) reported total vehicle sales of 270,200 units in January, a year-on-year increase of about 1% [2] - Chery Automobile (09973) saw total sales of 191,500 vehicles in January, a year-on-year decrease of about 10.7% [2] - Seres (09927) reported total vehicle sales of 45,900 units in January, a year-on-year increase of 104.85% [2] - Great Wall Motors (02333) sold approximately 90,300 vehicles in January, a year-on-year increase of 11.59% [2] - Li Auto-W (02015) delivered 27,668 new vehicles in January, a year-on-year decrease of 7.5% [2] - NIO-SW (09866) delivered 27,182 vehicles in January, a year-on-year increase of 96.1% [2] - GAC Group (02238) reported vehicle sales of 116,600 units in January, a year-on-year increase of 18.47% [2] - Great Wall Motors (02333) released a preliminary report indicating a net profit attributable to shareholders of 9.912 billion yuan for 2025, a year-on-year decrease of 21.71% [2] - Shandong Gold (01787) expects a net profit attributable to shareholders of approximately 4.6 billion to 4.9 billion yuan for 2025, a year-on-year increase of 56% to 66% [2] Earnings Forecast - SF Express (09699) expects a year-on-year profit increase of no less than 80% for 2025 [3] - China International Capital Corporation (03908) anticipates a net profit attributable to shareholders of 8.542 billion to 10.535 billion yuan for 2025, a year-on-year increase of 50% to 85% [3] - China Shenhua (01088) expects a year-on-year decline in net profit for 2025 [3] - Datang Power (00991) anticipates a net profit of approximately 6.8 billion to 7.8 billion yuan for 2025, a year-on-year increase of about 51% to 73% [3] - China Southern Airlines (01055) expects a net profit attributable to shareholders of 800 million to 1 billion yuan for 2025, turning a profit [3] - Air China (00753) warns of a net loss attributable to shareholders of approximately 1.3 billion to 1.9 billion yuan for 2025 [3] - China Eastern Airlines (00670) warns of a net loss attributable to shareholders of approximately 1.3 billion to 1.8 billion yuan for 2025 [3] - GAC Group (02238) expects a net loss attributable to shareholders of 8 billion to 9 billion yuan for 2025 [3] - Ansteel (00347) warns of a net loss attributable to shareholders of approximately 4.077 billion yuan for 2025, a year-on-year narrowing of 42.75% [3] - Junshi Biosciences (01877) warns of a net loss attributable to shareholders of approximately 873 million yuan for 2025, a year-on-year decrease of about 31.85% [3]

CMS-D017是一种新型选择性补体因子B小分子抑制剂。补体系统是先天免疫系统的重要组成部分，可 通过经典途径、凝集素途径和旁路途径被激活从而发挥生物学功能。补体因子B是一种主要由肝脏合成 的特异性丝氨酸蛋白酶，是补体旁路途径中的「核心开关」和「效应放大器」，其活性直接影响补体反 应的强度。CMS-D017通过靶向抑制补体因子B，阻止补体旁路途径的异常活化，减低膜攻击复合物对 靶组织和器官的损伤，缓解补体失调相关疾病的进展。CMS-D017在临床前研究中表现出优异的有效性 和安全性，临床拟用于治疗阵发性睡眠性血红蛋白尿症。CMS-D017未来还拟开发用于治疗补体参与介 导的肾脏疾病、年龄相关性黄斑变性和重症肌无力等疾病。 康哲药业(00867)公布，于2026年1月30日，集团自主研发的创新药CMS-D017胶囊获得中国国家药品监 督管理局(NMPA)签发的药物临床试验批准通知书。NMPA同意集团在中国健康参与者中开展评价CMS- D017安全性、耐受性、药代动力学和药效动力学特徵的临床试验。 ...

Core Viewpoint - Kangzheng Pharmaceutical (00867) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its innovative drug CMS-D017, which is a selective complement factor B small molecule inhibitor aimed at treating complement-mediated diseases [1] Group 1: Drug Development - CMS-D017 has been granted a clinical trial approval notice by NMPA to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants in China [1] - The drug targets complement factor B, a key component in the complement system, which is crucial for innate immunity and can be activated through various pathways [1] - CMS-D017 aims to prevent abnormal activation of the complement pathway, thereby reducing damage to target tissues and organs associated with complement dysregulation [1] Group 2: Clinical Applications - The drug has shown excellent efficacy and safety in preclinical studies and is intended for the treatment of paroxysmal nocturnal hemoglobinuria [1] - Future development plans for CMS-D017 include potential applications in treating complement-mediated kidney diseases, age-related macular degeneration, and myasthenia gravis [1]