机构：华源证券 研究员：刘闯 临床数据及真实世界研究中展现出积极结果。临床数据方面：其在境外开展的两项相同设计的III 期双 盲、随机、安慰剂对照研究（TRuE-V1 和TRuE-V2）中，产品治疗24 周后达到主要疗效指标面部白癜 风面积评分指数改善至少75%（F-VASI 75）的患者比例均为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。真实世界研究方面：磷酸芦可替尼乳膏在中国开展真实世界 研究，疗效积极，与境外关键临床研究结果一致。境内外临床研究中所有的次要疗效指标均显示出与主 要疗效指标一致的获益趋势，且白癜风治疗效果随疗程延长持续改善，安全性良好。 芦可替尼乳膏的特应性皮炎适应症未来可期。康哲药业在国内开展的磷酸芦可替尼乳膏治疗轻中度特应 性皮炎患者的III 期临床试验，已取得阳性结果。目前，公司正在中国积极推进磷酸芦可替尼乳膏治疗 特应性皮炎的新药上市申请，如若获批上市，将为中国广大特应性皮炎患者群体提供新的治疗选择。 盈利预测与评级： 我们预计2025-2027 年康哲药业的营业总收入为81.66/96.28/120.69 亿元， 增速分别 为9.3%/ ...

Major Events - InnoCare Pharma (09926) granted exclusive commercialization rights of Yixineng® to Jichuan Pharmaceutical [1] - Ying Si Intelligent (03696) received a milestone payment of HKD 39 million from Menarini, with the MEN2501 project completing its first patient dosing [1] - Xiansheng Pharmaceutical (02096) received a recent milestone payment related to the overseas licensing option agreement for SIM0500 with AbbVie [1] - Innovent Biologics (02577) completed significant design integration for related products on Google's AI hardware platform and signed a compliant supply agreement [1] - Federal Pharmaceutical (03933) obtained implied approval for clinical trials of UBT251 injection for OSA indications [1] - Kanghong Pharmaceutical (00867) received clinical trial approval for the innovative drug CMS-D017 capsule for complement-mediated kidney disease indications [1] - First Capital Holdings (00697) announced the successful IPO and listing of Shimon Holdings on the Shenzhen Stock Exchange [1] Operating Performance - Country Garden (02007) achieved a contract sales amount of approximately CNY 2.21 billion attributable to shareholders by January 2026 [1] - Nissin Foods (01475) reported an operating profit of JPY 5.672 billion from its China business segment for the first three quarters, representing a year-on-year increase of 99.8% [1] - Natural Beauty (00157) issued a profit warning, expecting an annual net profit of approximately HKD 8 million to HKD 10 million, marking a turnaround from losses [1]

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 aimed at treating complement-mediated kidney diseases [1][2]. Group 1: Drug Development - CMS-D017 is a novel selective complement factor B small molecule inhibitor that targets the complement system, a crucial part of the innate immune system [2]. - The drug aims to prevent abnormal activation of the complement pathway, thereby reducing damage to target tissues and organs associated with complement dysregulation [2]. - Clinical trials will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CMS-D017 in healthy participants in China [1]. Group 2: Indications and Future Development - CMS-D017 is intended for the treatment of various complement-mediated kidney diseases, including IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis, and C3 glomerulopathy [2]. - The drug has previously received approval for treating paroxysmal nocturnal hemoglobinuria and is also being developed for age-related macular degeneration and myasthenia gravis [2]. Group 3: Market Position and Strategy - If approved, CMS-D017 will strengthen the company's position in the kidney disease treatment market, complementing its other innovative drugs, such as Vifor (sucroferric oxyhydroxide chewable tablets for CKD hyperphosphatemia) and Daprodustat (for renal anemia) [3]. - The company is actively preparing to initiate clinical trials for CMS-D017, aiming for a swift market launch [4].

Core Viewpoint - Kangzheng Pharmaceutical has received approval from the National Medical Products Administration (NMPA) for clinical trials of its innovative drug CMS-D017, which targets complement-mediated kidney diseases [1][2]. Group 1: Product Overview - CMS-D017 is a novel selective small molecule inhibitor of complement factor B, which plays a crucial role in the complement system, a key component of the innate immune system [2]. - The drug aims to inhibit the abnormal activation of the complement pathway, thereby reducing damage to target tissues and organs associated with complement dysregulation-related diseases [2]. - CMS-D017 has shown excellent efficacy and safety in preclinical studies and is intended for the treatment of various complement-mediated kidney diseases, including IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis, and C3 glomerulopathy [2][3]. Group 2: Clinical Need and Market Potential - Complement-mediated kidney diseases (CMKD) encompass a range of primary and secondary glomerular diseases, with IgA nephropathy and idiopathic membranous nephropathy being prevalent in China [3]. - Current treatment options, such as steroids and immunosuppressants, have significant limitations, including limited efficacy and notable side effects, indicating a substantial unmet clinical need [3]. - Targeting complement factor B is considered an effective therapeutic approach for CMKD, and CMS-D017 may provide a superior treatment option for patients [3]. Group 3: Strategic Implications for the Company - If approved for market launch, CMS-D017 will enhance the company's strength in the kidney disease treatment sector, complementing its other innovative drugs, such as Vifor (for CKD-related hyperphosphatemia) and Dexamethasone (for renal anemia) [4]. - The synergy between CMS-D017 and existing products is expected to improve the company's competitive position and market presence in the nephrology field [4]. - The company is actively preparing to initiate clinical trial work to expedite the product's market entry [5].

Core Viewpoint - Kangzheng Pharmaceutical 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 kidney diseases [1][2]. Group 1: Drug Development - CMS-D017 is designed to inhibit complement factor B, a key component in the complement system that can lead to tissue damage when abnormally activated [2]. - The drug has shown excellent efficacy and safety in preclinical studies and is intended for conditions such as IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis, and C3 glomerulopathy [2]. - CMS-D017 previously received clinical trial approval for treating paroxysmal nocturnal hemoglobinuria on January 30, 2026, indicating its potential for multiple therapeutic applications [2]. Group 2: Market Position and Strategy - If approved for market launch, CMS-D017 will strengthen the company's position in the kidney disease treatment sector, complementing its other innovative drugs, such as Vifor (for CKD hyperphosphatemia) and Dexamethasone (for renal anemia) [3]. - The company is actively preparing to initiate clinical trials for CMS-D017, aiming for a swift market introduction [4].

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。 補體參與介導的腎臟疾病（Complement - mediated kidney disease,「CMKD」）是一類由 補體系統異常激活直接或間接介導的腎臟疾病，涵蓋多種原發性和繼發性腎小球疾病。 根據發病機制，CMKD可分為兩大類：（1）由補體系統異常活化直接介導的腎病，包 括C3腎小球病（C3 glomerulopathy, 「C3G」）、非典型溶血尿毒癥綜合徵、免疫複合 * 僅供識別 1 自願性及業務進展公告 創新藥補體因子B抑制劑CMS-D017 獲得補體參與介導的腎臟疾病適應症 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，於二零二六年二月三日，本集團自主研發的創新藥CMS-D017膠囊 （「CMS-D017」或「產品」）獲得中國國家藥品監督管理局（「NMPA」）簽發的藥 物臨床試驗批准通 ...

Fixed Income - The overall scale of interest rate bond funds has decreased, with total assets amounting to 3.0 trillion yuan as of Q4 2025, down by 0.09 trillion yuan from Q3 2025 [6][7] - The average yield of interest rate bond funds has rebounded to +0.44% in Q4 2025, compared to -0.48% in Q3 2025, but remains significantly lower than the 4.42% yield in 2024 [8][19] - The expected yield range for 10-year government bonds in 2026 is projected to be between 1.6% and 1.9%, with opportunities for long-term bonds anticipated to arise after significant market corrections [8][19] Manufacturing Sector - The manufacturing PMI fell back below the expansion threshold to 49.3 in January 2026, indicating a slowdown in production activities compared to the previous month [11][10] - The non-manufacturing PMI also decreased to 49.4, suggesting a contraction in service sector activities, with the composite PMI output index at 49.8 [11][10] - The consumption sector is expected to receive policy support, but the impact may be weaker than in 2025 due to high base effects from the previous year [11][10] Social Financing - The forecast for new loans in January 2026 is 4.9 trillion yuan, with social financing expected to reach 7.07 trillion yuan, indicating a slight year-on-year increase [15][18] - M2 is projected to reach 345.1 trillion yuan by the end of January, with a year-on-year growth of 8.3% [15][18] - The social financing growth rate is expected to decline to around 8.1% by the end of January 2026, following a peak in mid-2025 [18][15] Pharmaceutical Sector - The approval of phosphoric acid lebrikizumab cream for the treatment of vitiligo marks a significant milestone for the company, being the first targeted therapy for this condition in China [21][22] - Clinical trials have shown promising results, with a significant percentage of patients achieving a 75% improvement in vitiligo area after 24 weeks of treatment [21][22] - The company is also pursuing additional indications for the cream, including atopic dermatitis, which could further enhance its market potential [22][21] New Consumption Sector - The company holds exclusive operational rights for key scenic areas and has established a robust management system for mountain tourism, positioning it well for growth [25][26] - The opening of the Shenbai high-speed railway is expected to significantly increase visitor traffic, enhancing accessibility to the scenic area [27][26] - The company plans to raise 236 million yuan for expanding its facilities and improving transportation, which is anticipated to boost its operational capacity and customer experience [27][26]

证券研究报告 医药生物 | 化学制药 港股|公司点评报告 hyzqdatemark 2026 年 02 月 03 日 证券分析师 刘闯 SAC：S1350524030002 liuchuang@huayuanstock.com 市场表现： | 基本数据 | 2026 | 年 | 月 02 日 | 02 | | --- | --- | --- | --- | --- | | 收盘价（港元） | | | 15.12 | | | 一年内最高/最低（港 | | | 15.63/6.83 | | | 元） | | | | | | 总市值（百万港元） | | | 36,885.67 | | | 流通市值（百万港元） | | | 36,885.67 | | | 资产负债率（%） | | | 9.35 | | | 资料来源：聚源数据 | | | | | 康哲药业(00867.HK) 投资评级： 买入（维持） ——芦可替尼乳膏获批上市，掘金白癜风市场 投资要点： | 盈利预测与估值（人民币） | | | | | | | --- | --- | --- | --- | --- | --- | | | 2023 | 2024 | ...

机构：中金公司 公司近况 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。 评论 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，我们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。 临床疗效突出，海南试点应用已初步显示商业化潜力。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 ...

格隆汇2月3日｜中金发表报告指，康哲药业旗下德镁医药已于1月30日获得国家药品监督管理局批准磷 酸芦可替尼乳膏(白癜风适应症)新药上市许可申请。该行维持公司2025年盈利预测为17.4亿元，基于新 产品带来的增量收入，将2026年盈利预测上调5%至19.8亿元，并新增2027年盈利预测为24.2亿元。该行 维持对康哲药业的"跑赢行业"评级，目标价上调7%至16.5港元。 来源：格隆汇APP ...