信达证券（601059）发布研报称，首次覆盖，给予康哲药业(00867)"买入"评级，该行预计2025-2027年 公司营业收入分别为82.16亿元、98.59亿元、120.28亿元，同比增速分别为10%、20%、22%;归母净利 润分别为16.15亿元、18.50亿元、22.38亿元，同比增速分别为0%、15%、21%。该行看好公司中长期成 长性。 国内商业化能力卓越，海外东南亚市场研产销布局完备 公司通过合作开发及自主研发，高效布局了近40款创新管线，并已进入成果密集兑现阶段。目前已有6 款创新药成功上市实现商业化，处于NDA阶段的重磅创新产品包括：1)注射用Y-3，用于急性缺血性脑 卒中治疗，兼具预防卒中后抑郁焦虑，2025年12月NDA受理;2)德昔度司他片，用于非透析的成人慢性 肾脏病患者贫血治疗，2024年4月NDA受理;3)斯乐韦米单抗注射液，用于成人疑似狂犬病病毒暴露后的 被动免疫，2025年1月NDA受理;4)唯康度塔单抗注射液，用于破伤风的被动免疫，2025年5月NDA受 理;5)ZUNVEYL，用于治疗阿尔茨海默病，2025年7月NDA受理;6)MG-K10(IL-4Rα单抗)，特应性皮 ...

智通财经APP获悉，信达证券发布研报称，首次覆盖，给予康哲药业(00867)"买入"评级，该行预计 2025-2027年公司营业收入分别为82.16亿元、98.59亿元、120.28亿元，同比增速分别为10%、20%、 22%;归母净利润分别为16.15亿元、18.50亿元、22.38亿元，同比增速分别为0%、15%、21%。该行看好 公司中长期成长性。 信达证券主要观点如下： 国内商业化能力卓越，海外东南亚市场研产销布局完备 公司具备卓越的、覆盖全链路的商业化能力，拥有约4700人的专业学术推广团队，网络深度覆盖中国超 5万家医院及医疗机构、约30万家零售药店及主流电商平台，能够高效驱动产品放量。国际化战略方 面，公司前瞻性地在东南亚市场构建了完整的研发+注册与商业化+生产一体化布局，为公司打开了长 期、可持续的第二增长曲线。 公司通过合作开发及自主研发，高效布局了近40款创新管线，并已进入成果密集兑现阶段。目前已有6 款创新药成功上市实现商业化，处于NDA阶段的重磅创新产品包括：1)注射用Y-3，用于急性缺血性脑 卒中治疗，兼具预防卒中后抑郁焦虑，2025年12月NDA受理;2)德昔度司他片，用于非透析的 ...

国内专科商业化领军企业，创新转型开启新一轮成长周期康哲药业创立于1992 年，是国内领先的开放 式医药平台企业，以药品代理业务起步，历经三十余年发展，成功转型为创新型综合性医药企业。自国 家集采政策实施以来，公司原成熟产品如黛力新、波依定、优思弗一度承压，2023-2024 年收入下滑， 集采负面影响在2025 年上半年基本消化，公司营收与归母净利润增速均由负转正，心脑血管、消化等 基石业务企稳，皮肤健康、眼科等新兴业务快速增长。 机构：信达证券 研究员：唐爱金 报告内容摘要: 盈利预测与投资评级：我们预计2025-2027 年公司营业收入分别为82.16亿元、98.59 亿元、120.28 亿 元，同比增速分别为10%、20%、22%；归母净利润分别为16.15 亿元、18.50 亿元、22.38 亿元，同比增 速分别为0%、15%、21%。我们看好公司中长期成长性，首次覆盖给予"买入"评级。 风险提示：药品集中采购政策风险；创新产品研发与上市不及预期风险；创新产品商业化风险；国际化 经营风险。 国内商业化能力卓越，海外东南亚市场研产销布局完备公司具备卓越的、覆盖全链路的商业化能力，拥 有约4700 人的专 ...

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].

Core Viewpoint - The company plans to spin off Dermagene Pharmaceuticals, which will enhance its focus on the skin health sector and unlock significant value from its innovative pipeline [1] Group 1: Business Strategy - The spin-off of Dermagene Pharmaceuticals signifies a systematic layout in the skin health field, with its innovative pipeline covering all indications in skin health, potentially leading to high growth and independent value [1] - The company has five innovative drugs commercialized in China, with three more in the NDA stage, driving growth through a dual strategy of collaboration and self-research [1][2] Group 2: Financial Performance - The company reported a revenue of 4.002 billion yuan in the first half of 2025, a year-on-year increase of 10.83%, and a net profit of 941 million yuan, up 3.38% year-on-year, indicating a potential turning point in performance [1] - The impact of centralized procurement on the company's main products is expected to be fully absorbed by 2024, leading to a stabilization in revenue and a potential performance turnaround [2] Group 3: Future Projections - Revenue projections for the company from 2025 to 2027 are estimated at 8.166 billion yuan, 9.628 billion yuan, and 12.069 billion yuan, with growth rates of 9.3%, 17.9%, and 25.4% respectively [3] - The estimated market value for the company in 2026 is projected to be 67.7 billion HKD, based on a combination of existing and incremental values from both the company and Dermagene Pharmaceuticals [3]

Investment Rating - The report gives an initial investment rating of "Buy" for the company 康哲药业 (00867.HK) [4][8]. Core Views - The company is positioned as a leading innovative platform in the pharmaceutical industry, with a focus on commercializing its innovative pipeline and expanding its market presence [4][7]. - The planned spin-off of 德镁医药 is expected to unlock additional value in the skin health segment, which has a comprehensive pipeline covering all indications in this area [7][8]. - The company has shown signs of a performance turnaround, with a 10.83% year-on-year increase in revenue for the first half of 2025, indicating a potential inflection point in its financial performance [7][17]. Summary by Sections Financial Performance - The company reported a total revenue of 8,013 million RMB in 2023, with a projected revenue of 8,166 million RMB in 2025, reflecting a growth rate of 9.3% [6][8]. - The net profit attributable to shareholders is expected to increase from 1,620 million RMB in 2024 to 1,681 million RMB in 2025, with a growth rate of 3.8% [6][8]. - The company’s earnings per share (EPS) is projected to be 0.69 RMB in 2025, with a return on equity (ROE) of 9.3% [6][8]. Business Strategy - 康哲药业 has undergone multiple transformations over its 30-year history, evolving from a sales agent to a company that controls product rights and now focuses on innovative product development [13][14]. - The company has diversified its business into three main segments: cardiovascular/digestive, skin health, and ophthalmology, aiming to create specialized teams for each area [21][24]. - The internationalization strategy has been accelerated with the recent listing on the Singapore Exchange, marking a significant milestone in its global expansion efforts [24][25]. Innovation and Pipeline - The company has five innovative drugs that have been commercialized in China, with several others in the NDA stage, indicating a robust pipeline for future growth [7][8]. - Key innovative products include 德昔度司他片 for chronic kidney disease anemia and ABP-671 for gout, both of which are expected to contribute significantly to future revenues [43][45]. - The company is leveraging a dual approach of collaboration and self-research to drive innovation, aiming to meet unmet clinical needs and enhance its product offerings [40][41].

Core Viewpoint - Haitong International slightly adjusted the revenue forecast for Kangzheng Pharmaceutical (00867) for 2025-26E to 8.33/9.30 billion HKD, representing a year-on-year increase of +11.5%/+11.6% [1] - The net profit forecast for the same period was also adjusted to 1.67/1.88 billion HKD, with year-on-year growth of +3.4%/+12.9% [1] - The valuation model was changed to a discounted cash flow (DCF) model to better reflect the long-term value of the pipeline cash flow from Demy Pharmaceutical, with a target price of 18.38 HKD (+85%) [1] Financial Performance - Kangzheng Pharmaceutical achieved a revenue of 4 billion HKD in the first half of the year, a year-on-year increase of +11% [2] - Revenue from exclusive/brand products and innovative products reached 2.9 billion HKD, up +21% year-on-year, which is the core driver of the company's performance recovery [2] - The gross profit margin was 72%, with R&D expenses of 570 million HKD (down -8% year-on-year) and a net profit of 940 million HKD (up +3% year-on-year) [2] Business Growth - The recovery in revenue is attributed to the clearance of the impact from existing centralized procurement products and the steady growth of core products such as Weifurui and Meitai Tong [3] - Exclusive/brand and innovative product sales accounted for 62.1% of total revenue, up from 56.1% in the same period last year [3] - Revenue by segment includes: cardiovascular segment 2.2 billion HKD (+0.6% YoY), digestive/immunity segment 1.4 billion HKD (+4.9% YoY), skin health segment 500 million HKD (+104% YoY), and ophthalmology segment 360 million HKD (+18% YoY) [3] Innovation and Pipeline - The company has three New Drug Applications (NDA) under review, including Dexamethasone and Luracitinib [4] - Approximately ten clinical trials are progressing in China, including treatments for ischemic stroke and specific dermatitis [4] - Other potential products include Povorcitinib and CMS-D001, which are in various stages of clinical trials [4] Spin-off Plans - Kangzheng Pharmaceutical plans to spin off Demy Pharmaceutical for independent listing on the Hong Kong Stock Exchange by April 2025 [5] - The spin-off will be executed through a distribution method, allowing shareholders to directly hold shares in Demy Pharmaceutical [5] - Demy Pharmaceutical's pipeline addresses significant unmet clinical needs in skin diseases, supported by over 650 sales professionals covering more than 10,000 hospitals [5]

Core Viewpoint - Haitong International slightly adjusted the revenue forecast for Kangzheng Pharmaceutical (00867) for 2025-26E to 8.33/9.30 billion HKD, representing a year-on-year increase of 11.5%/11.6% [1] - The net profit forecast for the same period was adjusted to 1.67/1.88 billion HKD, reflecting a year-on-year growth of 3.4%/12.9% [1] - The valuation model was changed to a discounted cash flow (DCF) model to better reflect the long-term value of the pipeline cash flow from Demy Pharmaceutical, with a target price of 18.38 HKD (+85%) [1] Financial Performance - Kangzheng Pharmaceutical achieved a revenue of 4 billion HKD in the first half of the year, a year-on-year increase of 11% [2] - The revenue from major exclusive/brand products and innovative products was 2.9 billion HKD, up 21% year-on-year, which is the core driver of the company's performance recovery [2] - The gross profit margin was 72%, with R&D expenses of 570 million HKD (down 8% year-on-year) and a net profit of 940 million HKD (up 3% year-on-year) [2] Business Growth Drivers - The recovery in revenue is attributed to the clearance of the impact from existing centralized procurement products and the steady growth of core products such as Weifurui and Meitai Tong [3] - Exclusive/brand and innovative product sales accounted for 62.1% of total revenue, up from 56.1% in the same period last year [3] - Revenue by segment includes 2.2 billion HKD from cardiovascular, 1.4 billion HKD from digestive/immunity, 500 million HKD from skin health (up 104%), and 360 million HKD from ophthalmology [3] Innovation and Pipeline - The company has three NDA applications under review and approximately ten clinical trials progressing in China, including treatments for ischemic stroke and atopic dermatitis [4] - Potential products in development include Povorcitinib and CMS-D001, targeting various conditions [4] Spin-off Plans - Kangzheng Pharmaceutical plans to spin off Demy Pharmaceutical for independent listing on the Hong Kong Stock Exchange by April 2025 [5] - Demy Pharmaceutical's pipeline addresses significant unmet clinical needs in skin diseases and has over 650 sales professionals covering more than 10,000 hospitals [5]