2025年12月11日，康哲药业(00867)宣布，用于治疗急性缺血性卒中的1类创新药注射用Y-3(拟定中文通 用名：注射用洛贝米柳)的新药上市许可申请(NDA)已获得中国国家药品监督管理局(NMPA)受理。 康哲药业表示，中枢神经系统是其核心优势领域之一，已逐步形成深度产品布局，夯实市场基础。注射 用Y-3如获批上市，将与在售创新药维图可(丛集性癫痫)、原研品牌药黛力新(焦虑、抑郁)以及处于NDA 审评中的改良型新药ZUNVEYL(阿尔茨海默症)在专家网络与市场资源上产生高效协同。凭借康哲药业 卓越的商业化经验与合规高效的运营体系，加速推动创新疗法惠及更多患者，为中国缺血性脑卒中患者 带来疗效优异、作用更全面的新一代脑细胞保护剂。 注射用Y-3是全球首个基于脑卒中病理过程重要靶点PSD95-nNOS和MPO开发的脑细胞保护剂，作用于 缺血性脑卒中缺血级联反应多个关键病理过程，通过多靶点高选择性协同，更有利于发挥脑细胞保护作 用。产品具有优异的治疗缺血性脑卒中和潜在的预防卒中后抑郁焦虑症状的作用。注射用Y-3的中国Ⅲ 期临床研究达到主要疗效终点，患者临床获益明显，整体安全性良好。主要研究结果未来计划在国际学 ...

注射用Y-3是全球首个基于脑卒中病理过程重要靶点PSD95-nNOS和MPO开发的脑细胞保护剂，作用于 缺血性脑卒中缺血级联反应多个关键病理过程，通过多靶点高选择性协同，更有利于发挥脑细胞保护作 用。产品具有优异的治疗缺血性脑卒中和潜在的预防卒中后抑郁焦虑症状的作用。注射用Y-3的中国Ⅲ 期临床研究达到主要疗效终点，患者临床获益明显，整体安全性良好。主要研究结果未来计划在国际学 术会议上公布，整体研究将在国际学术期刊上发表。 康哲药业表示，中枢神经系统是其核心优势领域之一，已逐步形成深度产品布局，夯实市场基础。注射 用Y-3如获批上市，将与在售创新药维图可(丛集性癫痫)、原研品牌药黛力新(焦虑、抑郁)以及处于NDA 审评中的改良型新药ZUNVEYL(阿尔茨海默症)在专家网络与市场资源上产生高效协同。凭借康哲药业 卓越的商业化经验与合规高效的运营体系，加速推动创新疗法惠及更多患者，为中国缺血性脑卒中患者 带来疗效优异、作用更全面的新一代脑细胞保护剂。 智通财经APP获悉，2025年12月11日，康哲药业(00867)宣布，用于治疗急性缺血性卒中的1类创新药注 射用Y-3(拟定中文通用名：注射用洛贝米柳)的新药上 ...

Core Viewpoint - The report from Xingzheng International adjusts the profit forecast for Kangzhe Pharmaceutical (00867), expecting net profit for 2025-2027 to be CNY 1.661 billion, CNY 1.917 billion, and CNY 2.272 billion, representing year-on-year growth of 2.54%, 15.39%, and 18.57% respectively, maintaining a "Buy" rating [1] Group 1: Financial Performance - In the first half of 2025, the company's revenue reached CNY 4.002 billion, a year-on-year increase of 10.8%, with pharmaceutical sales contributing CNY 4.670 billion, up 8.9% [2] - The net profit attributable to shareholders was CNY 941 million, reflecting a 3.4% year-on-year growth, with a gross margin of 61.7% and a sales expense ratio of 30.3%, down 2.1 percentage points [2] - The company declared an interim dividend of CNY 0.1555 per share, totaling CNY 376 million, which accounts for approximately 39.99% of the net profit for the first half of 2025 [2] Group 2: Growth Drivers - The negative impact of national procurement on operating performance has diminished, with major exclusive, branded, and innovative products continuing to drive sales growth, accounting for 62.1% of total revenue, an increase of 6.0 percentage points year-on-year [3] - Revenue from the cardiovascular disease segment was CNY 2.216 billion, up 0.6%, while the digestive and autoimmune disease segment generated CNY 1.411 billion, a 4.9% increase; the skin health segment (Demei Pharmaceutical) saw revenue of CNY 498 million, up 104.3% [3] Group 3: Innovation and Product Development - The company has accelerated its innovation strategy since 2025, with five approved innovative drugs (Yiluqu, Weifurui, Meitai Tong, Weituo Ke, Laifulan) set to release commercial value [4] - Three innovative drugs are under NDA review in China, and two self-developed products have received IND approval, alongside two newly developed collaborative innovative products [4] - A new injectable product (Lizhenran) was approved in China in July 2025 [4] Group 4: Strategic Initiatives - The company plans to spin off its skin health business, Demei Pharmaceutical, for independent listing on the Hong Kong Stock Exchange, which has three marketed products and four in clinical stages, covering major skin disease treatments [5] - Additionally, two skincare products aimed at disease prevention and care have been launched [5]

Core Viewpoint - The report from Xingzheng International adjusts the profit forecast for Kangzhe Pharmaceutical (00867), expecting net profit attributable to shareholders to reach 1.661 billion yuan, 1.917 billion yuan, and 2.272 billion yuan for 2025-2027, with corresponding growth rates of 2.54%, 15.39%, and 18.57% respectively, maintaining a "buy" rating [1] Group 1 - In the first half of 2025, the company's revenue was 4.002 billion yuan, a year-on-year increase of 10.8%, with a profit attributable to shareholders of 941 million yuan, up 3.4% [2] - The gross margin for drug sales was 61.7%, with a sales expense ratio of 30.3%, down 2.1 percentage points, and a management expense ratio of 9.2%, up 0.8 percentage points [2] - The company declared an interim dividend of 0.1555 yuan per share, totaling 376 million yuan, which accounts for approximately 39.99% of the net profit attributable to shareholders for the first half of 2025 [2] Group 2 - The negative impact of national procurement on operating performance has passed, with major exclusive and innovative products driving sales growth, accounting for 62.1% of total revenue, an increase of 6.0 percentage points year-on-year [3] - Revenue from cardiovascular-related products was 2.216 billion yuan, up 0.6%; revenue from digestive/immunology-related products was 1.411 billion yuan, up 4.9%; revenue from skin health products was 498 million yuan, up 104.3%; and revenue from ophthalmology products was 358 million yuan, up 17.7% [3] Group 3 - The company has accelerated its innovation efforts in 2025, with five approved innovative drugs expected to release commercial value, and three innovative drugs currently under NDA review in China [4] - Two self-developed products have received IND approval, and two new collaborative innovative products have been added [4] - A new injectable product has been approved in China as of July 2025 [4] Group 4 - The company plans to spin off its skin health business, Dermy Pharmaceutical, for independent listing on the Hong Kong Stock Exchange, which has three marketed products and four in clinical stages as of the first half of 2025 [5] - Dermy Pharmaceutical has also launched two skincare product lines aimed at preventing and treating skin diseases [5]

Investment Rating - The investment rating for the company is "Buy" [1] Core Views - The company has shown continuous growth in innovative products, with a notable performance in the skin health line [4] - The company reported a revenue of 4.002 billion yuan in the first half of 2025, representing a year-on-year increase of 10.8%, and a net profit attributable to shareholders of 941 million yuan, up 3.38% [5] - The sales of exclusive/brand and innovative products increased by 20.6% year-on-year, accounting for 62.1% of total revenue [5] - The company is advancing its innovative drug pipeline, with several products in various stages of clinical trials [5] - The skin health line (Demeg Pharmaceuticals) achieved a revenue of 498 million yuan, a significant increase of 104.3% [5] - The company plans to spin off Demeg Pharmaceuticals for independent listing, which is expected to help in the revaluation of its skin care product line [5] - Revenue forecasts for 2025 to 2027 are 8.053 billion yuan, 9.439 billion yuan, and 11.651 billion yuan, with corresponding net profits of 1.685 billion yuan, 1.956 billion yuan, and 2.465 billion yuan [6] Summary by Sections Company Overview - The company is focused on innovative pharmaceuticals, particularly in cardiovascular, central nervous system, digestive, and renal fields [5] Financial Performance - The company’s current P/E ratio is 18.12, with a market capitalization of 32.787 billion HKD [5] - The projected revenue growth rates for 2025, 2026, and 2027 are 7.8%, 17.2%, and 23.4% respectively [6] Product Pipeline - The company has a robust pipeline with several innovative drugs under development, including those for chronic kidney disease and asthma [5] Market Position - The company has established a strong market presence with a comprehensive product matrix and experienced commercialization capabilities [5]

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]

Core Viewpoint - 康哲药业 reported a significant recovery in its operating performance for the first half of 2025, driven by the end of negative impacts from national procurement policies and sustained growth in exclusive/brand and innovative product sales, which now account for 62.1% of total revenue [1][2]. Financial Performance - The company's revenue increased by 10.8% year-on-year to RMB 4.002 billion, with a drug sales revenue growth of 8.9% to RMB 4.67 billion [1]. - Gross profit rose by 7.2% to RMB 2.892 billion, with drug sales gross profit also increasing by 7.2% to RMB 2.882 billion [1]. - Net profit attributable to shareholders grew by 3.1% to RMB 931.5 million, with earnings per share at RMB 0.3892 and an interim dividend of RMB 0.1555 per share declared [1]. Product and Market Development - The company has a pipeline of approximately 40 differentiated innovative products, with 5 innovative drugs already approved in China and commercialized [3]. - The sales of exclusive/brand and innovative products have shown a significant increase, contributing to the overall revenue growth [2]. - The company is focusing on specialized areas, with its skin health brand "德镁医药" becoming a leading innovative pharmaceutical company in China, planning to list independently on the Hong Kong Stock Exchange [2]. Strategic Initiatives - 康哲药业 is pursuing an internationalization strategy, having completed a secondary listing on the Singapore Exchange in July 2025, which is expected to enhance its brand influence in Southeast Asia and international markets [2]. - The company is actively advancing its research and development efforts, with around 20 self-developed projects progressing steadily, and 5 projects entering clinical development stages [3].

Core Viewpoint - 康哲药业 has reported a significant recovery in its operating performance for the first half of 2025, driven by the end of negative impacts from national procurement policies and sustained growth in exclusive/brand and innovative product sales, which now account for 62.1% of total revenue [1][2]. Financial Performance - The company's revenue increased by 10.8% year-on-year to RMB 4.002 billion, with a drug sales revenue growth of 8.9% to RMB 4.67 billion [1]. - Gross profit rose by 7.2% to RMB 2.892 billion, with drug sales gross profit also increasing by 7.2% to RMB 2.882 billion [1]. - Net profit attributable to shareholders grew by 3.1% to RMB 931.5 million, with earnings per share at RMB 0.3892 and an interim dividend of RMB 0.1555 per share declared [1]. Product and Market Development - The company has a pipeline of approximately 40 differentiated innovative products, with 5 innovative drugs already approved in China and commercialized [3]. - The sales of exclusive/brand and innovative products have shown a significant increase, contributing to the overall revenue growth [2]. - The company is focusing on specialized areas, with its skin health brand "德镁医药" becoming a leading innovative pharmaceutical company in China [2]. Strategic Initiatives - 康哲药业 is pursuing an internationalization strategy, having completed a secondary listing on the Singapore Exchange in July 2025, which is expected to enhance its brand influence in Southeast Asia and international markets [2]. - The company is actively exploring new retail, new media, and consumer healthcare avenues, with early successes noted in these areas [2].

Summary of 康哲药业 Conference Call Company Overview - 康哲药业 is undergoing a strategic transformation from original research drugs to innovative drugs, driven by both collaborative development and independent research. The company has received approval for 5 innovative drugs covering 6 indications and is actively expanding internationally, including a secondary listing in Singapore without involving financing or equity dilution [2][4]. Key Business Segments - The company operates four main business segments: - Cardiovascular and Digestive Health: Stabilized after the impact of the National Volume-Based Procurement (VBP) - Ophthalmology: Strong profitability - Skin Health: 德美医药 is set for a spin-off listing - International Business: Focused on Southeast Asia, expected to contribute to future growth [2][5]. Financial Performance - The core products' revenue has declined due to VBP, with projected revenue of 2.6 billion yuan for three core products in 2024. However, the impact of centralized procurement is expected to be cleared, leading to a phase of rapid growth as innovative drugs are approved [2][7]. - The company’s key product portfolio includes: - Existing national procurement products (波依定, 黛力新, 优思弗) expected to contribute 2.6 billion yuan in 2024 - Exclusive and brand drugs anticipated to maintain around 10% growth [8]. Innovative Product Pipeline - 康哲药业 has nearly 20 self-researched projects, with 5-6 in clinical development. Key upcoming products include: - Y3 injection for stroke treatment, expected to exceed 3 billion yuan in sales - ABP671 for hyperuricemia, with NDA submission expected in mid-2025 - 德西度司他片 for chronic kidney disease anemia, expected to be approved this year [3][10][12][13]. Impact of VBP - The company faced significant impacts from VBP, with core products previously accounting for over 50% of sales. The sales retention rate post-VBP was around 50% [6][7]. Spin-off of 德美医药 - The spin-off of 德美医药 is expected to be completed by the end of 2025, which will not significantly affect 康哲药业's overall financial status but will help improve its valuation. 康哲 will distribute 90.8% of 德美 shares to shareholders [3][15]. Market Expansion and Internationalization - 康哲药业 is expanding into Southeast Asia, establishing a regional headquarters in Singapore and planning a secondary listing. This move aims to explore new growth avenues without limiting business development [20][21]. R&D and Sales Expenses - In 2025, 康哲's R&D and sales expenses are expected to rise due to high costs associated with marketing and brand building for newly launched innovative drugs. Profit growth is anticipated to lag behind revenue growth this year, but significant profit increases are expected starting in 2026 as 德美 is no longer consolidated [22][23]. Conclusion - 康哲药业 is positioned for growth through its innovative drug pipeline and international expansion, despite facing challenges from VBP. The upcoming spin-off of 德美医药 and the focus on Southeast Asian markets are strategic moves to enhance overall company valuation and market presence.