中证报中证网讯(王珞)10月29日泰恩康（301263）官微发布消息，泰恩康旗下FIC创新小分子CKBA的最 新研究成果登上国际顶级期刊《Nature Aging》(2024年影响因子19.4)。该研究由CKBA发明人、上海交 通大学医学院附属第一人民医院王宏林团队完成，为阿尔茨海默症治疗提供了全新理论依据与药物开发 方向。 泰恩康表示，目前正推进CKBA在白癜风III期及玫瑰痤疮II/III期临床试验，同时将加速其治疗阿尔茨海 默症的研发进程，未来有望为全球千万患者带来新希望。 该研究构建了"MFE-2功能缺失→脂代谢障碍→炎性激活→神经退行性病变"的完整致病通路，展示了从 机制研究到转化应用的全链条布局，标志着我国在阿尔茨海默症干预领域的重要突破。 阿尔茨海默症作为全球最常见的神经退行性疾病，其核心致病路径尚未完全明确，脂代谢紊乱与脑内免 疫激活的关联机制缺乏直接证据。此次研究首次在机制层面揭示"脂质代谢-小胶质细胞活化-神经炎 症"的"脂-炎"轴关键环节，明确全新靶点MFE-2的靶向价值。 ...

本报讯(记者王镜茹)10月29日，泰恩康（301263）FIC创新小分子CKBA发明人、上海交通大学医学院附 属第一人民医院王宏林团队在国际顶级期刊《Nature Aging》在线发表题为《Loss of MFE-2impairs microglial lipid homeostasis and drivesneuroinflammation in Alzheimer's pathogenesis》的研究论文。 上海交通大学医学院附属第一人民医院王宏林团队从传统中药乳香来源的活性分子入手，围绕天然三萜 类化合物AKBA(乙酰-11-酮-β-乳香酸)通过化学修饰合成了数百个AKBA衍生分子，最终筛选出抑制免 疫细胞促炎型分化效果最显著的化合物-CKBA并展开机制探索，发现其具备优异的血脑屏障通透性和 靶向神经炎症作用能力，为阿尔兹海默症这一慢性神经炎症性疾病的分子靶向治疗提供了新理论依据与 药物开发方向。 该研究在机制层面首次揭示了"脂质代谢-小胶质细胞活化-神经炎症"这一"脂-炎"轴在阿尔兹海默症中的 关键环节，明确了全新靶点MFE-2作为交叉节点的靶向价值，为干预阿尔兹海默症的创新药研发奠定理 论基础，也证 ...

该研究在机制层面首次揭示了"脂质代谢—小胶质细胞活化—神经炎症"这一"脂—炎"轴在阿尔茨海默病中的关键环 节，明确了全新靶点MFE-2作为交叉节点的靶向价值，为干预阿尔茨海默病的创新药研发奠定理论基础，也证实了泰 恩康1.1类创新药CKBA作为新一代天然产物来源靶向免疫代谢的小分子候选药物的开发潜力。 口服CKBA可有效穿越血脑屏障，无明显毒副作用，具备良好药代动力学性质，并在阿尔茨海默病模型小鼠中表现出 多重治疗效应，包括改善认知功能、降低神经炎症水平、减少Aβ斑块负担和减轻焦虑行为。 2025年10月29日，泰恩康（301263）FIC创新小分子CKBA发明人、上海交通大学医学院附属第一人民医院王宏林团队 在国际顶级期刊《Nature Aging》（专注老龄化研究领域的《Nature》子刊， IF2024=19.4）在线发表题为《Loss of MFE-2 impairs microglial lipid homeostasis and drives neuroinflammation in Alzheimer's pathogenesis 》的研究论文。 阿尔茨海默病（Alzheimer's Disea ...

Core Insights - The recent Nobel Prize in Physiology or Medicine has reignited global interest in immunology, particularly focusing on immune tolerance and regulation, which aligns with the scientific core of the company's product CKBA [1][2][3] Company Overview - TianKang is recognized as a leading Chinese innovative pharmaceutical company, making significant strides in the immunotherapy sector with its core product CKBA, which indicates a forward-looking approach in precision medicine [1][4] - The company has shifted from a traditional sales-driven model to an integrated "research-production-sales" model, with a cumulative R&D investment of nearly 320 million yuan from 2023 to 2024, maintaining an R&D intensity exceeding 20%, significantly higher than the industry average [4] Product Development - CKBA is the world's first innovative small molecule targeting T cell fatty acid metabolism pathways, specifically binding to fatty acid metabolism enzymes ACC1/MFE-2, allowing for precise regulation of CD8+ cytotoxic T lymphocytes (CTLs) [3][5] - The clinical advancement of CKBA has been rapid, with Phase II clinical trials for vitiligo showing significant efficacy and safety advantages, and plans for Phase III trials are underway [4][5] Market Positioning - The immunotherapy market is growing at an annual rate of over 10%, but it is highly competitive and saturated. CKBA's targeted immune regulation offers a differentiated advantage, potentially creating a new market space [5] - The product's development reflects a broader industry shift from "immune suppression" to "immune reconstruction," resonating with the foundational research recognized by the Nobel Prize [5]

Core Viewpoint - The company TianKang (301263) clarified that CKBA is not the specific research outcome of the 2025 Nobel Prize in Medicine, but it focuses on the core areas of immunological "immune tolerance" and "immune regulation" [1] Summary by Relevant Categories - **Product Development** - CKBA is not a broad immunosuppressant but offers a more targeted approach compared to traditional immunosuppressants, providing a new strategy for restoring self-immune balance [1]

Core Viewpoint - The company held an investor meeting to discuss new drug development, dividend plans, and profit enhancement strategies, highlighting its commitment to innovation and shareholder returns [1]. New Drug Development Progress - Investors showed significant interest in the company's new drug development, particularly the Phase III clinical trial for CKBA targeting vitiligo, which is expected to start by the end of 2025 [2]. - The IIT study for vitiligo in children aged 2-12 is progressing steadily, with data expected to be released in Q4 of this year [2]. - The company plans to initiate clinical trials for CKBA in treating rosacea as soon as it receives the II/III seamless adaptive trial approval [2]. - CKBA is positioned as a first-in-class innovative small molecule drug with substantial potential in autoimmune diseases, with plans to expand research into multiple indications [2]. - The company will keep stakeholders updated on drug approval progress and will consider orphan drug application requirements for CKBA if it proves effective and safe for children [2]. Dividend and Profit Planning - The company confirmed a stable cash dividend policy, announcing a plan to distribute 2 yuan per 10 shares for the 2024 fiscal year, with future plans to adjust based on actual conditions [3]. - Due to increased market competition, the company reported a decline in revenue and gross margin, leading to short-term performance pressure [3]. - To drive profit growth, the company aims to advance CKBA's clinical trials, launch specialty generic drugs like compound sodium sulfate tablets, and accelerate the domestic production of gastrointestinal medications [3]. Employee Stock Ownership Plan Disclosure - The company is in the stock purchase phase of its employee stock ownership plan, which will be disclosed monthly for six months following shareholder meeting approval [4].

Core Insights - The article discusses the urgent need for effective treatments for immune skin diseases like vitiligo and rosacea, highlighting the lack of approved targeted therapies globally [1][2][3] - CKBA, an innovative drug derived from traditional Chinese medicine, is presented as a potential breakthrough in treating vitiligo, particularly for children aged 2 to 12 [5][6] - The article emphasizes the complexity of vitiligo's treatment landscape, with high recurrence rates and limited effective long-term therapies currently available [4][5] Group 1: Current Treatment Landscape - Vitiligo affects approximately 12 million children in China, with no approved new drugs for this demographic globally [2] - Current treatment options are limited to off-label use of corticosteroids and JAK inhibitors, with only 1.5% of ruxolitinib cream approved for patients over 12 in the U.S. [2][3] - The complexity of vitiligo's pathophysiology involves multiple targets and signaling pathways, complicating treatment efforts [2][3] Group 2: CKBA's Potential - CKBA is the first drug targeting T-cell fatty acid metabolism pathways, showing promising results in early clinical trials [3][5] - Initial Phase II trial results indicate that high-dose CKBA cream significantly improved vitiligo scores compared to placebo, with 36% of patients showing varying degrees of repigmentation [3][5] - If successful in Phase III trials, CKBA could become the first drug to provide both treatment and maintenance efficacy for vitiligo [5][6] Group 3: Broader Implications and Future Research - The article notes that CKBA may also have potential applications in treating other conditions, such as rosacea and Alzheimer's disease, indicating a broader therapeutic scope [7][9] - The research pipeline for Alzheimer's disease is expanding, with various drugs showing promise, including those targeting amyloid and tau proteins [8][9] - The exploration of immune-modulating drugs across different diseases highlights the potential for innovative treatments in previously challenging areas [9]

Core Insights - The Chinese innovative drug development landscape has significantly evolved over the past decade, transitioning from imitation to innovation, particularly in the field of immunotherapy [1][2][3] - China has become the world's second-largest innovative drug development base, with a projected outbound transaction value of innovative drugs reaching between $48.4 billion and $66 billion by mid-2025, accounting for over 30% of global business development transactions [2] - The approval rate of drugs entering clinical stages by the FDA is notably high, with half of these drugs originating from China, either through direct applications or acquisitions by major U.S. companies [2] Industry Developments - The first Shantou Health Expo highlighted advancements in innovative immunotherapy, attracting over a hundred participants from various sectors, including government, academia, and investment [1] - The shift from "following" to "running alongside" and even "leading" in the innovative drug industry is attributed to supportive national policies, technological breakthroughs, and deepening global collaborations [1][2] - The importance of high-quality clinical research, patient education, and private investment in drug development is emphasized as critical for the success of innovative drugs [3] Drug-Specific Innovations - CKBA, a first-in-class small molecule drug developed in collaboration with the Tianenkang team, shows promise in treating vitiligo by modulating T cell metabolism and reducing the risk of relapse [4][5] - The drug's efficacy and safety have been highlighted, particularly in pediatric patients, with expectations for its market release following successful phase III trials [5] - The potential for CKBA to address other inflammatory skin diseases, such as rosacea, is also noted, with a focus on its targeted action on the Th17 pathway [5][6] Future Directions - The need for international clinical validation of Chinese innovative drugs is stressed to enhance their commercial value, leveraging China's patient resources and clinical efficiency [6] - There is a call for better collaboration between academia, industry, and healthcare to transform clinical ideas into viable drug development projects [6] - The exploration of traditional Chinese medicine's active components for modern drug development is seen as a promising avenue for future research [3][6]

Investment Rating - The report maintains a "Positive" outlook for the industry, particularly highlighting the demand for new drugs for rosacea [9][25]. Core Insights - There is a significant demand for new drugs to treat rosacea, with an estimated prevalence of 3.48% in China, translating to approximately 49 million patients [9][13]. - The current clinical treatment options for rosacea are limited, with many recommended drugs not available in China, creating a pressing need for safe and effective innovative products [4][25]. - CKBA shows potential as a treatment for rosacea, with a clinical pipeline that is currently sparse, indicating a favorable competitive landscape for future development [9][19][23]. Summary by Sections Section 1: Demand for New Drugs - Rosacea is a chronic inflammatory disease affecting the central face, with a high psychological burden on patients, leading to a strong desire for treatment [13]. - A survey indicated that 95.3% of patients express a need for treatment, highlighting the urgency for new therapeutic options [13]. Section 2: CKBA Potential - CKBA has been shown to strongly inhibit the differentiation of Th17 cells, which are implicated in the pathogenesis of rosacea, suggesting its potential efficacy across various clinical manifestations of the disease [19][23]. - The global pipeline for rosacea treatments is limited, with only six active candidates since 2020, and domestic development is nearly non-existent [23]. Section 3: Investment Recommendations - Given the high demand and limited treatment options, the report recommends focusing on companies like 泰恩康 (Tainkang) for potential investment opportunities in the rosacea treatment space [4][25].

Investment Rating - The report assigns an "Accumulate" rating for the company, with a target price of 21.06 CNY based on a 54 times P/E ratio for 2025 [3][6]. Core Views - The company is expected to experience rapid progress in its core business or key products over the next 1-2 years, with projected earnings per share of 0.26, 0.39, and 0.62 CNY for 2024-2026 [3]. - The company has a solid foundation as a comprehensive pharmaceutical enterprise, having established a research and development platform and acquired a pipeline of high-potential products [10][15]. - The treatment for vitiligo is scarce, and the company's CKBA product is anticipated to stand out in the market due to its unique mechanism and promising clinical trial results [10][50]. Financial Summary - The company's revenue for 2022 was 783 million CNY, with a projected decline to 757 million CNY in 2024, followed by a recovery to 951 million CNY in 2025 and 1,214 million CNY in 2026, reflecting a growth rate of 25.7% and 27.6% respectively [5]. - The net profit attributable to the parent company is expected to decrease from 175 million CNY in 2022 to 111 million CNY in 2024, before increasing to 165 million CNY in 2025 and 262 million CNY in 2026 [5]. - The gross margin is projected to improve from 58.2% in 2022 to 69.7% in 2026, indicating a positive trend in profitability [5]. Business Overview - The company started as an agent for gastrointestinal and ophthalmic medications and has gradually expanded into various fields, establishing a robust R&D platform since 2015 [10][15]. - The core business segments include gastrointestinal medications, sexual health products, and ophthalmic drugs, with stable growth in revenue from these areas [10][23]. - The company has significantly increased its R&D investment, leading to the development of important products such as dapoxetine and a rich pipeline of innovative drugs [32]. Market Opportunity - The prevalence of vitiligo is high, with over 12.33 million patients in China, and the demand for effective treatments is unmet, creating a significant market opportunity for CKBA [10][37]. - The competitive landscape for vitiligo treatments is favorable, with CKBA being the only non-JAK inhibitor drug in the domestic pipeline, currently in Phase II clinical trials [50][51].