经济观察网泰恩康（301263）2026年将有多项关键事件值得关注，涉及公司治理、产品管线及市场动 态。 公司多个仿制药和创新药预计在2026年取得重要进展。复方硫酸钠片(国内首仿)与和胃整肠丸(国内独 家)的本地化生产注册均预计在2026年上半年获批。老花眼用药盐酸毛果芸香碱滴眼液(国内首仿)预计在 2026年下半年获批。此外，创新药CKBA乳膏针对儿童白癜风的II期临床试验计划于2026年第一季度启 动首例患者入组，并计划同期向FDA申报。 股票近期走势 2026年1月28日，公司发布《2026年员工持股计划(草案)》，拟向不超过145名员工实施股权激励，并设 定了2026年至2028年的业绩考核目标。其中，2026年营业收入目标值为10.00亿元，考核利润目标值为 3.00亿元。 产品研发进展 公司于2025年12月15日被纳入中证1000指数拟生效样本范围，市场预期其有望被纳入相关ETF的被动配 置范畴，可能对股票流动性产生长期影响。2026年2月2日，公司控股股东郑汉杰和孙伟文部分股份质 押，合计质押股份占公司总股本的13.81%，公告称此举为个人资金需要。2026年2月13日，泰恩康股价 上涨2. ...

Core Viewpoint - The company TianKang (301263) has initiated patient recruitment for the CKBA cream treatment for rosacea, addressing a significant unmet clinical need in China where no Class 1 innovative drugs have been approved for this indication [1] Group 1: Clinical Trials and Approvals - The CKBA cream for rosacea is currently in the patient recruitment phase for clinical trials [1] - The company plans to apply for breakthrough therapy designation if clinical trial results meet expectations, given the lack of approved innovative treatments for rosacea in China [1] - The Phase II clinical trial application for CKBA cream combined with narrowband ultraviolet B (NB-UVB) for treating non-segmental vitiligo in children aged 2-12 has been approved by NMPA, with plans to submit a clinical trial application to the FDA this year [1] Group 2: Information Disclosure - The company will fulfill its information disclosure obligations in accordance with regulations regarding any progress related to submissions to the FDA and BD [1]

在产品管线方面，根据公司1月22日披露的公告显示，公司核心在研产品CKBA乳膏针对儿童白癜风的II 期临床试验申请已获得批准，前期探索性研究显示其联合光疗方案疗效显著，该II期试验计划于2026年 第一季度启动首例患者入组，并计划同期启动FDA临床申报。 与此同时，公司仿制药业务迎来收获期，根据公司2025年11月21日披露的投资者关系活动记录表显示， 公司复方硫酸钠片(国内首仿)与和胃整肠丸(国内独家)的本地化生产注册均预计在2026年上半年获批； 老花眼用药盐酸毛果芸香碱滴眼液(国内首仿)则预计在2026年下半年获批。 根据公告，本次员工持股计划的资金来源为员工合法薪酬及自筹资金，公司不存在向持有人提供财务资 助或为其贷款提供担保的情形。计划购买回购股份的价格为16.93元/股，拟持有的标的股票数量不超过 198.51万股，约占公司总股本的0.47%。 草案明确了2026年至2028年三个年度的业绩考核目标。2026年度，营业收入目标值为10.00亿元，触发 值为9.00亿元；考核利润目标值为3.00亿元，触发值为2.70亿元。2027年度，营业收入目标值提升至 15.00亿元，触发值为13.50亿元；考 ...

Core Viewpoint - The announcement by TianKang (301263) highlights the approval of a clinical trial for CKBA cream, aimed at treating non-segmental vitiligo in children aged 2-12, marking a significant step in addressing an unmet medical need in this demographic [1] Group 1: Clinical Trial Approval - TianKang's subsidiary, Jiangsu Bochuangyuan Biopharmaceutical Technology Co., Ltd., received a clinical trial approval notice from the National Medical Products Administration for CKBA cream [1] - The trial will assess the safety, efficacy, and pharmacokinetic characteristics of CKBA cream in combination with narrowband ultraviolet B (NB-UVB) therapy [1] Group 2: Market Opportunity - CKBA cream is an innovative drug developed by the company specifically for treating pediatric vitiligo [1] - Approximately 32%-40% of total vitiligo patients are children, and currently, there are no approved products available for this indication globally [1]

CKBA作为一种全新靶点（First-in-Class，靶向ACC1/MFE-2）的免疫调节剂，并非传统的强效免疫抑制 剂，其核心作用在于抑制CD8+T细胞向Tc1及Tc17分化，下调IFN-γ和IL-17的表达，从而改善皮肤区域 免疫环境，有效阻止"白斑"扩增；而NB-UVB则可直接激活黑素干细胞，促进其分化为成熟黑素细胞并 产生黑素。 白癜风作为一种慢性自身免疫性疾病，以黑色素细胞功能性丧失导致的皮肤色素脱失为特征，全球患病 率达0.5%至2.0%，严重影响患者的容貌外观与生活质量。其中，儿童群体面临着更为严峻的挑战，儿 童白癜风患者约占总患者数的32%至40%。 然而，目前全球范围内尚无获批用于儿童白癜风治疗的产品，临床需求亟待满足。泰恩康表示，本次儿 童白癜风Ⅱ期临床试验申请获批后，公司将快速推进儿童白癜风Ⅱ期临床试验，争取CKBA乳膏获批成 为首个治疗2岁至12岁儿童白癜风的1类创新药，填补儿童白癜风诊疗空白。 本报讯 （记者王镜茹）1月22日晚，广东泰恩康医药股份有限公司（以下简称"泰恩康"）披露，其控股 子公司江苏博创园生物医药科技有限公司（以下简称"博创园"）收到国家药品监督管理局签发的《药物 ...

Core Viewpoint - The company Tianenkang (301263) announced that its subsidiary, Bochuangyuan, has received approval from the National Medical Products Administration for a clinical trial of CKBA cream in children aged 2 to 12 with non-segmental vitiligo [1] Group 1 - The clinical trial is a multi-center, randomized, double-blind, placebo-controlled Phase II study [1] - The study will evaluate the safety, efficacy, and pharmacokinetic characteristics of CKBA cream combined with narrowband ultraviolet B (NB-UVB) therapy [1] - The trial specifically targets participants who are children aged 2 years and older [1]

Group 1: Clinical Research and Development - The company has initiated a Phase II clinical trial for CKBA cream for pediatric vitiligo, with the application accepted by the National Medical Products Administration in November 2025 [2][3]. - The exploratory study included 30 pediatric patients aged 2-12 years, showing a significant improvement in VASI scores with a 56.53% change in the treatment group compared to a 16.67% change in the control group (P=0.0029) [3]. - The Phase II clinical trial is expected to begin patient enrollment in Q2 2026, with a goal to complete it by mid-2027 [4]. Group 2: Market Potential and Demand - There are currently no approved drugs for pediatric vitiligo (ages 2-12) globally, indicating a significant unmet clinical need [5]. - The estimated market size for pediatric vitiligo treatment in China exceeds 100 billion CNY, with annual treatment costs ranging from 15,000 to 20,000 CNY per patient [6]. - CKBA is expected to achieve annual peak sales exceeding 5 billion CNY once approved for pediatric use [6]. Group 3: Additional Clinical Developments - The company has completed Phase II trials for CKBA in adult vitiligo and plans to optimize the Phase III trial protocol, with an application expected in Q1 2026 [7]. - CKBA is also being developed for other indications, including rosacea and Alzheimer's disease, with clinical trials for rosacea expected to start in Q1 2026 [7]. Group 4: Business Growth and Future Plans - The company anticipates significant revenue growth in 2026 and explosive growth in 2027, driven by the approval of several core products [8]. - Key products expected to be approved include a combination capsule of finasteride and tadalafil, and a lidocaine and prilocaine aerosol, among others [8].

Core Insights - 泰恩康 has been awarded the "ESG New Rising Bull Award Top 20" at the 2025 Sustainable Development Forum, indicating its commitment to sustainable practices in the pharmaceutical industry [1] - The company is focused on deepening its innovation strategy during the "14th Five-Year Plan" period, particularly in drug research and commercialization [1][4] R&D Progress - 泰恩康's subsidiary, 江苏博创园生物医药科技有限公司, received a notice from the National Medical Products Administration for a Phase II clinical trial application for CKBA cream in treating non-segmental vitiligo in children aged 2-12 [2] - The company successfully completed a Phase II clinical trial for CKBA in adults and plans to submit a Phase III application soon [2] - CKBA is a novel immune modulator derived from traditional Chinese medicine, showing potential for treating various immune-related diseases, including Alzheimer's [3][4] Clinical Development - 泰恩康 has initiated preclinical research for CKBA in treating Alzheimer's disease, with plans to submit an IND application by the second half of 2026 [4] - The company emphasizes the importance of innovation in drug development, aiming to provide solutions for Alzheimer's patients globally [4][6] Strategic Focus - 泰恩康 has transitioned to a research-driven model, increasing R&D investment from 6.9% to 21.96% of revenue between 2022 and 2024 [4] - The company employs a "pyramid" R&D strategy, focusing on generic drugs at the base, modified chemical drugs and biologics in the middle, and innovative drugs at the top [5][6] Product Structure - 泰恩康 has established three main product segments: sexual health, gastrointestinal, and ophthalmology, with notable products like "爱廷玖" and "和胃整肠丸" [6][7] - The company is expecting several core drugs to be approved soon, which will enhance its product structure and drive revenue growth [7]

Core Insights - The company, Taiankang, received the "ESG New Star Golden Bull Award Top 20" at the 2025 Golden Bull Enterprise Sustainable Development Forum, indicating its commitment to sustainable practices in the pharmaceutical industry [1] - During the 14th Five-Year Plan period, the company aims to deepen its focus on the pharmaceutical sector and implement an innovation-driven development strategy, enhancing its research and commercialization of innovative drugs [1][4] R&D Progress - Taiankang's subsidiary, Jiangsu Bochuangyuan Biopharmaceutical Technology Co., Ltd., received a notice from the National Medical Products Administration (NMPA) for the acceptance of its Phase II clinical trial application for CKBA cream in treating non-segmental vitiligo in children aged 2-12 [2] - The company successfully completed the Phase II clinical trial for CKBA in adult vitiligo patients and plans to submit a Phase III trial application soon [2] - CKBA is a novel immune modulator derived from traditional Chinese medicine, showing potential for treating other immune-related diseases, including Alzheimer's disease [3][4] Clinical Research and Development - The company has initiated preclinical research for CKBA in treating Alzheimer's disease, with plans to submit an Investigational New Drug (IND) application by the second half of 2026 [4] - CKBA has been recognized for its unique mechanism and potential in addressing Alzheimer's disease, which is increasingly prevalent due to aging populations [3][4] Innovation Strategy - Taiankang has established a comprehensive R&D system, focusing on various therapeutic areas, including dermatology, ophthalmology, and gastrointestinal health [5] - The company employs a "pyramid" R&D strategy, emphasizing innovative drug research at the top, supported by improved chemical drugs and biopharmaceuticals [6] - The company has transitioned from a sales-driven model to a research-driven approach, with R&D investment rising from 6.9% to 21.96% of revenue from 2022 to 2024 [4] Product Structure and Market Position - Taiankang has developed three main product segments: sexual health, gastrointestinal, and ophthalmic medications, with notable products like "Aiting Jiu" and "He Wei Zheng Chang Wan" [6][7] - The company is preparing to launch several core drugs, including domestic first generics, which are expected to enhance its product portfolio and drive revenue growth [7]

Core Viewpoint - The company, Tai En Kang, is poised to address a significant unmet clinical need in the treatment of pediatric vitiligo, with its innovative drug CKBA potentially becoming the first approved treatment for children aged 2-12 years [1] Group 1: Market Opportunity - There are currently no approved drugs for vitiligo in children aged 2-12 globally, and existing therapies are often used off-label [1] - The estimated number of vitiligo patients in China exceeds 30 million, with children accounting for approximately 32%-40% of this population, indicating a substantial market demand [1] - The annual treatment cost for pediatric vitiligo is estimated to be between 15,000 to 20,000 yuan, suggesting a market size exceeding 100 billion yuan [1] Group 2: Product Development - CKBA, derived from natural products like frankincense, is a new immunomodulator that offers greater targeting and safety compared to traditional immunosuppressants, making it particularly suitable for pediatric use [1] - The company anticipates that CKBA cream could be approved as the first innovative drug for treating vitiligo in children aged 2-12, and it is expected to become the preferred option for maintenance therapy [1] - Projections indicate that, once approved, the annual peak sales for CKBA in the pediatric vitiligo market could exceed 5 billion yuan [1] Group 3: Regulatory Progress - On November 20, the company announced that its subsidiary, Bo Chuang Yuan, has had the application for CKBA cream (Class 1 chemical drug) for pediatric vitiligo Phase II clinical trials accepted by the National Medical Products Administration [1]