11月26日，由中国证券报、中国国新主办的2025年金牛企业可持续发展论坛暨第三届国新杯·ESG金牛 奖颁奖典礼在苏州举行，泰恩康获得"ESG新锐金牛奖二十强"殊荣。 泰恩康董事长、总经理郑汉杰在接受中国证券报记者采访时表示，"十五五"期间，公司将持续深耕医药 产业，坚定不移实施创新发展战略，不断深化创新药研发和商业化布局，推动公司持续稳健发展，为健 康中国建设贡献更多力量。 研发进展不断 在获得重磅奖项的同时，最近泰恩康创新药研发工作也取得重要进展。11月21日，泰恩康披露公告，控 股子公司江苏博创园生物医药科技有限公司收到国家药监局签发的受理通知书，同意受理博创园提交的 CKBA乳膏联合窄谱中波紫外线在2-12岁（含2岁）儿童非节段型白癜风受试者中的Ⅱ期临床研究申 请。 公开资料显示，白癜风是一种慢性自身免疫性疾病，严重影响患者容貌和生活质量。今年8月，泰恩康 顺利完成CKBA成人白癜风适应症Ⅱ期临床试验，近期将向国家药监局提交Ⅲ期临床试验申请。但对于 儿童白癜风患者，目前全球没有获批产品用于儿童白癜风的治疗。因此，针对儿童白癜风患者迫切需要 开发一种安全、有效、可长期使用的创新疗法。按照计划，本次儿童白 ...

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]

泰恩康介绍，CKBA来自乳香天然产物，是一种新型免疫调节剂，与传统免疫抑制剂相比更具靶向性和 安全性，非常适合儿童白癜风用药以及后续的维持治疗。基于CKBA治疗白癜风独特的靶点和机制， CKBA乳膏有望获批首个2-12岁儿童白癜风创新药，并成为白癜风维持治疗的首选药物。经测算，仅考 虑儿童白癜风用药，CKBA获批后国内年度销售峰值有望超50亿元。 11月20日，泰恩康公告，控股子公司博创园的CKBA乳膏(化学药品1类)申报2-12岁儿童白癜风II期临床 试验获国家药监局受理。 中证报中证网讯(王珞)泰恩康（301263）11月21日披露投资者活动关系记录表。公司在回答投资者提问 时表示，目前全球范围内2-12岁儿童白癜风尚无获批药物，现有疗法多为超说明书使用；国内白癜风患 者人数预测超3000万，儿童白癜风患者约占总白癜风患者的32%-40%，儿童白癜风存在巨大未被满足的 临床需求，按年治疗费用1.5万元-2万元简单测算，儿童白癜风市场规模超千亿元。 ...

Group 1: Clinical Trial Overview - The company has received approval from the National Medical Products Administration for a Phase II clinical trial of CKBA cream for treating vitiligo in children aged 2-12 years, with a total of 30 patients enrolled over a 24-week period [3][4]. - The study showed that the 1.5% CKBA cream combined with NB-UVB therapy resulted in a VASI score improvement of -56.53%, significantly better than the control group’s -16.67% (P=0.0029) [3][4]. - The exploratory study validated the effectiveness and safety of the CKBA cream in pediatric vitiligo patients, providing a basis for larger-scale trials [3][4]. Group 2: Market Potential and Demand - There are currently no approved drugs for pediatric vitiligo globally, with an estimated 30 million vitiligo patients in China, of which 32%-40% are children [4][5]. - The annual treatment cost for pediatric vitiligo is estimated at 15,000 to 20,000 CNY, suggesting a market potential exceeding 100 billion CNY [4][5]. - If approved, CKBA is projected to achieve annual sales exceeding 5 billion CNY in the pediatric vitiligo market [4][5]. Group 3: Competitive Landscape - CKBA is the first innovative drug in China to conduct Phase II clinical trials for children under 12 with vitiligo, with no existing approved treatments [5][6]. - The drug's unique mechanism as an immune modulator offers targeted treatment, making it safer and more suitable for children compared to traditional immunosuppressants [4][5]. Group 4: Future Development Plans - The company plans to submit an application for a Phase III clinical trial for adult vitiligo based on the successful completion of Phase II trials [5][6]. - There are ongoing preparations for a Phase II/III clinical trial for CKBA in treating rosacea, with an IND application for Alzheimer's disease planned for the second half of 2026 [6][9]. - The company anticipates significant revenue growth in 2026 and explosive growth in 2027 as new products are approved [10].

此次临床试验申请获受理，是泰恩康在创新药研发道路上的又一重要里程碑，也体现了公司"聚焦未被 满足的临床需求，打造高质量创新药管线"的发展理念。未来，泰恩康将持续深耕医药健康领域，以更 多创新成果守护公众健康，为投资者创造长期价值。 这标志着泰恩康在儿童白癜风创新治疗领域迈出了关键一步，有望为万千患病儿童及家庭带来新的希 望。此次申报的CKBA乳膏联合NB-UVB疗法，凭借独特的协同作用机制展现出显著优势。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。 值得关注的是，CKBA作为上海交通大学王宏林团队从乳香天然产物修饰而来的创新小分子，是全球首 个靶向T细胞脂肪酸代谢通路的创新药物，其创新价值与临床潜力已获得国际学术界高度认可。 本报讯(记者王镜茹)近日，广东泰恩康（301263）医药股份有限公司(以下简称"泰恩康")传来 ...

（文章来源：北京商报） 北京商报讯（记者丁宁）11月20日晚间，泰恩康（301263）发布公告称，公司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"）于近日收到国家药品监督管理局签发的受理通知书，同意受 理博创园提交的CKBA乳膏联合窄谱中波紫外线在2-12岁（含2岁）儿童非节段型白癜风受试者中的安 全耐受性、疗效和药代动力学特征的多中心、随机、双盲、安慰剂对照II期临床研究申请。 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， CKBA有望成为首个儿童白癜风靶向治疗的候选1类创新药，填补儿童白癜风诊疗空白。 ...

智通财经APP讯，泰恩康(301263.SZ)公告，公司控股子公司江苏博创园生物医药科技有限公司(简称"博 创园")于近日收到国家药品监督管理局签发的受理通知书，同意受理博创园提交的CKBA乳膏联合窄谱 中波紫外线(简称"NB-UVB")在2-12岁(含2岁)儿童非节段型白癜风受试者中的安全耐受性、疗效和药代 动力学特征的多中心、随机、双盲、安慰剂对照II期临床研究申请。 ...

泰恩康公告，控股子公司江苏博创园生物医药科技有限公司于近日收到国家药品监督管理局签发的受理 通知书，同意受理博创园提交的CKBA乳膏联合窄谱中波紫外线在2-12岁（含2岁）儿童非节段型白癜 风受试者中的安全耐受性、疗效和药代动力学特征的多中心、随机、双盲、安慰剂对照II期临床研究申 请。 ...

格隆汇11月20日丨泰恩康(301263.SZ)公布，控股子公司江苏博创园生物医药科技有限公司（简称"博创 园"）于近日收到国家药品监督管理局签发的受理通知书，同意受理博创园提交的CKBA乳膏联合窄谱 中波紫外线（简称"NB-UVB"）在2-12岁（含2岁）儿童非节段型白癜风受试者中的安全耐受性、疗效 和药代动力学特征的多中心、随机、双盲、安慰剂对照II期临床研究申请。 ...

Investment Rating - The report maintains a "Buy" rating for the company [3][6]. Core Insights - The company is experiencing pressure on profitability, but progress on research and development (R&D) products is on track [2]. - Revenue for the first three quarters of 2025 was 526 million yuan, a year-on-year decrease of 8.1%, with a net profit attributable to the parent company of 31 million yuan, down 73.0% year-on-year [12]. - The company is expected to see a gradual recovery in revenue growth, with projections of 754 million yuan in 2025, 964 million yuan in 2026, and 1.308 billion yuan in 2027, reflecting growth rates of 4.6%, 27.8%, and 35.8% respectively [5][12]. Financial Forecasts - The earnings per share (EPS) for 2025, 2026, and 2027 are projected to be 0.22 yuan, 0.48 yuan, and 0.85 yuan respectively, revised down from previous estimates [3]. - The company’s gross margin is expected to improve from 57.0% in 2025 to 70.8% in 2027, while the net profit margin is projected to increase from 12.3% to 27.6% over the same period [5][12]. - The target price for the company is set at 32.64 yuan based on a price-to-earnings (P/E) ratio of 68 times for 2026 [3][6]. Clinical Development Progress - The company is set to initiate Phase III clinical trials for CKBA for vitiligo and Phase II/III trials for rosacea by the end of 2025 [12]. - Several high-potential products are progressing through the review process, with expectations for approvals either by the end of this year or next year [12].