证券代码：301263 证券简称：泰恩康 公告编号：2025-080 广东泰恩康医药股份有限公司 关于全资子公司收到药品注册受理通知书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假 记载、误导性陈述或者重大遗漏。 审核结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审 查，决定予以受理。 二、药品相关情况简介 吲哚布芬片是一种血小板聚集抑制剂，通过可逆性抑制环氧化酶及多种诱 导剂，降低血栓风险，用于动脉硬化引起的缺血性心血管病变、缺血性脑血管 病变、静脉血栓形成。也可用于血液透析时预防血栓形成。原研药由意大利 Farmitalia Carlo Erba 公司（现属辉瑞）开发，商品名为 Ibustrin。米内网数据显 示，吲哚布芬片 2024 年国内城市公立、县级公立、乡镇卫生三大终端市场销售 额约为 14 亿元，2025 年上半年销售额约为 8.3 亿元。 广东泰恩康医药股份有限公司（以下简称"公司"）全资子公司安徽泰恩 康制药有限公司于近日收到国家药品监督管理局（以下简称"国家药监局"） 签发的吲哚布芬片境内生产药品注册上市许可申请《受理通知书》，国家药监 局根据《中华人民 ...

证券代码：301263 证券简称：泰恩康 公告编号：2025-079 广东泰恩康医药股份有限公司 关于全资子公司收到甲巯咪唑片药品注册证书 的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假 记载、误导性陈述或者重大遗漏。 广东泰恩康医药股份有限公司（以下简称"公司"）全资子公司山东华铂 凯盛生物科技有限公司于近日收到国家药品监督管理局（以下简称"国家药监 局"）签发的甲巯咪唑片《药品注册证书》。现将相关情况公告如下： 剂型：片剂 规格：5mg；10mg 注册分类：化学药品 4 类 药品批准文号：国药准字 H20256095、国药准字 H20256096 上市许可持有人：山东华铂凯盛生物科技有限公司 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本 品符合药品注册的有关要求，批准注册，发给药品注册证书。质量标准、说明 书、标签及生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规 范要求方可生产销售。 二、药品相关情况简介 甲状腺功能亢进症(Hyperthyroidism)简称"甲亢"， 是甲状腺激素分泌过 多导致机体兴奋性增高和代谢亢进为主要表现的一组临床综合征。根 ...

据悉，中证1000指数选取中证800指数样本以外的规模偏小且流动性好的1000只证券作为指数样本，与 沪深300和中证500等指数形成互补。在业内人士看来，泰恩康纳入中证1000指数，既印证了公司基本面 的稳健质地与市场流动性的良好表现，也标志着其投资价值较大程度获得指数编制机构的权威认可。同 时，泰恩康有望纳入相关ETF的被动配置范畴，为股价形成支撑。 12月3日，泰恩康（301263）在投资者关系平台上表示，公司已被纳入中证1000指数拟生效样本范围， 调整将于2025年12月15日起正式生效。 数据显示，当前中证1000指数相关ETF有17只，总规模超过1600亿元。以泰恩康最新的市值水平大致估 算其纳入中证1000指数后所占权重为1‰左右，则泰恩康可吸引逾1.6亿元被动资金配置。 ...

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]

Group 1 - The company has been included in the sample range of the CSI 1000 Index, which will take effect on December 15, 2025 [1] - An investor inquired about the company's inclusion in the CSI 1000 Index on the investor interaction platform [2]

泰恩康（301263.SZ）12月1日在投资者互动平台表示，公司已提交的儿童白癜风二期临床试验申请和成 人白癜风三期临床试验申请是独立提交的，是两个不同的临床试验，覆盖不同的年龄段，其中2-12岁儿 童白癜风目前全球尚未有获批药物。公司目前有计划争取在2026年向FDA申报儿童白癜风的IND申请， 关于BD的情况如有进展会根据信息披露规则及时履行信息披露义务。 （文章来源：每日经济新闻） 每经AI快讯，有投资者在投资者互动平台提问：请问下ckba治疗白癜风申请突破性疗法是否已提交cde 审核，贵公司是全覆盖申请还是分成人和儿童单独申请？ ...

格隆汇12月1日丨泰恩康(301263.SZ)在投资者互动平台表示，公司已提交的儿童白癜风二期临床试验申 请和成人白癜风三期临床试验申请是独立提交的，是两个不同的临床试验，覆盖不同的年龄段，其中2- 12岁儿童白癜风目前全球尚未有获批药物。公司目前有计划争取在2026年向FDA申报儿童白癜风的IND 申请，关于BD的情况如有进展会根据信息披露规则及时履行信息披露义务。 ...

Market Performance - The pharmaceutical sector experienced a slight increase of +0.14% on November 28, 2025, underperforming the CSI 300 index by 0.11 percentage points, ranking 27th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical devices (+1.53%), hospitals (+0.95%), and other biological products (+0.70%) performed well, while offline pharmacies (-0.55%), vaccines (-0.46%), and medical research outsourcing (-0.33%) lagged behind [1] - Top three gainers in individual stocks were Haiwang Pharmaceutical (+10.03%), Baihua Pharmaceutical (+10.01%), and Hefei China (+7.49%); the top three decliners were Yue Wannianqing (-13.71%), Zhongsheng Pharmaceutical (-10.00%), and Guangji Pharmaceutical (-9.98%) [1] Industry News - The CDE announced that AbbVie's Upadacitinib extended-release tablets are proposed for priority review, targeting severe alopecia areata in adults and adolescents aged 12 and above [2] - Upadacitinib is a JAK inhibitor effective for various immune-mediated inflammatory diseases, with a stronger inhibitory effect on JAK1 compared to JAK2, JAK3, and TYK2; this priority review in China suggests accelerated access for alopecia patients [2] Company News - Guobang Pharmaceutical (605507) announced an employee stock ownership plan involving 270 employees, aiming to raise up to 185 million yuan, with a stock cap of 10% of total equity and a duration of 24 months, including a 12-month lock-up period [3] - Tianen Kang (301263) reported that its subsidiary Shandong Huabo Kaisheng received a drug registration certificate for Baricitinib tablets from the National Medical Products Administration, confirming compliance with registration requirements [3] - Yipinhong (300723) announced that its subsidiary Guangzhou Yipinhong received approval for Esomeprazole Magnesium Enteric-Coated Suspension from the National Medical Products Administration, meeting registration standards [3] - Enhua Pharmaceutical (002262) stated that it received a drug registration certificate for Oxycodone Hydrochloride Extended-Release Tablets from the National Medical Products Administration, confirming compliance with registration requirements [3]

Core Viewpoint - The announcement indicates that the company’s wholly-owned subsidiary, Shandong Huabo Kaisheng Biotechnology Co., Ltd., has received a drug registration certificate for Baricitinib tablets from the National Medical Products Administration [2] Group 1 - The drug registration certificate signifies regulatory approval for Baricitinib tablets, which may enhance the company's product portfolio and market presence [2] - This approval could potentially lead to increased revenue streams for the company through the commercialization of Baricitinib [2]