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]

泰恩康11月28日公告，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 核准签发的巴瑞替尼片《药品注册证书》。巴瑞替尼是一种Janus 激酶（JAK）抑制剂，可阻断一种或 多种JAK 激酶家族成员的活性，从而抑制激活炎症的途径，由礼来制药公司和Incyte 合作开发。巴瑞替 尼最早于2017年在欧盟和英国上市，获批适应症为类风湿关节炎；2018年获得美国FDA批准被用于治疗 某些患有中度至重度活动性类风湿关节炎的成年患者，2022 年6 月，美国FDA批准了巴瑞替尼口服片剂 用于治疗患有严重斑秃的成年患者。该产品未来的具体销售情况可能受到行业政策、市场环境等因素影 响，具有不确定性。 ...

格隆汇11月28日丨泰恩康(301263.SZ)公布，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（简称"国家药监局"）签发的巴瑞替尼片《药品注册证书》。巴瑞替尼是一种Janus 激酶(JAK)抑制剂，可阻断一种或多种JAK激酶家族成员的活性，从而抑制激活炎症的途径，由礼来制 药公司和Incyte合作开发。 ...

Core Viewpoint - The company TianKang (301263.SZ) has received a drug registration certificate for Baricitinib tablets from the National Medical Products Administration, indicating a significant regulatory milestone for the company in the pharmaceutical sector [1] Group 1: Company Developments - TianKang's wholly-owned subsidiary, Shandong Huabo Kaisheng Biotechnology Co., Ltd., has been granted the drug registration certificate for Baricitinib tablets [1] - Baricitinib is identified as a Janus kinase (JAK) inhibitor, which can block the activity of one or more members of the JAK kinase family, thereby inhibiting pathways that activate inflammation [1]

每经AI快讯，11月28日，泰恩康（301263）公告，公司全资子公司山东华铂凯盛生物科技有限公司收 到国家药品监督管理局签发的巴瑞替尼片《药品注册证书》。该产品用于治疗类风湿关节炎、严重斑秃 等。 ...

智通财经APP讯，泰恩康(301263.SZ)公告，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签发的巴瑞替尼片《药品注册证书》。巴瑞替尼是一种Janus激酶(JAK)抑制剂，可 阻断一种或多种JAK激酶家族成员的活性，从而抑制激活炎症的途径。 ...

证券代码：301263 证券简称：泰恩康 公告编号：2025-078 广东泰恩康医药股份有限公司 关于全资子公司收到巴瑞替尼片药品注册证书 的公告 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"）签发的巴瑞替尼片《药品注册证书》。现将相关情况公告如下： 一、申请注册药品的基本情况 受理号：CYHS2302467 药品名称：巴瑞替尼片 剂型：片剂 规格：2mg 注册分类：化学药品 4 类 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。 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。 药品批准文号：国药准字 H20256060 四、对公司的影响及风险提示 该产品未来的具体销售情况可能受到行业政策、市场环境等因素影响，具 有不确定性，敬请广大投资者审慎决 ...