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 - The core viewpoint of the article highlights that TianKang (SZ 301263) will hold an investor meeting on November 21, 2025, where the company's Vice President and Secretary of the Board, Li Ting, will address investor inquiries [1] - For the year 2024, TianKang's revenue composition is as follows: 61.1% from pharmaceutical agency, 37.28% from pharmaceutical manufacturing, 1.51% from pharmaceutical technology services, and 0.12% from other businesses [1] - As of the report, TianKang's market capitalization stands at 12.1 billion yuan [1]

Core Viewpoint - The company, 泰恩康, announced the release of a portion of shares pledged by its controlling shareholder, indicating a potential positive shift in shareholder confidence and liquidity [1]. Group 1: Shareholder Actions - The controlling shareholder, 孙伟文, has released 6.72 million shares from pledge [1]. - As of the announcement date, the total number of pledged shares by 郑汉杰 is 35.5 million, representing 40.17% of his holdings [1]. - 孙伟文 has pledged a total of 7.9 million shares, which accounts for 11.93% of her holdings [1]. Group 2: Financial Performance - For the year 2024, the revenue composition of 泰恩康 is as follows: 61.1% from pharmaceutical agency, 37.28% from pharmaceutical manufacturing, 1.51% from pharmaceutical technology services, and 0.12% from other businesses [1]. - The current market capitalization of 泰恩康 is 12.1 billion yuan [1].

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].

证券代码：301263 证券简称：泰恩康 公告编号：2025-077 广东泰恩康医药股份有限公司 关于控股股东、实际控制人部分股份解除质押的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有 虚假记载、误导性陈述或重大遗漏。 广东泰恩康医药股份有限公司（以下简称"公司"）于近日收到公司控股股东、 实际控制人孙伟文女士的通知，获悉其所持有的公司部分股份办理了解除质押的 手续，具体情况如下： | 股东 | 是否为控股股 东或第一大股 | 本次解除 | 占其所 持股份 | 占公司总 | 质押 | 质押 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 名称 | 东及其一致行 | 质押数量 （股） | 比例 | 股本比例 | 起始日 | 解除日 | 质权人 | | | 动人 | | （%） | （%） | | | | | 孙伟文 | 是 | 6,720,000 | 10.15 | 1.58 | 2024-12-09 | 2025-11-20 | 渤海国际 信托股份 | | | | | | | | | 有限公司 | | 合计 | - | 6 ...

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 ...

Core Insights - Guangdong Taiankang Pharmaceutical Co., Ltd. has made significant progress in the innovative treatment of pediatric vitiligo with the acceptance of its clinical trial application for CKBA cream combined with narrowband ultraviolet B (NB-UVB) for children aged 2-12 [1][2] - The global prevalence of vitiligo, a chronic autoimmune disease characterized by skin pigment loss, is high, with children accounting for 32%-40% of cases, highlighting a substantial unmet clinical need in this demographic [1] Group 1 - The acceptance of the clinical trial application marks a key advancement for the company in the pediatric vitiligo treatment sector, potentially providing new options for affected children and their families [1] - Currently, there are no approved products for treating vitiligo in children globally, indicating a significant market opportunity for the company [1] - The company aims to address unmet clinical needs and enhance its innovative drug pipeline, reinforcing its commitment to public health and long-term value creation for investors [2] Group 2 - CKBA, a First-in-Class innovative drug with global intellectual property rights, is progressing steadily in its indication layout, with adult vitiligo in Phase II trials and plans for Phase III submission [2] - The company is also preparing for II/III phase trials for rosacea and advancing preclinical research for Alzheimer's disease, with an IND application planned for the second half of 2026 [2] - The acceptance of the pediatric vitiligo indication further enriches the company's indication matrix, showcasing its deep accumulation in innovative drug research and development [2]

（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。 ...

Group 1 - EVE Energy signed a procurement framework agreement with its affiliate, Smoore International, for continuous procurement of battery cells starting from January 1, 2026 [1] - Zhaoyi Information plans to issue H-shares and list on the Hong Kong Stock Exchange [1] - Fuke Environmental announced a change in its stock abbreviation to "Fuke Technology" effective November 26 [1] Group 2 - Dajia Weikang's shareholder and director terminated a share reduction plan ahead of schedule, having reduced 1% of total shares [2] - Aohong Electronics received approval from the China Securities Regulatory Commission for the issuance of convertible bonds [2] - Yingfeng Environment's controlling shareholder plans to issue exchangeable bonds not exceeding 1 billion yuan [2] Group 3 - Longshen Rongfa's subsidiary obtained a renewed drug production license covering various pharmaceutical products [4] - Xinhua News' subsidiary invested 15 million yuan in a fund with a total commitment of 221 million yuan [5] - Guang'an Aizhong appointed two new deputy general managers [6] Group 4 - Fosun Pharma's subsidiary's drug for gastric cancer treatment was included in the breakthrough therapy program by the National Medical Products Administration [7] - Nanjiao Foods reported a significant decline in October net profit due to rising raw material costs [8] - Nanfeng Co. won two nuclear power project bids totaling 928.7 million yuan [10] Group 5 - Puluo Pharmaceutical received a drug registration certificate for its Cefdinir capsules [11] - Liming Co.'s subsidiary received environmental approval for a new pesticide raw material project [12] - Longhua New Materials' expansion project for polyether polyols has commenced trial production [13] Group 6 - Pumen Technology's products received IVDR CE certification from TÜV Rheinland [15] - China Chemical reported new contracts worth 312.67 billion yuan from January to October [18] - China Nuclear Construction achieved new contracts totaling 123.84 billion yuan as of October [19] Group 7 - Changshu Bank's executives plan to purchase at least 550,000 shares of the bank [20] - Shandong Steel's subsidiary is applying for bankruptcy liquidation to focus on core business [21] - Huakang Clean is expected to win a bid for a purification system project worth 176 million yuan [23] Group 8 - Huawu Co. plans to internally transfer subsidiary equity [24] - Tianen Kang's subsidiary received clinical trial acceptance for a new drug [26] - Tianyi Medical's subsidiary obtained a medical device registration certificate for a blood dialysis product [27] Group 9 - Xuelang Environment is facing a pre-restructuring application from creditors [27] - Chitianhua's subsidiary resumed production after passing safety inspections [28] - Huaping Co.'s director plans to reduce 0.03% of company shares [30] Group 10 - Xizhuang Co. plans to establish a wholly-owned subsidiary in Singapore [31] - Ruisheng Intelligent's subsidiary won a 60.23 million yuan ICT project bid [32] - Junyi Digital plans to invest 120 million yuan in Guanghong Precision [33] Group 11 - Fuguang Co.'s controlling shareholder plans to increase holdings between 80 million to 150 million yuan [34] - Ganyue Express reported a 13.68% increase in logistics revenue in October [39] - Jiangsu Sop terminated its 2025 private placement plan [41] Group 12 - Langke Intelligent's shareholders plan to reduce a total of 1.68% of company shares [42] - Yuantong Express reported an 8.97% increase in express product revenue in October [45] - Jinbei Automotive plans to invest 158 million yuan to acquire 52% of Zhongtuo Technology [46]

泰恩康（301263）(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。 ...