格隆汇1月30日丨泰恩康(301263.SZ)近日接受特定对象调研时表示，公司目前重点聚焦国内2-12岁儿童 白癜风适应症的注册上市，仅国内市场就已具备较大规模。从全球范围来看，儿童白癜风治疗领域同样 是空白，FDA尚未批准相关产品，拓展海外市场确实存在一定的时间成本和难度。但鉴于CKBA独特的 作用机制，安全性良好，联合用药的前期数据效果显著，公司对其市场前景充满信心，计划今年启动美 国FDA的IND申报工作，逐步探索海外市场的发展空间。 ...

格隆汇1月30日丨泰恩康(301263.SZ)近日接受特定对象调研时表示，公司目前重点聚焦国内2-12岁儿童 白癜风适应症的注册上市，仅国内市场就已具备较大规模。从全球范围来看，儿童白癜风治疗领域同样 是空白，FDA尚未批准相关产品，拓展海外市场确实存在一定的时间成本和难度。但鉴于CKBA独特的 作用机制，安全性良好，联合用药的前期数据效果显著，公司对其市场前景充满信心，计划今年启动美 国FDA的IND申报工作，逐步探索海外市场的发展空间。 ...

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, 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]