Core Viewpoint - The company is focusing on the registration and market launch of treatments for pediatric vitiligo in the domestic market, which has significant potential [1] Group 1: Domestic Market Focus - The company is concentrating on the registration and market launch of treatments for children aged 2-12 with vitiligo [1] - The domestic market for this indication is already substantial [1] Group 2: Global Market Potential - There is a global gap in the treatment of pediatric vitiligo, with no FDA-approved products available [1] - The company acknowledges that expanding into overseas markets will involve time and challenges [1] Group 3: Product Confidence and Future Plans - The company expresses strong confidence in the market prospects of its product due to its unique mechanism of action and good safety profile [1] - Plans are in place to initiate the IND application process with the FDA in the United States this year to explore overseas market opportunities [1]

Core Viewpoint - The company is focusing on the registration and market launch of treatments for pediatric vitiligo in the domestic market, which has significant potential [1] Group 1: Domestic Market Focus - The company is primarily targeting the registration and market launch of treatments for children aged 2-12 with vitiligo [1] - The domestic market for this indication is already substantial, indicating a strong potential for growth [1] Group 2: Global Market Potential - There is a global gap in the treatment of pediatric vitiligo, with no FDA-approved products currently available [1] - The company acknowledges the challenges and time costs associated with expanding into overseas markets [1] Group 3: Product Confidence and Future Plans - The company expresses confidence in the market prospects for its product due to the unique mechanism of action and good safety profile of CKBA [1] - Plans are in place to initiate the IND application process with the FDA in the United States this year, aiming to explore development opportunities in international markets [1]

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]