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泰恩康(301263) - 2025年11月21日投资者关系活动记录表
2025-11-21 08:46
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].