Group 1: Clinical Trial Results - The Phase II clinical trial for CKBA ointment in treating non-segmental vitiligo has shown positive efficacy and safety, meeting expected goals and supporting the initiation of Phase III trials [4] - The average age of participants in the Phase II trial was over 40 years, with inclusion criteria specifying ages between 18 and 65 years and a total body surface area (BSA) of depigmentation between 3% and 10% [4][6] Group 2: Future Plans - The company plans to submit a breakthrough therapy application to the National Medical Products Administration and aims to start Phase III clinical trials for CKBA by the end of 2025, focusing on facial efficacy and expanding the age range to 12-65 years [4][9] - The Phase II/III clinical trial application for rosacea has been accepted, with plans to expedite patient enrollment by the end of 2025 [9] Group 3: Efficacy and Safety Analysis - In the high-dose group (1.5% BID), 36% of participants showed improvement in facial vitiligo scores, outperforming the placebo group [5] - The incidence of treatment-emergent adverse events (TEAE) in the high-dose group was 18%, indicating a favorable safety profile [7] Group 4: Treatment Comparisons - CKBA ointment, derived from natural medicine, is positioned as a safer alternative to traditional therapies, which may cause damage to melanocytes and have higher side effects [8] - The recurrence rate for vitiligo patients after stopping treatment is approximately 30%-50% within one year, necessitating long-term maintenance therapy [6]
泰恩康(301263) - 2025年8月4日投资者关系活动记录表