Core Insights - Guangdong Tianenkang Pharmaceutical Co., Ltd. announced positive results from the Phase II clinical trial of its innovative drug CKBA ointment for treating non-segmental vitiligo, showing a 36% improvement in disease and repigmentation rates in the high-dose group [1] - The company plans to submit a Breakthrough Therapy Designation (BTD) application to the National Medical Products Administration (NMPA) and accelerate the Phase III clinical trial [1] Company Developments - The Phase II clinical trial was led by Professor Xu Aie, a renowned vitiligo expert, who noted that the efficacy rate of CKBA could be higher if only facial repigmentation is assessed [1] - CKBA is derived from natural frankincense active small molecules, exhibiting strong anti-inflammatory and antioxidant properties, which may enhance efficacy when used in conjunction with phototherapy [1] Industry Context - Vitiligo is a chronic autoimmune skin disease affecting over 22 million people in China, with existing treatments having significant limitations [2][3] - Current mainstream treatments include calcineurin inhibitors and corticosteroids, which have drawbacks in efficacy, safety, and long-term adherence [3] - The potential market for innovative vitiligo drugs in China is estimated to exceed 20 billion yuan, indicating a significant opportunity for new therapies [3]
200亿元潜在蓝海！泰恩康全球首创CKBA软膏白癜风II期临床获成功，近期将提交突破性疗法认定申请