Core Viewpoint - The company has successfully submitted a new drug clinical trial application for its core product CBT-009 to the National Medical Products Administration of China, marking a significant milestone in its clinical development in the Chinese market [1] Group 1: Product Development - CBT-009 is a novel, non-aqueous atropine eye formulation developed independently by the company, aimed at treating myopia in children and adolescents aged 5 to 19 [1] - Compared to existing aqueous atropine eye drops, CBT-009 significantly enhances formulation stability, allowing for long-term storage at room temperature without the need for preservatives, thereby improving patient compliance and experience [1] Group 2: Regulatory Progress - The successful submission of the new drug clinical trial application is seen as a solid foundation for advancing the third phase of clinical trials in the important Chinese market [1] - The company will continue to closely monitor the review progress by the drug review center and will issue further announcements to inform shareholders and potential investors of relevant developments [1]
拨康视云-B成功向药品审评中心提交CBT-009新药临床试验申请