Diokang Shiyun-B (02592) successfully submitted a CBT-009 new drug clinical trial application to the Drug Evaluation Center

Zhitongcaijing · 3d ago

Zhitong Finance App News, Baokang Shiyun-B (02592) announced that ADS Therapeutics LLC (ADS USA), a wholly-owned subsidiary of the company registered in Delaware, United States of America (US), has successfully submitted a new drug clinical trial application for CBT-009, one of the Group's core products, to the Drug Evaluation Center (Drug Evaluation Center) of the China National Drug Administration (NDRA).

CBT-009 is a novel, non-aqueous atropine ophthalmic preparation independently developed by the Group to treat myopia in children and adolescents aged 5 to 19. Compared with existing water-based atropine eye drops, CBT-009 significantly improves formulation stability, can be stored at room temperature for a long time without preservatives, and greatly improves patients' compliance and usage experience.

The Company believes that the successful submission of a new drug clinical trial application to the Drug Evaluation Center marks an important milestone in the clinical development of CBT-009 in China and lays a solid foundation for the Group to advance phase III clinical trials in this important market. The Group will continue to closely monitor the review progress of the Drug Review Center and issue separate announcements in due course to inform the Company's shareholders and potential investors of the latest relevant developments.