BolaKang Vision Cloud's new drug application for the treatment of presbyopia lotion has been approved for clinical trials in the United States

AASTOCKS
2026.02.16 06:17

Bokang Shiyun - B (02592.HK) announced that its U.S. registered subsidiary ADS USA has completed the review period for the new drug clinical trial application for CBT-199 submitted to the U.S. Food and Drug Administration on December 12 of last year. Since the U.S. FDA has not issued any clinical trial suspension orders, the new drug clinical trial application is now effective, and the clinical trial has been deemed safe to proceed. CBT-199 is a novel topical ocular emulsion for the treatment of presbyopia.

The group has commenced the drug discovery process for CBT-199 in the People's Republic of China in 2023. CBT-199 has been undergoing safety and tolerability assessments in preclinical animal studies since June 2023, and these studies are expected to assist in future clinical trials.

The company believes that the clinical trial of CBT-199 being deemed safe to proceed marks a key milestone in the clinical development of CBT-199, and the group has officially been authorized to initiate Phase 2 clinical trials