CLOUDBREAK-B Shares Drop Over 6% to Record Low Following Withdrawal of CBT-009 Clinical Trial Application

Stock News
03/20

CLOUDBREAK-B (02592) fell more than 6%, hitting a low of HK$1.82, marking a new record low since its listing. As of the time of writing, the stock was down 6.09% to HK$1.85, with a turnover of HK$740,100. On the news front, on the evening of March 19, CLOUDBREAK announced that it had held a pre-IND consultation meeting with the Center for Drug Evaluation in January 2024 regarding a potential placebo-controlled multi-regional clinical trial for CBT-009 ophthalmic emulsion, an atropine eye drop based on semi-fluorinated alkanes for the treatment of myopia in children and adolescents, which could be conducted in China and other regions. Based on the communication at that time, the group formally submitted a new drug clinical trial application in December 2025, which was accepted in January 2026. After the submission of the application, the Center for Drug Evaluation approved a comparable drug for market launch in China. Following subsequent communication with the Center, the company believes that including China in the multi-regional clinical trial may present difficulties due to differing regulatory requirements across regions. To avoid subsequent R&D risks and to better allocate the group's resources, the company has decided to proactively withdraw the existing new drug clinical trial application for the potential Phase III trial in China.

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