CLOUDBREAK-B (02592) has announced that it has decided to voluntarily withdraw its existing New Drug Clinical Trial Application (NDCTA) for CBT-009 ophthalmic emulsion. CBT-009 is an atropine eye drop based on semi-fluorinated alkanes intended for the treatment of myopia in children and adolescents.

The company had previously held a pre-NDCTA consultation meeting with the Center for Drug Evaluation (CDE) in January 2024 regarding a potential placebo-controlled multi-regional clinical trial for CBT-009 in China and other regions. Based on the communication at that time, the group formally submitted the NDCTA in December 2025, which was accepted in January 2026.

Following the submission, a comparable drug was approved for marketing in China by the CDE. After subsequent communication with the CDE, the company believes that including China in the multi-regional clinical trial may present difficulties due to differing regulatory requirements across regions.

To mitigate future R&D risks and allocate the group's resources more effectively, the company has opted to withdraw the current application for the potential Phase III trial in China. CLOUDBREAK-B remains committed to developing its semi-fluorinated alkanes platform and will reassess the clinical development strategy for CBT-009 based on the latest regulatory requirements and market conditions.

Once supplementary studies are completed or the clinical trial protocol is adjusted, the company will, as appropriate, re-engage in pre-application consultations with the CDE or resubmit a clinical trial application. The research, development, and NDCTA processes for the group's other core products, including CBT-004 and CBT-199, continue to proceed according to schedule. For another core product, CBT-001, the company expects to complete its Phase III multi-regional clinical trial in the third quarter of 2026.