Cloudbreak Pharma Inc. (CLOUDBREAK-B, 02592) has voluntarily withdrawn its Investigational New Drug (IND) application in China for CBT-009, an SFA+ atropine ophthalmic emulsion aimed at treating juvenile myopia.

The decision follows China’s recent approval of a comparable product and subsequent discussions with the Center for Drug Evaluation (CDE) indicating divergent regional regulatory requirements, which would complicate inclusion of China in a multi-regional Phase 3 trial. Management stated that reallocating resources and mitigating development risk underpin the withdrawal.

Cloudbreak will maintain investment in its semi-fluorinated alkane (SFA+) platform and intends to reassess CBT-009’s clinical strategy. Options include additional supplementary studies, protocol adjustments, pre-submission consultations with the CDE, or a future resubmission of the IND.

Pipeline Status • CBT-004 and CBT-199: Research and development activities, including IND preparations, remain on schedule. • CBT-001: The Phase 3 multi-regional clinical trial (MRCT) is expected to complete in 3Q 2026.

The company reiterated that there is no guarantee of ultimate approval or commercialisation for CBT-009 or any other core product. Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares.