CLOUDBREAK-B (02592) announced that its wholly-owned subsidiary, ADS Therapeutics LLC (ADS USA), incorporated in Delaware, United States, has completed the review period for the Investigational New Drug (IND) application for CBT-199. The IND was submitted to the U.S. Food and Drug Administration (FDA) on December 12, 2025. CBT-199 is a potential best-in-class ophthalmic candidate drug developed by the Group. As the FDA did not issue any clinical hold order, the IND is now effective, and the clinical trial is deemed safe to proceed. CBT-199 is a novel topical ophthalmic emulsion intended for the treatment of presbyopia, a common age-related condition where the eye's lens gradually thickens and loses elasticity, leading to a progressive decline in the ability to focus on nearby objects. Utilizing the Group's proprietary water-insoluble platform formulation, CBT-199 contains a parasympathomimetic miotic agent. It works by inducing pupil constriction to create a pinhole effect, thereby increasing the depth of focus and improving near vision. This anhydrous formulation is designed to prevent the degradation of the active ingredient over time, enhancing drug stability. It features a consumer-friendly, self-preserving multi-dose bottle design with an extended shelf life, offering a comfortable and soothing user experience. The Group initiated the drug discovery process for CBT-199 in China in 2023. Since June 2023, CBT-199 has been undergoing safety and tolerability evaluations in preclinical animal studies. These studies are expected to support future clinical trials. The Company believes that the clearance for the clinical trial to proceed safely represents a critical milestone in the clinical development of CBT-199. The Group has now been formally authorized to initiate Phase 2 clinical trials. The Group will continue to closely monitor the review progress and will issue further announcements to keep the Company's shareholders and potential investors informed of the latest developments regarding the Group's business.