CLOUDBREAK-B(02592) has successfully applied for patents in Japan and Europe, which will enhance and accelerate the global commercialization potential of CBT-009.

CLOUDBREAK-B (02592) announced that its wholly-owned subsidiary, ADS Therapeutics LLC (ADS USA), registered and established in Delaware, USA, has successfully obtained the following patents related to one of the group's core products, CBT-009: The Japan Patent Office granted a patent on September 25, 2025, with patent number 7749020, which was published in the official gazette of the Japan Patent Office on October 3, 2025. This patent involves various ophthalmic topical compositions (including non-aqueous ophthalmic topical compositions containing specified amounts of atropine, medium-chain triglycerides liquid carriers, and selected perfluoroalkane compounds) and their uses (such as slowing down the progression of myopia); and The European Patent Office granted a patent on November 26, 2025, with patent number 4225284, which was published in the European Patent Office's European Patent Bulletin issue 2025/48 on the same day. This patent involves various ophthalmic topical compositions, including ophthalmic topical compositions with atropine and perfluoroalkanes as liquid carriers for treating eye diseases such as myopia. CBT-009, as the group's core product, is a novel atropine ophthalmic formulation used for the treatment of myopia in children and adolescents aged 5 to 19. It is designed as a non-aqueous formulation, which improves stability, safety, and patient tolerance compared to existing aqueous formulations. Preclinical studies of CBT-009 were initiated in China and the USA in 2021 and 2022. The combined Phase 1 and Phase 2 clinical trials of CBT-009 were completed in Australia in January 2023, demonstrating good safety and efficacy. In September 2024, after six months of ocular toxicity studies, the group received approval from the FDA indicating no objection to conducting Phase 3 clinical trials. The group also initiated juvenile animal toxicity studies in China in February 2025 and is actively preparing for the initiation of Phase 3 clinical trials for CBT-009. The company expects that CBT-009 will outperform its competitors and other existing treatment methods in terms of drug stability, safety, patient tolerance, and shelf life, once approved, it will become the best product in its class. The company believes that the successful patent applications are important milestones in the development process of CBT-009, which will enhance its global coverage and promote the commercialization process. The group is expected to collaborate with major pharmaceutical companies to establish licensing arrangements for production, development, and distribution of CBT-009 in key high-end markets in Japan and Europe. It is anticipated that these collaborations and licensing arrangements will enhance and accelerate the global commercialization potential of CBT-009.