CLOUDBREAK-B (02592) announced that its wholly-owned subsidiary, ADS Therapeutics LLC (ADS USA), incorporated in Delaware, USA, has successfully obtained the following patents related to its core product, CBT-009:

1. A patent granted by the Japan Patent Office (Patent No. 7749020) on September 25, 2025, and published in the official gazette on October 3, 2025. This patent covers various topical ophthalmic compositions, including non-aqueous formulations containing specific concentrations of atropine, medium-chain triglyceride liquid carriers, and selected semifluorinated alkane compounds, as well as their applications (e.g., slowing myopia progression).

2. A patent granted by the European Patent Office (Patent No. 4225284) on November 26, 2025, and published in the European Patent Bulletin (Issue 2025/48) on the same day. This patent pertains to topical ophthalmic compositions, including those with atropine and semifluorinated alkanes as liquid carriers, for treating eye disorders such as myopia.

CBT-009, a key product of the group, is a novel atropine-based ophthalmic formulation designed to treat juvenile myopia in children and adolescents aged 5 to 19. As a non-aqueous solution, it offers improved stability, safety, and patient tolerability compared to existing aqueous formulations.

Preclinical studies for CBT-009 were initiated in China and the US in 2021 and 2022, respectively. The combined Phase 1 and Phase 2 clinical trials were completed in Australia in January 2023, demonstrating favorable safety and efficacy. In September 2024, following a six-month ocular toxicity study, the company received a no-objection letter from the US FDA to proceed with Phase 3 trials. Additionally, juvenile animal toxicity studies commenced in China in February 2025, with preparations underway for Phase 3 trials.

The company expects CBT-009 to outperform competing atropine-based treatments and existing therapies in terms of drug stability, safety, patient tolerability, and shelf life, positioning it as a best-in-class product upon approval.

These patent approvals mark a significant milestone in CBT-009's development, enhancing its global reach and accelerating commercialization. The group anticipates potential collaborations with major pharmaceutical companies to establish licensing arrangements for the production, development, and distribution of CBT-009 in Japan and Europe—key high-value markets. Such partnerships are expected to further amplify and expedite CBT-009's global commercialization prospects.