Core Viewpoint - The successful patent grants for CBT-009 represent a significant milestone in the product's development, enhancing its global reach and commercial potential [1][3]. Group 1: Patent Achievements - ADS Therapeutics LLC, a wholly-owned subsidiary of the company, has been granted patents in Japan and Europe for CBT-009, which involves various ophthalmic compositions aimed at treating myopia [1]. - The Japanese patent (No. 7749020) was issued on September 25, 2025, and published on October 3, 2025, covering non-aqueous ophthalmic compositions containing specific amounts of atropine and other compounds [1]. - The European patent (No. 4225284) was granted on November 26, 2025, and published on the same day, also focusing on ophthalmic compositions for treating myopia [1]. Group 2: Product Development - CBT-009 is a novel atropine ophthalmic formulation designed for treating myopia in children and adolescents aged 5 to 19, offering improved stability, safety, and patient tolerance compared to existing aqueous formulations [2]. - The combined Phase 1 and Phase 2 clinical trials for CBT-009 were completed in Australia in January 2023, demonstrating good safety and efficacy [2]. - The company received a non-objection letter from the FDA in September 2024, allowing the initiation of Phase 3 clinical trials after a six-month ocular toxicity study [2]. Group 3: Commercialization Potential - The successful patent applications are expected to facilitate collaborations with major pharmaceutical companies for the production, development, and distribution of CBT-009 in key markets like Japan and Europe [3]. - These collaborations and licensing arrangements are anticipated to enhance and accelerate the global commercialization potential of CBT-009 [3].
拨康视云-B于日本及欧洲成功申请专利 将提升并加速CBT-009的全球商业化潜力