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Diakang Shiyun-B (02592): Cloudbreak USA is scheduled to officially hold a Phase 2 post-clinical trial meeting with the US Food and Drug Administration on December 10

智通財經·12/08/2025 04:33:01
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According to Zhitong Finance App, Baokang Shiyun-B (02592) announced that Cloudbreak Therapeutics LLC (Cloudbreak USA), a wholly-owned subsidiary of the Company registered in California, United States of America (US), is scheduled to officially hold a Phase 2 post-clinical trial meeting with the US Food and Drug Administration (US Food and Drug Administration) on December 10, 2025. The conference involves the Group's clinical-stage drug candidate CBT-004.

As disclosed in the Company's prospectus dated June 24, 2025 and the Group's interim report for the six months ended June 30, 2025:

CBT-004 is a potential first-of-its-kind ophthalmic drug. It uses a multi-kinase inhibitor to target vascular endothelial growth factor receptors and platelet-derived growth factor receptors, and is suitable for treating vascularized blepharoid plaques. The Group began phase 2 clinical trials of CBT-004 in December 2023 and completed in May 2025. The results showed that CBT-004 was safe and well tolerated in subjects, and reached a primary endpoint and several secondary endpoints in terms of efficacy. The Group completed the clinical trial report in July 2025 and plans to hold a phase 2 post-clinical trial meeting with the US Food and Drug Administration.

This Phase 2 post-clinical trial conference is an important milestone in the CBT-004 development process. It is used to discuss requirements related to potential phase 3 clinical trial development and new drug applications in the CBT-004 development process. The Company will issue further announcements in due course to ensure that the Company's shareholders and potential investors can keep abreast of the latest developments in the Group's business.