Diokang Shiyun-B (02592) successfully held the CBT-004 Phase 2 post-clinical trial conference

Zhitong Finance App News, Baokang Shiyun-B (02592) announced that on December 10, 2025, the company's wholly-owned subsidiary Cloudbreak USA successfully held a Phase 2 post-clinical trial meeting with the US Food and Drug Administration. The conference involved the clinical development of CBT-004. CBT-004 is a potential first-in-class preservative-free eye drop suitable for treating vascularized blepharoplasty. This condition is common in people with excessive UV exposure and the elderly.

At the Phase 2 post-clinical trial meeting, the US Food and Drug Administration provided feedback on the following matters: drug stability and specification studies, non-clinical studies required to support the submission of proposed new drug applications to the US Food and Drug Administration, and the design and end of the CBT-004 phase 3 clinical study. Among them, the US Food and Drug Administration and Cloudbreak USA reached a consensus on the following matters: reducing congestion symptoms as the main end point for CBT-004 approval, its statistical and clinical significance, and symptom relief as a potential common primary endpoint.

The Phase 2 post-clinical trial conference was held based on the results of the Phase 2 clinical trial completed in May 2025 and the clinical trial report completed in July 2025. The report showed that CBT-004 was safe and well tolerated in subjects, and reached the main efficacy end point and several secondary efficacy endpoints. In particular, the results of the Phase 2 clinical trial showed that CBT-004 has curative effects in reducing conjunctival congestion, and the effect can be seen as soon as 7 days after the first dose. An improvement in symptoms including burning or tingling, itching, and foreign body sensation was also observed during the 28-day treatment period. The improvement effect of some symptoms remained significant 4 weeks after discontinuation of the drug. Adverse events that occurred during treatment were minor and temporary, and were not considered related to the studied drug.

The company believes that the successful holding of the Phase 2 post-clinical trial conference marks significant progress in the clinical development of CBT-004. In particular, it has promoted it into phase 3 clinical research, paving the way for commercialization of the new CBT-004 drug application and approval.