Diakang Shiyun-B (02592): The US Drug Administration completed the safety review of the CBT-358 new drug clinical trial application

Zhitongcaijing · 1d ago

According to Zhitong Finance App, Baokang Shiyun-B (02592) announced that on July 14, 2026, the review period for the CBT-358 new drug clinical trial application (new drug clinical trial application) submitted to the US Food and Drug Administration (US Drug Administration) on May 21, 2026 has been completed. The US Drug Administration has completed the safety review of the new drug clinical trial application and has no objection to the proposed clinical study.

As disclosed by the Company in the Group's 2025 Report dated March 31, 2026 and the voluntary announcement dated May 22, 2026 relating to the latest business developments:

CBT-358 is a recent addition to our product pipeline. It is a complex drug combining semifluoroalkanes (SFA+) and transient receptor potential protein 8 (transient receptor potential protein 8) agonists to treat dry eyes. This field is a multi-billion dollar global market. By combining these two ingredients, CBT-358 is expected to treat dry eyes caused by insufficient tear secretion and improve comfort.

The Company believes that since the US Drug Administration has completed the safety review of CBT-358, it marks a key milestone in the clinical development of CBT-358. The Group will continue to closely monitor the progress of the review and issue separate announcements in due course to inform the Company's shareholders and potential investors about the latest developments in the Group's business.