Shanghai Zhimeng Biopharma said on October 31 that it had completed enrollment of 255 patients in a Phase 2/3 trial of its investigational ALS drug, CB03-154.

The company said the study involves 15 research centers in mainland China and is led nationally by Professor Fan Dongsheng of Peking University Third Hospital. Its main efficacy measure is the change in patients’ ALS Functional Rating Scale–Revised scores after 39 weeks.

The announcement concerns recruitment into the study. It does not report whether the drug improved patients’ symptoms, function or survival, and it provides no new clinical safety findings.

A ClinicalTrials.gov record for the study, NCT07082192, describes a randomized trial comparing CB03-154 with placebo. The registry also lists a subsequent open-label extension and a main study assessment at 39 weeks.

The registry record was last updated on September 22, before the company’s latest announcement. That older entry still lists recruitment as ongoing and estimates enrollment at 240. The new figure of 255 and the claim that enrollment is complete come from Zhimeng’s October 31 release; they are not a newly updated registry count.

Zhimeng said it anticipates Phase 2 topline results in the third quarter of 2027. If those results are positive, it plans to seek conditional approval in China. Those are the company’s stated plans, rather than confirmed results or a regulatory decision.

CB03-154 is described by the company as a selective potassium-channel opener. The trial is intended to test its efficacy and safety in ALS; completing enrollment does not establish either.

The company also reported separate development programs for focal epilepsy and major depressive disorder. The enrollment milestone announced here concerns the ALS study in China.

Sources Shanghai Zhimeng Biopharma — October 31 enrollment announcement: https://www.prnewswire.com/news-releases/zhimeng-biopharma-has-completed-the-patients-enrollment-of-its-investigational-drug-cb03-154-in-the-pivotal-phase-23-als-clinical-trial-302924801.html ClinicalTrials.gov — NCT07082192, registry record last updated September 22: https://clinicaltrials.gov/study/NCT07082192