# Zhimeng Biopharma has completed the patients enrollment of its investigational drug, CB03-154, in the pivotal Phase 2/3 ALS clinical trial.

- Link: https://www.thailand-business-news.com/pr-news/zhimeng-biopharma-has-completed-the-patients-enrollment-of-its-investigational-drug-cb03-154-in-the-pivotal-phase-2-3-als-clinical-trial
- Published: 2026-10-31T12:00:00+07:00
- Author: PR Newswire

SHANGHAI, Oct. 31, 2026 /PRNewswire/ —** Shanghai Zhimeng Biopharma, Inc. ( "Zhimeng
Biopharma") **announced today that its independently developed next-generation potassium
channel opener, CB03-154, intended for the treatment of amyotrophic lateral sclerosis(
ALS), has successfully completed patient enrollment in its pivotal Phase 2/3 clinical
trial, in total enrolled 255 patients. This significant milestone marks the entry
of the critical stage in the clinical development of CB03-154 for ALS in China, 
laying a solid foundation for the upcoming analysis of topline data and potential
new drug application submissions.

This pivotal clinical trial has been conducted in China, with Professor Fan Dongsheng
from the 3^(rd) Affiliated Hospital of Peking University serving as the national
leading principal investigator (Leading PI), and involving a total of 15 clinical
research centers in Mainland China. The study aims to evaluate the efficacy and 
safety of CB03-154 in patients with ALS, with the primary efficacy endpoint being
the change from baseline in the ALSFRS‑R score at Week 39. Previously, CB03-154 
received approval from the China CDE in July 2025 to initiate Phase 2/3 clinical
trials for ALS, and in October 2023 it was granted Orphan Drug Designation (ODD)
by the U.S. FDA.

As a rare disease, ALS poses numerous unique challenges in drug development. Notably,
based on the current clinical progress, if the Phase 2 topline results are positive
in the third quarter of 2027, Zhimeng Biopharma plans to submit a marketing application
to the China CDE for a conditional approval. This strategy is expected to enable
ALS patients to gain access to innovative therapies sooner, reflecting the company’s
patient‑centered R&D philosophy in the rare‑disease space.

CB03-154 is a next-generation, selective potassium‑channel opener of the voltage‑
gated KCNQ2/3, independently discovered and developed by Zhimeng Biopharma, and 
possesses potential best-in-class properties. By modulating neuronal excitability
and restoring the balance between excitation and inhibition, this compound has demonstrated
neuroprotective effects on motor neurons in preclinical studies. The completion 
of enrollment in this pivotal clinical trial marks the entry of a critical phase
of validating the efficacy and safety of CB03-154 in patients with ALS.

In terms of clinical development, CB03-154 has been steadily advancing across multiple
CNS indications. As of October 2026, in addition to the ALS indication, the drug
has already entered the Phase 2 clinical trial for Focal Epilepsy in China and Australia.
Furthermore, in June 2026, it received approval from the China CDE to initiate a
Phase 2 trial for Major Depressive Disorder (MDD). The concurrent advancement of
these three clinical studies fully underscores CB03-154’s broad development potential
in the field of central nervous system disorders.

Dr. Huanming Chen, the Founder and CEO of Zhimeng Biopharma, stated: "The completion
of patient enrollment for the pivotal Phase 2/3 clinical trial of CB03-154 marks
a strategically significant milestone for Zhimeng Biopharma in the field of ALS 
treatment. I would like to extend my sincere appreciation to Professor Fan Dongsheng
and the investigators at all clinical research centers across China for their dedicated
efforts, as well as to all ALS patients and their families who participated in the
trial for their selfless commitment. Moving forward, we will spare no effort to 
advance clinical development and regulatory submissions, striving to bring a truly
effective new treatment option to ALS patients in China and around the world as 
soon as possible."

**About Zhimeng **

Founded in 2018, Shanghai Zhimeng Biopharma, Inc, is a clinical stage biopharmaceutical
company dedicated to the research and development of original small‑molecule drugs.
The company focuses on liver diseases and central nervous system disorders, with
a strong pipeline targeting treatment options for refractory epilepsy, neuropathic
pain, amyotrophic lateral sclerosis (ALS), major depressive disorder (MDD), and 
other neurological conditions. In addition to its CNS portfolio, Zhimeng Biopharma
has also made significant progress in the field of functional cure for chronic hepatitis
B; its leading product, ZM‑H1505R (capsid inhibitor), has entered pivotal Phase 
3 trial in China.

**Disclaimer**

This press release contains forward-looking statements. While Zhimeng considers 
the projections to be based on reasonable assumptions, these forward-looking statements
may be called into question by a number of hazards and uncertainties, so that actual
results may differ materially from those anticipated in such forward-looking statements.

For more information, please visit:_ [www.corebiopharma.com](http://www.core-biopharma.com/)_

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