SHANGHAI, Sept. 11, 2025 /PRNewswire/ — Shanghai Zhimeng Biopharma, Inc. (“Zhimeng Biopharma”) announced that its self-developed novel next-generation KCNQ2/3 potassium channel opener, CB03-154, has recently received clinical trial approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate a Phase 2 clinical trial in China for refractory epilepsy. This follows the CDE’s approval in July of this year for Phase 2/3 clinical studies in amyotrophic lateral sclerosis (ALS). The upcoming trial is a randomized, double-blind, placebo-controlled, multinational, multicenter study designed to evaluate the clinical efficacy, safety, and tolerability of CB03-154 as an adjunctive therapy in adult patients (18-70 years old) with focal epilepsy.
Epilepsy is a common neurological disorder characterized by seizures or episodes of abnormal behavior, sensations, and sometimes loss of consciousness. It affects approximately 90 million patients globally, with about 9 million in China. Existing treatments fall far short of meeting the clinical needs of epilepsy patients; nearly 30% have refractory epilepsy that cannot be controlled with monotherapy. The pathogenesis of the disease is related to alterations in ion channels and synaptic transmission/connectivity, primarily caused by an imbalance between neuronal excitation and inhibition. As the structural basis for neuronal excitability and activity, dysfunctional ion channels are closely associated with the development of epilepsy. Among them, potassium (K+) channels are the most widely distributed and diverse type of ion channel, primarily involved in regulating neuronal excitability and the frequency and amplitude of action potentials.
CB03-154 is a novel next-generation KCNQ2/3 potassium channel opener developed by Zhimeng Biopharma. It demonstrates good chemical and metabolic stability, in vitro and in vivo anti-epileptic activity/efficacy, pharmacokinetic properties, and safety. It also possesses more specific ion channel selectivity, potentially overcoming the safety issues associated with first-generation drugs. Currently, clinical studies for CB03-154 in epilepsy are also underway in Australia.
Research suggests that KCNQ2/3 potassium channel openers could be effective not only for epilepsy but also for major depressive disorder (MDD), ALS, and neuropathic pain. Previously, CB03-154 tablets had also been granted Orphan Drug Designation (ODD) by the U.S. FDA for development in the treatment of ALS patients.
Dr. Huanming Chen, Chief Executive Officer (CEO) of Zhimeng Biopharma, stated: ” Zhimeng has consistently focused on research in liver diseases and central nervous system disorders. From target exploration to molecule optimization, from pharmaceutical research to preclinical evaluation, we have always advanced our projects with a scientifically rigorous attitude, ultimately gaining continuous recognition from regulatory agencies. Thanks to the team’s efforts and the support of all investors and research institutions. We are committed to deepening our work in areas of unmet clinical need, progressing clinical trials in full speed, and providing patients with safer and more effective treatment options.”
As a clinical-stage biopharmaceutical company, Zhimeng Biopharma has consistently focused on the development of innovative drugs for antiviral and central nervous system diseases. The company has established a rich pipeline covering multiple stages of the hepatitis B virus (HBV) replication cycle and several indications within neurological disorders. Besides the investigational drug CB03-154 for epilepsy and ALS, the company’s novel HBV core protein inhibitor, ZM-H1505R, for the treatment of chronic hepatitis B (CHB), has also entered pivotal Phase 3 clinical studies.
About Zhimeng
Founded in 2018, Shanghai Zhimeng Biopharma, Inc. is a biopharmaceutical company dedicated to develop small-molecule drug discovery focused on the functional cure of chronic hepatitis B (CHB), as well as novel therapies for CNS disorders, including epilepsy, neuropathic pain (e.g., cancer-related pain), amyotrophic lateral sclerosis (ALS), major depressive disorder (MDD), and bipolar disorder. Zhimeng has successfully completed multiple rounds of financing.
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SOURCE Shanghai Zhimeng Biopharma, Inc.
