Shanghai, August 14, 2025 – Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma" or the "Company") today announced the achievement of a significant new milestone: FPFD of its Phase III clinical trial for ZM-H1505R (Canocapavir), a next-generation core protein allosteric modulator (CpAM) for the treatment of chronic hepatitis B (CHB). The first patient has been successfully dosed at The First Hospital of Jilin University. This follows the designation of ZM-H1505R tablets as a Breakthrough Therapy for chronic hepatitis B by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in January 2025.
This Phase III trial is a multicenter, randomized, double-blind, placebo-controlled study with an open-label extension. Led by Professor Niu Junqi from The First Hospital of Jilin University as the lead Principal Investigator, the trial plans to enroll approximately 1,300 CHB patients across roughly 80 sites in China. Eligible patients are those who have received nucleos(t)ide analogue (NA) monotherapy for at least 12 months but have not achieved complete virological response (CVR). The study aims to evaluate the efficacy and safety of ZM-H1505R (Canocapavir) combined with NAs compared to NA monotherapy. The primary endpoint is the difference in the proportion of subjects achieving CVR (defined as HBV DNA ≤ 10 IU/mL) at Week 48 of the double-blind treatment period between the ZM-H1505R plus NAs group and the NA monotherapy group.
The hepatitis B virus (HBV) is the primary cause of CHB. Relevant data indicates that there are approximately 86 million HBV carriers in China, of whom about 30 million are CHB patients. However, the diagnosis rate is only 18.7%, and the treatment rate is less than 11%, significantly below the World Health Organization (WHO) 2030 targets (90% diagnosis rate, 80% treatment rate). While current nucleos(t)ide antiviral drugs can effectively control HBV replication and delay the progression of liver cirrhosis in most patients, they rarely achieve functional cure (defined as HBsAg clearance). Patients require long-term treatment and face the risk of viral rebound upon discontinuation. Therefore, novel therapeutic approaches targeting different stages of the HBV life cycle are critically important.
ZM-H1505R, a potent pyrazole-based capsid assembly modulator independently developed by Zhimeng Biopharma, inhibits HBV core protein formation through a novel chemical scaffold, thereby blocking the viral replication cycle. Compared to currently reported Class I and Class II HBV core inhibitors, it possesses a distinct chemical structure and maintains potent antiviral activity against mutant viruses resistant to Class I/II core inhibitors and nucleos(t)ide analogues (NAs). Phase II clinical trial data demonstrated that after 24 weeks of treatment with ZM-H1505R 100 mg combined with Entecavir (ETV), 82.1% of subjects achieved HBV DNA levels meeting the criteria for Complete Virological Response，significantly higher than the 14.3% rate observed in the NA monotherapy group. The initiation of this Phase III trial marks a critical step for ZM-H1505R from Phase II development toward regulatory submission, aiming to validate its efficacy and safety in a larger patient population.
As an innovative drug R&D platform focused on liver diseases, Zhimeng Biopharma's pipeline targets multiple stages of the HBV replication cycle. The company aims to achieve functional cure for CHB by comprehensively inhibiting viral replication and protein expression while inducing effective antiviral immune responses. This strategy seeks to provide more effective clinical treatment options, ultimately improving patients' quality of life and offering hope to HBV patients and their families.
About Zhimeng Biopharma
Founded in 2018, Zhimeng Biopharma is dedicated to the discovery and development of novel small molecule therapeutics. Beyond its commitment to achieving functional cure for chronic hepatitis B, the company is also deeply engaged in developing innovative drugs for challenging neurological disorders, including refractory epilepsy, neuropathic pain (such as cancer pain), amyotrophic lateral sclerosis (ALS), major depressive disorder (MDD), and bipolar disorder. Zhimeng Biopharma has successfully secured multiple rounds of financing to date.