Shanghai Zhimeng Biopharma, Inc.

SHANGHAI, Oct. 20, 2023 /PRNewswire/ -- Shanghai Zhimeng Biopharma Inc. ("Zhimeng"), announced that one of its innovative small-molecule KCNQ2/3 selective opener compounds (CB03), developed for the treatment of amyotrophic lateral sclerosis (ALS), received orphan drug designation (ODD) from US FDA. CB03 is also being developed for other central nervous diseases, such as refractory epilepsy, major depressive disorders (MDD), etc. CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases independently developed by Zhimeng. A phase 1 study for the evaluation of the safety, tolerability, and pharmacokinetics of CB03 in healthy subjects is currently ongoing in Australia and US. The phase 1 study is expected to complete the dosing phase (both single dose and multiple dose) before the end of 2023. "The orphan drug designation by US FDA for CB03 is an important milestone in its global clinical development for ALS and other central nervous system diseases," said Dr. Huanming Chen, President and CEO of Zhimeng. "Since ALS is a very serious disease without adequate treatment options, we hope our dedicated efforts will allow us to bring a safer and more effective medicine to ALS patients worldwide as the first indication for CB03." About CB03 Studies on neurons indicate that the hyperexcitability of neurons is the one of the important underlying causes associated with neurodegenerative and neuropsychic CNS diseases, including ALS, epilepsy, MDD, neuropathic pain, among others. As the most widely distributed and the most diverse group of ion channels, potassium (K+) channels are mainly involved in the modulation of neuronal excitability and the frequency and amplitude of action potential discharges. CB03 as a KCNQ2/3 potassium ion channel opener thus has its potential for become a safe and effective treatment option for ALS and other CNS diseases. As a new generation of selective KCNQ2/3 potassium channel opener, CB03 showed better chemical and metabolic stability, higher biological/pharmacological activities in in vitro and ALS animal disease models, and more druggable pharmacokinetic properties. Thus, CB03 is unlikely to present the same safety concerns as other channel openers and warrant further clinical development to demonstrate potential benefits in the ALS patient population. About Amyotrophic lateral sclerosis (ALS) ALS is a neurodegenerative disease that affects nerve cells in the brain and spinal cord. ALS causes loss of muscle control and the disease gets worse over time. The exact causes of ALS are still not known, but neuron hyperexcitability causing neuron damage may play an important role in disease initiation and progression. A small number (about 10%) of ALS cases are inherited. ALS often begins with muscle twitching and weakness in an arm or leg, trouble swallowing or slurred speech. Eventually ALS affects control of the muscles needed to move, speak, eat, and breathe. A large percentage of ALS patients may only survive for 3-5 years after diagnosis of the disease. There are a few drugs approved for treating the symptoms of ALS or slowing down the disease progression, but currently no cure for this fatal disease. About Zhimeng Zhimeng is a clinical-stage biopharmaceutical company committed to developing innovative drugs for the treatment of chronic hepatitis B (CHB) and severe neurological diseases with significant unmet medical needs. The company has recently announced the successful completion of the phase Ib clinical trial on its novel HBV capsid inhibitor, Canocapavir (ZM-H1505R), and has started the phase II study in June 2022. In addition, the clinical trial application of the company's TLR8 agonist (CB06) was approved by the FDA in December 2021, and the phase I study was launched in the United States in March 2022. 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: com

Shanghai, China. December 27, 2022. Shanghai Zhimeng Biopharma, Inc. (“Zhimeng”), an innovation-driven biopharmaceutical company focused on the development of innovative drugs for the treatment of chronic hepatitis B and central nervous system diseases, announced dosing of the first participant in Phase II study of its novel HBV capsid assembly modulator Canocapavir (ZM-H1505R) in China/Hong Kong. Following the completion of a Phase Ia study of ZM-H1505R in the United States in 2021 and a Phase Ib study in China in 2022, Zhimeng initiated the Phase IIa trial of ZM-H1505R in China/Hong Kong in August 2022, which is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ZM-H1505R in combination with Entecavir (ETV) compared with ETV monotherapy in patients with chronic hepatitis B who have been receiving ETV monotherapy for at least 12 months. Zhimeng expects to receive the topline results from this trial in the middle of 2023.

SHANGHAI, June 14, 2022 /PRNewswire/ -- Shanghai Zhimeng Biopharma announces that it will report the positive results obtained from a phase 1b study on its HBV capsid inhibitor ZM-H1505R in the International Liver Congress in June 22-26, 2022 (the EASL meeting). The recently completed phase 1b study was to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antiviral activity of ZM-H1505R in a double-blind, randomized, placebo-controlled, dose escalating study in treatment-naïve chronic hepatitis B (CHB) patients. Patients were divided into three cohorts (10 patients each) and randomized within each cohort in a ratio of 4:1 to receive an ascending dose of 50, 100, or 200 mg of ZM-H1505R, or placebo once a day for 28 consecutive days. ZM-H1505R was safe and well tolerated within this dose range, with most AEs being mild to moderate in severity. No SAE was observed and there was no withdrawal due to AE. A proportional relationship was observed between dose and plasma exposure of ZM-H1505R. At day 28, the mean plasma Cmin were 2.73, 7.05, and 14.56 folds of its protein-binding adjusted HBV DNA EC50 for 50, 100, and 200 mg doses, respectively. Serum levels of HBV DNA and HBV pgRNA were significantly reduced from baselines after 28 days of treatment with ZM-H1505R. The mean maximal reductions from baselines in HBV DNA were -1.54, -2.50 and -2.75 log10 IU/mL, and in HBV pgRNA were -1.53, -2.35 and -2.34 log10 IU/mL in the 50, 100 and 200 mg cohorts, respectively. The mean maximal declines from baseline in HBcrAg were -0.61 and -0.51 log10 IU/mL in the 100 and 200 mg cohorts, respectively. "We are pleased to see the positive safety and preliminary efficacy results of ZM-H1505R from this phase 1b study." Commented Dr. Huanming Chen, CEO of Zhimeng Biopharma. "We believe that HBV capsid inhibitors such as ZM-H1505R will play an important role in further reducing the viruses in patients who have been treated with a NA for a long time but still have low levels of viremia. We are also confident that ZM-H1505R may become a component of a combination therapy for functional cure of CHB. With such promising results of ZM-H1505R, we will initiate a phase 2 trial in Q3 of 2022 to further evaluate its safety and efficacy". About ZM-H1505R ZM-H1505R is a small-molecule HBV capsid assembly modulator with a novel pyrazole structure currently being evaluated for the treatment of chronic hepatitis B (CHB). It is active against most HBV variants that show resistance to other HBV capsid modulators. About Zhimeng Biopharma Zhimeng Biopharma is a clinical-stage biopharmaceutical company committed to developing innovative drugs for the treatment of chronic hepatitis B (CHB) and severe neurological diseases with significant unmet medical needs. The company has recently announced the launch of the first-in-human phase I study of its novel TLR8 agonist, developed for CHB, in the US in March 2022; and the first-in-human phase I study of its novel small molecule, KCNQ2/3 selective opener, developed for the treatment of refractory epilepsy, in the US in May 2022. For more information, please visit: SOURCE Shanghai Zhimeng Biopharma, Inc.