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

Funding to accelerate the discovery and development of drugs for high value and traditionally undruggable targets SAN JOSE, Calif., July 27, 2022 /PRNewswire/ -- BridGene Biosciences, Inc., a biotechnology company leveraging a proprietary chemoproteomic platform to discover and develop small-molecule drugs for high-value, traditionally undruggable targets, today announced the completion of a $38.5 million Series B financing by Lapam Capital, Junson Capital and Dyee Capital. Proceeds from the offering will be used to further develop BridGene's chemoproteomic platform IMTAC™, which enables the screening of small molecules against the whole proteome or against a prioritized target in live cells to discover drug candidates for high value and traditionally undruggable targets that drive diseases, including cancers. The unique advantage of IMTAC™ is that it can efficiently identify hits for two major types of traditionally undruggable targets. By using covalent small molecules, BridGene can identify hits for targets with shallow binding pockets. BridGene can also identify hits via live cell screening for targets with temporary binding pockets that only form in live cells such as protein: protein interactions. This brings unprecedented opportunities for the development of small-molecule drugs for traditionally undruggable targets. The proceeds will also be used to develop BridGene's leading pipeline project, a covalent TEAD inhibitor, as well as a few other undisclosed first-in-class oncology pipeline projects, which were initiated based on discoveries using the IMTAC™ platform. "This financing, along with our collaboration with Takeda Pharmaceutical announced last year, significantly strengthens our resources to discover breakthrough medicines for patients," said Ping Cao, Ph.D., CEO and co-founder of BridGene. "Our pioneering work has expanded the scope of chemoproteomics technology from screening just covalent small molecules to also screening non-covalent small molecules, and from targeting just cysteine to targeting multiple amino acids. Our technology uniquely enables us to discover small-molecule drugs for traditionally undruggable targets with unparalleled speed and efficiency. It also enables us to build a pipeline with first-in-class drugs targeting well-known high-value and traditionally undruggable targets. Our long-term goal is to find small-molecule drugs for the most important targets in the proteome." "BridGene's chemoproteomics platform IMTAC™ is impressive and unique. It breaks the limitations of traditional chemoproteomics technology and greatly expands its scope. BridGene has established an outstanding scientific team, which has extensive experience in chemoproteomic technology and drug development. We believe that BridGene has the potential to grow to a leading company in the field of drugging traditionally undruggable targets," said Mr. Zhihua Yu, Chairman of Lapam Capital. About Lapam Capital Headquartered in Beijing, Lapam Capital is a leading healthcare venture capital firm in China. Lapam is currently managing five RMB funds and one USD fund, with more than 10 billion RMB under management. Lapam Capital focuses on investments in early to middle stage fast-growing companies that have innovative pharmaceuticals and medical devices. It has invested in about 60 biopharmaceutical companies and 10 medical device companies to date, including Betta Pharma, RemeGen Co. Ltd., Clover Biopharmaceuticals, Yahong Meditech, Stemirna Therapeutics, Binhui Biotech, ImmuneOnco Biopharmaceuticals, Biostar Pharmaceuticals, Aibo Medical Robot Co. Ltd. and many other companies with great potential. Lapam Capital has a professional investment team with more than 20 years' international and domestic biopharmaceutical industry R&D and management experience and can provide comprehensive value-added supports for the invested companies. About Junson Capital Junson Capital is a global multi-asset investment management company with venture capital and private equity, public market investments, real estate investments, and alternative investments. With its long dedication to technology and healthcare, Junson Capital manages more than 30 portfolio companies and aims at backing disruptive technology and science leaders. As a global organization, Junson Capital has investment professionals located in Hong Kong, New York, Palo Alto and Singapore. About Dyee Capital Dyee Capital focuses on investments in the fields of healthcare and information technology. The management team has many years of investment, investment banking, and industry experience, as well as extensive market resources and professional post-investment service experience. Dyee Capital has invested in many innovative pharmaceutical companies, including Zelgen Biopharmaceuticals, Allist Pharmaceuticals, InventisBio, Ionova Life Science, Ark Biosciences, Leads Biolabs, Yingli Pharma, and Zhimeng Biopharma. About BridGene Biosciences BridGene is a biotechnology company focused on discovering and developing innovative small molecules that drug traditionally undruggable targets, providing new paths to treat diseases. By using its proprietary chemoproteomics platform, IMTAC™, BridGene can screen small molecules against proteins in live cells to discover drug candidates for high value and traditionally undruggable targets. For this purpose, BridGene takes advantage of its proprietary, diverse library of tagged, drug-like small molecules. The ultimate goal is to enable breakthrough small molecule drug discovery with expanded mechanisms to treat diseases with targets previously inaccessible to small molecules. The uniqueness of BridGene's technology allows it to perform IMTAC™ screening for both covalent and non-covalent molecules, target different amino acids and discover new targets for disease treatments by deconvoluting phenotypic screening hits. The company is advancing a diversified pipeline of first-in-class drugs for targets in multiple disease areas. For more information, visit . Contact Tiberend Strategic Advisors, Inc. Investors Jonathan Nugent +1-205-566-3026 [email protected] Media Bill Borden +1-732-910-1620 [email protected] Dave Schemelia +1-609-468-9325 [email protected] SOURCE BridGene Biosciences

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.