Congratulate! Zhimeng pharmaceutical independently researched and developed the inhibitor and obtained the FDA clinical trial license

On January 17, Shanghai Zhimeng Pharmaceutical Technology Co., Ltd (hereinafter referred to as Zhimeng pharmaceutical) announced that its independently developed new generation nucleocapsid inhibitor zm-h1505r for the treatment of chronic hepatitis B officially obtained the clinical trial license of the US FDA on January 14, 2020 local time It is worth mentioning that zm-h1505r is the first clinical product approved by FDA in the research and development pipeline of Zhimeng pharmaceutical for HBV, which has a new mechanism of action Zm-h1505r is a novel pyrazole nucleocapsid inhibitor, which is different from other type I and type II HBV core protein allosteric regulators (cpams) Zm-h1505r has a new mechanism of action It can prevent HBV replication and effectively block the formation of HBV cccDNA by interfering with the normal formation of viral nucleocapsid and blocking the packaging of pgRNA The preclinical data showed that zm-h1505r is a powerful inhibitor of HBV nucleocapsid, which can effectively inhibit HBV replication in vitro and in vivo, and has high activity for major HBV genotypes (a, B, C and D) Zm-h1505r still has high antiviral activity to HBV variants that have been resistant to other nucleocapsid inhibitors or nucleoside drugs The data of preclinical experimental animals show that zm-h1505r has excellent safety, ideal bioavailability and metabolic stability, and clear metabolic pathway and metabolites In vitro efficacy data showed that zm-h1505r combined with the existing standard treatment drugs nucleoside and interferon, the efficacy showed significant plus cooperation In the upcoming phase 1 clinical trial, healthy volunteers will be taken as subjects to evaluate the safety and tolerance of zm-h1505r after single and multiple incremental oral doses, and to study the absorption, distribution, metabolism, excretion and other pharmacokinetics of drugs in vivo as well as the impact of food on pharmacokinetics According to Zhimeng pharmaceutical press release, there are about 240 million people infected with chronic hepatitis B virus (HBV) in the world, and about 650000 people die of liver failure, cirrhosis and liver cell cancer caused by chronic hepatitis B every year In China, nearly 93 million people are infected with chronic hepatitis B virus, of which more than 30 million have developed into chronic hepatitis B and need treatment The pathogenesis of hepatitis B virus is complex, and the existing drugs can not meet the clinical needs Zm-h1505r is the first clinical product approved by FDA in the research and development pipeline of Zhimeng pharmaceutical for HBV In the field of chronic hepatitis B treatment, Zhimeng pharmaceutical's product pipeline covers multiple mechanisms of the life cycle of hepatitis B virus, including nucleocapsid inhibitors for antiviral replication, RNA de stabilizers for inhibiting the expression of hepatitis B virus surface antigens and other proteins, and immunomodulators It is reported that the development strategy of Zhimeng medicine is to inhibit the replication of virus, the expression of virus protein, and induce effective anti-virus immune response to inhibit the virus, and finally achieve the functional cure of chronic hepatitis B Zhimeng pharmaceutical is an original small molecule drug R & D company focusing on chronic hepatitis B and central nervous disease Dr Chen Huanming, the core founder of Zhimeng pharmaceutical, is a senior expert in new drug design and pharmaceutical chemistry He has rich experience in drug research and development He has led many projects from drug discovery to clinical research and development in different pharmaceutical enterprise platforms, including multinational pharmaceutical enterprises, international cros, and biotechnology companies His experience covers all stages of new drug research and development Dr Zhang Zhijun, chief scientific officer of Zhimeng pharmaceutical, has more than 20 years of experience in new drug research and development He has been responsible for the development of HIV, HBV, HCV and bacterial infection drugs in Oklahoma University and multinational pharmaceutical enterprises in the United States Dr Zhang has served as the research and development director of viral drugs in sanofiasia He has a profound precipitation and practice in the research progress and new drug development of different targets in the life cycle of hepatitis B In addition to the layout in the field of functional cure of chronic hepatitis B, Zhimeng pharmaceutical also has a deep layout in the research and development of small molecule innovative drugs for neurological diseases such as stroke, epilepsy (including general epilepsy and intractable epilepsy), neuropathic pain (such as cancer pain), depression, etc Stroke, epilepsy and pain are common diseases of nervous system The incidence rate of stroke is high, mortality is high, and disability rate is high Epilepsy is also one of the most complex diseases in neurology The risk of early death of epilepsy patients is three times higher than that of the general population Depression and anxiety and other mental disorders will worsen the seizure In November 2019, Zhimeng pharmaceutical announced the completion of nearly 100 million yuan pre-A round of financing, led by zeyue capital and Shenzhen Venture Capital, with zhilang venture capital following The financing amount will be used for phase I clinical research of hepatitis B nucleocapsid inhibitor, as well as clinical application research and follow-up pipeline development of other projects.