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Today, China's State Drug Administration Drug Review Center (CDE) announced that the company has submitted a clinical trial application (IND) for a class 1 new drug ZM-H1505R tablet in China, which was accepted on September 1.
ZM-H1505R is a type of hepatitis B virus (HBV) nuclear casing inhibitor intended to be developed to treat chronic HBV infection.
, according to the CDE website, this is the first IND submitted in China since the founding of The League Pharmaceuticals.
screenshot Source: CDE.com The company is committed to developing innovative drugs for chronic hepatitis B (CHB) and the central nervous system.
In view of the complexity of the causes of liver disease, the strategy adopted by Pharma is to develop a variety of new and more effective anti-hepatitis B virus drugs for joint and multi-directional suppression of HBV, and to restore the immune function of patients through the use of new immunomodulation agents.
November 2019, the company announced the completion of nearly 100 million yuan of Pre-A round of financing, jointly led by Zeyue Capital and Shenzhen Ventures.
ZM-H1505R is a new generation of viral nuclear casing inhibitors developed by ZM-H1505R to be used to treat chronic hepatitis B virus infection.
According to an earlier press release issued by Pharma Pharmaceuticals, ZM-H1505R, as a new structure of pyridoxine-like shell inhibitors, has a completely new mechanism of action that can prevent the replication of hepatitis B virus by interfering with the normal formation of viral kernels and blocking the packaging of pre-genome RNA (PgRNA), and effectively blocking the formation of HBV co-priced closed cyclic DNA (cccDNA).
January, ZM-H1505R was licensed for clinical trials in the United States, the first FDA-approved clinical product in the research and development pipeline of HBV.
Currently, ZM-H1505R is conducting a randomized, double-blind, placebo-controlled Phase 1 trial in the United States to assess the safety, toerability, and pharmacodynamics of ZM-H1505R oral single and multiple incremental doses (SAD/MAD) in healthy subjects.
ZM-H1505R clinical trial application for CDE acceptance, meaning the drug is also expected to soon enter clinical trials in China.
it is worth mentioning that this is also the first IND submitted in China in the three years since the founding of the company.
addition to the ZM-H1505R, the company's product pipeline includes five research and development projects, according to the company's pharmaceutical website.
of these products are targeted at liver disease, including HBsAg inhibitors, TLR8 agitants, and OX40 astrists.
two other products are aimed at neurological disorders, one to develop treatments for epilepsy and pain and the other to treat stroke.
's Pharmaceutical Products Pipeline (Photo Source: Chi-League Pharmaceutical Official Website) Reference: China's State Drug Administration Drug Review Center (CDE). Retrieved Sep 01,2020, from .2. From.