China's first new target IAP inhibitor for apoptosis pathways for hepatitis B treatment

Yasheng Pharmaceutical, China's leading original innovative drug research and development company, recently announced that it has received a new clinical trial of a new small molecule IAP inhibitor APG-1387 for hepatitis B indications issued by the China Food and Drug Administration (CFDA). This means that APG-1387 will be the first IAP inhibitor in China to be used in the treatment of hepatitis B.

"Clinical drugs for the treatment of hepatitis B are very effective in inhibiting viral replication, but the clinical cure rate (ie, HBsAg disappears) is very low. Therefore, most patients with hepatitis B need long-term use of antiviral drugs." APG-1387 clinical research is responsible for Ren, Vice Chairman of the China Hepatitis Prevention and Treatment Foundation, Chairman of the Asia-Pacific Association for the Study of Liver Diseases (APASL) in 2017, former Chairman of the Chinese Medical Association Infectious Diseases Branch, and Professor Hou Jinlin, Director of the Liver Disease Center of the Southern Hospital of Southern Medical University, said that the treatment of PG-1387 The novel mechanism of action of hepatitis B is very exciting and it is expected to further validate its potential to eliminate HBV infection in patients with AXA's clinical trial in APG-1387.

APG-1387 is a new generation of high-efficiency specific inhibitor of apoptosis protein inhibitor (IAP) designed and developed by Yasheng Pharmaceutical. It mainly induces and accelerates apoptosis by mimicking endogenous Smac molecules to degrade IAPs. Process. A preclinical study completed by Professor Zhang Xiaoyong from the Liver Disease Center of the Southern Hospital found that the expression of IAPs in the liver of patients with chronic hepatitis B was up-regulated, resulting in immune evasion of HBV-infected hepatocytes and could not be killed by specific T cells. APG-1387 treatment can effectively inhibit the expression of IAPs in hepatocytes and promote the elimination of HBV DNA and HBV surface antigen mediated by virus-specific T cells, thereby curing chronic HBV infection. The advantage of IAP inhibitors for the treatment of hepatitis B virus infection is that, depending on the ability of specific T cells to recognize, it is possible to preferentially kill infected cells without affecting healthy cells.

It is noteworthy that the Global Hepatitis Report 2017 released by the World Health Organization last year showed that the number of people infected with hepatitis B or hepatitis C worldwide has exceeded 325 million, and about 1.34 million people have lost their lives each year. In China, the number of carriers of chronic hepatitis B virus has reached 90 million, the number of patients with chronic hepatitis B has reached 30 million, and only 2 million have been treated, less than 1/10 of the total. According to data from research and consulting firm GlobalData, China will remain the largest market for hepatitis B in the next decade and will continue to maintain high growth. It is estimated that by 2020, China's hepatitis B drug market will reach 20 billion yuan, and the long-term will reach 30 billion. At present, there is no drug on the market that can completely cure hepatitis B, and the demand for drugs is huge.

“The entry of APG-1387 into clinical development in China is a key step in our global development strategy. We expect this drug to offer more possibilities for hepatitis B patients who are in urgent need of more effective treatments.” Ya Yisheng, Chief Medical Officer of Yasheng Pharmaceutical According to the doctor, Yasheng Pharmaceutical is also currently conducting clinical development of cancer for APG-1387. Previously, APG-1387 has completed clinical phase I dose climbing trials for advanced solid tumors in China and Australia. In November last year, APG-1387 was approved by the US FDA new drug clinical trial, and will be used in combination with tumor immunotherapy for the treatment of advanced solid tumors and malignant hematological tumors.

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