Nanjing Sanhome Pharmaceutical Co., Ltd has announced that its Category 1 drug alfosbuvir has been market approved by the National Medical Products Administration (NMPA) following a priority review. The drug is approved in combination with daclatasvir as a treatment for adult chronic hepatitis C virus (HCV) infection with genes 1, 2, 3, and 6 in patients who have initially been treated with interferon, with or without compensatory cirrhosis.
Mechanism of Action of Alfosbuvir
Alfosbuvir is an inhibitor of HCV NS5B RNA dependent RNA polymerase, which is necessary for virus replication. It is a nucleotide prodrug that is metabolized into a pharmacologically active metabolite (SH229M3) in cells. This metabolite can be inserted into HCV RNA by NS5B polymerase, effectively stopping the replication process.
Market Approval Landscape for HCV Drugs in China
Among the total of 15 drugs approved for HCV in China, only three are home-grown, highlighting the significance of Nanjing Sanhome’s alfosbuvir as a domestically developed treatment option. This approval not only expands the treatment options for patients with chronic hepatitis C but also underscores the progress of China’s pharmaceutical industry in developing innovative drugs to address public health needs.-Fineline Info & Tech