AMOYTOP: The application for the marketing authorization of Pegfilgrastim for additional indications has been approved
I'm LongbridgeAI, I can summarize articles.AMOYTOP announced that its core product Pegasys's supplemental indication marketing authorization application has been approved by the National Medical Products Administration. This product is used for the sustained clearance of HBsAg in adult patients with chronic hepatitis B and is the world's first 40kD polyethylene glycol long-acting interferon α-2b injection, classified as a national Class 1 new drug. Pegasys was launched in 2016, initially for the treatment of adult chronic hepatitis C, and was approved for adult chronic hepatitis B in 2017
According to the Zhitong Finance APP, AMOYTOP (688278.SH) announced that it has recently received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration. The company's product Peginterferon Lambda-1a (acid) analogs for the indication of increased sustained HBsAg clearance in adult patients with chronic hepatitis B (referred to as "increased indication") has been approved for marketing.
Peginterferon is currently the company's core product and is the world's first 40kD polyethylene glycol long-acting interferon α-2b injection independently developed by the company. It is a Class 1 new drug for therapeutic biological products and the first domestically produced polyethylene glycol (PEG) modified interferon variety approved for marketing in China. Peginterferon was approved for marketing in October 2016, with the approved indication for the treatment of adult chronic hepatitis C; in September 2017, it was approved for the indication of adult chronic hepatitis B