AMOYTOP: The application for the marketing authorization of Pegfilgrastim for additional indications has been approved

Zhitong
2025.10.12 08:25
portai
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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