Henlius’ Trastuzumab Approved In China

Becomes First China-Developed mAb Biosimilar Approved In Both China And EU

Shanghai Henlius Biotech has received the first Chinese approval for a trastuzumab biosimilar version of Herceptin.

Chinese - EU flags
Henlius’ trastuzumab biosimilar has been approved in both China and the EU • Source: Shutterstock

Shanghai Henlius Biotech has seen its HLX02 trastuzumab become the first approved biosimilar of Herceptin in China as well as “the first China-developed monoclonal antibody biosimilar to be approved both in China and in the EU,” after receiving approval from China’s National Medical Products Administration.

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