Shots:

• The approval is based on comparative quality studies- clinical studies including preclinical data and resulted in bio-similarity- comparable efficacy and safety of Zercepac (HLX02) vs Herceptin
• Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies- preclinical studies- a P-I clinical study and a global multi-center P-III clinical study
• Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer- HER2+ metastatic breast cancer- and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

Ref: Henlius | Image: Behance