First trastuzumab biosimilar approved by NMPA

Shanghai Henlius Biotech (2696: HK) says that its trastuzumab biosimilar HLX02, developed and manufactured by Henlius independently, has been approved by China’s National Medical Products Administration (NMPA), referencing Roche’s (ROG: SIX) blockbuster cancer drug Herceptin.

On July 27, HLX02, under the brand name Zercepac, was approved by the European Commission (EC), making it the first China-developed monoclonal antibody (MAb) biosimilar to be approved both in China and in the European Union.

HLX02 is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer. Trastuzumab has been included in China's National Reimbursement Drug List (NRDL) since 2017. According to the Interim Measures for the Administration of Drugs in the NRDL, drugs in the NRDL are managed by their common names, and drugs with common names that have been listed in the NRDL will automatically enter the NRDL.