NMPA (China) approves Zercepac to treat Breast Cancer and Gastric Cancer -Shanghai Henlius Biotech.

Shanghai Henlius Biotech, Inc. announced that the trastuzumab biosimilar ???® (HLX02, EU brand name: Zercepac), developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). On 27th July, Zercepac has also been approved by the European Commission (EC), making HLX02 the first China-developed mAb biosimilar to be approved both in China and in the EU. The common name of ???® is trastuzumab injection (150mg/vial, without preservative) and it is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer, which corresponds to all the indications approved in China of the trastuzumab originator. Trastuzumab has been included in China’s National Reimbursement Drug List (NRDL) in 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.