Shots:

• The acceptance follows P-III study demonstrating bio-similarity data between HLX02 and reference product trastuzumab sourced from EU in 649 patients with HER2+ m-breast cancer and P-I study resulting equivalence in PK & safety studies b/w HLX02 and reference trastuzumab sourced from both EU and China
• In Jun’18- Henlius granted exclusive commercialization rights of HLX02 to Accord across 53 countries including UK- Germany in Europe. HLX02 & HLX03 (adalimumab- biosimilar) both are under NMPA review in China
• HLX02 is the first biosimilar of trastuzumab developed in China- indicated for HER2+ early-stage breast cancer- HER2+ metastatic breast cancer- untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer

Click here to read full press release/ article | Ref: PRNewsWire | Image: Henlius