Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02 (biosimilar, trastuzumab)

Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02 (trastuzumab, biosimilar)

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