Shots:
- On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac
- Henlius followed the NMPA and EMA’s biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, Herceptin
- Analytical studies, preclinical studies, P-I study, and a P-III study showed that HLX02 is highly similar to the reference in terms of quality, safety, and efficacy. Additionally, HLX01 (biosimilar, rituximab) received NMPA’s approval in 2019
Click here to read full press release/ article | Ref: PRNewswire | Image: GMP News
Related News: Henlius Reports Positive Results of HLX04 (biosimilar, bevacizumab) in P-III Trial for Metastatic Colorectal Cancer
