Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

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