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