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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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