Henlius Reports NMPA’s Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

 Henlius Reports NMPA’s Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Henlius Reports NMPA’s Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Shots:

  • NMPA has accepted the NDA of HLX04, based on the series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies & clinical studies. The NDA acceptance makes HLX04 the fourth product of Henlius that has received NMPA’s NDA acceptance & can be potentially used for the treatment of advanced/ metastatic or recurrent NSCLC and metastatic colorectal cancer
  • The P-III study assessing the efficacy, safety, and immunogenicity of HLX04 or the reference bevacizumab + oxaliplatin and fluoropyrimidine-based CT (XELOX or mFOLFOX6) as a 1L treatment in Chinese patients with metastatic colorectal cancer
  • The study met its 1EPs of PFS @36wks.and has shown similarity to the reference product in terms of efficacy, safety, and immunogenicity. Additionally, Henlius is evaluating the HLX04 in combination with HLX10 for the treatment of solid tumors and is the first dual mAb combo therapy that has received IND approval

Click here ­to­ read full press release/ article | Ref: Henlius | Image: EDN

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Tuba Khan is an Editor and Digital Marketing expert at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in Lifesciences industry. She covers Pharma, Medical devices, Diagnostics and Digital health segment. Tuba also has an experience of digital and social media marketing and can run the campaign independently. She is also certified as a Digital marketer and social media marketer. She can be contacted on tuba@pharmashots.com

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