Henlius Reports NMPA's Acceptance of NDA for HLX04 (biosimilar- bevacizumab)

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Henlius Reports NMPA's Acceptance of NDA for HLX04 (biosimilar- bevacizumab)


  • 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

­ Ref: Henlius | Image: EDN

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