Shots: The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in […]Read More
Shots: The P-III HLX04-mCRC03 study involve assessing of HLX04 (7.5mg/kg, q3w, when combined with XELOX or 5mg/kg, q2w when combined with mFOLFOX6) vs reference bevacizumab + CT (XELOX or mFOLFOX6) as a 1L treatment in 675 patients in a ratio (1:1) with mCRC Results: PFSR36wk (46.4% vs 50.7%); no difference in 2EPs including OS, PFS, ORR, […]Read More
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 […]Read More
Shots: HLX04 is a biosimilar that binds to vascular endothelial growth factor (VEGF) for inhibiting angiogenesis where VEGF acts for promoting growth of blood vessels can inhibit tumor angiogenesis further preventing tumor growth or metastasis. The biosimilar was developed under Chinese biosimilar guideline The P-III HLX04-mCRC03 trial involves assessing of HLX04 (biosimilar, bevacizumab) or Avastin […]Read More
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