Henlius Presents Results of HLX04 (biosimilar- bevacizumab) in P-III Study at ESMO Asia 2020
- 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 2EPs including OS- PFS- ORR- TTR and DoR; safety and immunogenicity profiles were similar b/w HLX04 and the reference
- The NMPA has accepted the NDA for HLX04. Additionally- Henlius has submitted a patent for a new formulation of HLX04 with potential better safety and stability- designed for ophthalmic use
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