Shots:
- The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab)
- BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity
- Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L colorectal cancer and has also developed an ophthalmic formulation, HLX04-O, for wAMD. The NDA for HLX04-O has been accepted by China’s NMPA, with a global P-III trial completed to support future worldwide filings
Ref: Henlius | Image: Henlius | Press Release
Related News: Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)
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