Henlius Doses First Patient In China For Ophthalmic Bevacizumab
Follows US FDA Approving Henlius’ Investigational New Drug Application
Chinese firms Shanghai Henlius Biotech and Essex Bio-Technology have announced a key milestone in their Chinese Phase I clinical study for the HLX04-O biosimilar bevacizumab candidate to treat wet age-related macular degeneration.
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Henlius has focused its efforts on becoming a fully-fledged biopharmaceutical company during 2021, moving away from its roots as a biosimilar drug company.
Shanghai Henlius Biotech has celebrated its fourth Chinese biosimilar approval with the NMPA’s endorsement of its bevacizumab biosimilar. The company is also working on an ophthalmic version to treat wAMD.
China’s Henlius has received international recognition of Phase I and III clinical trial results for its bevacizumab biosimilar, HLX04, providing “strong evidence for the efficacy and safety similarity between HLX04 and the reference bevacizumab.” The company has submitted its NDA for the product to the NMPA for various indications.