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Henlius’ Ophthalmic Bevacizumab Program Moves Ahead

IND Approval From US FDA Follows Nod From Australia’s TGA

Executive Summary

Shanghai Henlius Biotech is planning to move forward with wet AMD trials for its bevacizumab biosimilar rival to Avastin following a nod from the US FDA.

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Henlius Gets Fourth Chinese Biosimilar With Bevacizumab Nod

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.

Henlius Bevacizumab Trials Results Get International Recognition

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.

Henlius Capitalizes On Biosimilar Launches

Henlius has announced plans to expand its global footprint and bolster its manufacturing capacity after seeing its sales shoot up in 2020 based on three new launches.

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