Henlius’ Rituximab Results Bolster RA Ambitions In China
Reports Positive Phase III Data At National Congress Of Chinese Rheumatology
Shanghai Henlius Biotech has taken its groundbreaking Chinese rituximab biosimilar a step closer to securing a key rheumatoid arthritis indication.
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Henlius says it can now pursue a “differentiated strategy” for its HLX01 rituximab biosimilar in China, after winning approval for a key rheumatoid arthritis indication from the NMPA.
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.
Shanghai Henlius Biotech has filed with China’s NMPA to add a rheumatoid arthritis indication to its HLX01 approved rituximab biosimilar, despite the originator not being approved for RA in China.