SRNE - Sorrento partner receives Chinese approval for infliximab biobetter application

Sorrento Therapeutics' (SRNE) partner Mabpharm Ltd has received New Drug Application ((NDA)) approval for its infliximab biobetter antibody in China. Sorrento holds exclusive commercial rights to this product outside of China and plans to file a Biologics License Application ((BLA)) for the infliximab biobetter antibody in the U.S. and Europe in 2021. The Chinese approval covers 6 different indications including adult ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, adult and childhood Crohn’s disease, fistula Crohn’s disease, and psoriasis. Sorrento is planning to meet with FDA and EMA to discuss the data package and gain concurrence on the path forward to a BLA or MAA.

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Sorrento partner receives Chinese approval for infliximab biobetter application