Big Molecule Watch
April 5, 2017

China’s FDA Accepts JHL Biotech’s Clinical Trial Application for Rituximab Biosimilar in NHL

JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients.  JHL1101 is a rituximab biosimilar candidate that JHL is pursuing as part of its strategic biologics alliance with Sanofi.  According to the press release, JHL previously obtained EU and Taiwanese regulatory approval to compare JHL1101 to MABTHERA (rituximab) with respect to pharmacokinetics, pharmacodynamics, immunogenicity, safety, and efficacy in anti-tumor necrosis factor (TNF) inadequate responder patients with moderate to severe rheumatoid arthritis.