China FDA Accepts JHL’s First Clinical Trial Application

JHL1101 is a proposed rituximab biosimilar that JHL is pursuing as part of its strategic biologics alliance with Sanofi, and it is the first product in JHL’s pipeline. Material used to support the CTA was manufactured at JHL’s facility in Wuhan, China, where JHL operates the world’s largest biopharmaceutical manufacturing facility that is based on single-use technologies. Rituximab is used to treat Rheumatoid Arthritis (RA) and Non-Hodgkin’s Lymphoma (NHL). In China, rituximab is used to treat NHL. Each year, about 4.3 million Chinese are diagnosed with cancer, and about 80,000 of these diagnoses are NHL.

JHL is developing biosimilars for Chinese and global markets. In addition to conducting trials in China, JHL is the only Greater Chinabased biosimilars developer to have received European Union and Taiwanese regulatory approval to conduct clinical trials of the proposed rituximab biosimilar: a randomised, double-blind, parallel group, multicentre study comparing the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and efficacy of JHL1101 versus EU sourced MabThera in anti-tumor necrosis factor (TNF)

According to Racho Jordanov, JHL’s co-founder and chief executive officer, “This submission represents years of work. It is a milestone for JHL and the first of many submissions to come. This is JHL’s first step towards making an important oncology therapy more accessible and affordable to Chinese patients, and I am exceptionally proud of our fantastic team for making JHL1101 a reality.”

China fda accepts, jhl’s first clinical trial application