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news.JHL Biotech has secured approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) to start clinical trial for JHL1101, a rituximab biosimilar developed to treat rheumatoid arthritis.
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The biosimilar is manufactured by JHL’s Taiwanese subsidiary. It is the first company from the Greater China to secure European approval for clinical trial of a monoclonal antibody biosimilar.
Under the randomized, double-blind, multinational phase I trial, JHL will enroll about 150 patients with severe rheumatoid arthritis in locations across Europe.
The company will establish similarity of JHL1101 with its reference product, Roche’s MabThera. Plans also include demonstrating pharmacokinetic and pharmacodynamic similarity to MabThera as well as the safety and efficacy of JH1101.
JHL said as a biosimilar with the similar delivery mechanism and dosing as MabThera, JHL1101 is free from phase II trial requirements.
It can undergo phase III trial after the completion of the phase I study and similarity with the reference product is further validated.
JHL CEO Racho Jordanov said: "Countless international pharmaceutical companies have attempted to develop a rituximab biosimilar.
"Rituximab has a complex structure, and JHL had to develop a product identical in quality, safety, and efficacy to its Roche reference.
"We are proud to have produced this product and advance it into clinical development. We currently have four other therapies in development, and this event marks the beginning of an exciting new stage in JHL’s growth."