The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a Phase I clinical trial of JHL1101, a potential treatment for rheumatoid arthritis (RA).
JHL1101 is a rituximab biosimilar, which was developed and manufactured by a Taiwanese subsidiary of JHL Biotech.
The company is the first biotech firm from the Greater China region to receive European approval for a clinical trial of a monoclonal antibody biosimilar.
Around 150 patients with severe RA will be enrolled in the trial, which is designed to compare JHL1101 with its reference product, Roche’s MabThera.
The company seeks to show pharmacokinetic (PK) and pharmacodynamic (PD) similarity to Mather as well as the safety and efficacy of JH1101.
Patients across Europe are expected to be enrolled in the trial later this year.
JHL1101 is a biosimilar with the same delivery mechanism and dosing as MabThera.
It is exempt from Phase II trial requirements, but is eligible for a Phase III trial if the Phase I trial validates similarities with its reference product.
One of the most commonly used monoclonal antibody treatments for RA, rituximab is know across the world as MabThera, except for the US, Canada and Japan where it is administered under the name Rituxan.
JHL CEO Racho Jordanov said: "JHL is the first company from Greater China to receive European approval to conduct biosimilar clinical trial, which speaks to the quality of our team and commitment of our people.
"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."
JHL develops new protein-based therapies and biosimilars. Its facilities comply with the US, European Union, and ICH cGMP regulations and standards.
Image: A rheumatoid arthritis case. Photo: courtesy of James Heilman, MD.