JHL Biotech Inc., a biopharmaceutical startup, announced that the first patient has been dosed in the company's phase I clinical trial of JHL1101 (a proposed rituximab biosimilar) in rheumatoid arthritis patients.
The randomised, double-blind, parallel group, multicentre study will compare the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and efficacy of JHL1101 versus EU sourced MabThera in anti-tumor necrosis factor (TNF) inadequate responder patients with moderate to severe rheumatoid arthritis. The study is designed to enroll 150 patients from the European Union, Russia, Taiwan, and Ukraine.
According to Racho Jordanov, JHL's co-founder and CEO, "I am happy to announce formal commencement of the Phase I trial of JHL1101. JHL is committed to increasing access to exceptional quality biologics, and our phase I European clinical trial will provide a means to prove the safety, efficacy, and high quality of JHL1101."
JHL Biotech Inc. is a biopharmaceutical startup founded by a group of industry veterans with deep experience in pharmaceutical development and operations. JHL is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity, and the China Development Industrial Bank.