JHL Biotech Receives Approval From European Authorities to Begin Biosimilar Clinical Trial

Inventariando China

HSINCHU, Taiwan, Feb. 2016 — JHL Biotech, Inc. (Stock Code: 6540.TWO) announced it has received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin clinical trial for JHL1101, a rituximab biosimilar developed and manufactured by its Taiwanese subsidiary to treat rheumatoid arthritis. JHL is the first company from the Greater China region to receive European approval for clinical trial of a monoclonal antibody biosimilar.

The randomized, double-blind, multinational Phase I trial will establish similarity of JHL1101 with its reference product, Roche’s MabThera. JHL seeks to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity to MabThera as well as the safety and efficacy of JH1101. Approximately 150 patients with severe rheumatoid arthritis will participate in locations throughout Europe. Enrollment of patients into the study is expected to begin in 2016.

As a biosimilar with the same delivery mechanism and dosing as MabThera, JHL1101 is exempt…

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