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

HSINCHU, TaiwanFeb. 14, 2016 /PRNewswire/ -- 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 from Phase II trial requirements and is eligible to undergo Phase III trial when the Phase I trial is concluded and similarity with the reference product is further validated. MabThera is the brand name for rituximab in most of the world, except for the United StatesCanada, and Japan where it is administered under the name Rituxan. Rituximab is one of the most commonly used monoclonal antibody treatments for rheumatoid arthritis.

JHL Chief Executive Officer 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."

About JHL Biotech

JHL Biotech Inc. (Stock Code: 6540.TWO) is a biotech startup founded by a group of industry veterans with deep experience in pharmaceutical development and operations. JHL is supported by the commitment of premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity, and the China Development Industrial Bank. JHL Biotech's mission is to provide the world with low-cost medicines of exceptional quality. To this end, JHL is focused on research and development of new protein-based therapies and biosimilars.

JHL Biotech has built world-class facilities in accordance with United States, European Union, and ICH cGMP regulations and standards. The JHL Center of Excellence in Taiwan is able to support biosimilar pre-clinical and early-clinical phase R&D work. JHL's facility in Wuhan, China will be able to support commercial-scale manufacturing of biologic therapies. This infrastructure gives JHL the unique ability to manufacture its own product and execute contract orders for select clients

For more information, please visit www.jhlbiotech.com.

Media Contact:

Max Chan, Chief Financial Officer

Contact Phone Number: +886-(0)3-658-3899 #700

Contact Email: [email protected]  

This press release contains forward-looking statements, including without limitation all statements related to JHL Biotech's clinical development program for JHL1101. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon JHL Biotech's current expectations. Forward-looking statements involve risks and uncertainties. JHL Biotech's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of significant known and unknown risks and uncertainties.  JHL Biotech is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.