JHL Biotech Announces First Patient Randomized in the Phase III Study of JHL1101 to Treat Diffuse Large B-Cell Lymphoma
HSINCHU, Taiwan and WUHAN, China, Dec. 27, 2018
HSINCHU, Taiwan and WUHAN, China, Dec. 27, 2018 /PRNewswire/ -- JHL Biotech announced today that the first patient at Beijing Cancer Hospital has been successfully randomized in the Phase III study of JHL1101 to treat diffuse large B-cell lymphoma (DLBCL).
The Phase III study is a multinational, randomized, double-blind, positive-controlled, parallel group clinical study. It compares the efficacy and safety of JHL1101 in combination with CHOP (J-CHOP) versus rituximab in combination with CHOP (R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. CHOP is the standard chemotherapy treatment for diffuse large B-cell lymphoma. The study is being conducted in Europe, China, and other parts of Asia.
JHL1101, a biosimilar product to rituximab which is a monoclonal antibody targeting CD20, is being developed by JHL Biotech for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA).
After completion of similarity assessment in quality attributes and preclinical, a pharmacokinetic (PK) study is being conducted in RA patients in Europe. Earlier this year, the Chinese regulatory authority approved the clinical trial application of the Phase III study.
"Rituximab is an important biologic for the treatment of lymphoma and rheumatoid arthritis. Unfortunately, it is very expensive for patients and healthcare payers. JHL1101 would provide an affordable treatment for these patients," said Mr. Racho Jordanov, CEO, JHL Biotech. "This is a significant milestone for JHL, and a step forward in our goal to become a global leader in developing, manufacturing, and commercializing biologics."
In addition to JHL1101, JHL has several other biosimilars currently in or expected to be in clinical trials. These include:
- Bevacizumab biosimilar, JHL1149, used for the treatment of several cancers, the most common of which are metastatic colorectal cancer, non-small cell lung cancer, and ovarian cancer, as well as cervical cancer, renal cell carcinoma, and glioblastoma. Pharmacokinetics study in Europe has been conducted. Received clinical trial approval for Phase III in China in 2018.
- Dornase alfa biosimilar, JHL1922, to manage symptoms of cystic fibrosis. Pharmacokinetics study in Europe has been conducted. Expected Phase III trial in Europe in 2019.
- Trastuzumab biosimilar, JHL1188, to treat breast cancer. Expected pharmacokinetics study in Australia in 2019.
About JHL Biotech
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. JHL Biotech's mission is to provide the world with low-cost medicines of exceptional quality. JHL is focused on research and development of new protein-based therapies and biosimilars. JHL has two world-class facilities built in accordance with United States, European Union, and ICH cGMP regulations and standards. For more information, please visit www.jhlbiotech.com.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. JHL undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements.
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SOURCE JHL Biotech