HSINCHU and WUHAN, China, Feb. 22, 2018 /PRNewswire/ — JHL Biotech Inc. announced that the European authority, Bulgarian Drug Agency, has approved a Phase I Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149.
JHL will conduct a three-arm pharmacokinetic study in healthy volunteers in Bulgaria beginning March 2018. The data from this trial will support the rapid development and commercialization of JHL1149.
JHL1149 would provide an affordable alternative to bevacizumab, a biologic used to treat many cancers, the most common of which are metastatic colorectal cancer, lung cancer, and ovarian cancer. In 2016, bevacizumab generated worldwide revenues of approximately US$7 billion.
JHL has several biosimilars currently in or expected to be in clinical trials. These include:
- Rituximab biosimilar, JHL1101, to treat rheumatoid arthritis and Non-Hodgkin’s Lymphoma. Currently in Phase I trial in Europe. Expected Phase III trial in Europe and Phase I and III trials in China in 2018.
- Dornase alfa biosimilar, JHL1922, to manage symptoms of cystic fibrosis. Currently in Phase I trial in Europe. Expected Phase III trial in Europe in 2018.
- Trastuzumab biosimilar, JHL1188, to treat breast cancer. Expected Phase I trial in Europe in 2018.
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’s mission is to provide the world with low-cost medicines of exceptional quality. JHL is focused on the 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