JHL Biotech Submits Clinical Trial Application in Europe for Proposed Dornase Alfa Biosimilar to Affordably Manage Symptoms of Cystic Fibrosis
HSINCHU, Taiwan and WUHAN, China, Dec. 20, 2017 /PRNewswire/ -- JHL Biotech (Stock Code: 6540.TWO) announced today that it has submitted a Phase 1 Clinical Trial Application to the Dutch Healthcare Authority for its proposed dornase alfa biosimilar, JHL1922, to improve pulmonary function in cystic fibrosis patients.
JHL1922 would provide an affordable alternative to dornase alfa, which is indicated for daily administration to improve pulmonary function in cystic fibrosis patients in conjunction with other standard therapies. The clinical trial will be conducted in the Netherlands beginning March 2018.
JHL Biotech is developing JHL1922 as a proposed similar biological product to dornase alfa. Dornase alfa is a recombinant human deoxyribonuclease I (rhDNase I), an enzyme which selectively cleaves deoxyribonucleic acid (DNA). Dornase alfa is sold under the brand name Pulmozyme® in the United States and the European Union and was first approved for treatment of cystic fibrosis in the U.S. in 1993 and in Europe in 1994.
Cystic fibrosis affects over 100,000 people worldwide, and dornase alfa is an important part of the treatment regimen. Estimates show the cost of dornase alfa treatment is US$12,000 -$40,000 per patient per year, with only about 30,000 patients receiving this treatment.
"JHL1922 would increase affordable access to an important therapeutic for cystic fibrosis patients, and we look forward to conducting the Phase I trial in Europe," said Racho Jordanov, CEO, JHL Biotech.
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About JHL Biotech
JHL Biotech Inc. (Stock Code: 6540.TWO) 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 Biotech 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.
Forward-Looking Statements
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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