Dutch health Authority approves clinical trial of enzyme by China biopharmaceutical startup
JHL Biotech, Inc. is a biopharmaceutical startup founded by a group of industry veterans with deep experience in pharmaceutical development and operations. It 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 is focused on the research and development of new protein-based therapies and biosimilars.
The Dutch Healthcare Authority has approved a Clinical Trial Application for JHL’s dornase alfa biosimilar, JHL1922, to improve pulmonary function of cystic fibrosis patients. The Phase I clinical trial will be conducted in the Netherlands beginning March 2018.
JHL1922 will provide patients with 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. Dornase alfa is sold under the brand name Pulmozyme® in the European Union (EU) and in the United States (US). It is a recombinant human deoxyribonuclease I (rhDNase I), an enzyme which selectively cleaves deoxyribonucleic acid (DNA). Dornase alfa 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.