European Authorities Approve JHL Biotech's Clinical Trial Application for Dornase Alfa Biosimilar to Affordably Manage Symptoms of Cystic Fibrosis

HSINCHU, Taiwan and WUHAN, China I March 1, 2018 I JHL Biotech announced that 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 would 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.

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.
  • Trastuzumab biosimilar, JHL1188, to treat breast cancer. Expected Phase I trial in Europe in 2018.
  • Bevacizumab biosimilar, JHL1149 to treat many cancers, the most common of which are metastatic colorectal cancer, lung cancer, and ovarian cancer. Currently in Phase I trial in Europe. Expected Phase I trial in China 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


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