JHL Biotech has affirmed DHA’s approval of Clinical Trial Application for JHL’s JHL1922

JHL Biotech has asserted that the Dutch Healthcare Authority has sanctioned a Clinical Trial Application for JHL’s dornase alfa biosimilar, JHL1922 to enhance pulmonary function of cystic fibrosis patients. The Phase I clinical trial will conducted in the Netherlands commencing in March 2018.

JHL1922 would offer patients with an affordable alternative to dornase alfa signalled for enhancing 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.