Biopharmaceutical startup JHL Biotech (Stock Code:6540.TWO) disclosed on Wednesday that it has filed a Phase 1 Clinical Trial Application with the Dutch Healthcare Authority for its planned dornase alfa biosimilar, JHL1922, for the improvement of pulmonary function in cystic fibrosis patients.
In conjunction with the filing, the company will conduct its clinical trial in the Netherlands beginning March 2018.
The company stated 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. JHL1922 is a proposed similar biological product to dornase alfa.
According to the company, 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 US and the EU and was first approved for treatment of cystic fibrosis in the US in 1993 and in Europe in 1994.
Cystic fibrosis reportedly 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 USD12,000 -USD40,000 per patient per year, with only about 30,000 patients receiving this treatment.
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