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JHL Biotech submits CTA in Europe for proposed dornase alfa biosimilar to affordably manage symptoms of CF

Hsinchu, Taiwan
Friday, December 22, 2017, 16:00 Hrs  [IST]

JHL Biotech has announced 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 US 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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