Italfarmaco and Jcr Pharmaceuticals partner on Hunter syndrome therapy

Italfarmaco Spa and Jcr Pharmaceuticals have entered into an exclusive licensing agreement for the development and commercialization of JR-141. This enzyme replacement therapy is currently in Phase 3 clinical trials for the treatment of Hunter syndrome, also known as mucopolysaccharidosis type II (MPS II).

JR-141 utilizes Jcr’s proprietary J-Brain Cargo technology, which allows the recombinant fusion protein to cross the blood-brain barrier. This capability is designed to address both somatic and neuronopathic symptoms of the disease by delivering the enzyme directly to the brain. The molecule has been approved and marketed in Japan since 2021 under the name pabinafusp alfa.

The partnership aims to secure regulatory approval from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Brazil’s Anvisa. Upon approval, Italfarmaco will manage commercialization and distribution in the United States, Europe, and Latin America, while Jcr Pharmaceuticals will remain responsible for production.