JCR Pharmaceuticals Receives Marketing Authorization in the United Arab Emirates for IZCARGO™, a Blood-Brain Barrier-Penetrating Enzyme Replacement Therapy for Hunter Syndrome
- This marketing authorization is the first for IZCARGO™ outside of Japan -
JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”), a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, today announced that IZCARGO™ (pabinafusp alfa, or JR-141), a blood-brain barrier-penetrating enzyme replacement therapy (ERT) for Hunter syndrome developed using JCR’s proprietary J-Brain Cargo® technology, received marketing authorization in the United Arab Emirates (UAE).
This marks the first marketing authorization for IZCARGO™ outside of Japan. IZCARGO™ was approved and launched in Japan in 2021 and is currently being evaluated in an ongoing global Phase III clinical trial.
JCR has been working to expand access to IZCARGO™ outside of Japan while advancing its global clinical development program. As part of this effort, JCR entered into a distribution agreement with Taiba Middle East FZ LLC (“Taiba”) and pursued regulatory approval in the UAE based on the product’s marketing authorization in Japan. Under this agreement, JCR will also seek marketing authorization for IZCARGO™ in countries across the Middle East and North Africa (MENA) region, while Taiba will be responsible for sales and distribution in the relevant territories.
