JCR Pharmaceuticals Co., Ltd. a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, announced an exclusive licensing agreement with Menagen Pharmaceutical Industries LLC (headquartered in Oman, CEO: Saif Al Hasani, “Menagen”) to seek local marketing authorizations and to commercialize Agalsidase Beta BS I.V. Infusion [JCR] (the “product”) upon approval across nine MENAT markets. The product is a recombinant enzyme replacement therapy (ERT) for Fabry disease currently marketed in Japan.

Under the agreement, Menagen will file local applications in the licensed territories across the MENAT markets, leveraging the product’s Japanese approval. The licensed territories include: the Kingdom of Saudi Arabia, United Arab Emirates, the Sultanate of Oman, the State of Kuwait, the State of Qatar, the Kingdom of Bahrain, the Republic of Türkiye, the Republic of Iraq, and the Arab Republic of Egypt. Following local approvals, JCR will supply the product, and Menagen will lead commercialization in the region.

“This agreement allows us to broaden access to our Fabry therapy beyond Japan,” said Shin Ashida, Chairman, President and CEO of JCR Pharmaceuticals. “By working with Menagen, we aim to improve treatment options for people living with Fabry disease across these markets.”

Developed by JCR, the product is a biosimilar ERT for Fabry disease and is the first lysosomal storage disorder (LSD) enzyme therapy manufactured in Japan using serum-free cell culture. JCR launched the product in Japan in November 2018 and, since 2022, has been marketed by Sumitomo Pharma Co., Ltd. under a commercialization agreement. Domestic net sales in FY2024 were approximately JPY 1.1 billion.

JCR does not expect a material impact on FY2025 consolidated results.