JCR Pharmaceuticals Announces Licensing Agreement with Menagen to Commercialize Agalsidase Beta BS I.V. Infusion [JCR] Across Nine MENAT Markets

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HYOGO, Japan--(BUSINESS WIRE)--Oct 1, 2025--

JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”), a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, today 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.

About Fabry Disease
Fabry disease is a rare, X-linked inherited lysosomal storage disorder caused by deficiency or reduced activity of α-galactosidase A. Enzyme deficiency leads to accumulation of globotriaosylceramide (GL-3) and globotriaosylsphingosine (Lyso-GL-3) within lysosomes, resulting in multisystem involvement and a broad spectrum of clinical manifestations.

Reference: Burlina A, et al. An expert consensus on the recommendations for the use of biomarkers in Fabry disease. Mol Genet Metab. 2023; 139(2): 107585.

About JCR Pharmaceuticals Co., Ltd.
JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceutical company that develops treatments that go beyond rare diseases to solve the world’s most complex healthcare challenges. We continue to build upon our 50-year legacy in Japan while expanding our global footprint into the U.S., Europe, and Latin America. We improve patients’ lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. Our approved products in Japan include therapies for the treatment of growth disorder, MPS II (Hunter syndrome), Fabry disease, acute graft-versus host disease, and renal anemia. Our investigational products in development worldwide are aimed at treating rare diseases including MPS I (Hurler, Hurler-Scheie and Scheie syndrome), MPS II, MPS IIIA and B (Sanfilippo syndrome type A and B), and more. Our core values – Putting people first, Forging our own path, Always advancing, and Committed to excellence – mean that the work we do benefits all our stakeholders, including partners, patients and employees. We strive to expand the possibilities for patients while accelerating medical advancement at a global level. For more information, please visit JCR’s global website: https://jcrpharm.com/.

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SOURCE: JCR Pharmaceuticals Co., Ltd.

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PUB: 10/01/2025 01:13 PM/DISC: 10/01/2025 01:12 PM

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