JCR Pharmaceuticals Selected for Japan's Regenerative Medicine CDMO Subsidy Program
Project Overview
1) Project Title
JCR Regenerative Medicine CDMO Enhancement
2) Description
Building on its expertise in regenerative medicine, JCR will strengthen its biomanufacturing capability through facility upgrades and workforce training.
3) Period
Approval date – December 31, 2027
Background and Rationale
Since the 2015 approval of TEMCELL ® HS Inj., JCR has steadily built expertise in regenerative medicine while ensuring a stable, long-term product supply. The company is now developing an AAV gene therapy platform, JUST-AAV, based on its proprietary J-Brain Cargo ® technology for delivery across the blood-brain barrier.
To leverage these assets as a development and manufacturing partner for regenerative medicine products, JCR applied for this government subsidy to support manufacturing-related capital investment.
Looking Ahead
With this subsidy, JCR will invest not only in its own pipeline but also in new partnerships, strengthen as its role in biomanufacturing in regenerative and gene/cell therapies.
About the Regenerative CDMO Subsidy Program
This subsidy program supports the development of domestic CDMO (Contract Development and Manufacturing Organization) facilities and talent to ensure Japan's capacity to manufacture regenerative, cell, and gene therapies. For details, visit: https://cdmo-hojo.jp/ (Japanese only).
About JUST-AAV
JUST-AAV is a proprietary platform technology that utilizes modified adeno-associated virus (AAV) vectors. The technology entails insertion of miniaturized antibodies against receptors on selected tissues, organs or the blood-brain barrier onto the capsid surface, enhancing targeted delivery to those tissues and organs. Further capsid modifications minimize off-target effects and improve safety. The name is derived from ' J CR' ' U ltimate destination of organ' ' S afeguarding against off-target delivery' and ' T ransformative technology' reflecting its potential for broad application across various diseases.
About the J-Brain Cargo ® Platform Technology
JCR Pharmaceuticals has developed a proprietary blood-brain barrier-penetrating technology, J-Brain Cargo ®, to bring biotherapeutics into the central nervous system. The first drug developed based on this technology and approved in Japan for the treatment a lysosomal storage disorder is IZCARGO ® (INN: pabinafusp alfa).
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/.
Cautionary Statement Regarding Forward-Looking Statements
This document contains forward-looking statements that are subject to known and unknown risks and uncertainties, many of which are outside our control. Forward-looking statements often contain words such as 'believe,' 'estimate,' 'anticipate,' 'intend,' 'plan,' 'will,' 'would,' 'target' and similar references to future periods. All forward-looking statements regarding our plans, outlook, strategy and future business, financial performance and financial condition are based on judgments derived from the information available to us at this time. Factors or events that could cause our actual results to be materially different from those expressed in our forward-looking statements include, but are not limited to, a deterioration of economic conditions, a change in the legal or governmental system, a delay in launching a new product, impact on competitors' pricing and product strategies, a decline in marketing capabilities relating to our products, manufacturing difficulties or delays, an infringement of our intellectual property rights, an adverse court decision in a significant lawsuit and regulatory actions. This document involves information on pharmaceutical products (including those under development). However, it is not intended for advertising or providing medical advice. Furthermore, it is intended to provide information on our company and businesses and not to solicit investment in securities we issue. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the factors that could cause actual results to differ materially, even if new information becomes available in the future.
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