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JCR Pharmaceuticals Initiates Phase III Clinical Trial of JR-142 in Japan, a Long-Acting Growth Hormone Therapy

JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”) today announced that the first patient has been dosed in the Phase III clinical trial of JR-142 (INN: redalsomatropin alfa) in Japan, marking a significant milestone in the development of this innovative treatment. JR-142 is a long-acting growth hormone therapy and is being studied in patients with pediatric growth hormone deficiency.

The trial involves 54 pediatric patients and will compare the efficacy of JR-142 to JCR’s existing product, Growject®. Patients will receive treatment over a 52-week period, with growth outcomes serving as the primary measure of success. Detailed trial information is available through Japan Register of Clinical Trials (jRCT2031240282).

“I am thrilled to see progress in the development of treatments for pediatric patients,” said Professor Noriyuki Namba, Division of Pediatrics and Perinatology at Tottori University Faculty of Medicine, and the Medical Expert of the study. “Growth hormone therapy typically requires daily injections, but JR-142, as a long-acting therapy, offers the possibility of once-weekly dosing. This advancement has the potential to significantly ease the burden on children and their families, improving both convenience and quality of care while maintaining high safety standards.”

JCR remains committed to the growth hormone field by ensuring a stable supply of high-quality pharmaceuticals and expanding treatment options to meet diverse patient needs.

About Growject®

Growject® is an injectable preparation containing recombinant human growth hormone, first launched in Japan by JCR in 1995. The dosage is administered subcutaneously 6–7 times per week, adjusted according to the indicated condition.

About JCR Pharmaceuticals Co., Ltd.

JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceuticals company that is expanding possibilities for people with rare and genetic diseases worldwide. We continue to build upon our 49-year legacy in Japan while expanding our global footprint into the US, 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. JCR strives to expand the possibilities for patients while accelerating medical advancement at a global level. Our core values – reliability, confidence, and belief – benefit all our stakeholders, including patients, partners, and employees. For more information, please visit https://www.jcrpharm.co.jp/en/site/en/.

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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