Teijin Pharma Receives Manufacturing and Marketing Approval in Japan for YORVIPATH® as the Treatment for Hypoparathyroidism[Teijin Pharma]

NEWS RELEASE Teijin Pharma Receives Manufacturing and Marketing Approval in Japan for YORVIPATH® as the Treatment for Hypoparathyroidism Tokyo, August 25, 2025 --- Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, announced today that it has received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for YORVIPATH® Subcutaneous Injection 168 μg Pen, 294 μg Pen, and 420 μg Pen (general name: palopegteriparatide), a treatment for adults with hypoparathyroidism. This approval follows Teijin Pharma’s acquisition of a development and commercialization license from Ascendis Pharma A/S, which is headquartered in Copenhagen, Denmark. Teijin Pharma President Masaki Taneda said, “Teijin Pharma has set a long-term vision of becoming a company that solves the challenges of patients, families and communities who need more support with rare and intractable diseases. We are pleased to offer this new treatment to patients in Japan with hypoparathyroidism. Our continued collaboration with Ascendis Pharma has played a great role in achieving this milestone. We expect YORVIPATH® will be soon delivered to patients who need it in Japan.” Jan Møller Mikkelsen, CEO of Ascendis Pharma, A/S said, “We congratulate Teijin on this important regulatory milestone. Ascendis is committed to expanding global availability of YORVIPATH®, a unique product that has delivered substantial benefits to adults managing with the significant health and quality of life burdens of hypoparathyroidism, and we look forward to it being available for patients in Japan.” Hypoparathyroidism is an endocrine disease caused by insufficient levels of parathyroid hormone (PTH), the primary regulator of calcium and phosphate balance in the body. Individuals with hypoparathyroidism may experience a range of severe and potentially life- threatening short-term and long-term complications. These include characteristic muscle spasms in the arms and legs known as tetany, as well as numbness in the limbs and around the mouth. In severe cases, the condition may affect the entire body and cause epilepsy-like seizures. In the long -term, there is a risk of devel oping complications, including renal impairment, ectopic calcification, and cognitive dysfunction. Current conventional therapy for hypoparathyroidism consists of active vitamin D and calcium, which aims to address hypocalcemia. However, some patients may have difficulty maintaining optimal blood calcium levels and controlling symptoms. This therapy may also cause hypercalcemia, hypercalciuria, nephrocalcinosis, nephrolithiasis, and renal dysfunction. There has been a need for a new treatment that can maintain physiological PTH levels for 24 hours per day to address these issues fundamentally. YORVIPATH® is a prodrug of PTH (1-34) with sustained release developed by Ascendis Pharma owing to the TransCon technology ＊. It is administered once daily, designed to provide active PTH within the physiological range for 24 hours/day in adults with hypoparathyroidism. This drug is the first of its kind in Japan and is expected to be a fundamental treatment for hypoparathyroidism. ＊https://ascendispharma.com/technology/ Teijin Pharma obtained the development and commercialization license for Japan from Ascendis Pharma on November 29, 2023, and has been developing palopegteriparatide as a new treatment for hypoparathyroidism in Japan. Based on the data from a Phase III clinical trial conducted by Ascendis Pharma in Japan, Teijin Pharma submitted the manufacturing and marketing application in December 2024. Palopegteriparatide has been designated as an orphan drug in Japan, the United States, and Europe. Ascendis Pharma has received regulatory approval for YORVIPATH® for the treatment of adults with hypoparathyroidism in the United States, European Union, Norway, Iceland, Liechtenstein, and Great Britain (covering England, Wales, and Scotland), and has also been available to patients in other countries under named patient programs. Teijin Pharma aims to become a company that solves the challenges faced by patients, families, and communities in need of greater support, with a long -term vision focused on rare and intractable diseases. By combining its business foundation in home health care with pharmaceuticals and medical devices, Teijin Pharma seeks to provide new value that allows patients to continue treatment comfortably at home, contributing to the dissemination of necessary treatments in pharmaceuticals and medical devices. About the Teijin Group Teijin (TSE: 3401) is a technology -driven global group with two core businesses: high - performance materials and healthcare solutions. Established in 1918 as Japan’s first rayon manufacturer, Teijin today comprises some 150 companies employing 20,000 people. Teijin is committed to its Purpose, “Pioneering solutions together for a healthy planet.” Teijin works together with employees and external partners to achieve its Long -Term Vision, “To be a company that supports the society of the future.” Teijin posted consolidated revenue of JPY 1,005.5 billion and total assets of JPY 1,061.3 billion in the fiscal year ending March 31, 2025. Press Contact Corporate Communication Department Teijin Limited [email protected]

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