Teijin : Pharma Limited Applies for Manufacturing and Marketing Approval in Japan for New Weekly Pediatric Growth Hormone Deficiency Treatment

The application, submitted to the Pharmaceuticals and Medical Devices Agency on February 12, 2026, is based on results of global Phase III clinical trials conducted by Ascendis Pharma. Teijin Limited, the parent company of Teijin Pharma Limited, signed an exclusive licensing agreement for this treatment with Ascendis Pharma on November 29, 2023.

Growth hormone is essential to overall endocrine health, promoting growth and maintaining normal body composition, cardiovascular function, and metabolism. Growth hormone deficiency, a rare disorder caused by insufficient secretion of growth hormone from the pituitary gland, results in delayed growth and short stature in children. In Japan, the incidence of newly diagnosed GHD among children under 15 years of age is reported to be approximately 1.15 per 10,000.1Current treatment in Japan mainly involves daily subcutaneous self-injection of recombinant human growth hormone (somatropin) by the patient or caregiver. This approach may impose significant physical and psychological burdens, often leading to poor adherence and reduced therapeutic outcomes.2There is a need for new treatment options that provide efficacy and safety comparable to those of daily injections which may reduce negative effects of frequent dosing on children and families.

Lonapegsomatropin is a prodrug of somatropin administered once per week by the patient or caregiver, designed to provide sustained release of active, unmodified somatropin. In Ascendis Pharma's global Phase III clinical trial (heiGHt trial), the mean annualized height velocity after 52 weeks of treatment was 11.2 cm/year, in the once-weekly lonapegsomatropin group, compared to 10.3 cm/year, in the daily somatropin group. These results demonstrated not only non-inferiority but also superiority in annualized height velocity over daily somatropin, with a similar safety profile.

Ascendis Pharma received approval for use in the United States in August 2021 and the European Union in January 2022 for the treatment of pediatric GHD. It is marketed by Ascendis Pharma as SKYTROFA®.

Teijin Pharma Limited has been contributing to the improvement of patients' quality of life through the provision of various treatments, including pharmaceuticals such as SOMATULINE®, REVCOVI®and YOVIPATH®for rare diseases. By obtaining swift approval and rapid market introduction of lonapegsomatropin, the company aims to help provide additional support to patients, families and communities. The launch of new drugs for rare diseases is a key pillar of this vision.

1, Kanzaki, Susumu. Research on the Registration and Evaluation of Growth Hormone Therapy. Report of the FY2017 Health and Labour Sciences Research Grant (Research Project for Intractable Diseases Policy: "Practical Foundation Study Contributing to the Promotion of Measures for Chronic Pediatric Diseases"). https://www.shouman.jp/research/pdf/21_29/29_19.pdf

2, Cutfield WS, Derraik JG, Gunn AJ, et al. Non-compliance with growth hormone treatment in children is common and impairs linear growth. PLoS One. 2011;6(1):e16223. doi:10.1371/journal.pone.0016223. PMID: 21305004.

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 approximately 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.

Corporate Communication Department Teijin Limited

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