drugset / Press release

VISEN Pharmaceuticals Announces Commercial Launch and First Prescription of Lonapegsomatropin in Mainland China

2026-07-23 · Visen Pharmaceuticals (Shanghai) Co., Ltd. · original visenpharma.com ↗

(July 23, 2026, Shanghai) —— VISEN Pharmaceuticals (2561.HK) an innovative biopharmaceutical company focused on endocrine diseases, today announced the commercial launch of its core product lonapegsomatropin in Mainland China. Lonapegsomatropin is a prodrug of somatropin administered once weekly, providing sustained release of active, unmodified somatropin, indicated in China for the treatment of children with growth hormone deficiency (GHD) 1 . Its first prescription issued at Shanghai, marking a milestone in patient access in the region. As an innovative biopharmaceutical company focusing on endocrinology, VISEN Pharmaceuticals has thus taken a significant step from R&D to commercialization. The Phase III clinical trial in China demonstrated non-inferiority and superiority over daily somatropin in annualized height velocity (AHV) among treatment-naive Chinese PGHD patients 2 . PGHD is a serious disease caused when the pituitary gland does not produce enough growth hormone. Children with GHD are not only characterized by short stature, but they also may experience metabolic abnormalities, psychosocial challenges and poor quality of life 3 . The current standard of care for the treatment of GHD requires patients to receive daily injections of somatropin over many years. The administrative burden of daily injections often results in poor patient compliance and can lead to suboptimal treatment outcomes 4 . To support the commercial launch of lonapegsomatropin, VISEN Pharmaceuticals has established a diversified coverage network covering public hospitals and mid-to-high-end private medical institutions. With the steady progress of lonapegsomatropin commercialization, it will benefit more PGHD children and their families across China. ********************* Approval code:COMU20260725/CN/PR References : Lonapegsomatropin for Injection [Package Insert]. Approval Date: January 20, 2026. Ying Y, et al. Once-Weekly Lonapegsomatropin Was Efficacious and Well Tolerated in Chinese Children with Growth Hormone Deficiency: Results from a Phase 3 Randomized Trial. Horm Res Paediatr. 2026 Feb 27:1-12. The Subspecialty Group of Endocrinology, Hereditary and Metabolic Diseases, the Society of Pediatrics, Chinese Medical Association. Guidelines for the Diagnosis and Treatment of Growth Hormone Deficiency in Chinese Children. Chinese Journal of Pediatrics. 2024;62(1):5-11. The Subspecialty Group of Endocrinology, Hereditary and Metabolic Diseases, the Pediatric Society, Chinese Medical Doctor Association. Expert Guidance on Clinical Application of Long-Acting Growth Hormone Based on TransCon Technology. Chinese Journal of Practical Pediatrics. 2026;41(5):353-361. About lonapegsomatropin Lonapegsomatropin was developed by Ascendis Pharma A/S as TransCon hGH, who markets it as SKYTROFA® for pediatric and adult GHD in markets outside of Greater China. VISEN Pharmaceuticals has exclusive rights to develop, manufacture and commercialize three of Ascendis Pharma’s endocrine disease products (lonapegsomatropin, palopegteriparatide, and navepegritide) in Greater China. About VISEN Pharmaceuticals (2561.HK) VISEN Pharmaceuticals is an innovative biopharmaceutical company focused on endocrine diseases. We are dedicated to providing innovative therapies and compassionate, patient-centric care, because we believe that achieving better treatment processes and outcomes results in living better lives. Putting patients' needs first, VISEN is committed to providing first-in-class or best-in-class products and treatments for endocrine diseases. Our therapeutic areas cover endocrine diseases in adults and children, and rare endocrine diseases. VISEN comprises seasoned professionals with multinational pharmaceutical experiences and leverages cutting-edge technologies and leading resources across the world. We are focused on the Chinese market, headquartered in Suzhou, and have established offices in Shanghai, Beijing, Hong Kong and Taipei. Our goal is to enable Chinese endocrine patients to benefit from the world's most advanced and reliable treatment solutions earlier. On March 21st, 2025, VISEN officially listed on the Main Board of The Stock Exchange of Hong Kong (HKEX). For more information, please visit our website: www.visenpharma.com Contact us: [email protected]

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