VISEN launches palopegteriparatide in China's Hainan Boao Pilot Zone as the first and only hormone replacement therapy for hypoparathyroidism
VISEN
Endocrine-related Disease Treatment Drug Developer
On September 23, 2025, VISEN Pharmaceuticals (2561.HK), an innovative biopharmaceutical company focused on endocrine diseases, announced that palopegteriparatide (TransCon PTH) has been approved by the Hainan Medical Products Administration for clinical use1 for the treatment of adult chronic hypoparathyroidism (HP). It will be clinically applied in Shanghai Ruijin Hospital's Hainan subsidiary, Shanghai Jiao Tong University School of Medicine. Palopegteriparatide is the first and currently only approved hormone (PTH) replacement therapy for hypoparathyroidism globally. The launch of this product in Boao fills the long-standing gap in hormone replacement therapy for HP in China. It enables domestic patients to access this cutting-edge global treatment without traveling abroad, which significantly improves the accessibility of innovative medicines and brings therapeutic hope to HP patients.
Technological Breakthrough: Innovative PTH Replacement Therapy Breaks Through the Dilemma of Traditional Treatment
Hypoparathyroidism (HP) is an endocrine disease with a group of clinical syndromes caused by insufficient level of parathyroid hormone (PTH). There are around 400,000 patients with HP in China. Conventional therapy consists of high-dose oral calcium and active vitamin D or analogues, aiming to raise serum calcium to a lower level of normal range or slightly below the normal range. This can alleviate hypocalcemia symptoms to a certain extent but cannot fundamentally address the metabolic abnormalities and complications caused by PTH deficiency2.
Compared to conventional therapy, parathyroid hormone (PTH) replacement therapy targets the underlying cause of disease by supplementing deficient PTH and continuously stabilizing PTH levels within the normal physiological range, making PTH replacement therapy a more physiologically ideal treatment for hypoparathyroidism (HP). Palopegteriparatide breaks through drug development barriers via the innovative TransCon technology. It is designed to restore PTH at physiologic levels for 24 hours each day to address both the short-term symptoms and long-term complications of the disease. Globally, it generated long term data up to 4 years which reinforces the safety profile and durability of response in patients treated with palopegteriparatide, including sustained normalization of skeletal dynamics and significant and sustained improvements in kidney function.
Pony Lu, CEO and Executive Director of VISEN Pharmaceuticals, stated: “The approval of palopegteriparatide in China Hainan Boao Lecheng Pilot Zone for the treatment of hypoparathyroidism in adults is achieved with the support from favorable national pharmaceutical innovation policy and the Hainan Boao Lecheng Pilot Zone, as well as the clinical experts from Ruijin Hospital (Hainan). Boao Lecheng Pilot Zone is an important gateway for international innovative drugs to enter China. We are very glad to see that Chinese patients with hypoparathyroidism (HP) can simultaneously benefit from the world-leading hormone replacement therapy, helping them get rid of many treatment dilemmas in this field that have long existed due to the lack of etiology-targeted therapy in this field. Palopegteriparatide is one of the key products in the company's endocrine product pipeline. Its initial launch in Boao will significantly increase the awareness of this product among clinicians and HP patients, which helps accelerate the product commercialization upon potential NDA approval in China.”
References：
1. Gov.cn. New policy hastens approval of overseas drugs, equipment, 2019 Sep
2. Chinese Society of Osteoporosis and Bone Mineral Research, etc. Chinese Journal of Osteoporosis and Bone Mineral Research,2018,11(4):323-337.
Source: VISEN Pharmaceuticals