By Fineline Cube 
Visen Pharmaceuticals (HKG: 2561) announced today that its innovative drug palopegteriparatide (TransCon PTH) has received official approval for clinical use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone. The once‑daily, sustained‑release prodrug will be administered at Ruijin Hospital Hainan Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, to treat adults with chronic hypoparathyroidism (HP).
Product Overview
- Mechanism – Palopegteriparatide is a sustained‑release prodrug of PTH1‑34 that delivers stable physiological levels of parathyroid hormone throughout a 24‑hour period via a single subcutaneous injection.
- Clinical Need – Chronic hypoparathyroidism is a rare, life‑threatening condition that urgently requires safe, long‑acting therapy; palopegteriparatide addresses this unmet need with a novel dosing strategy.
Regulatory Milestone
- Pilot‑Zone Approval – The Hainan Boao Lecheng International Medical Tourism Pilot Zone is a high‑profile regulatory sandbox; approval here signals strong confidence in the drug’s safety and efficacy profile.
- Strategic Placement – By securing a launch in one of China’s most internationally focused medical tourism hubs, Visen positions palopegteriparatide for rapid uptake by both domestic and foreign patients.
Clinical Context
- Target Population – Adults with chronic hypoparathyroidism who require daily PTH replacement.
- Treatment Advantage – The once‑daily, stable‑release profile reduces dosing burden and improves adherence compared with current intermittent PTH therapies.
Joint Venture Background
- Visen Pharmaceuticals – A 2018 joint venture between Ascendis and Chinese investors, combining Ascendis’s expertise in peptide drug development with local manufacturing and distribution capabilities.
- Manufacturing Capabilities – The partnership leverages state‑of‑the‑art Chinese production facilities to ensure scalable, cost‑effective supply of palopegteriparatide.
Implications for China
- Market Expansion – The approval opens a new therapeutic class for endocrine disorders in China, potentially creating a sizable market for the company.
- Innovation Signal – Demonstrates China’s willingness to fast‑track advanced biologics in pilot zones, encouraging further collaboration between domestic and foreign biopharma.-Fineline Info & Tech