莱特灵®(Ryaltris®)复方鼻喷剂
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远大医药(00512.HK):全球创新产品莱特灵®(Ryaltris®)复方鼻喷剂在中国获批上市
Ge Long Hui· 2025-11-10 09:41
Core Viewpoint - Yuan Da Pharmaceutical has received a drug registration certificate from the National Medical Products Administration of China for Ryaltris® nasal spray, marking a significant advancement in its respiratory and critical care research [1] Group 1: Product Development - Ryaltris® is a novel combination nasal spray that includes an antihistamine and a corticosteroid, designed for the symptomatic treatment of moderate to severe allergic rhinitis in adults and children aged 6 and above [1] - The product has achieved a "zero supplementary information" approval process, indicating a streamlined regulatory pathway [1] Group 2: Market Potential - Ryaltris® has already been approved by the FDA in January 2022 and has seen strong sales performance in various countries including Australia, Russia, South Korea, the UK, and the EU, highlighting its significant market potential [1] - The product aims to improve patient compliance by providing a more convenient and effective treatment option for allergic rhinitis patients in China [1] Group 3: Strategic Partnerships - The company entered into an exclusive licensing agreement with Glenmark in February 2019, securing the exclusive commercialization rights for Ryaltris® in China [1]