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远大医药:全球创新产品莱特灵 (Ryaltris )复方鼻喷剂在中国获批上市
Zhi Tong Cai Jing· 2025-11-10 09:57
Core Viewpoint - The approval of Ryaltris (GSP301NS) by the National Medical Products Administration (NMPA) marks a significant milestone for the company in the respiratory and critical care sector, providing a new treatment option for allergic rhinitis in China [1][2] Group 1: Product Development and Approval - Ryaltris is a novel combination nasal spray that combines an antihistamine and a corticosteroid, approved for treating moderate to severe seasonal allergic rhinitis in adults and children aged 6 and above [1] - The product received FDA approval in January 2022 and has been successfully launched in multiple countries, demonstrating strong sales performance and market potential [1] - The Phase III clinical trial (GSP301-308) involved 535 patients and showed that Ryaltris outperformed single-agent controls in efficacy, safety, and pharmacokinetics [2] Group 2: Market Opportunity - China has one of the highest prevalence rates of allergic rhinitis globally, with approximately 17.6% of adults affected, translating to nearly 250 million people, including around 130 million with moderate to severe persistent allergic rhinitis [3] - Current treatment options in China primarily consist of single-agent formulations, indicating a significant unmet clinical need and a vast market opportunity for combination therapies like Ryaltris [3] Group 3: Strategic Focus - The respiratory and critical care sector is a core strategic area for the company, with a comprehensive product portfolio addressing various respiratory conditions [4] - The company is committed to innovation and has several products in development targeting unmet clinical needs, including sepsis and acute respiratory distress syndrome [4] - The company aims to enhance its product pipeline and industry position through a combination of independent research and global expansion strategies [5]