Core Viewpoint - The approval of Ryaltris® nasal spray by the National Medical Products Administration of China marks a significant advancement for the company in the respiratory and critical care sector, providing a new treatment option for allergic rhinitis patients in China [1][3]. 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, as well as perennial allergic rhinitis in adults and children aged 12 and above [2][3]. - The product received FDA approval in January 2022 and has been successfully launched in multiple countries, including Australia, Russia, South Korea, the UK, and the EU, demonstrating strong sales performance and significant market potential [2][3]. - The clinical trial for Ryaltris® (GSP 301-308) involved 535 patients and showed that its efficacy ratings surpassed those of the single-agent control treatments, confirming its safety and pharmacokinetic characteristics [3]. 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 individuals, including around 130 million with moderate to severe persistent allergic rhinitis [4]. - Current treatment options in China primarily consist of single-agent formulations, indicating a pressing clinical need and a substantial market opportunity for combination therapies like Ryaltris® [4]. Group 3: Strategic Focus and Future Plans - The respiratory and critical care sector is a core strategic area for the company, with a comprehensive product portfolio addressing various respiratory conditions, including asthma and chronic obstructive pulmonary disease [5]. - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and expand its product pipeline through a global operational strategy [6].
远大医药(00512)：全球创新产品莱特灵®(Ryaltris®)复方鼻喷剂在中国获批上市