GRAND PHARMA (00512) announced that Ryaltris® (GSP 301 NS), a globally innovative compound nasal spray developed by Glenmark Specialty S.A. (Glenmark), has recently received drug registration approval from China's National Medical Products Administration (NMPA). The product is indicated for the treatment of allergic rhinitis (AR) in adults and children, achieving approval without supplementary data requests—a significant milestone in the group's respiratory and critical care portfolio.
GRAND PHARMA secured exclusive commercialization rights for Ryaltris® in China through a licensing agreement with Glenmark in February 2019. Ryaltris® is a novel combination nasal spray containing an antihistamine and a corticosteroid, approved for moderate-to-severe seasonal AR in patients aged 6 and above, as well as perennial AR in patients aged 12 and above. As a compound formulation, it offers enhanced convenience and efficacy, improving patient adherence and providing a new treatment option for AR patients in China.
Previously approved by the U.S. FDA in January 2022, Ryaltris® has also gained market authorization in Australia, Russia, South Korea, the UK, and the EU, demonstrating strong sales performance and market potential. In China, the product completed Phase III trials (GSP 301-308) in September 2023 after receiving NMPA approval for clinical trials in October 2021. The study, involving 535 seasonal AR patients, compared Ryaltris® against single-agent controls (Patanase® NS and Nasonex® NS), confirming superior efficacy, safety, and pharmacokinetics.
China has one of the highest AR prevalence rates globally, affecting approximately 17.6% of adults—nearly 250 million people, with 130 million suffering moderate-to-severe persistent AR. Current guidelines recommend intranasal antihistamines and corticosteroids as first-line treatments, with combination therapy showing superior symptom relief. However, China's market remains dominated by single-agent nasal sprays, highlighting unmet demand and significant growth potential.
GRAND PHARMA has established a robust respiratory portfolio, including core products like Qienuo (a China-exclusive AR treatment) and two global innovative asthma therapies, Enzhu Run® and Enming Run®, now covered under China’s national reimbursement list. The group also launched the first generic fluticasone propionate nasal spray in April 2025.
Moving forward, GRAND PHARMA will continue advancing its R&D strategy, focusing on critical unmet needs such as sepsis, acute respiratory distress syndrome (ARDS), and sinusitis. By integrating independent innovation with global partnerships, the group aims to strengthen its leadership in respiratory and critical care, delivering cutting-edge therapies to patients worldwide.
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