Glenmark Pharmaceuticals’ wholly-owned subsidiary -- Glenmark Specialty S.A. has received approval from National Medical Products Administration (NMPA) of China for RYALTRIS Compound Nasal Spray (GSP 301 NS) for the treatment of Allergic Rhinitis (AR) in adults and children -- specifically for treatment of moderate to severe seasonal AR in adults and pediatric patients 6 years of age and older, and moderate to severe perennial AR in adults and pediatric patients 12 years of age and older. The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline and reflects continued progress in advancing innovative and differentiated therapies for patients with chronic conditions.
RYALTRIS is a first-of-its-kind fixed-dose combination nasal spray that brings together an olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid) to treat the symptoms of allergic rhinitis. It is Glenmark’s first globally commercialized branded specialty product and is already approved in the United States, European Union, United Kingdom, Australia, South Korea, and Russia. Commercialization in China will be undertaken by Grand Pharmaceuticals Group under an exclusive licensing agreement.
The NMPA approval follows successful completion of Phase III clinical trial (GSP 301-308) for RYALTRIS Compound Nasal Spray conducted in China, enrolling 535 patients across multiple trial centers. Results demonstrated that RYALTRIS outperformed monotherapy comparators (Patanase NS and Nasonex NS) in efficacy scores, while also meeting endpoints for safety, tolerability, and pharmacokinetics.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
