Glenmark Specialty S A announced that the National Medical Products Administration (NMPA) of China has approved 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 paediatric patients six years of age and older, and moderate to severe perennial AR in adults and paediatric 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 commercialised branded specialty product and is already approved in the United States, European Union, United Kingdom, Australia, South Korea, and Russia. Commercialisation 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 centres. Results demonstrated that RYALTRIS outperformed monotherapy comparators (Patanase NS and Nasonex NS) in efficacy scores, while also meeting endpoints for safety, tolerability, and pharmacokinetics.

Commenting on the collaboration, Christoph Stoller, President and Business Head-Europe and Emerging Markets, Glenmark Pharmaceuticals, said, “The approval of RYALTRIS in China is a significant step in expanding our specialty respiratory portfolio. China is a priority market for Glenmark, and together with Grand Pharmaceuticals, our focus is on enabling access to this treatment for patients and healthcare professionals.”

In FY25, RYALTRIS was launched in 11 international markets, expanding its presence to 45 countries.