Glenmark Pharma gets China approval for RYALTRIS nasal spray to treat allergic rhinitis

Glenmark Pharmaceuticals Ltd on Monday (November 10) said its wholly-owned subsidiary, 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.

The approval covers moderate to severe seasonal allergic rhinitis in adults and pediatric patients aged six years and older, and moderate to severe perennial allergic rhinitis in adults and pediatric patients aged twelve years and older.

The approval was granted with zero supplementation requests, marking an important milestone in Glenmark’s respiratory pipeline. The company said the approval reflects continued progress in advancing innovative and differentiated therapies for patients with chronic conditions.

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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, the European Union, the United Kingdom, Australia, South Korea, and Russia. Commercialisation in China will be undertaken by Grand Pharmaceuticals Group Limited under an exclusive licensing agreement.

The NMPA approval follows successful completion of Phase III clinical trial (GSP 301-308) for RYALTRIS Compound Nasal Spray was conducted in China, enrolling 535 patients across multiple trial centers.

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Results demonstrated that RYALTRIS outperformed monotherapy comparators (Patanase NS and Nasonex NS) in efficacy scores, while also meeting endpoints for safety, tolerability, and pharmacokinetics.

Shares of Glenmark Pharmaceuticals Ltd ended at ₹1,835.80, up by ₹20.75, or 1.14%, on the BSE.