Glenmark Specialty S.A. has received approval from China’s National Medical Products Administration (NMPA) for Ryaltris® Compound Nasal Spray (GSP 301 NS). The treatment is for Allergic Rhinitis (AR) in adults and children. This approval marks a significant milestone for Glenmark’s respiratory pipeline, reflecting advancements in therapies for chronic conditions. Commercialization will be handled by Grand Pharmaceuticals Group Limited.
Ryaltris® Approval in China
Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd., announced that the National Medical Products Administration (NMPA) in China has approved Ryaltris® Compound Nasal Spray (GSP 301 NS) for the treatment of Allergic Rhinitis (AR). The approval covers treatment for moderate to severe seasonal AR in adults and pediatric patients 6 years and older, and moderate to severe perennial AR in adults and pediatric patients 12 years and older.
Significance of the Approval
The approval, granted without any supplementation requests, highlights Glenmark’s progress in respiratory innovation and its commitment to differentiated therapies for patients with chronic conditions. Ryaltris® is a fixed-dose combination nasal spray that combines olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid) to alleviate allergic rhinitis symptoms.
Global Presence
Ryaltris® is already approved in the United States, European Union, United Kingdom, Australia, South Korea, and Russia. Grand Pharmaceuticals Group Limited will manage commercialization in China under an exclusive licensing agreement.
Clinical Trial Success
The NMPA approval was based on a successful Phase III clinical trial (GSP 301-308) conducted in China, involving 535 patients. The trial demonstrated that Ryaltris® outperformed monotherapy comparators (Patanase NS and Nasonex NS) in efficacy, while also meeting safety, tolerability, and pharmacokinetic endpoints.
Company Perspective
Christoph Stoller, President and Business Head – Europe and Emerging Markets at Glenmark Pharmaceuticals Ltd., stated that the approval of Ryaltris® in China is a significant step in expanding the company’s specialty respiratory portfolio. China is a priority market for Glenmark.
Expanded Market Reach
As of FY25, Ryaltris® has launched in 11 international markets, expanding its presence to 45 countries.
Source: BSE
