Glenmark Secures China Approval For RYALTRIS®, Reinforcing Respiratory Innovation Leadership
2025-11-10 · Glenmark Pharmaceuticals Ltd. India · original glenmarkpharma.com ↗
Glenmark Secures China Approval For RYALTRIS®, Reinforcing Respiratory Innovation Leadership Mumbai, India, November 10, 2025 – Glenmark Specialty S.A., a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., today 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 pediatric patients 6 years of age and older, and moderate to severe perennial AR in adult s 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 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 conducted in China, enroll ing 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. Commenting on the collaboration, Christoph Stoller, President and Business Head - Europe and Emerging Markets, Glenmark Pharmaceuticals Ltd., 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. About Glenmark Pharmaceuticals Limited Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a research‐led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2022; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2022. Glenmark’s Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3 million lives over the last decade through its CSR interventions. For more information, visit www.glenmarkpharma.com. You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma) For more information, please contact: Aakanksha Pilay | [email protected] | +91 7218171062 Adfactors PR | [email protected] | +91 88502 91322
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