Glenmark Receives China Approval for RYALTRIS Nasal Spray, First Fixed-Dose Combination for Allergic Rhinitis
核心洞察
China's National Medical Products Administration (搜索) approved RYALTRIS nasal spray for treating moderate to severe allergic rhinitis (搜索) in adults and children, marking a significant regulatory milestone for Glenmark.
RYALTRIS represents a first-of-its-kind fixed-dose combination therapy combining olopatadine hydrochloride and mometasone furoate in a single nasal spray formulation.
The approval was granted with zero supplementation requests following successful Phase III trials involving 535 patients across multiple Chinese centers.
Glenmark Pharmaceuticals has achieved a significant regulatory milestone with China's National Medical Products Administration (搜索) (NMPA) approving RYALTRIS Compound Nasal Spray for treating allergic rhinitis (搜索) in adults and children. The approval, granted with zero supplementation requests, covers moderate to severe seasonal allergic rhinitis in patients aged six years and older, and moderate to severe perennial allergic rhinitis in patients aged twelve years and older.
Breakthrough Combination Therapy
RYALTRIS represents a first-of-its-kind fixed-dose combination nasal spray that combines olopatadine hydrochloride, an antihistamine, with mometasone furoate, a corticosteroid, to address allergic rhinitis (搜索) symptoms. This innovative formulation marks Glenmark's first globally commercialized branded specialty product and demonstrates the company's commitment to developing differentiated therapies for chronic respiratory conditions.
Clinical Trial Success
The NMPA approval follows the successful completion of a Phase III clinical trial (GSP 301-308) conducted specifically in China, which enrolled 535 patients across multiple trial centers. The study results demonstrated that RYALTRIS outperformed monotherapy comparators, specifically Patanase NS and Nasonex NS, in efficacy scores while meeting all endpoints for safety, tolerability, and pharmacokinetics.
Global Market Expansion
RYALTRIS has already secured regulatory approvals in multiple international markets, including the United States, European Union, United Kingdom, Australia, South Korea, and Russia. In fiscal year 2025, the product was launched in 11 international markets, expanding its global presence to 45 countries. Commercialization in China will be undertaken by Grand Pharmaceuticals Group Limited (搜索) under an exclusive licensing agreement.
"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," said Christoph Stoller, President and Business Head for Europe and Emerging Markets at Glenmark Pharmaceuticals.
Market Impact
The regulatory success has been reflected in Glenmark's stock performance, with shares ending at ₹1,835.80, up by ₹20.75 or 1.14% on the BSE following the announcement. The approval represents an important milestone in Glenmark's respiratory pipeline and reflects continued progress in advancing innovative therapies for patients with chronic conditions.