Glenmark Specialty S.A., a wholly-owned subsidiary of Glenmark Pharmaceuticals, 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 treatment has been approved for moderate to severe seasonal AR in adults and paediatric patients aged six years and older, and moderate to severe perennial AR in adults and paediatric patients aged 12 years and older. The approval was granted with zero supplementation requests.
RYALTRIS is a fixed-dose combination nasal spray containing olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid) for the treatment of allergic rhinitis symptoms. 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.
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.”