GRAND PHARMA's Innovative Allergic Rhinitis Combination Nasal Spray Approved for Launch in China

Recently, GRAND PHARMA announced that its jointly developed compound nasal spray of olopatadine hydrochloride and mometasone furoate (brand name: Ryaltris) has been approved by China's National Medical Products Administration (NMPA) for the treatment of moderate-to-severe allergic rhinitis (AR) in patients aged 6 years and older. This product is a novel combination nasal spray containing an antihistamine (olopatadine) and a corticosteroid (mometasone furoate), which has already been approved in multiple countries and regions, including the U.S., Australia, Russia, South Korea, and the U.K.

In China, the olopatadine-mometasone furoate compound nasal spray received approval for Phase III clinical trials (GSP 301-308) in October 2021. GSP 301-308 was a randomized, double-blind, double-dummy, three-arm, multicenter, parallel-controlled Phase III clinical study involving 535 seasonal allergic rhinitis patients. Participants were randomly assigned in a 1:1:1 ratio to the olopatadine-mometasone furoate compound nasal spray treatment group or one of two reference single-drug comparator groups—olopatadine hydrochloride nasal spray and mometasone furoate nasal spray—to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of Ryaltris®.

Clinical results demonstrated that the olopatadine-mometasone furoate compound nasal spray achieved superior efficacy scores compared to the single-drug reference treatment groups. Additionally, the drug met all predefined clinical endpoints in terms of safety, tolerability, and pharmacokinetic profiles.