Glenmark's Ryaltris nasal spray gets China approval for allergic rhinitis

Glenmark Pharmaceuticals Ltd on Monday said its arm Glenmark Specialty SA has received approval from China's National Medical Products Administration for the nasal spray RYALTRIS used to treat allergic rhinitis.

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 adults and pediatric patients 12 years of age and older, the company said in a statement.

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, it added.

"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," Glenmark Pharmaceuticals Ltd President and Business Head, Europe and Emerging Markets, Christoph Stoller said.

The NMPA approval follows the successful completion of Phase III clinical trial for RYALTRIS compound nasal spray conducted in China, enrolling 535 patients across multiple trial centers, the company said.

In FY25, RYALTRIS was launched in 11 international markets, expanding its presence to 45 countries, it added.