Healthcare/Biotech
|
Updated on 10 Nov 2025, 11:28 am
Reviewed By
Akshat Lakshkar | Whalesbook News Team
▶
Glenmark Pharmaceuticals Limited announced a significant milestone today as its subsidiary, Glenmark Specialty SA, secured approval from China's National Medical Products Administration (NMPA) for its RYALTRIS Compound Nasal Spray. This nasal spray is designed to treat allergic rhinitis.
The approval specifically covers the treatment of moderate to severe seasonal allergic rhinitis in adults and pediatric patients aged 6 years and older, as well as moderate to severe perennial allergic rhinitis in adults and pediatric patients aged 12 years and older. Glenmark highlighted that the approval was granted without any requests for supplemental information, underscoring the quality of the submission and the drug's readiness.
This development is seen as a crucial advancement for Glenmark's respiratory drug portfolio. Christoph Stoller, President and Business Head for Europe and Emerging Markets at Glenmark Pharmaceuticals Limited, emphasized that China is a priority market and that the company, in collaboration with Grand Pharmaceuticals, is focused on ensuring patient access to this innovative treatment.
The NMPA approval follows the successful completion of a Phase III clinical trial for RYALTRIS conducted within China, which involved 535 patients. Furthermore, the company noted that RYALTRIS has been launched in 11 international markets during Fiscal Year 2025, expanding its reach to a total of 45 countries worldwide.
Impact: This approval is expected to significantly boost Glenmark Pharmaceuticals' market presence and revenue streams, especially in the large and growing Chinese pharmaceutical sector. It solidifies the company's competitive position in the respiratory therapy area and provides a strong platform for future growth. Rating: 7/10.
Difficult Terms: * **Allergic Rhinitis (AR)**: A common allergic reaction that causes symptoms like sneezing, runny nose, itchy nose, and watery eyes, often triggered by pollen, dust, or animal dander. * **National Medical Products Administration (NMPA)**: The regulatory authority in China responsible for overseeing the safety, efficacy, and quality of drugs and medical devices. * **Seasonal Allergic Rhinitis**: Allergic rhinitis that occurs during specific seasons, typically when certain plants pollinate, such as spring or fall. * **Perennial Allergic Rhinitis**: Allergic rhinitis that occurs year-round, often triggered by indoor allergens like dust mites, mold, or pet dander.