Glenmark gets China approval for Ryaltris nasal spray for allergies

Glenmark's Ryaltris nasal spray, already approved in the US, EU and other markets, has now secured China's NMPA approval, strengthening its global respiratory portfolio

Glenmark Specialty S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals, has secured approval from China’s National Medical Products Administration (NMPA) for Ryaltris Compound Nasal Spray (GSP 301 NS), marking a significant expansion of its specialty respiratory portfolio in one of the world’s largest healthcare markets.

 

The nasal spray has been approved for the treatment of moderate to severe seasonal allergic rhinitis (AR) in adults and children aged six and above, and moderate to severe perennial AR in adults and children aged 12 and above. Notably, the NMPA granted approval without seeking any additional data or supplementation, reflecting the robustness of Glenmark’s clinical submissions. The milestone strengthens the company’s innovation-led respiratory pipeline and supports its strategy to scale differentiated therapies for chronic conditions across global markets.

 

How large is the allergic rhinitis market in China?

 

The global allergic rhinitis treatment market is estimated at $16.03 billion in 2024 and projected to grow to about $23.38 billion by 2034. It is estimated that China accounts for 8–9 per cent of the global market, or around $460 million in 2024, which may expand to over $650 million by 2034.

 

What is Ryaltris and how does it work?

 

Ryaltris is a first-of-its-kind fixed-dose combination nasal spray that brings together olopatadine hydrochloride, an antihistamine, and mometasone furoate, a corticosteroid, offering comprehensive relief from 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.

 

Who will commercialise Ryaltris in China?

 

Commercialisation in China will be undertaken by Grand Pharmaceuticals Group Limited under an exclusive licensing agreement, enabling the product to leverage the partner’s strong on-ground presence and distribution capabilities.

 

“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, Europe and emerging markets, Glenmark Pharmaceuticals.

 

What does this approval mean for Glenmark’s global presence?

 

The approval positions Glenmark to further strengthen its footprint in the global respiratory therapeutics market, particularly in high-prevalence geographies like China.