Changfeng Pharmaceutical (02652) Olopatadine Mometasone Nasal Spray Clinical Trial Application Approved by NMPA

LootboxPhobia · 2026-03-09T01:58:44+00:00

Changfeng Pharmaceutical's Olopatadine Mometasone Nasal Spray clinical trial application has been approved by the National Medical Products Administration, marking the product's entry into the clinical trial phase. This development demonstrates the company's capabilities in complex formulations and complements existing products for allergic rhinitis and chronic sinusitis, further strengthening its market competitive advantage.

LootboxPhobia

2026-03-09 01:58:44

Abstract generation in progress

China Securities Journal APP News, Changfeng Pharmaceutical (02652) announced that the clinical trial application (CTA) for Olopatadine Mometasone Nasal Spray has been approved by the National Medical Products Administration (NMPA) of the People’s Republic of China. The company is the first in China to submit a clinical trial application for a generic version of this product.

The approval of this CTA marks a milestone in advancing this product into the clinical trial phase. Developing a fixed-dose combination nasal spray faces significant technical challenges, especially in formulation stability, suspension systems, spray consistency, and large-scale production. The progress of this product further demonstrates the group’s execution capabilities in complex nasal spray formulations and integrated medical devices.

Additionally, this product complements the group’s existing portfolio of allergic rhinitis (AR) and chronic rhinosinusitis (CRS) products, which currently include Fluticasone Furoate Nasal Spray (Shufei Min®), Mometasone Furoate Nasal Spray, and Budesonide Nasal Spray. This portfolio covers a wide range of age groups and disease stages, providing long-term management options for upper respiratory tract diseases. The company believes that its comprehensive capabilities in complex formulations and precise delivery will continue to strengthen its competitive advantage in both domestic and global markets.

The group will maintain active communication with the NMPA and promote subsequent clinical activities in accordance with regulatory requirements.

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