CF PHARMTECH (02652) Receives CTA Approval for Combined Nasal Spray Targeting Allergic Rhinitis

Bulletin Express
03/09

CF PHARMTECH (02652) received approval from the National Medical Products Administration for a clinical trial application (CTA) concerning a nasal spray that combines olopatadine hydrochloride and mometasone furoate monohydrate. According to the announcement dated March 9, 2026, the submission acceptance numbers are CYHL2500215 and CYHL2500214, and the proposed indication covers moderate-to-severe allergic rhinitis in adults and children aged 12 and older.

This product merges an antihistamine and a corticosteroid in a single formulation, addressing convenience and adherence challenges for moderate-to-severe allergic rhinitis. The approval confirms progress in tackling technical requirements related to formulation stability, spray consistency, and large-scale manufacturing, reflecting CF PHARMTECH’s capacity in complex nasal spray formulations and drug-device integration.

The newly approved product aligns with CF PHARMTECH’s existing portfolio, which features azelastine hydrochloride and fluticasone propionate nasal spray (Shu Fei Min®), mometasone furoate nasal spray, and budesonide nasal spray for conditions such as allergic rhinitis and chronic rhinosinusitis. The announcement notes that the CTA approval does not guarantee successful commercialization or future regulatory approvals, and there remain high-tech and high-risk factors in pharmaceutical research and development.

CF PHARMTECH specializes in inhalation drug delivery technology, offering integrated capabilities from device engineering to regulatory filings. The pipeline focuses on respiratory and nasal diseases, with strategic growth into additional therapeutic areas. The announcement highlights the company’s globally compliant manufacturing systems and expanding commercialization network as part of its long-term strategy.

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