CF PHARMTECH (02652): NMPA Accepts Marketing Application for Budesonide Nasal Spray

Stock News01-30

CF PHARMTECH (02652) announced that the marketing authorization application for its Budesonide Nasal Spray has been accepted by China's National Medical Products Administration (NMPA). Nasal sprays represent a complex formulation with high technical barriers.

Leveraging its nasal drug delivery technology platform, the company has established a comprehensive product matrix covering multiple indications and the full-course management of respiratory and rhinitis conditions. The company's existing product portfolio in this area includes: Azelastine/Fluticasone Nasal Spray (Shufei Min®): the first antihistamine-steroid compound nasal spray in China, which was included in the National Reimbursement Drug List in 2023; Mometasone Furoate Nasal Spray: a first-line treatment for allergic rhinitis in adults and children aged 3 and above; Budesonide Nasal Spray (this product): indicated for patients aged 6 and above, targeting seasonal acute episodes, perennial maintenance therapy, and nasal polyps; and Olopatadine/Mometasone Nasal Spray: targeting moderate to severe allergic rhinitis symptoms in adolescents aged 12 and above and adults.

The acceptance of the Budesonide Nasal Spray application further enriches the company's product pipeline in the field of allergic rhinitis, demonstrating its determination and capability to deepen its presence in the respiratory inhalation therapy sector and providing patients with high-quality treatment options.

The Group will actively communicate with the NMPA and advance subsequent review procedures in accordance with regulatory requirements.

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