CF PHARMTECH (02652): The clinical trial application for the Olodaterol Mometasone nasal spray has been accepted by the NMPA.

CF PHARMTECH (02652) announced that the clinical trial application for the fixed combination formulation of olodaterol and mometasone nasal spray (product) developed independently by the company has been accepted by the National Medical Products Administration (NMPA) of China. The product is a fixed combination nasal spray developed independently by the company. The acceptance of the clinical trial application marks its official entry into the regulatory review stage for potential clinical development by the NMPA. The indication is intended to cover moderate to severe allergic rhinitis in specific age groups. The product combines antihistamine and corticosteroid in a single nasal spray. Through clinical studies, the company aims to evaluate whether this fixed combination formulation can provide a convenient treatment option for patients whose symptoms are not effectively controlled by a single therapy. This milestone aligns with the company's strategy to establish a differentiated portfolio of respiratory and nasal products and leverage its formulation, device integration, and manufacturing capabilities in the field of nasal drug-device combination products. Allergic rhinitis typically requires management with multiple treatment mechanisms, particularly in moderate to severe cases. This product is designed as a fixed combination, delivering olodaterol hydrochloride for antihistamine-related symptoms (such as sneezing and itching) and mometasone furoate for inflammation-related symptoms through nasal spray suspension. Fixed combination formulations can reduce the need for patients to use multiple products separately, enhancing medication convenience and compliance. These potential benefits still need to be validated through clinical verification and regulatory review. The company believes that advancing this product is of significant importance for the following reasons: Expanding the range of nasal care products: If successfully developed and approved, the product will strengthen the company's portfolio of allergy and rhinitis products and provide a broader range of treatment options for moderate to severe patients (depending on the approved labeling); Platform technology practice: The progress of this project showcases the company's research and development capabilities in the field of nasal suspension formulations and drug-device integration, which often have higher technical barriers and quality requirements compared to standard formulations; and Potential commercial synergy: Once approved for marketing, the product can complement the company's existing portfolio of respiratory and nasal products, strengthening market coverage in the treatment of airway diseases. The company will continue to communicate and collaborate with the NMPA throughout the review process and comply with relevant laws and regulations. Upon receiving regulatory review results and any necessary approvals as stipulated, the company will proceed with subsequent clinical development activities.