Core Viewpoint - The company has received a notice of acceptance from the National Medical Products Administration (NMPA) for its clinical trial application of the self-developed fixed combination nasal spray, Olopatadine Mometasone, marking the start of regulatory review for potential clinical development [1][2] Group 1: Product Development - The product is a fixed combination nasal spray designed to treat moderate to severe allergic rhinitis in specific age groups, combining an antihistamine and a corticosteroid in a single formulation [1] - The clinical research aims to evaluate whether this fixed combination can provide a convenient treatment option for patients whose symptoms are not effectively controlled by monotherapy [1] Group 2: Strategic Importance - Advancing this product is significant for the company as it will expand the allergy and rhinitis product line, offering broader treatment options for moderate to severe patients, depending on the approved label [2] - The project highlights the company's R&D capabilities in nasal suspension formulations and drug-device integration, which typically have higher technical barriers and quality requirements compared to standard formulations [2] Group 3: Market Positioning - Once approved, the product is expected to complement the existing respiratory and nasal product portfolio, enhancing market coverage in the field of airway disease treatment [2] - The company will maintain communication and cooperation with NMPA during the review process and comply with relevant laws and regulations [2]
长风药业(02652)：奥洛他定莫米松鼻喷雾剂临床试验申请获NMPA受理