CF PHARMTECH (02652) announced that the clinical trial application for its self-developed fixed-dose combination product, Olopatadine Mometasone Nasal Spray, has been accepted by China's National Medical Products Administration (NMPA). The product is a proprietary fixed-dose nasal spray formulation developed by the group. The acceptance of the clinical trial application marks its official entry into the regulatory review phase for potential clinical development under NMPA oversight. The intended indications cover moderate-to-severe allergic rhinitis in specific age groups. The product combines an antihistamine with a corticosteroid in a single nasal spray. Through clinical studies, the group aims to evaluate whether this fixed-dose combination can provide a convenient treatment option for patients whose symptoms are not adequately controlled by monotherapy. This milestone aligns with the group's strategy of building a differentiated respiratory and nasal product portfolio while leveraging its expertise in formulation, device integration, and manufacturing for nasal drug-device combination products. Allergic rhinitis often requires management with multiple therapeutic mechanisms, particularly for moderate-to-severe cases. The product is designed as a fixed-dose combination delivered via a nasal spray suspension: Olopatadine Hydrochloride—an antihistamine component targeting histamine-related symptoms (such as sneezing and itching); and Mometasone Furoate Hydrate—a corticosteroid component addressing inflammation-related symptoms. Fixed-dose combinations may reduce the need for patients to use multiple products separately, potentially improving convenience and adherence. Such potential benefits remain subject to clinical validation and regulatory review. The company considers advancing this product significant for the following reasons: Expanding Rhinitis Care Portfolio—If successfully developed and approved, the product could strengthen the group's allergy and rhinitis product line while offering broader treatment options for moderate-to-severe patients (subject to approved labeling); Platform Technology Implementation—This project demonstrates the group's R&D capabilities in nasal suspension formulations and drug-device integration, which typically involve higher technical barriers and quality requirements compared to standard dosage forms; and Potential Commercial Synergies—Upon approval, the product could complement the group's existing respiratory and nasal product portfolio, enhancing market coverage in airway disease treatment. The company will maintain communication and collaboration with NMPA throughout the review process while complying with relevant laws and regulations. Following regulatory review outcomes and any required approvals (if applicable), the group will proceed with subsequent clinical development activities.
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