CF PHARMTECH (02652) Receives NMPA Approval for Clinical Trial Application of Olopatadine Mometasone Nasal Spray

Stock News
Mar 09

CF PHARMTECH (02652) has announced that the Clinical Trial Application (CTA) for its Olopatadine Mometasone Nasal Spray has been approved by the National Medical Products Administration (NMPA) of China. The company is the first in China to submit a generic drug clinical trial application for this product. The approval of the CTA marks a milestone in advancing the product into the clinical trial phase. Developing a fixed-dose compound nasal spray presents significant technical challenges, particularly in formulation stability, suspension systems, spray consistency, and scalable manufacturing. Progress on this product further demonstrates the group's execution capabilities in complex nasal spray formulations and drug-device integration. Additionally, the product complements the group's existing portfolio for allergic rhinitis (AR) and chronic rhinosinusitis (CRS), which currently includes Azelastine Fluticasone Nasal Spray (Shufei Min®), Mometasone Furoate Nasal Spray, and Budesonide Nasal Spray. This portfolio covers a wide range of age groups and disease stages, providing accessible long-term management solutions for upper respiratory diseases. The company believes that its integrated capabilities in complex formulations and precise drug delivery will continue to strengthen its competitive advantage in domestic and global markets. The group will maintain active communication with the NMPA and proceed with subsequent clinical activities in accordance with regulatory requirements.

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