Boji Medical gets clinical trial nod for ear infection drug FCZR

Guangzhou Boji Medical & Biotechnological Co., Ltd. announced it has received approval from the National Medical Products Administration for the clinical trial of its drug, FCZR. The approval covers two notification numbers, 2025LP02257 and 2025LP02258, indicating different specifications of the drug. FCZR is classified as a Class 2.2/2.4 chemical drug, targeting otomycosis, a common ear infection.

The company stated that the clinical trial application for FCZR, accepted on June 19, 2025, meets the relevant requirements for drug registration. FCZR is an improved new drug (Class 2.2/2.4) based on a known active ingredient, with optimized dosage form, formulation, administration route, and indications, particularly for otomycosis. The drug is designed for topical application via eardrops.

Boji Medical emphasized that obtaining this clinical trial approval is a preliminary achievement in new drug development and will not significantly impact the company's operating performance. However, due to the inherent uncertainties and complexities of drug development, including trial progress, results, and market competition, the company cautioned investors about potential risks.