By Fineline Cube 
Boji Medical Technology Co., Ltd. (SHE: 300404) has secured approval from the National Medical Products Administration (NMPA) to initiate clinical trials of FCZR, a Class 2.2/2.4 improved new drug designed specifically for the treatment of otomycosis.
Why FCZR Matters
- Optimized Formulation – FCZR is a liquid eardrop that delivers the active ingredient directly to the ear canal, ensuring full contact with lesions even in hidden corners.
- Localised Action – By concentrating the drug at the site of infection, FCZR promises a faster, more complete cure while reducing systemic exposure.
- First‑Mover Advantage – No other liquid eardrop with this clinical profile is approved for marketing in China or internationally, positioning FCZR as a unique solution in the ENT market.
Disease Landscape
Otomycosis, a fungal infection of the external ear canal, is common in hot, humid climates and often recurs. Conventional treatments rely on multi‑step regimens that can be inconvenient and less effective. FCZR’s single‑dose, user‑friendly format addresses these shortcomings and could redefine standard care.
Next Steps
- Phase I/II Trials – The NMPA‑approved study will enroll patients across multiple ENT centers in China, evaluating safety, tolerability, and preliminary efficacy.
- Regulatory Pathway – Successful trial outcomes will pave the way for a marketing application under the Class 2.2/2.4 pathway, potentially granting Boji a first‑to‑market position.
- Global Expansion – Boji plans to explore approvals outside China, leveraging its experience with Class 2.4 products and a growing international regulatory portfolio.
Investment Implications
Boji’s successful navigation of the NMPA approval process showcases its capability to develop and advance innovative ENT therapies. The FCZR pipeline, coupled with the company’s CRO expertise, positions Boji as a compelling candidate for investors interested in niche therapeutic areas with high unmet need.-Fineline Info & Tech