Apeloa subsidiary secures NMPA approval for Cefdinir capsules

Apeloa Pharmaceutical Co., Ltd. announced its subsidiary, Zhejiang Prokangyu Pharmaceutical Co., Ltd., has obtained a drug registration certificate for Cefdinir Capsules from the National Medical Products Administration. This approval, categorized as a Class 4 chemical drug, allows Zhejiang Prokangyu Pharmaceutical Co., Ltd. to market the 0.1g capsules.

Cefdinir Capsules are indicated for various infections caused by susceptible strains, including pharyngitis, pneumonia, otitis media, cystitis, and skin infections. According to market data, the Chinese hospital market for Cefdinir Capsules in 2024 was 3.8 bn units, with sales totaling RMB 310m. As of the announcement date, the cumulative R&D investment for Cefdinir Capsules reached RMB 528.18m.

This registration certificate signifies that the product meets the quality and efficacy standards for generic drugs, enabling Apeloa to participate in future national centralized procurement tenders. This is expected to boost the product's market sales and enhance the company's competitiveness. Apeloa Pharmaceutical emphasizes its commitment to quality, safety, and compliance in drug development and manufacturing, while also cautioning investors about potential risks from policy changes and market fluctuations.