CSPC PHARMA's Amphotericin B Liposome Injection Receives EU Marketing Authorization

Stock News
Apr 29

CSPC PHARMA has announced that the marketing application for its independently developed Amphotericin B Liposome Injection (HC1507G2) has been approved in the European Union. This approval marks a breakthrough as the first Chinese liposomal formulation to enter the European market, representing a critical step in the global expansion of advanced pharmaceutical preparations. The approved indications include treatment of severe systemic and/or deep fungal infections affecting one or more human organs, as well as empirical therapy for suspected fungal infections in febrile neutropenic patients who have not responded to broad-spectrum antibiotic treatment and for whom appropriate testing has failed to identify bacterial or viral causes. Amphotericin B is a macrolide polyene antifungal antibiotic that works by binding to sterols in fungal cell membranes, altering membrane permeability. The liposomal formulation provides a unique delivery system that enables targeted accumulation at infection sites, maintaining potent antifungal activity while reducing drug exposure in healthy tissues such as kidneys. This significantly lowers nephrotoxicity and infusion-related reactions, improving safety and therapeutic index. The successful approval further enriches the company's international product pipeline in anti-infective therapeutics, demonstrating its comprehensive capabilities in research, mass production, quality management, and regulatory compliance for complex injectables. It enhances CSPC PHARMA's competitiveness in the global advanced formulations market while providing safer and more effective treatment options for patients with fungal infections.

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