CSPC PHARMA (01093): Approval obtained for Liposomal Amphotericin B for injection (HC1507G2) in Europe.

CSPC PHARMA (01093) announced that the company's independently developed injection-grade liposomal amphotericin B (HC1507G2) has been approved for marketing in the European Union. The approval of this product marks a significant milestone as the first Chinese liposomal formulation to be marketed in Europe, representing a key step in expanding into the high-end formulation market. The approved indications for this product include severe systemic and/or deep-seated fungal infections in one or more human organs, as well as empiric therapy for suspected fungal infections in febrile neutropenic patients who have not responded to broad-spectrum antibiotics and where appropriate testing has failed to identify a bacterial or viral cause. Liposomal amphotericin B is a polyene antifungal antibiotic that exerts its antifungal action by binding to sterols in the fungal cell membrane, altering membrane permeability. This liposomal formulation provides a unique delivery system for amphotericin B, allowing it to preferentially accumulate at the site of infection, maintaining high antifungal activity while reducing exposure in normal tissues such as the kidneys, thereby significantly reducing renal toxicity and infusion-related reactions, improving safety and enhancing the therapeutic index. The successful approval of this product further enriches the company's international product pipeline in the anti-infective field, showcasing the company's comprehensive strength in high-end complex injectable drug development, large-scale production, quality management, and registration. This approval effectively enhances the company's competitiveness in the global high-end formulation market, while also providing safer and more effective treatment options for more patients with fungal infections.