Bocaan^® (Posaconazole Oral Suspension) is primarily indicated for the prophylaxis of invasive Aspergillus and Candida infections and for the treatment of oropharyngeal candidiasis, including cases refractory to itraconazole and/or fluconazole, thereby precisely addressing key clinical needs in antifungal therapy.

As a second-generation triazole antifungal, Posaconazole was developed by Merck through structural optimization of itraconazole. First approved in the U.S. in 2003 as an oral suspension and introduced to the Chinese market in 2013 via NMPA approval, Posaconazole is highly recommended by numerous authoritative domestic and international guidelines and expert consensus for its broad antifungal spectrum, high tissue concentrations, potent antifungal activity, excellent stability, and favorable safety profile. It is widely used for the prevention and treatment of Candida and Aspergillus infections, as well as the treatment of Mucorales infections, earning strong clinical recognition and value.

Currently, three dosage forms of Posaconazole have been successively launched in China. Among them, the oral suspension due to its well-established foundation in clinical experience and the distinct advantage of being suitable for pediatric use, holds a major market share; the enteric-coated tablets, with their benefits of convenient administration and excellent stability, occupy a portion of the market; and the intravenous formulation plays a crucial role in the treatment of severe infections.

The Posaconazole Oral Suspension approved for launch by Beimei Pharma is a Class 5.2 marketing application, with an approved specification of 105 mL: 4.2 g. This approval further diversifies the range of available clinical treatment options and helps address the therapeutic needs of a broader patient population.

Notably, the use of Posaconazole Oral Suspension in pediatric populations is well recognized. The U.S. FDA has approved its injection, tablet, oral dry suspension, and oral suspension formulations for the prophylaxis of invasive Aspergillus and Candida infections in high-risk pediatric patients, such as those undergoing hematopoietic stem cell transplantation or those with chemotherapy-induced prolonged neutropenia due to malignancies^【1】. The 8th European Conference on Infections in Leukemia (ECIL 8): 2020 Guideline for the Diagnosis, Prevention, and Treatment of Invasive Fungal Diseases in Pediatric Patients recommends Posaconazole Oral Suspension for the prophylaxis of invasive fungal diseases in children aged 1 month to 12 years post-chemotherapy or post-hematopoietic stem cell transplantation^【2】. In China, Posaconazole Oral Suspension is approved for children aged 13 years and above with severe immunodeficiency for the prophylaxis of invasive Aspergillus and Candida infections, as well as for the treatment of oropharyngeal candidiasis, including itraconazole- and/or fluconazole-refractory cases. In the future, its use in China is expected to potentially expand to include pediatric patients aged 2 years and above.

Significant unmet clinical needs remain in the field of antifungal therapy, representing a “blue ocean market” with vast potential. The successful approval of Bocaan® marks a significant breakthrough for Beimei Pharma in the anti-infective field, showcasing the company’s strong capabilities in pharmaceutical R&D and regulatory submission. Moving forward, Beimei Pharma will continue to focus on addressing urgent clinical demands, delivering more high-quality pharmaceutical products to patients and contributing to the advancement of China’s healthcare industry.

References

【1】U.S. Package Insert

【2】8th European Conference on Infections in Leukaemia: 2020 guidelines for the diagnosis, prevention, and treatment of invasive fungal diseases in paediatric patients with cancer or post-haematopoietic cell transplantation