Announcement on Acceptance of Application for

Posaconazole oral suspension 

Generic name: Posaconazole oral suspension

Dosage form: oral suspension  

Registration category: 5.2 category

Beimei Pharma and Deva Holding A.Ş. have come to an exclusive license agreement for Posaconazole oral suspension in December 2020. According to the agreement, Beimei Pharma is responsible for the registration and commercialization of the product in mainland China. On September 27, 2021, Beimei has officially received the acceptance letter issued by the Drug Evaluation Center of the National Medical Products Administration and the review was initiated. 

Posaconazole is a derivative of itraconazole, a second-generation triazole antifungal drug approved for the prevention of invasive Aspergillus and Candida infections, and the treatment of oropharyngeal candidiasis in China. Posaconazole is the sole drug among antifungal drugs that is clearly approved for prophylactic use. With a broad antibacterial spectrum, good efficacy, well tolerability and low adverse effects, prophylactic use status and recommendation level of posaconazole in the guidelines are increasing as clinical uses continue to expand.

Invasive fungal disease (IFD) is a major cause of morbidity and mortality in immunocompromised patients. Patients with hematologic malignancies, such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), undergoing chemotherapy or hematopoietic stem cell transplantation (HSCT), are at high risk of developing IFD. In addition to the above causes, children who have immune dysfunction, ICU stay, solid organ transplantation and newborns (low birth weight) are also the high-risk factors for IFD. In recent years，the incidence of IFD in children has been on the rise and the prophylactic use of antifungals has been shown to reduce the incidence of IFI. Currently, fluconazole, itraconazole and other antifungal agents other than triazoles are commonly used in clinical practice. Posaconazole, a new generation of triazole antifungal agents, has an expanded antifungal spectrum and is more effective than other antifungal agents in preventing IFI in patients with hematological malignancies and HSCT, while reducing all-cause mortality and IFI-related mortality without increasing the incidence of adverse events.

In 2020, global market for systemic antifungal drugs exceeded US$5 billion, with China accounting for US$700 million. Posaconazole has global sales of US$150 million and the sales of more than US$70 million in China. The dosage forms of oral suspension, enteric tablets and injectables have been approved in China in 2013, 2018 and 2021 respectively. Currently only original oral suspension is available on the domestic market, the market is still in its infancy and sales are forecast to continue to grow steadily in the coming years.

Beimei’s Posaconazole Oral Suspension is an imported generic formulation, which has been approved for marketing in several European countries, such as Germany. The oral suspension is administered 1 to 3 times daily, depending on the indication and stage of treatment. The product contains a precise measuring device for accurate and convenient dosing and is suitable for children, the elderly, and people with swallowing difficulties. In addition, the product has good taste and is easily accepted by children, thus improving compliance with administration.