Pfizer Announces China Approval of CRESEMBA (Isavuconazonium Sulfate Capsules), the First Oral Antifungal for Invasive Mucormycosis in Adults

Beijing, December 17, 2021 /PR Newswire/ -- Pfizer, Inc. announced today that its novel antifungal drug, Cresemba (isavuconazole sulfate capsules, 100 mg), has recently been approved by the National Medical Products Administration for the treatment of invasive mucormycosis in adults.

As a new triazole antifungal drug,康新博is produced in China.The First in ChinaThe oral antifungal drug approved for the treatment of invasive mucormycosis in adults marks a new era in the clinical treatment of invasive mucormycosis infections in China, offering a new therapeutic option for patients with this rare fungal infection that has an extremely high mortality rate.

Invasive mucormycosis is a rare fungal infection that can affect multiple organs, commonly involving the rhino-orbital-cerebral region, lungs, and other areas. Due to the difficulty in diagnosis and non-specific clinical symptoms, its true incidence may be underestimated.^[1]。

The clinical prognosis of invasive mucormycosis is also not optimistic, with a high mortality rate. The overall epidemiological mortality rate is close to 50%, and the mortality rate for patients with hematological tumors, pulmonary infections, and central nervous system involvement can reach 70%.^[2]-[3]`, and if appropriate antifungal drugs are not provided in a timely manner, it can significantly increase patient mortality. The mortality rate can reach 82.9% if treatment is delayed for 12 weeks.`^[4]Therefore, for high-risk groups of invasive mucormycosis such as patients with hematological malignancies, solid organ and hematopoietic stem cell transplantation, use of glucocorticoids, diabetes mellitus, antifungal prophylaxis, and major trauma, early diagnosis and treatment should be performed.

For many years, the existing treatment options for invasive mucormycosis in China have had numerous limitations, such as poor patient tolerance and a single drug formulation. The clinical prognosis has also been discouraging, with a high mortality rate. The approval of Cresemba brings new hope for the treatment of invasive mucormycosis, aiding adult patients in receiving timely treatment.

Peng Zhenke, President of Pfizer Biopharmaceuticals Group, China, said: "Pfizer has always been committed to the goal of 'delivering breakthrough innovations that change patients' lives.'VeryWe are pleased that our innovative antifungal drug, Amplyx (Amplyx), has been officially approved for the treatment of invasive mucormycosis in adults, providing an innovative treatment option for patients with this condition. In the future, Pfizer will introduce more innovative drugs to China to meet unmet clinical treatment needs and benefit more patients."

Currently, Kangxinbo has been approved for marketing in more than 60 countries and regions worldwide, including the United States, the United Kingdom, France, and Switzerland.

^[1] Prakash H Chakrabarti A.J Fungi (Basel). 2019 Mar 21;5(1)26.

^[2] Chamilos G et al. Clin Infect Dis. 2008;47(4):503–9.

^[3] William J Steinbach et al. J Infect. 2012 Nov;65(5):453-64.

^[4] Wirawan Jeong et al. Int J Antimicrob Agents. 2019 May;53(5):589-597.