Kang Xinbo, the first oral antifungal drug for adult invasive mucormycosis in China, was officially approved

China, December 17, 2021 – Pfizer today announced that a new antimicrobial drug, Consaconazole Sulfate, CRESEMBA, 100 mg, has recently been approved by the State Drug Administration for the treatment of invasive mucormycosis in adults.

As a new triazole antifungal drug, Kang Xinbo is the first oral antifungal drug approved for the treatment of invasive mucormycosis in adults in China, and its approval marks the opening of a new pattern in the field of invasive mucormycosis infection treatment in China, bringing new treatment drugs to patients with rare fungal infections with a high fatality rate in invasive mucormycosis.

Invasive mucormycosis is a rare fungal infection that affects multiple organs and is common in the nose-orbital-brain and lung areas, and its true incidence may be underestimated due to difficult diagnosis and nonspecific clinical symptoms [1].

The clinical prognosis of invasive mucormycosis is also not optimistic, showing a high mortality rate. The overall epidemiological mortality rate is close to 50%, the mortality rate in patients with hematological tumors, lung infections, and central 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, with a 12-week delay in treatment up to 82.9% [4]. Therefore, patients with high risk of invasive mucormycosis, such as blood malignancies, solid and hematopoietic stem cell transplantation, the use of glucocorticoids, diabetes mellitus and antifungal drug prevention, and patients with major trauma, should be diagnosed and treated as soon as possible.

Over the years, the existing invasive mucormycosis treatment plan in China still has many limitations such as poor patient tolerance and single drug dosage form, and the clinical prognosis is not optimistic, showing a high mortality rate. Kang Xinbo's approval brings new hopes for the treatment of invasive mucormycosis to the clinic, and helps adult invasive mucormycosis patients to receive timely treatment.

"Pfizer has always aimed to 'bring breakthrough innovations that change the lives of patients' with the goal of 'bringing breakthrough innovations that change the lives of patients', and we are very pleased that our innovative antifungal drug Kang Xinbo has been officially approved for the treatment of invasive mucormycosis in adults, providing innovative treatment options for patients with this type of disease," said Zhenke Peng, President of Pfizer Biopharmaceutical Group China. In the future, Pfizer will introduce more innovative drugs into China to meet the unmet clinical treatment needs and benefit more patients. ”

At present, Kangxinbo has been approved for listing in more than 60 countries and regions around the world, such as the United States, Britain, France, and Switzerland.

About CRESEMBA:

The innovative drug Kangxinbo (Isaconazole sulfate capsules, CRESEMBA, 100 mg) is an oral triazole antifungal drug approved by the State Drug Administration for the treatment of invasive mucormycosis in adults. At present, Kangxinbo has been approved in more than 60 countries and regions such as the United States, Britain, 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.