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NMPA approval of antifungal Cresemba for invasive aspergillosis in China.-Pfizer + Basilea

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Published:18th Jan 2022
Basilea Pharmaceutica Ltd. announced that its license partner, Pfizer Inc. has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the oral formulation of its antifungal Cresemba (isavuconazole) for the treatment of adult patients with invasive aspergillosis. This is the second approved indication for oral Cresemba in China, after the approval for the treatment of adult patients with invasive mucormycosis, which was received in December 2021.

Pfizer submitted separate marketing authorization applications for the intravenous formulations of Cresemba for the treatment of invasive aspergillosis and mucormycosis and these are under regulatory review by the Center for Drug Evaluation at the NMPA.

The license agreement between Basilea and Pfizer covers Europe (excluding the Nordic countries), Russia, Turkey, Israel, as well as China (including Hong Kong and Macao) and sixteen countries in the Asia Pacific region. In addition to receiving mid-teen royalties on sales, Basilea remains eligible for further milestone payments of up to approximately $600 million under the agreement with Pfizer.

Condition: Infectious Diseases/ Invasive Aspergillosis
Type: drug

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