AstraZeneca/Pfizer's Ceftaroline Fosamil Nears China Approval

By Baihuawen

On July 24, the marketing application for ceftaroline fosamil for injection submitted by AstraZeneca/Pfizer in China entered the administrative approval phase, with expectations of imminent approval and launch in the Chinese market.

Ceftaroline fosamil (brand name: Zinforo) received FDA approval for market launch in October 2010. As a fifth-generation cephalosporin antibiotic, it is clinically indicated primarily for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). AstraZeneca previously held global commercialization rights for Zinforo, with the rights in North America and Japan held by Allergan and Takeda, respectively.

In August 2016, Pfizer acquired the rights to market several anti-infective drugs, including Zinforo, outside the United States from AstraZeneca, through an upfront payment of $550 million, deferred payments of $175 million, milestone payments of up to $250 million, sales-related payments of $600 million, and subsequent sales royalties.