Biontech plans to file for approval of cancer drug in 2025

Mainz. BioNTech, a company that rose to prominence with its coronavirus vaccine, plans to submit its first regulatory application for a cancer drug by the end of this year. The Mainz-based company announced that the application is planned for a next-generation chemotherapy treatment for uterine cancer in the United States.

This type of therapy uses so-called antibody-drug conjugates. These are designed to deliver chemotherapy drugs more specifically to cancer cells using antibodies.

BioNTech is still aiming for its first oncology market approval in 2026. Late Phase 3 clinical trials are underway for several drug candidates and for the treatment of various cancer types.

On the way there, BioNTech suffered a net loss of €415.8 million in the first quarter of 2025 – once again more than the €315.1 million in the same period of the previous year. Sales in the first three months of 2025 amounted to €182.8 million (previous year: €187.6 million).

"Our first-quarter sales are in line with our expectations and reflect the seasonal demand for Covid-19 vaccines," said Chief Financial Officer Jens Holstein. The strategic goal remains to develop BioNTech into a leading biotech company with multiple oncology products by 2030.

RND/dpa