AstraZeneca has entered into an exclusive global licensing agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib), a recently FDA-approved oral treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The deal could be worth up to $1.5 billion, comprising an undisclosed upfront payment and various development, regulatory, and sales-based milestone payments. This acquisition strengthens AstraZeneca's position in the lucrative oncology market, especially in targeted therapies for lung cancer, an area where its blockbuster drug Tagrisso is not effective against exon 20 insertion mutations.
Zegfrovy, known as sunvozertinib during development, received accelerated FDA approval based on a Phase 2 study showing an overall response rate of 46% and a duration of response of 11.1 months. It is indicated for patients whose disease has progressed during or after chemotherapy. Dizal, founded in 2017 partly by former AstraZeneca staff including CEO Xiaolin Zhang, had been exploring partnerships for U.S. commercialization. The drug was internally discovered by Dizal scientists and is already commercially available in China, where it was approved in 2023.
The agreement positions AstraZeneca to compete with existing treatments for this specific NSCLC mutation, such as Johnson & Johnson's Rybrevant, an intravenous bispecific antibody. While Rybrevant was the first approved and later gained full FDA approval for first-line use, Zegfrovy offers the advantage of being an oral small molecule. This could provide safety, tolerability, and convenience benefits over infused therapies like Rybrevant, although Zegfrovy's label includes warnings for interstitial lung disease, gastrointestinal problems, skin reactions, and eye toxicity. The deal allows AstraZeneca to leverage its extensive global commercial infrastructure to maximize Zegfrovy's market penetration.
