Biopharmaceutical company AstraZeneca PLC (STO: AZN; LON: AZN; NYSE: AZN) said on Tuesday it has completed its exclusive global licence agreement with China-based Dizal Pharmaceutical Co., Ltd (SSE: 688192) for Zegfrovy (sunvozertinib), an oral irreversible EGFR inhibitor for lung cancer, giving AstraZeneca worldwide rights to develop and commercialise the medicine.
Zegfrovy is approved in the US and China for 2nd-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. These patients have a real-world five-year overall survival rate as low as 8%, highlighting the need for new therapies. AstraZeneca plans to launch the drug in the US in the fourth quarter of 2026.
A supplemental New Drug Application for 1st-line use has been accepted by the US Food and Drug Administration, supported by positive Phase III data. Zegfrovy has also been submitted for 1st-line approval to China's Center for Drug Evaluation, and both the US FDA and China's CDE have granted Breakthrough Therapy Designation in this setting.
AstraZeneca will pay Dizal USD600m upfront and up to USD900m in milestone payments, with additional tiered royalties on global sales. The transaction does not affect AstraZeneca's 2026 financial guidance.
Zambon receives European Commission approval for Hopledo in Parkinson's disease
Pfizer and BioNTech granted FDA approval for XFG-adapted COVID-19 vaccine
Annovis Bio schedules corporate update webinar for next week
Cellenkos' CK0803 granted US FDA Fast Track designation for ALS
Labcorp to offer FDA-cleared pTau-217 blood test for Alzheimer's assessment
Tempus announces receipt of FDA clearance for AI pulmonary hypertension detection product
European Commission grants orphan designation for Vanda's imsidolimab
United Therapeutics wins FDA acceptance for ralinepag PAH filing
Acadia wins EU approval for DAYBU as first treatment for Rett syndrome
Gilead expands Trodelvy role in first-line metastatic triple-negative breast cancer in Europe
GSK's Jemperli wins FDA priority review for advanced rectal cancer
European Commission grants orphan designation for Lundbeck's asedebart