AstraZeneca PLC（AZN）のニュースとイベントAZNAstraZeneca PLC

AstraZeneca Completes Exclusive License Agreement for Zegfrovy with Dizal

AstraZeneca announced the completion of the exclusive license agreement with Dizal Pharmaceutical for Zegfrovy - sunvozertinib -, an oral irreversible epidermal growth factor receptor, or EGFR, inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialize Zegfrovy. Zegfrovy is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer, or NSCLC, with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8%. Zegfrovy is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during Q4 for this indication. A supplemental New Drug Application for approval of Zegfrovy in the 1st-line setting has been accepted by the FDA. Zegfrovy has also been submitted for approval in the 1st-line setting to China's Center for Drug Evaluation. The US FDA and China's CDE both granted Breakthrough Therapy Designation to Zegfrovy in this setting. AstraZeneca will make an upfront payment of $600M to Dizal together with additional payments of up to $900M upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. This transaction does not impact AstraZeneca's financial guidance for 2026.

AstraZeneca Completes Exclusive License Agreement with Dizal for Zegfrovy

AstraZeneca announced the successful completion of the previously announced exclusive license agreement with Dizal Pharmaceutical for Zegfrovy, an oral irreversible epidermal growth factor receptor, EGFR, inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialise Zegfrovy. Zegfrovy is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8% underscoring the unmet need for new treatment options. Zegfrovy is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication.

AstraZeneca and HUTCHMED's Orpathys Shows Significant Survival Improvement in NSCLC Phase III Trial

Positive high-level results from the SANOVO Phase III trial showed Tagrisso plus Orpathys demonstrated a statistically significant meaningful improvement in progression-free survival, PFS, versus Tagrisso alone in treatment-naive patients with epidermal growth factor receptor-mutated locally advanced or metastatic non-small cell lung cancer, NSCLC, and MET overexpression. The PFS benefit was demonstrated in both the high MET and the intention-to-treat trial populations. In both patient populations, the combination also demonstrated very encouraging clinical benefit in overall survival, a secondary endpoint of the trial. The trial will continue to follow up on these results. Orpathys is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.