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.
Genezen agrees manufacturing collaboration with Galibra Neuroscience
Viking Therapeutics launches Phase 3 clinical programme for oral VK2735 in obesity
Coya Therapeutics plans open-label extension of COYA 302 ALS trial
Takeda reports positive Phase 2/3 results for investigational immunodeficiency therapy
Galderma to acquire ZO Skin Health for USD1.5bn to expand skincare portfolio
Orexo reports encouraging initial bioavailability results for oral semaglutide formulation
Pharming reports positive Phase II results for leniolisib in genetic immune disorders
Telix to present 20 abstracts on cancer theranostics at EANM Congress
CelLBxHealth secures USD65,000 pharmaceutical research contract
FDA grants Breakthrough Therapy Designation to Legacy Healthcare's CINAINU (LH-8)
Racura Oncology receives approval for RC220 trial to proceed to higher dose
Blue Lake Biotechnology reports interim data from Phase 1/2a paediatric clinical trial of BLB201
ArkBio reports FDA clearance of IND application for AK0406
Enodia Therapeutics partners with Pfizer on Sec61-targeting drug development