Chentide Pharmaceuticals and AstraZeneca's Lung Cancer Drug Zorifertinib Approved in China for EGFR-Mutated NSCLC with CNS Metastases
Alpha Biopharma
Innovative Drug Developer
AstraZeneca
Pharmaceutical Technology Research and Development Provider
On November 20, the official website of the National Medical Products Administration showed,Alpha Biopharma and AstraZeneca’s Collaboratively Developed EGFR Inhibitor Zorifertinib (AZD3759) Approved for Marketing, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and are accompanied by central nervous system (CNS) metastases, as a first-line treatment.
Zorifertinib is an effective, orally administered, reversible inhibitor of tyrosine kinase activity associated with epidermal growth factor receptor activating mutations (L858R and Exon 19Del) (EGFR-TKI).Specifically designed for the treatment of patients with advanced non-small cell lung cancer and central nervous system metastases. Preclinical and early clinical data show that zoritini has a blood-brain barrier penetration rate of up to 100%.
The approval of Zorifertinib is mainly based on the positive results of the Phase II/III EVEREST study. This study is a randomized, open-label, international multicenter Phase II/III clinical trial (n=492), and it is also the world's only large-scale prospective international multicenter clinical trial targeting patients with EGFR mutation-positive non-small cell lung cancer and central nervous system metastases to date.
In January 2018, Alpha Biopharma entered into a cooperation agreement with AstraZeneca to advance the Phase II and III clinical development of the product.
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