Orpathys approved in China for lung cancer and MET gene alterations

Orpathys (savolitinib) has been granted conditional approval in China for the treatment of patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.

This approval follows a priority review designation by China’s National Medical Products Administration (NMPA) and marks the first regulatory approval globally for this oral, potent and selective MET tyrosine kinase inhibitor (TKI).

In 2011, Anglo-Swedish pharma major AstraZeneca (LSE: AZN) and China’s Hutchmed (Nasdaq: HCM), formerly known as Hutchison China MediTech, entered a global licensing agreement to jointly develop and commercialize Orpathys. Hutchmed is responsible for the manufacturing and supply of the drug, and AstraZeneca for its commercialization in China and worldwide. Sales of Orpathys will be recognized by AstraZeneca.