HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that the China National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for its Orpathys (savolitinib). The Chinese company is seeking approval for its MET tyrosine kinase inhibitor (TKI), when combined with Tagrisso (osimertinib), to treat patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET amplification who have experienced disease progression on first-line EGFR inhibitor therapy.
Savolitinib: A Selective MET Inhibitor
Savolitinib was approved in China with conditions for the treatment of locally advanced or metastatic NSCLC with MET exon 14 skipping alterations in June 2021, marking it as the first selective MET inhibitor in the country. This milestone was achieved through a partnership between HutchMed and UK pharmaceutical major AstraZeneca, which began in 2011 to co-develop the drug and enhance its commercialization.
Tagrisso: A Third-Generation EGFR TKI
Tagrisso is a third-generation, irreversible EGFR TKI with confirmed clinical activity in NSCLC patients, including those with central nervous system metastasis. The acceptance of the NDA for priority review also triggers a milestone payment from AstraZeneca to HutchMed, highlighting the significance of this development in the collaboration.-Fineline Info & Tech
