HUTCHMED (China) Limited announced the first commercial sale in China of ORPATHYS® (savolitinib), HUTCHMED's oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase, which occurred on July 12, 2021. This follows less than three weeks after the June 22, 2021approval of ORPATHYS® in China for the treatment of patients with locally advanced or metastatic 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. Under the terms of the license and collaboration agreement between HUTCHMED and AstraZeneca (“AstraZeneca”), a USD 25 million non-creditable and non-refundable milestone payment is triggered by the first commercial sales of ORPATHYS® in China.

HUTCHMED is responsible for the clinical development, marketing authorization, manufacturing and supply of ORPATHYS® in China, while AstraZeneca is responsible for its commercialization for which it will pay HUTCHMED fixed royalties of 30% based on all China sales. More than a third of the world's lung cancer patients are in China and, among those with NSCLC, approximately 2-3% have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene.1,2,3 This mutation is more common (13-22%) among patients with pulmonary sarcomatoid carcinoma (PSC), a rare and aggressive subtype of NSCLC usually resistant to chemotherapy. ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”) that has demonstrated clinical activity in advanced solid tumors.

It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification. ORPATHYS® is marketed in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.