HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Gastric Cancer

HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN) and approved in China on July 12, is to be awarded breakthrough therapy designation (BTD) in China. The BTD status is specifically for savolitinib’s use as a third-line treatment for locally advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction with MET gene amplification.

Orpathys: A Pioneering MET Inhibitor in China
Orpathys marks HutchMed’s third product to enter the market and is China’s first mesenchymal-epithelial transformation factor (MET) inhibitor approved for the treatment of non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations in patients who have progressed after chemotherapy or are unsuited to systemic therapy. The drug’s entry into the National Reimbursement Drug List (NRDL) earlier this year, secured through price negotiations, underscores its significance in addressing unmet medical needs in China.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry