Hehuang Pharmaceutical (00013) announced that the marketing application for savolitinib (savolitinib) for the treatment of gastric cancer patients with MET amplification in China has been accepted and included in priority review

Zhitong Finance App News, Hehuang Pharmaceutical (00013) announced that the marketing application for savolitinib (savolitinib) for adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma who failed to amplify the MET gene after at least 2 treatments has been accepted by China's State Drug Administration and included in priority review.

The marketing application for the new drug is based on data from a single-arm, multi-center, open-label phase II registration study of sevotinib in the treatment of gastric cancer patients with MET amplification conducted in China. The study reached the primary endpoint of objective response rate (ORR) assessed according to RECIST 1.1. Additional details of the study can be found on clinicaltrials.gov and search registration number NCT04923932.

Sevotinib was listed by the State Drug Administration as a breakthrough treatment for this potential indication in 2023. The State Drug Administration included this innovative therapy as a breakthrough treatment and approved it as a new treatment for serious diseases. Clinical evidence shows clear advantages over existing treatment methods.