GENFLEET-B Shares Surge Over 5% in Morning Session on Second Breakthrough Therapy Designation for GFH375

GENFLEET-B (02595) rose more than 5% during morning trading. At the time of writing, the stock was up 4.55% to HK$37.2, with a turnover of HK$5.53 million. The increase follows an announcement from GENFLEET that its oral KRAS G12D (ON/OFF) inhibitor GFH375 has been included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation of the National Medical Products Administration. The designation is for the monotherapy treatment of patients with KRAS G12D-mutated metastatic pancreatic cancer who have received at least one prior systemic therapy. This is the first KRAS G12D inhibitor monotherapy regimen in China to receive a BTD for pancreatic cancer. Previously, GFH375 became the first KRAS G12D inhibitor in China to be included in a BTD for non-small cell lung cancer. Overseas clinical research for GFH375/VS-7375 was initiated last year in the United States by GENFLEET's partner Verastem Oncology. VS-7375 has already received Fast Track Designation from the U.S. FDA for the treatment of first-line and subsequent-line KRAS G12D-mutated pancreatic ductal adenocarcinoma.