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An announcement from Genfleet Therapeutics (Shanghai), Inc. Class H ( (HK:2595) ) is now available.
GenFleet announced that its oral KRAS G12D (ON/OFF) inhibitor GFH375 has received a second Breakthrough Therapy Designation in China, this time as the first KRAS G12D inhibitor monotherapy recognized for treating KRAS G12D-mutant metastatic pancreatic cancer after at least one prior systemic therapy. This follows an earlier Chinese Breakthrough Therapy Designation for non-small cell lung cancer and complements U.S. FDA Fast Track status for the partnered asset VS-7375, underscoring GFH375’s potential to reshape treatment of KRAS G12D-driven tumors.
GFH375 has entered the world’s first phase III registrational trial of an oral KRAS G12D inhibitor monotherapy, being run across about 40 sites in China, with supporting phase I/II data already featured as late-breaking abstracts and oral presentations at major oncology meetings. Against the backdrop of poor outcomes and high KRAS mutation rates in pancreatic cancer, the new designation and advancing global development with Verastem enhance GenFleet’s clinical and regulatory momentum, strengthen its positioning in precision oncology, and signal potential new options ahead for patients with KRAS G12D-mutant disease.
More about Genfleet Therapeutics (Shanghai), Inc. Class H
GenFleet Therapeutics (Shanghai) Inc. is a China-based biopharmaceutical company focused on developing innovative targeted oncology therapies, including selective and pan-RAS inhibitors and a bispecific antibody for cancer cachexia. The company collaborates with global partners such as Verastem Oncology and is building a pipeline aimed at hard-to-treat solid tumors, with a particular emphasis on pancreatic cancer driven by RAS/MAPK pathway mutations.
Average Trading Volume: 1,953,710
Technical Sentiment Signal: Strong Buy
Current Market Cap: HK$13.52B
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