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GenFleet Wins China Breakthrough Therapy Nod for KRAS G12D Lung Cancer Drug

Story Highlights
  • GenFleet’s KRAS G12D inhibitor GFH375 secured China’s Breakthrough Therapy Designation for previously treated NSCLC patients.
  • GFH375 advances globally with phase III pancreatic cancer trial and Verastem partnership, strengthening GenFleet’s oncology position.
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GenFleet Wins China Breakthrough Therapy Nod for KRAS G12D Lung Cancer Drug

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Genfleet Therapeutics (Shanghai), Inc. Class H ( (HK:2595) ) has provided an update.

GenFleet Therapeutics announced that its oral KRAS G12D (ON/OFF) inhibitor GFH375 has received Breakthrough Therapy Designation from China’s Center for Drug Evaluation for previously treated KRAS G12D-mutant non-small cell lung cancer patients. The designation is backed by phase I/II data showing best-in-class monotherapy efficacy and manageable safety, with preliminary results already highlighted at major international oncology conferences.

GFH375 is advancing rapidly in the global KRAS G12D inhibitor race, including the world’s first phase III trial of an oral KRAS G12D inhibitor in metastatic pancreatic cancer and multiple ongoing mono- and combination-therapy studies in China and overseas. Through its collaboration with Verastem Oncology, GenFleet retains China rights while Verastem holds ex-China development and commercialization rights, bolstering GFH375’s global development and reinforcing GenFleet’s position in precision oncology.

More about Genfleet Therapeutics (Shanghai), Inc. Class H

GenFleet Therapeutics (Shanghai) Inc. is a China-based biopharmaceutical company focused on developing targeted oncology therapies, particularly small-molecule inhibitors against RAS/MAPK pathway-driven cancers. Its portfolio includes the marketed KRAS G12C inhibitor fulzerasib and pipeline assets such as GFH375, aimed at addressing significant unmet needs in solid tumors with specific KRAS mutations.

Average Trading Volume: 762,445

Technical Sentiment Signal: Strong Sell

Current Market Cap: HK$10.15B

See more data about 2595 stock on TipRanks’ Stock Analysis page.

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