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Press Release
  • Promising Phase II Efficacy & Safety Data from KROCUS Study Indicate Potential of fulzerasib (KRAS G12C Inhibitor) in Combination with cetuximab as Next-generation First-line NSCLC Standard-or-care: GenFleet Therapeutics Announces Latest Findings in a Late-breaking Abstract at the Mini Oral Presentation of 2025 ELCC Annual Meeting

    The KROCUS study delivered impressive efficacy across all trial participants and particularly exceptional tumor response among brain-metastatic patients. Additionally, the regimen demonstrated better safety/tolerability over fulzerasib monotherapy in second-line and above NSCLC treatment;

    Mar 28, 2025
  • GenFleet Therapeutics Receives Clinical Trial Approval from China’s NMPA for GFS202A, a Bispecific Antibody Targeting GDF15 and IL-6, in a Phase I Study Treating Cancer Cachexia Patients

    Cachexia is highly prevalent in cancer, and it severely affects patients’ survival rate and tolerance to cancer treatments. Extensive research conducted worldwide has identified the key roles of GDF15 and IL-6 in the progression of cachexia. To date, no therapies targeting both GDF15 and IL-6 have been approved in the world, and GFS202A is the first China-developed GDF15-targeted therapy entering clinical stage.

    Mar 12, 2025
  • GenFleet Therapeutics Doses the First Patient in Phase II Trial of GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor

    This multi-center, open-label (~20 sites in China) trial enrolls patients with advanced G12D-mutant solid tumors, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC)—three cancer types with high prevalence of G12D mutations

    Feb 28, 2025
  • Updated Results from Phase II Registrational Study of Fulzerasib Monotherapy Orally Presented at the 2024 World Conference on Lung Cancer

    Fulzerasib (GFH925/IBI351) received approval in China on Aug. 21 for the treatment of adult patients with advanced NSCLC harboring KRAS G12C mutation who have received at least one systemic therapy. The first hospital prescription was issued on Aug. 31 and the medications were already shipped to chain pharmacies across the country.

    Sep 10, 2024
  • GenFleet Announces the First Approval of a KRAS G12C Inhibitor in China for Treatment of Advanced Non-small Cell Lung Cancer Patients Harboring KRAS G12C Mutation

    The NDA approval is based on the results from a single-arm registrational study (NCT05005234) intended to evaluate the efficacy and safety of fulzerasib monotherapy in advanced NSCLC patients with KRAS G12C mutation who failed or were intolerant to the standard treatment in China. The updated data from this registration study has been published in full manuscript in the Journal of Thoracic Oncology (JTO) and selected for oral presentation at the 2024 World Conference on Lung Cancer (WCLC) .

    Aug 24, 2024
  • GenFleet Therapeutics Finishes Dosing of the First Patient with GFH375, a KRAS G12D (ON/OFF) Inhibitor, in a Phase 1/2 Trial in China

    GFH375 was selected as Verastem’s lead discovery program from its collaboration with GenFleet established in 2023. GFH375/VS-7375 is an oral, potent and selective KRAS G12D dual inhibitor of ON (GTP) and OFF (GDP) states.

    Jul 12, 2024
  • GenFleet Receives IND Approval from China’s NMPA for GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, in a Phase I/II Clinical Trial Treating Advanced Solid Tumor Patients with KRAS G12D Mutation

    GFH375 is a highly potent and selective KRAS G12D inhibitor targeting both "ON" (GTP-bound) and "OFF" (GDP-bound) states of the protein. According to the latest preclinical findings posted at 2024 AACR annual meeting, GFH375 demonstrated preliminary safety data, favorable oral bioavailability and potent efficacy across preclinical models; moreover, GFH375 holds the potential for treating G12D-mutant cancers with brain metastases.

    Jun 19, 2024
  • GenFleet Therapeutics Announces Efficacy & Safety Result from Phase II Trial for First-line NSCLC Treatment in KROCUS Study, fulzerasib (KRAS G12C Inhibitor) in Combination with cetuximab, in a Late-breaking Abstract at the Oral Presentation of 2024 ASCO Annual Meeting

    The preliminary result of the trial was accepted as a late-breaking abstract and selected for oral presentation at the clinical science symposium of lung cancer treatment, highlighting the combination therapy's promising efficacy and its excellent safety/tolerability profile. Notably, this marks the first time that a KRAS G12C inhibitor is combined with an EGFR inhibitor as a first-line NSCLC treatment with its data presented at a global academic event.

    Jun 02, 2024
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GenFleet Therapeutics (Shanghai)

1206 Zhangjiang Road, Building A, Shanghai

021-6882 1388

201203

GenFleet Therapeutics (Zhejiang)

1 Yunhai Road, Building 3 (Southern Division), Level 4, Shaoxing City, Zhejiang Province

0575-8258 6890

312000

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