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Press Release
  • 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
  • GenFleet Therapeutics Announces FDA's Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

    It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer(NSCLC)patients with G12C mutation.

    Apr 19, 2024
  • GenFleet Announces Potent Anti-tumor Efficacy of GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, and its Potential in Combination Therapy with RAF/MEK Clamp at 2024 AACR Annual Meeting

    GFH375 is a highly potent and selective KRAS G12D inhibitor targeting both "ON" (GTP-bound) and "OFF" (GDP-bound) states of the protein. With preliminary safety data, favorable oral bioavailability and potent efficacy across preclinical models, GFH375 also holds the potential for treating KRAS G12D mutant cancers with brain metastases.

    Apr 10, 2024
  • GenFleet Announces Broad-spectrum Activity of GFH547, an Oral panRAS (ON) Inhibitor, and Its Potential to Overcome Resistance against SIIP-based KRAS Inhibitors in Late-breaking Research Abstract of 2024 AACR Annual Meeting

    GFH547 is developed with novel mechanism of action by reshaping and repurposing intracellular cyclophilin A (CypA) protein to target active RAS proteins across most wild/mutant subtypes. Preclinical data demonstrated profound panRAS inhibitory activity of GFH547 and it holds the potential to overcome adaptive and acquired resistance against SIIP (switch II pocket)-based KRAS inhibitors.

    Apr 10, 2024
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GenFleet Therapeutics (Shanghai)

1206 Zhangjiang Road, Building A, Shanghai

021-6882 1388

201203

GenFleet Therapeutics (Zhejiang)

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0575-8258 6890

312000

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