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  • GenFleet Overview
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Media
Press Release
  • GenFleet Therapeutics Announces First Patient Dosed in a Phase Ib/II Study of GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, Combined with Cetuximab or Chemotherapy (AG) for Advanced Solid Tumors including First-line Pancreatic Ductal Adenocarcinoma (PDAC)

    Phase Ib trial will be conducted at approximately 15 investigational sites including Beijing Cancer Hospital. The primary objectives of the overall study are to evaluate the safety/tolerability, efficacy and pharmacokinetic profile of GFH375 in combination with cetuximab or chemotherapy. In the phase II trial, the combination of GFH375 with chemotherapy (albumin-bound paclitaxel and gemcitabine, AG) will be administered to untreated patients with advanced PDAC, while the combination of GFH375 wi

    Oct 22, 2025
  • GenFleet Announces Promising Efficacy Data of GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, among Advanced PDAC Patients in a Late-breaking Oral Presentation at ESMO Congress 2025

    Among 59 heavily pretreated patients with advanced disease (nearly 70% in the third- or later-line setting) who had their first dose at least 4 months prior to data cut-off date and finished at least one post-treatment tumor assessment: the objective response rate was 40.7%; the disease control rate was 96.7%; the median progression-free survival (PFS) was 5.52 months and the 4-month OS rate was 92.2%.

    Oct 19, 2025
  • GenFleet Therapeutics Announces First Patient Dosed with GFH276, a Molecular Glue Pan RAS (ON) Inhibitor, in a Phase I/II Study Treating RAS-mutant Cancer Patients

    GFH276 is the third candidate in GenFleet’s RAS-targeted matrix to enter clinical research, following successful development of a marketed KRAS G12C inhibitor (fulzerasib) and a phase-II KRAS G12D inhibitor (GFH375).

    Sep 29, 2025
  • GenFleet Therapeutics (2595.HK) Completes Initial Public Offering on HKEX

    "Over the past eight years, we've built a powerful pipeline that includes the first China-developed KRAS inhibitor. Anchored by a leading-edge RAS-targeted matrix, the pipeline tackles critical unmet needs globally in cancers such as pancreatic, lung, and colorectal cancer. Riding the waves of innovation, we've kept moving forward and delivered novel therapeutics and solid out-licensing milestones, for the benefit of patients and the value creation of shareholders."

    Sep 19, 2025
  • GenFleet Therapeutics Announces Acceptance of Updated Efficacy and Safety Data of GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Advanced NSCLC Patients as Late-breaking Abstract for Mini Oral Presentation of IASLC 2025 World Conference on Lung Cancer

    The conference will take place in Barcelona, Spain from Sept. 6-9, with a mini oral presentation scheduled for Sept. 7 to highlight the efficacy and safety data of GFH375 in patients with advanced non-small cell lung cancer (NSCLC).

    Aug 14, 2025
  • GFH375 (Oral KRAS G12D Inhibitor) Granted with FDA Fast Track Designation for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

    Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Programs with FTD are eligible for more frequent interactions with FDA to discuss the candidate’s development plan, as well as a rolling review of NDA or BLA to facilitate Accelerated Approval and Priority Review if relevant criteria are met.

    Jul 25, 2025
  • Fulzerasib Granted with Second Approval: First China-developed KRAS G12C Inhibitor Launched in Macau, for Advanced NSCLC Treatment

    Fulzerasib was the first China-developed KRAS G12C inhibitor that had its NDA approved with Priority Review Designation in Aug 2024 by NMPA. Fulzerasib has also earned Class 1 recommendation in treatment for KRAS G12C-mutant NSCLC in the 2025 CSCO guidelines, offering patients a new option of targeted therapy with durable efficacy and good tolerability.

    Jul 09, 2025
  • GenFleet Therapeutics Announces Phase I Data from Clinical Study of GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, Treating KRAS G12D-mutant Advanced Solid Tumors in a Rapid Oral Presentation at 2025 ASCO Annual Meeting

    Among 49 patients orally administered at daily dosages of 400 or 600 mg: 43 patients who received at least one post-treatment tumor assessment achieved an objective response rate (ORR) of 42% and a disease control rate (DCR) of 91%; the ORR was 52% and DCR was 100% among 23 efficacy-evaluable PDAC patients, and the ORR was 42% and DCR was 83% among 12 efficacy-evaluable NSCLC patients.

    Jun 03, 2025
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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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