GenFleet Therapeutics, a commercial-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced today that the fulzerasib, the first commercialized product in GenFleet’s pipeline, has been included in the 2025 National Reimbursement Drug List (NRDL) of China. This product was successfully included into the NRDL on its first negotiation attempt, for treatment of advanced non-small cell lung cancer (NSCLC) adult patients harboring KRAS G12C mutation who have received at least one systemic therapy. The updated list will take effect on January 1, 2026.
GenFleet and Innovent Biologics entered into a licensing collaboration for fulzerasib in 2021. Fulzerasib was approved in the Chinese mainland (2024) and China’s Macau (2025), positioning it as China’s first marketed KRAS G12C inhibitor and the third globally. Prior to its launch, fulzerasib monotherapy received breakthrough therapy designation for treating advanced NSCLC and advanced colorectal cancer treatment (CRC); fulzerasib was also granted with priority review designation for its new drug application by China’s National Medical Products Administration. Clinical data from its monotherapy study in advanced NSCLC were featured in late-breaking abstract and oral sessions at global conferences including AACR, ESMO Asia, and WCLC.
“We are pleased that fulzerasib, offering a novel treatment option for lung cancer patients harboring KRAS G12C mutation, has been included in China’s updated NRDL one year after its approval. The launch of fulzerasib builds on a six-year development program that has validated GenFleet’s integrated R&D system; the program also paves the way to establish our leading-edge RAS-targeted matrix, comprising selective and Pan RAS inhibitors of diverse modalities. Moving forward, we remain committed to delivering more accessible and affordable innovative therapies to benefit patients and their families worldwide.”stated Jiong Lan, Ph.D., Chief Executive Officer of GenFleet.
Beyond monotherapy, GenFleet commenced a European multicenter phase I/II trial in 2023 to evaluate fulzerasib in combination with cetuximab. Spearheaded by European lung cancer expert Professor Rafael Rosell, the study represents the world's first KRAS/EGFR dual-targeting regimen for front-line NSCLC treatment. The KROCUS study has demonstrated promising efficacy and better safety profile than late-line fulzerasib monotherapy, with the combo trial’s phase II data selected for late-breaking abstracts and oral sessions at prestigious academic conferences including ASCO and ELCC.
About Dupert® (fulzerasib, KRAS G12C Inhibitor)
Discovered by GenFleet Therapeutics, fulzerasib (GFH925/IBI351) is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.
In September 2021, GenFleet Therapeutics and Innovent entered into an exclusive license agreement for the development and commercialization of GFH925 in China (including the Chinese mainland, Hong Kong, Macau and Taiwan).
In January 2023, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for fulzerasib for the treatment of patients with advanced NSCLC harboring KRAS G12C mutation who have received at least one systemic therapy. In May 2023, the CDE of China’s NMPA granted another BTD for fulzerasib for the treatment of advanced CRC patients with KRAS G12C mutation who have received at least two systemic therapies. In August 2024, the CDE of NMPA has approved fulzerasib for the treatment of advanced NSCLC patients harboring KRAS G12C mutation who have received at least one systemic therapy.
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