GenFleet Therapeutics

GenFleet is a globally oriented biotech company focused on innovative drug development, targeting unmet clinical needs in oncology and immunological diseases. Centered on disease biology mechanisms and translational medicine, GenFleet has established an independent and integrated R&D system to tackle innovative targets and indications that lack clinical validation, with global intellectual property rights. Since its founding in 2017, GenFleet has built a pipeline comprising multiple self-developed "global new" large and small molecule projects. Several products have entered global multicenter clinical trials in China, Europe, and the United States, including multiple late-stage or pivotal clinical studies. Dabot® (GFH925, Fuzoradenib) is the first domestically launched product in GenFleet’s pipeline and also the first KRAS G12C inhibitor approved in China and the third globally. It received priority review from the National Medical Products Administration (NMPA) and two Breakthrough Therapy designations. The first-line combination therapy of Fuzoradenib and Cetuximab has entered Phase II research in Europe, marking the world’s first first-line treatment regimen combining KRAS and EGFR inhibitors for non-small cell lung cancer. Currently, the company has formed an integrated and deepened matrix for RAS-targeted therapies and is actively expanding its pipeline into other "global new" targeted drugs and novel therapeutic modalities. Meanwhile, GenFleet has been continuously strengthening its commercial collaboration network in recent years, reaching strategic licensing agreements with multiple listed companies inside and outside China, as well as initiating "global new" clinical collaborations, achieving significant progress.