GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies, is dedicated to serving significant global unmet medical needs in oncology and immunology. Based on the deep understanding of disease biology and translational medicine, GenFleet’s proprietary and fully integrated R&D platform highlights multiple cutting-edge products with novel mechanisms and global IP.
Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 10 programs, many of which have entered later-stage or pivotal clinical trials across China (including Taiwan), the United States, Europe and Australia. Dupert® (fulzerasib) is the first approved KRAS G12C inhibitor in China and the third globally; it also received NDA priority review designation and two breakthrough therapy designations in 2023. Additionally, the first-line combination therapy of fulzerasib and cetuximab has progressed into phase II study in Europe, marking the world's first treatment integrating KRAS and EGFR inhibitors for first-line non-small cell lung cancer.
With accomplished capabilities in developing RAS-pathway targeted therapies, GenFleet's also vigorously pursuing the development of other innovative therapies and novel modalities. Furthermore, it's expanding commercial collaborative network through strategic out-licensing agreements or clinical cooperations with prestigious listed companies including Innovent, Verastem, SELLAS and Merck, BeiGene. GenFleet is expected to progress additional programs into the clinic, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years.
In an era of unprecedented innovation, the boom of innovative drug development will not only revolutionize the blueprint of the pharmaceutical industry at large, but also transform the health management plan of each individual in future. Adhering to the R&D of original products with global intellectual property rights, GenFleet strives to provide patients with accessible first-in-class therapies and to step further with the mission of delivering valuable healthcare solutions.
Robust R&D engine powered by cutting-edge innovation
From small molecules to a variety of advanced therapies, GenFleet's first-in-class pipeline always highlights the exploration of targets and indications without proof of concept while integrating a diversified portfolio of R&D models on the company's grand platform. Powered by scientific expertise and efficient execution, GenFleet aims to shape up a robust engine of novel drug development and a balanced matrix of industry-leading products.
Researching into latest mechanisms of onco-immunology
Since our establishment, GenFleet has always been inspired by the great expectations of immunotherapies treating refractory and terminal diseases. Addressing huge unmet medical needs, we focus our endeavor on the development of ground-breaking therapies targeting cancers and autoimmune diseases. On the basis of disease biology and translational medicine, we spare no efforts to build a grand R&D platform researching into latest biological mechanism of cancer pathways, tumor microenvironment and human immunoregulation. We look forward to uncovering the secrets of our immune system and exploring more original targets in the adventure of drug development.
Eco-friendly sites within high-tech parks of Yangtze Delta region
Headquartered in Shanghai's Zhangjiang Science City, GenFleet establishes its R&D center of over 4000 square meters in 3 office buildings. Introducing green chemistry guidelines, we execute laboratory practices and handle waste discharge strictly in accordance with industrial standards to fulfill our environmental responsibilities. In a technology-driven and environmentally-friendly fashion, GenFleet will join efforts with other enterprises to create an innovation hub prospering in Zhangjiang, Shanghai. Founded in 2018, GenFleet's branch in Zhejiang Province of the Yangtze River Delta region includes a laboratory area of over 1,000 square meters encompassing 7 R&D and pilot-scale production modules. Besides, its CMC site extends across a site of above 33,000 square meters where local authorities already conducted inspection and certification of GenFleet's manufacturing facilities in conformity with national policies of environmental protection and fire prevention. The branch will vigorously formulate energy management principles, improve internal risk assessment and upgrade waste discharge system to perform corporate responsibility of energy conservation and emission reduction. Encouraged by fast economic growth of the Yangtze River Delta, GenFleet will relentlessly enhance its R&D platform and gradually unravel its long-term plans of commercialization.
