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February 22 2023, Shanghai—Abbisko Therapeutics Co., Ltd. (“Abbisko” hereafter) today announced that ABSK121, a next-generation small molecule FGFR inhibitor overcoming FGFR resistance mutations, has obtained clinical trial approval from the National Medical Products Administration (“NMPA”) of the People’s Republic of China, and will soon launch the Phase I clinical trial for the treatment of patients with advanced solid tumors in China. This marks another major developmental milestone for this program, which was also granted IND approval from US FDA recently. ABSK121 is a small molecule FGFR inhibitor that was discovered and developed by Abbisko to address both primary FGFR2 and FGFR3 oncogenic alterations and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cholangio, bladder and many other types of cancers. In preclinical studies, ABSK121 demonstrated superior potency and broadest coverage across a wide range of clinically relevant mutations that drive primary disease and acquired resistance.
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