News & Press
Abbisko Therapeutics Obtained ABSK091 IND Approval from NMPA
December 14, 2020, Shanghai—Abbisko Therapeutics Co., Ltd. (“Abbisko” hereafter) today announces that it has obtained IND approval of ABSK091 (AZD4547), a FGFR inhibitor by National Medical Products Administration (NMPA) of China, and will initiate a phase Ib/II clinical study.
ABSK091 is a potent, orally available small molecule FGFR inhibitor with high selectivity. ABSK091 has been tested in multiple clinical studies in the United States and Europe to evaluate the safety and preliminary efficacy in patients of many tumor types. Accumulated data have demonstrated that ABSK091 was well tolerated and efficacious in patients, with clinical Proof-of-Concept achieved in Urothelial carcinoma and other cancers harboring FGFR alterations. In November 2019, Abbisko entered into a licensing agreement with AstraZeneca and obtained global rights for development, manufacture and commercialization of ABSK091.