News & Press

Abbisko Therapeutics Announces Receiving of the IND Approval by the China NMPA for ABSK-011, A Novel FGFR4 Inhibitor

Mar 09,2020
By Abbisko

March 9, 2020, Shanghai – Abbisko Therapeutics, a clinical-stage biopharmaceutical company, today announces that it has received the regulatory approval by the National Medical Products Administration (NMPA) of China to initiate its phase 1 trial for ABSK-011, a novel FGFR4 inhibitor in advanced solid tumors.

ABSK-011 is independently discovered and developed by Abbisko Therapeutics with full intellectual property rights worldwide. It is an orally administrated, highly potent, and selective small molecule inhibitor of FGFR4 with best-in-class drug-like properties. Through disruption of FGF19-FGFR4 pathway activities, ABSK-011 offers a potential novel therapeutic approach to treat cancers such liver cancers harboring aberrant FGFR4 pathway alterations. Liver cancer in China accounts for ~50% of the global incidence with poor survival rate and limited treatment options, representing a major unmet clinical needs in the territory and around the world. To date, no FGFR4-targeted therapies have been approved worldwide.

ABSK-011 is the first program of Abbisko Therapeutics to be approved for clinical studies in China. In December 2019, Abbisko has also received the IND approval in Taiwan to conduct first-in-human studies of ABSK-011.

Founded in April 2016, Abbisko Therapeutics Co., Ltd. is a biopharmaceutical company dedicated to discovering and developing innovative therapeutics to treat cancer and other diseases with unmet medical needs. The founders and core team of Abbisko are industrial veterans with strong leadership and managerial experiences from top international pharmaceutical companies. Over three years, Abbisko has established a strong oncology pipeline with multiple programs entering the clinic.

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