News & Press

Abbisko Therapeutics Has Obtained IND Approval for ABSK061, an Innovative and Highly Selective FGFR2/3 Inhibitor, from the NMPA

Mar 03,2022
By Abbisko

3 March 2022, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that ABSK061, a self-developed, orally available, highly selective FGFR2/3 inhibitor, has obtained clinical trial approval from the National Medical Products Administration of the People’s Republic of China (NMPA), and will soon launch the Phase I clinical trial in humans for the treatment of patients with advanced solid tumors. ABSK061 has also become the first selective, small-molecule FGFR2/3 inhibitor approved by the FDA and the NMPA for clinical trial worldwide.

ABSK061 is a next-generation, orally available, highly potent and highly selective small molecule FGFR2/3 inhibitor independently developed by Abbisko Therapeutics with global intellectual property rights. The first-generation pan-FGFR inhibitors have demonstrated clinical efficacy in multiple tumors carrying FGFR2/3 variants and are progressively approved for marketing globally. However, the therapeutic window and efficacy are limited by the side effects associated with FGFR1 inhibition. With reduced FGFR1 activity while maintaining strong potency against FGFR2/3, ABSK061 is expected to achieve improved therapeutic window and clinical efficacy as a second-generation FGFR inhibitor and gradually replace the first-generation pan-FGFR inhibitor. In addition to oncology, ABSK061 also has great potential in a variety of non-oncology indications, such as achondroplasia.

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