Abbisko Therapeutics Completed Dosing of First Patient for Its First-in-Class Highly Selective FGFR2/3 Inhibitor ABSK061

Abbisko Therapeutics Co., Ltd today announced completion of dosing of the first patient in the Phase 1 clinical trial in advanced solid tumors for ABSK061, which becomes the first highly selective FGFR2/3 inhibitor advanced into clinical stage globally. The clinical trial is a First-in-Human Phase 1 study of ABSK061 to assess the safety, tolerability, pharmacokinetics in patients with advanced solid tumors, and to determine the Recommended Phase 2 Dose (RP2D) and evaluate preliminary anti-tumor activities. The trial is currently being conducted in both China and US. ABSK061 is a next-generation, orally available, highly potent and selective small molecule FGFR2/3 inhibitor independently discovered and developed by Abbisko Therapeutics with global intellectual property rights. Several first-generation pan-FGFR inhibitors have demonstrated clinical efficacy in multiple types of tumor carrying FGFR2/3 alterations and have been approved globally, including China and US. Their therapeutic window and efficacy, however, 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. In addition to oncology indications, ABSK061 also has great potential to expand its use in non-oncology indications, such as achondroplasia. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd., a subsidiary of Abbisko Cayman Limited (HKEX Stock Code: 2256.HK), is biopharmaceutical company dedicated to discovering and developing innovative medicines in China and around the world. The company was established by a group of seasoned drug hunters with rich R&D and managerial expertise from top multinational pharmaceutical companies, who have participated in the R&D of a number of new drugs for clinical and marketing purpose. Abbisko Therapeutics focuses on the research and development of new oncology drugs, with the core of small molecule precision therapy and small molecule tumor immunotherapy drugs. In response to the needs of patients and the pharmaceutical market, it has been committed to developing potential first-in-class or best-in-class innovative drugs for novel and high potential drug targets by adhering to the concept and standard of international new drug development to improve the quality of life of patients in China and globally. Since its founding in 2016, Abbisko Therapeutics has built up an extensive pipeline of 14 innovative small molecule programs focused on precision oncology and immuno-oncology, including six clinical stage assets and eight pre-clinical stage assets. As of date of press release, Abbisko Therapeutics has received 13 IND or clinical trial approvals in four countries and regions.

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