25 October 2022, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that its CSF-1R inhibitor ABSK021 has been approved by the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration of the People’s Republic of China (“NMPA”) for a randomized, double-blind, placebo-controlled and multicenter Phase III clinical study in patients with tenosynovial giant cell tumor (“TGCT”). ABSK021 is the first small molecule inhibitor approved for Phase III clinical trial among all drug candidates in the Company’s pipeline, and the first highly selective CSF-1R inhibitor developed by a Chinese company that has entered Phase III clinical trial.

ABSK021 is a novel, orally available, highly selective and highly potent small molecule CSF-1R inhibitor that is independently developed by Abbisko Therapeutics. In July 2022, ABSK021 was granted the breakthrough therapy designation by the CDE of NMPA for the treatment of TGCT that is not amenable to surgery. A number of studies have shown that blocking the CSF-1/CSF-1R signaling pathway could effectively modulate and change macrophage functions, and potentially treat many macrophage-dependent human diseases.

Abbisko Therapeutics has completed a Phase Ia dose escalation study for ABSK021 in the U.S., and has a Phase Ib multi-cohort expansion  trial ongoing in both the U.S. and China. In addition to TGCT indication, Abbisko Therapeutics is actively exploring the potential of ABSK021 in treating many types of solid tumors in clinic, and has collaborated with Sperogenix (Shanghai) MedTech Co., Ltd. in exploring its potential for treating amyotrophic lateral sclerosis and other central nervous system diseases. As of the date of this press release, no highly selective CSF-1R inhibitor has been approved in China.

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