News & Press

Abbisko Therapeutics obtained pivotal Phase III clinical trial approval for CSF-1R inhibitor ABSK021 from the CDE of NMPA

Oct 25,2022
By Abbisko
Back

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.


Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.


Tel:(+86) 021-68912098

E-Mail:Bd@abbisko.com
    PR@abbisko.com
    IR@abbisko.com

Copyright © 2021 All rights reserved:Abbisko Therapeautics     沪ICP备17056565号-1    PRIVACY POLICY