Tonghua Golden-Horse, UCB Seek China Approvals for Alzheimer’s, Myasthenia Gravis Drugs

China’s Tonghua Golden-Horse Pharmaceutical Industry Co. Ltd. and Belgium-based UCB (FRA: UNC) are seeking marketing approvals in China for two advanced treatments targeting neurodegenerative and autoimmune conditions, according to the Center for Drug Evaluation (CDE) website. Tonghua Golden-Horse’s octohydroaminoacridine succinate, designed to treat mild to moderate Alzheimer’s disease (AD), and UCB’s zilucoplan, aimed at systemic myasthenia gravis (gMG) with positive acetylcholine receptor (AChR) antibodies, are the latest contenders in these therapeutic areas.

Octohydroaminoacridine succinate, a proprietary small-molecule acetylcholinesterase inhibitor, boasts a dual inhibitory action on acetylcholinesterase and butyrylcholinesterase. In vitro studies suggest its potency surpasses that of conventional first-line therapies by several fold, promising enhanced clinical outcomes. Phase I and II trials have validated its efficacy and demonstrated a favorable safety profile.

Zilucoplan, on the other hand, is a novel C5 complement inhibitor that disrupts the terminal complement pathway and the formation of membrane attack complexes (MAC). This daily, self-administered therapy was approved in the U.S. in October 2023 for treating AChR antibody-positive gMG, offering a targeted approach for adult patients.- Flcube.com

Fineline Info & Tech