China’s Hotgen Biotech Co., Ltd (SHA: 688068) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb) AA001. The drug is intended for the treatment of mild cognitive impairment caused by Alzheimer’s disease (AD) and mild to moderate AD. This approval marks a significant step forward in the development of novel treatments for Alzheimer’s disease.
Innovative Treatment Strategy
Research has identified that the excessive loss of neural synapses mediated by antibody drugs is a key factor in the failure of immunotherapy for Alzheimer’s disease. Hotgen Biotech proposes a new strategy involving the use of ineffective response fragments (Fc segments) or non-functional β-amyloid protein (Aβ) antibodies. This approach aims to improve the efficacy of antibody drugs while reducing toxic side effects. AA001, developed based on this strategy, is a novel anti-AD candidate drug.
Future Development and Clinical Trials
With the NMPA’s approval, Hotgen Biotech is poised to initiate clinical trials for AA001. These trials will provide valuable insights into the drug’s safety and efficacy in treating Alzheimer’s disease. The development of AA001 underscores Hotgen’s commitment to advancing innovative therapies for neurodegenerative diseases.-Fineline Info & Tech
