The world’s first new drug for the treatment of Alzheimer’s disease in nearly two decades – and perhaps the only treatment with the potential to reverse the condition was approved by the Chinese government. The National Medical Products Administration said the drug, Oligomannate, had been approved for the treatment of “mild to moderate Alzheimer’s disease and improving cognitive function”.
In preclinical studies, the drug demonstrated the ability to block the abnormal rise in intestinal flora metabolites, regulate peripheral and central inflammation, decrease deposition of amyloid protein and tau hyperphosphorylation and improve cognitive function. Green Valley plans to launch the drug in China by the end of the year. Early next year, the company intends to conduct a global Phase III clinical trial in the US, Europe and Asia to support regulatory submissions worldwide.
Over the past two decades pharmaceutical companies have invested hundreds of billions of US dollars and brought more than 320 candidate drugs to clinical trial. Only five were approved for clinical use to relieve symptoms, and none could stop the brain cells from withering away. Due to repeated costly failures, Alzheimer’s-related programmes have been terminated in many large medical companies. A major challenge for the Chinese research team was to explain the mechanism, with authorities reluctant to approve a new drug unless researchers could explain exactly why it worked. There were many theories on the causes of Alzheimer’s, but none seemed to apply to the drug.