In November 2019, Shanghai Green Valley Pharmaceuticals received approval from China’s National Medical Products Administration (NMPA) for Oligomannate as a new oral treatment for mild to moderate Alzheimer's disease (AD). The decision followed the results of a Phase III clinical trial enrolling 818 participants in China. Oligomannate was found to be safe, well tolerated and showed a statistical significant improvement in cognitive function in people with mild to moderate AD compared to placebo. The new drug called Oligomannate or GV-971 is derived from marine brown algae, a seaweed, and works by restoring balance to the gut microbiota.
On 8 April, the company has received approval from the Food and Drug Administration (FDA) to start a Phase III clinical trial with Oligomannate in the US with more than 2,000 people with mild to moderate AD. The randomised and placebo trial will be conducted for a year and will be followed by six months of open study when all the participants will receive the drug. The company expects to complete the Phase III trial in 2024.