China’s National Medical Products Administration granted conditional approval to the drug Oligomannate (GV-971), the regulator said in a statement on its website.
Shanghai Green Valley Pharmaceuticals said in a separate statement the drug received the regulator’s approval for treatment of “mild to moderate Alzheimer’s disease and improving cognitive function,” following a Phase 3 clinical trial in China.
“Trial results demonstrated that Oligomannate statistically improve cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit,” the company said.
It said it expects the drug to be available in China by early 2020 and plans to apply for marketing authorization in “selected countries following the China launch.” It plans a multi-center global Phase 3 clinical trial with sites in the U.S., Europe and Asia starting early next year to support those filings.
Numerous drugmakers have tried and failed to develop medicines to arrest the memory-destroying disease. Biogen Inc. abandoned a major trial of an Alzheimer’s drug in March, but said Oct. 22 it will ask U.S. regulators to approve an experimental therapy after a new analysis of data from two failed trials showed promising results.
The drug is a low molecular acid oligosaccharide compound extracted from marine brown algae, according to the Chinese regulator’s statement. The regulator said it requires further studies on the drug’s pharmacology, safety and effectiveness after it’s launched to the market.
Professor Geng Meiyu at the Chinese Academy of Sciences Shanghai Institute of Materia Medica is the drug’s lead inventor, the company said.