Alzheimer's disease is an irreversible, progressive brain disorder that destroys memory and thinking skills over time, and eventually, the ability to carry out the simplest tasks. In most people with Alzheimer's, symptom affects at least 50 million people worldwide, and the number is expected to increase as populations age. China has roughly 10 million people with Alzheimer's, the most in the world.
Shanghai Green Valley Pharmaceuticals (Green Valley) today announced that China's National Medical Products Administration (NMPA) has approved Oligomannate (GV-971) as new drug for the treatment of "mild to moderate Alzheimer's disease (AD) and improving cognitive function."
The drug, regarded as the world's first innovative therapy the disease in 17 years, will be available to Chinese patients before the end of this year, its developers announced.
China's Medical regulator approved the market launch of the drug, making it the only Alzheimer's medicine out of more than 320 developed by pharmaceutical companies around the globe to survive clinical trials, despite the investment of hundreds of billions of US dollars over the past two decades.
Extracted from brown algae, the orally taken drug is the world's first multi-targeting and carbohydrate-based drug for Alzheimer's. The first production line for the drug, which will meet the needs of 2 million patients, will begin running this week.
Alzheimer's patients will be able to buy the drug around the country from Dec 29, and more production lines will gradually be put into place for market demand, according to Shanghai Green Valley Pharmaceutical, one of the drug's developers.
One of the drug developers said there were previously five medicines with limited efficacy used to treat the disease, which was discovered a century ago.
A phase III clinical trial of the drug involving 818 patients completed in July last year had "proven to continuously and effectively improve cognition among mild to moderate Alzheimer's disease sufferers over a period of nine months," said Geng Meiyu, lead researcher on the drug and a researcher.
"Addiction and serious toxicity of the therapy haven't been identified in research so far," she said.
Preparations are being made for the drug's clinical trials in the United States and international multi-center research, its developers said, with initial communication with the US Food and Drug Administration already completed.
"Green Valley has established a professional team and hired world-renowned experts in this field as consultants in preparation for initiating clinical trials in the US," said Lyu Songtao, the company's chairman. "We don't exclude the possibility of collaborating with international research institutions to perform clinical trials in the US."
