China approves drug to cure Alzheimer's; to go on sale from next month

Beijing: In a major breakthrough, China has approved a home-grown drug to cure Alzheimer’s, the first in two decades, state media reported on Monday.

China’s National Medical Products Administration has approved the market launch of the drug, GV-971, last Saturday, state-run China Daily reported.

Patients will be able to buy the drug around China from December 29, and more production lines will gradually be put into operation to satisfy the market demand, according to Shanghai Green Valley Pharmaceutical, one of the drug’s developers.

The drug is 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, the report said.

Extracted from brown algae, the orally taken drug is the world’s first multi-targeting and carbohydrate-based drug for Alzheimer’s, the administration said.

It can treat mild to moderate forms of the disease and improve cognition, it said.

The first production line for the drug, which will meet the needs of two million patients, will begin running this week.

Alzheimer’s disease, an irreversible and progressive brain disorder that slowly destroys memory, thinking ability and the capability to carry out simple tasks, 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 highest in the world.

The Chinese Academy of Sciences’ Shanghai Institute of Materia Medica, which jointly developed the GV-971 with Green Valley and Ocean University of China after 22 years of research, 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 with SIMM.

“Addiction and serious toxicity of the therapy haven’t been identified in research so far,” she said.

Scientists said the drug functions mainly by rebalancing gut microbiota, reducing neuro-inflammation and reducing cognitive impairment. Some doctors from home and abroad, including David Holtzman, chairman of the American Neurological Association, said they believe GV-971 will provide a new medical solution for patients.

Preparations are being made for the drug’s clinical trials in the US and international multi-centre 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,” the Daily report quoted Lyu as saying.