A homegrown drug that is the world's first innovative therapy for treating Alzheimer's disease in 17 years will be available to Chinese patients before the end of this year, its developers said on Sunday.
GV-971, the home-grown drug treating Alzheimer's disease. (Photo provided to China Daily)
China's National Medical Products Administration approved the market launch of the drug, GV-971, on Saturday, 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 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 2 million patients, will begin running this week. Patients will be able to buy the drug around the country from Dec 29, and more production lines will gradually be put into operation to satisfy market demand, according to Shanghai Green Valley Pharmaceutical, one of the drug's developers.
The Chinese Academy of Sciences' Shanghai Institute of Materia Medica, which jointly developed the drug 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.
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 most in the world. 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 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."