Alzheimer's breakthrough drug hits the shelves

A widely-anticipated Alzheimer's disease drug hit pharmacy shelves on Sunday as the drug was launched in Beijing.

Home-grown GV-971, the first Alzheimer's disease treatment to be approved for 17 years, is now available in DTP (direct-to-patient) pharmacies across the country.

One box of 42 capsules is priced at 895 yuan (US$130). A prescription is needed to make the purchase.

Seaweed-based GV-971, has been seen to improve cognitive ability in people suffering from mild-to-moderate Alzheimer’s by regulating bacteria in the gut.

In November, the National Medical Products Administration approved sales of the drug, but further research of its pharmacological mechanism, monitoring of long-term safety and effectiveness is still required.

The drug was developed by the Ocean University of China, Shanghai Green Valley Pharmaceutical Company and  Chinese Academy of Sciences Shanghai Institute of Materia Medica.

In an earlier interview, Lu Songtao, chairman of Green Valley, said that it is initially expected to benefit 500,000 patients a year. As production expands, 2 million patients will be able to use the drug each year.

Green Valley claim that the clinical trials involving 1,200 Chinese patients showed an effectiveness of GV-971 around 78 percent.

Third-phase clinical trials, led by Peking Union Medical College Hospital and Shanghai Mental Health Center, were carried out in 34 hospitals and provided solid evidence of the efficacy and safety of the drug.

Green Valley plans to invest a further US$3 billion in research to promote the drug globally.

One of the research teams will be led by Jeffrey Cummings, winner of the Lifetime Achievement Award by the American Alzheimer’s Association, and will conduct third-phase clinical trials on over 2,000 patients in more than 200 trial centers in North America, the EU, East Asia and the Asia-Pacific. The trials are expected to be completed by 2024.

Green Valley plans to complete global registration of the drug by 2025.

Currently, there are about 50 million Alzheimer’s sufferers in the world, expected to rise to 150 million by 2050, according to the World Alzheimer Report 2018. In China, 10 million people live with Alzheimer’s, nearly 20 percent of the world total. The number could reach 40 million by 2050.

Alzheimer's disease is the third biggest health risks for the elderly, following cardiovascular disease and cancer. It costs each patient over 130,000 yuan a year, according to a report by neurologist Jia Jianping and his team from Xuanwu Hospital of the Capital Medical University.

Alzheimer's was discovered about a century ago. Prior to the approval of GV-971, only five treatments have been allowed onto the market. While reducing some of the symptoms of the condition, none of them have been able to prevent progress of the disease.

Over the last two decades, pharmaceutical companies worldwide have spent hundreds of billions in the search for new treatments, with more than 320 drugs failing clinical trials.

In Alzheimer’s patients, excessive amyloid β proteins clump together to form plaques and tangles which impair brain function. Scientists have been dedicated to finding ways to eliminate the toxic proteins, mainly by targeting the brain.

Geng Meiyu from the Shanghai Institute of Materia Medica took an unconventional approach, based on the findings that poor gut health has close connection with Alzheimer’s. She has led the research on GV-971 since1997.