The Chinese pharmaceutical market sees another significant victory in recent weeks as it is announced that China has conditionally approved the first new Alzheimer’s drug to hit the global market in 17 years, and it will be distributed worldwide for long-term testing.
The seaweed-derived drug GV-971, more colloquially known as Oligomannate, appears to improve cognition in patients with mild to moderate Alzheimer’s disease, a form of dementia that accounts for around 70% of all dementia globally, according to the WHO. The NMPA initially approved the drug to market in November, with full approval to come in spring 2020, provided that certain animal safety study results are submitted by the Shanghai-based Green Valley Pharmaceutical Co., one of the drug’s co-developers.
New China drug registration laws in the wake of the 2018 re-formation of the CFDA have created a more homogeneous environment in which pharmaceutical companies can carry out their research, with the NMPA willing to assist those who are prepared to make ambitious and bold moves in the pursuit of new pharmaceuticals to aid a globally ageing population. It is, perhaps, for these reasons that scientists have developed Oligomannate, which operates in such a different fashion to current Alzheimer’s drugs on the market.
Rather than focus on acetylcholinesterase inhibitors, as an overwhelming majority of Alzheimer’s research has, researchers instead opted to study the gut, noting a decreased presence of Alzheimer’s disease in those who consumed seaweeds prominently in their diet. Vincent Mok, head of the Division of Neurology at the Chinese University of Hong Kong, told CNN that in relation to acetylcholinesterase inhibitors, the new method “is just as effective but it has fewer side effects. It will also open up new avenues for Alzheimer’s research, focusing on the gut microbiome.”
More than 1,100 Chinese patients suffering from mild to moderate Alzheimer’s disease took part in clinical trials, with the last test taking place over a treatment period of nine months, using 818 participants. The illness affects almost 10 million people in China – around one-fifth of global sufferers – and currently costs patients up to ¥130,000 ($18,700) per annum, as opposed to Oligomannate, estimated to cost around ¥43,000 ($6,200).
Green Valley has released a statement that reveals plans to invest a further $3bn over the next 10 years in order to fully understand its underlying working mechanisms, in addition to long-term safety, effectiveness and further global trials. A better understanding of mechanisms, Green Valley say, could theoretically lead to similar application of the drug in the fight against Parkinson’s disease and vascular dementia, two related neurological illnesses.
Meanwhile, Lu Songtao, chairman of the pharmaceutical company, went on to state that he welcomed any scepticism, and said: “It’s totally understandable for our drug to be questioned. We are confident because we see clear benefits from patients in the clinical trials.” With a strong economic investment backing these words, it may be that China will be the one to find the long-sought answer to Alzheimer’s disease.