China has approved its first home-based Alzheimer's treatment ̵
Oligomannate, which contains marine brown algae material, was given a conditional signal to treat mild to moderate Alzheimer's, China's National Medical Products Administration said Saturday.
In phase 3 clinical studies, it showed statistically significant cognitive improvements in patients with the disease of mild to moderate severity.
The drug is a result of many years of research from a Chinese team led by Geng Meiyu at the Chinese Institute of Science's Shanghai Institute of Materia Medica and Shanghai Green Valley Pharmaceuticals.
It is the first new treatment for the disease to gain government approval for more than a decade and a half.
Long ago, the team noticed that individuals who consumed high amounts of seaweed had lower rates of Alzheimer's, the most common type of dementia. This led to many years of experimentation that eventually resulted in the trials of Oligomannate, also called GV-971.
"I have been researching Alzheimer's disease for 50 years, participated in several global multicenter studies of multiple drugs, and have never found a satisfactory treatment for Alzheimer's disease," says Zhang Zhenxin, medical doctor and lead investigator of the trial and professor of neurology at Peking Union Medical College Hospital in Beijing. The outcome of the nine-month trial against Oligomannate is exciting. We finally see hope and dawn. I am genuinely happy for the patients and their families. "
The drug is expected to be available in China over the next two months," Green Valley said, adding that it will apply for marketing authorization in several countries after the China launch. Once on the market, it will conduct global clinical trials in the US, Europe and elsewhere in Asia, it says.
Unlike previous drugs that directly target the brain, Oligomannate aims to change the environment of the patient's gut – which in turn reduces inflammation of the brain.
The previous attempts, many of which failed, include billions of dollars spent on pharmaceutical giants, including Pfizer Inc.
Merck & Co.
and Johnson & Johnson
Several other Chinese companies are also working on Alzheimer's treatments. Jiangsu Lanfeng Biochemical Co.
002513, + 9.98%
and Zhejiang Jingxin Pharmaceutical Co.
002067, + 0.33%
– both listed on the Shenzhen Stock Exchange – so the stock prices rose a maximum of 10% on Monday. Green Valley is currently unlisted.
Allergan & # 39; s 2003
AGN, + 0.69%
Forest Labs was the last company to successfully develop an Alzheimer's drug called Namenda, but the company faced an antitrust lawsuit as it forced patients to switch to an extended form of release of the drug. Other companies have faced their own problems – either regulatory barriers, price overruns or poor therapeutic results.
"This is the first new treatment for Alzheimer's disease that has been approved in many years, and we applaud this innovation," said Jeffrey Cummings, deputy head of research at the Department of Brain Health at the University of Nevada, Las Vegas. (Cummings is also the founder of the Center for Neurodegeneration and Translational Neuroscience at the Cleveland Clinic and a Green Valley scientific advisor.)
However, the drug will face continuous scrutiny. China's green light represents only conditional approval, and ongoing studies are required to ensure that regulators are fully satisfied with the substance's safety and efficacy.
Dementia affects around 50 million people globally, and Alzheimer's accounts for two-thirds of cases, according to the United States-based Alzheimer's Association. The financial burden is estimated at more than $ 600 billion per year.
Tanner Brown is a contributor to MarketWatch and Barrons and producer of the Caixin-Sinica Business Brief podcast.