China approved his first domestic treatment for Alzheimer's is a new algae-based drug and the first breakthrough since 2003 in an area that has been frustrating scientists and pharmaceutical companies for decades.
According to the National Administration of Medical Products of China on Saturday, the oligomannate containing material from marine brown algae received conditional approval for the treatment of mild to moderate Alzheimer's disease.
In Phase 3 clinical trials, this showed statistically significant cognitive improvements in patients with mild to moderate disease.
The drug is the result years of research from a Chinese team led by Geng Meiu of the Shanghai Institute of Material Medicine at the Shanghai Academy of Sciences of China and Shanghai Green Valley pharmaceutical company.
This is the first new treatment for this disease that has received regulatory approval in more than a decade and a half.
A long time ago, the team noticed that people who consumed large amounts of seaweed had lower levels of Alzheimer's disease, the most common type of dementia. This led to years of experimentation that ultimately led to trials with oligomannate, also called GV-971.
“I have been researching Alzheimer's disease for 50 years, participating in numerous global multicenter studies of several drugs, and have never found a satisfactory treatment for Alzheimer's disease,” said Zhang Zhenxin, a doctor and chief research researcher and professor. neurology at the Beijing Medical College Hospital in Beijing. “The result of the nine-month trial of the Oligomannat is impressive. We finally see hope and dawn. I am sincerely 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 after launch in China it will be used to obtain marketing authorization in several countries. Having appeared on the market, he will conduct global clinical trials in the USA, Europe and other Asian countries.
Unlike previous drugs that directly affected the brain, Oligomannat seeks to change the patient’s intestinal environment, which in turn reduces inflammation in the brain.
Those previous attempts, many of which have failed, include billions of dollars spent by pharmaceutical giants, including Pfizer Inc.
Merck & Co.
and Johnson and Johnson
Several other Chinese companies are also working on Alzheimer's. Jiangsu Lanfeng Biochemical Company
and Zhejiang Jingxin Pharmaceutical Co.
Both shares are listed on the Shenzhen Stock Exchange. On Monday, their prices rose 10%. Green Valley is currently not listed.
In 2003, Allergan
Forest Labs was the last company to successfully develop a cure for Alzheimer's disease called Namenda, but the company faced an antitrust lawsuit when it forced patients to switch to a sustained release dosage form. Other companies are faced with their own problems – be it regulatory hurdles, overpricing or poor therapeutic results.
“This is the first new Alzheimer's disease cure approved over the years, and we welcome this innovation,” said Jeffrey Cummings, vice president of research for brain health at the University of Nevada, Las Vegas. (Cummings is also the founding director of the Center for Neurodegeneration and Translational Neuroscience at the Cleveland Clinic and a scientific consultant in Green Valley.)
However, the drug will undergo ongoing research. China's green light is only conditional approval, and ongoing research is needed to ensure that regulators are completely satisfied with the safety and efficacy of the drug.
According to the US-based Alzheimer's Association, dementia affects about 50 million people worldwide, with two-thirds of all cases of Alzheimer's. financial burden estimated at over 600 billion dollars a year.
Tanner Brown is a contributor to MarketWatch, Barron & # 39; s and producer of the Caixin-Sinica Business Brief podcast.
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