Ahead of Europe and the US, a Chinese pharmaceutical company has developed and approved a treatment for Alzheimer's that could help people with mild Alzheimer's regain cognitive function.
Last Saturday, China's state drug administration gave conditional approval to a product called Oligomannate from Shanghai Lvye Pharmaceutical Co.
The agency said it needed to continue studying the efficacy of the drug, and that approval could be withdrawn if safety issues arose.
美国制药公司Johnson & Johnson, Merck, Pfizer 和Eli Lilly最近相继因安全问题而放弃了治疗阿尔兹海默症的研发项目，而中国突破了这一问题。近20年来，美国已实施400个临床实验，花费上亿元美金，只为找到有效治疗阿尔兹海默症的药物。
Pharmaceutical companies in the United States called Johnson & Johnson, Merck and Pfizer and Eli Lilly have recently abandoned due to safety issues in the treatment of Alzheimer's research and development projects, and break through the problem in China.Over the past 20 years, the United States have implemented 400 clinical trials and spent hundreds of millions of dollars, only to find effective drugs for the treatment of Alzheimer's disease.
The new drug is the first approved treatment for a neurodegenerative disease in 17 years.Green valley noted that Oligomannate will be approved for sale in China in late 2019.After that, green valley will conduct phase iii clinical trials abroad by 2020, and hopes to gain approval to market the drug in the U.S. and Europe.
阿尔兹海默症症协会首席会长，Maria C. Carrillo博士在一份生命中回复《中国日报》：“我代表全球成千上万的阿尔兹海默症患者，阿尔兹海默症协会表示认可中国食品药物监督管理总局有条件批准以海藻为原料，用于治疗轻度至中度阿尔兹海默症的Oligomannate这一举措。
Dr. Maria C. Carrillo, chief of alzheimer's disease association, in a reply in the China Daily life: "On behalf of the world hundreds of thousands of patients with Alzheimer's disease, Alzheimer's association says approval conditional approval of China's food and drug supervision and administration of administration with seaweed as raw materials, used in the treatment of mild to moderate Alzheimer's disease Oligomannate such a move.
Oligomannate, an oral drug made from extracts of brown algae, works by suppressing certain bacteria in the gut that cause neurodegeneration and inflammation in the brain. Jointly developed by Shanghai institute of materia medica, Chinese academy of sciences, Shanghai green valley pharmaceutical and ocean university.
The new drug has been tested on 818 people in trials, but doctors warn there may be no cure for those whose brains have deteriorated beyond repair, or who are wandering around or need help with toilet or bath breaks.
The results showed that Oligomannate statistically improved cognitive function in patients with mild to moderate AD at just four weeks, and the benefit was maintained at each follow-up evaluation, Shanghai Lvye Pharmaceutical said in a statement.
Alzheimer's disease begins with memory loss and affects cognitive ability. So far, there is no cure. People over the age of 65 are particularly at risk, but about 200,000 people under the age of 65 have the disease.
In China, 9.5 million people suffer from Alzheimer's and the country's population is rapidly aging. More than 5.8 million people in the United States have dementia, according to the Alzheimer's association. It is the sixth leading cause of death in people 65 and older.
n August, the Chinese government overhauled its drug law to allow conditional approval of drugs with "predictable" clinical value for some life-threatening diseases for which treatment is unavailable, reported by Reuters.
Professor zhang zhenxin, lead investigator of the phase iii clinical trial of Oligomannate and professor of neurology at Peking union medical college hospital, told the journal medical letters in Beijing that "the results of the nine-month Oligomannate trial are exciting."
Finding a cure for Alzheimer's is an expensive path with many failures.But last month, Biogen, based in Cambridge, mass., said it would seek U.S. federal drug administration approval next year to market its drug aducanumab, which could help slow the effects of the disease.