An Alzheimer's Drug is expected to go on sale in China——Mars Translator
阿尔兹海默症药物有望在中国上市-火星译客
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2019-12-12 19:59
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火星译客

一家中国制药公司赶在欧美前面,已研发批准了一种治疗阿尔兹海默症的药物,这种药物可帮助轻度阿尔兹海默症患者恢复认知功能。

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.

上周六,中国国家药品监督管理局有条件地批准了上海绿叶制药有限公司的一款名为Oligomannate的产品。

Last Saturday, China's state drug administration gave conditional approval to a product called Oligomannate from Shanghai Lvye Pharmaceutical Co.

药物监督总局表明,需要继续研究药品药效药效,如果发生了安全问题,有可能会撤回批准。

The agency said it needed to continue studying the efficacy of the drug, and that approval could be withdrawn if safety issues arose.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.

这种新药是17年以来首个获批的治疗神经退行性疾病的药物。绿谷制药指出,Oligomannate将在2019年末在中国获批上市。在那之后绿谷公司将于2020年在国外进行三期临床实验,并希望能获准将药物投入欧美市场。

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是以褐藻提取物为原料制成的口服药物,通过抑制肠道中导致大脑神经退化和炎症的某些细菌发挥作用。由中国科学院上海药物研究所、上海绿谷制药和海洋大学联合开发的。

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.

试验中,在818人身上进行了测试,但是医生警告说,对于那些大脑已经退化到无法修复,或者四处游荡或需要帮助上厕所或洗澡的患者,可能无法治愈。

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.

绿谷制药公司在声明中提到:试验结果表明,仅4周,Oligomannate就在统计学上改善了轻度至中度AD患者的认知功能,而且在每次随访评估时,这种益处都能够维持。

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.

阿尔茨海默症始于记忆丧失并影响认知能力。迄今为止,还没有治愈的方法。65岁以上的人患病风险特别大,但在65岁以下就约有20万人患有这种疾病。

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.

在中国,有950万人患有阿尔茨海默症,而中国人口正在迅速老龄化。根据阿尔兹海默症协会的数据,在美国,有超过580万人患有老年痴呆。在65及65岁以上的人群中,它是导致死亡的第六大原因。

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.

据路透社报道,今年8月,中国政府对药品法进行了全面修订,允许对一些无法获得治疗的危及生命的疾病具有“可预见性”临床价值的药物进行有条件地批准。

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.

张振新教授——Oligomannate三期临床试验首席研究者、北京协和医院神经病学教授,在北京接受《医药通讯》的采访时表示“为期9个月的Oligomannate试验结果令人兴奋"。

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."

寻找治疗老年痴呆症的方法是一条代价高昂的道路,会面临许多失败。但上个月,总部位于马萨诸塞州坎布里奇的Biogen表示,明年将寻求美国联邦药物管理局批准上市,以推销其药物阿杜卡奴单抗,该药可能有助于减缓这种疾病的影响。

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.

“治愈是可能的。我们对细胞水平上发生的事已经了解得够多了”,阿尔茨海默症研究基金会首席发展官亨特安斯汀在接受《中国日报》采访时表示。“这并不是在试图弄清楚宇宙是如何被创造出来的;这是一个合理的需要去解决和克服的事情。我们只需要投入大量资源。”

"A cure is possible.We know enough about what happens at the cellular level, "Hunter Ansteen, chief development officer of the Alzheimer's research foundation, told China Daily. "It's not trying to figure out how the universe was created; This is a reasonable thing to solve and overcome. We just need to put in a lot of resources."

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