阿尔兹海默症药物有望在中国上市
Alzheimer's drug in China shows promise
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2019-12-05 15:44
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火星译客

A Chinese pharmaceutical firm has surged ahead of the US and Europe to develop and approve an Alzheimer's drug that could help the cognitive functions of patients with a mild form of the disease.

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。

The drug Oligomannate, a product of Shanghai-based Green Valley Pharmaceuticals, was given conditional approval Saturday by China's National Medical Products Administration.

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。

Research into the drug's efficacy is still needed and it could be withdrawn if safety issues arise, the organization said.

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 Chinese breakthrough comes after major US pharmaceutical firms Johnson & Johnson, Merck, Pfizer and Eli Lilly recently abandoned projects to develop a drug for Alzheimer's over safety issues. Over nearly 20 years, there have been 400 clinical trials and billions of US dollars spent trying to find a cure.

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。

The new drug will be the first approved in 17 years to treat the degenerative disease. Green Valley said Oligomannate would be released in China by the end of 2019. The company will then carry out phase three trials abroad in 2020 and later seek approval to market the drug in the US and Europe.

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。

Dr Maria C. Carrillo, chief science officer at the Alzheimer's Association, told China Daily in a statement: "On behalf of the tens of millions worldwide living with Alzheimer's disease, the Alzheimer's Association acknowledges and welcomes the announcement that China's National Medical Products Administration conditionally approved the seaweed-based drug Oligomannate for mild to moderate Alzheimer's dementia.''

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。

Oligomannate, taken orally, is made from extracts of brown algae as raw material and works by suppressing certain bacteria in the gut that causes neural degeneration and inflammation in the brain. It was jointly developed by the Chinese Academy of Sciences' Shanghai Institute of Materia Medica, Green Valley and Ocean University.

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。

During trials, it was tested on 818 people, but doctors warn it may not cure patients whose brains had degenerated beyond repair, or who wandered or needed help using the bathroom or bathing.

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。

"Trial results demonstrated that Oligomannate statistically improved cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit," Green Valley Pharmaceuticals said in a statement.

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。

Alzheimer's disease starts with memory loss and impacts cognitive ability. To date, there is no cure. Those aged 65 and up are at particular risk, but around 200,000 people aged below 65 have the disease.

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。

In China, 9.5 million people have Alzheimer's, amid a rapidly aging population. In the US, more than 5.8 million live with it, according to the Alzheimer's Association. It is the country's sixth-leading cause of death among those age 65 and older.

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 August, Beijing overhauled its drug laws by allowing conditional approval for some medicines with "predictable" clinical value for life-threatening diseases where treatment was not available, Reuters reported.

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。

Professor Zhang Zhenxin, a leading principal investigator of the phase three trial of Oligomannate and professor of neurology at Peking Union Medical College Hospital in Beijing told : "The result of the nine-month trial of Oligomannate is exciting."

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"。

Finding a cure for Alzheimer's has been a costly road with many failures. But last month, Biogen, based in Cambridge, Massachusetts, said next year it would seek approval from the Federal Drug Administration to market its drug aducanumab, which it said could help slow the effects of the disease.

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。

"A cure is possible. We know enough about what's going on at the cellular level," Hunter K. Anstine, chief development officer for the Alzheimer's Research Foundation, told China Daily. "This is not trying to figure out how the universe was created; this is a reasonable thing to figure out and conquer. We just need to put a lot of resources into it."

“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。”

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