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我国原创治疗阿尔茨海默病新药获批上市

中国日报网 2019-11-04 11:26

11月2日,国家药品监督管理局批准了上海绿谷制药有限公司治疗阿尔茨海默病新药——九期一(○内加“R”)(甘露特钠,代号:GV—971)的上市申请。

甘露特钠,代号:GV—971

 

A homegrown drug, GV-971,which is the world's first innovative therapy for treating Alzheimer's disease in 17 years will be available to Chinese patients before the end of this year, its developers said on Sunday.
11月3日,治疗阿尔茨海默病国产新药——九期一(○内加“R”)(甘露特钠,代号:GV—971)的研发机构表示,该药将在今年年底与国内患者见面,填补了全球阿尔茨海默病治疗领域17年无新药上市的空白。

该药以海洋褐藻提取物为原料(materials extracted from brown algae),制备获得的低分子酸性寡糖化合物,可明显改善轻度至中度阿尔茨海默病患者认知功能(treat mild to moderate forms of the disease and improve cognition)。

Alzheimer's disease, an irreversible and progressive brain disorder that slowly destroys memory, thinking ability and the capability to carry out simple tasks, affects at least 50 million people worldwide, and the number is expected to increase as populations age.
阿尔茨海默病是一种不可逆的、渐进型大脑紊乱病症,会缓慢损坏记忆力、思考能力以及执行简单任务的能力,全世界至少有5000万患者,随着人口老龄化加剧,患者数量还会继续增加。

China has roughly 10 million people with Alzheimer's, the most in the world.
我国有阿尔茨海默病患者约1000万人,是世界上患者人数最多的国家。


新药作用机制是什么?

Scientists said the drug functions mainly by rebalancing gut microbiota, reducing neuro-inflammation and reducing cognitive impairment.
科学家表示,该药主要通过重塑肠道菌群平衡,减少相关神经炎症的发生,从而改善认知功能障碍。


新药效果如何?

A phase III clinical trial of the drug involving 818 patients completed in July last year had "proven to continuously and effectively improve cognition among mild to moderate Alzheimer's disease sufferers over a period of nine months," said Geng Meiyu, lead researcher on the drug and a researcher with the Chinese Academy of Sciences' Shanghai Institute of Materia Medic.
该药主要发明人、中国科学院上海药物研究所研究员耿美玉介绍,“九期一”的3期临床试验研究于去年7月完成了818例受试者的服药观察,在为期36周的试验中,“九期一”能够明显改善轻、中度阿尔茨海默病患者的认知功能障碍。


何时上市?

The first production line for the drug will begin running this week. Patients will be able to buy the drug around the country from Dec 29, and more production lines will gradually be put into operation, which will meet the needs of 2 million patients, according to Shanghai Green Valley Pharmaceutical, one of the drug's developers.
该药的研发机构之一、上海绿谷制药有限公司表示,“九期一”将于本周投产第一批,预计12月29日投放至全国。生产企业正在筹建新工厂,建成后可满足每年200万患者用药量的生产、销售。


【相关词汇】

认知障碍 cognitive impairment

临床实验 clinical trials

食品药品安全 food and drug safety

电子追溯制度 electronic tracking system


参考来源:人民日报、新京报

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