我國原創(chuàng)治療阿爾茨海默病新藥獲批上市

11月2日，國家藥品監(jiān)督管理局批準(zhǔn)了上海綠谷制藥有限公司治療阿爾茨海默病新藥——九期一(○內(nèi)加“R”)(甘露特鈉，代號(hào)：GV—971)的上市申請。

甘露特鈉，代號(hào)：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，治療阿爾茨海默病國產(chǎn)新藥——九期一(○內(nèi)加“R”)(甘露特鈉，代號(hào)：GV—971)的研發(fā)機(jī)構(gòu)表示，該藥將在今年年底與國內(nèi)患者見面，填補(bǔ)了全球阿爾茨海默病治療領(lǐng)域17年無新藥上市的空白。

該藥以海洋褐藻提取物為原料(materials extracted from brown algae)，制備獲得的低分子酸性寡糖化合物，可明顯改善輕度至中度阿爾茨海默病患者認(rèn)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.

阿爾茨海默病是一種不可逆的、漸進(jìn)型大腦紊亂病癥，會(huì)緩慢損壞記憶力、思考能力以及執(zhí)行簡單任務(wù)的能力，全世界至少有5000萬患者，隨著人口老齡化加劇，患者數(shù)量還會(huì)繼續(xù)增加。

China has roughly 10 million people with Alzheimer's, the most in the world.

我國有阿爾茨海默病患者約1000萬人，是世界上患者人數(shù)最多的國家。

新藥作用機(jī)制是什么?

Scientists said the drug functions mainly by rebalancing gut microbiota, reducing neuro-inflammation and reducing cognitive impairment.

科學(xué)家表示，該藥主要通過重塑腸道菌群平衡，減少相關(guān)神經(jīng)炎癥的發(fā)生，從而改善認(rèn)知功能障礙。

新藥效果如何?

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.

該藥主要發(fā)明人、中國科學(xué)院上海藥物研究所研究員耿美玉介紹，“九期一”的3期臨床試驗(yàn)研究于去年7月完成了818例受試者的服藥觀察，在為期36周的試驗(yàn)中，“九期一”能夠明顯改善輕、中度阿爾茨海默病患者的認(rèn)知功能障礙。

何時(shí)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.

該藥的研發(fā)機(jī)構(gòu)之一、上海綠谷制藥有限公司表示，“九期一”將于本周投產(chǎn)第一批，預(yù)計(jì)12月29日投放至全國。生產(chǎn)企業(yè)正在籌建新工廠，建成后可滿足每年200萬患者用藥量的生產(chǎn)、銷售。

【相關(guān)詞匯】

認(rèn)知障礙 cognitive impairment

臨床實(shí)驗(yàn) clinical trials

食品藥品安全 food and drug safety

電子追溯制度 electronic tracking system