Alzheimer's drug in China shows promise
來(lái)源：火星譯客
譯員：ad84
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.
一家中國(guó)制藥公司趕在歐美前面，已研發(fā)批準(zhǔn)了一種治療阿爾茲海默癥的藥物，這種藥物可幫助輕度阿爾茲海默癥患者恢復(fù)認(rèn)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，中國(guó)國(guó)家藥品監(jiān)督管理局有條件地批準(zhǔn)了上海綠葉制藥有限公司的一款名為Oligomannate的產(chǎn)品。
Research into the drug's efficacy is still needed and it could be withdrawn if safety issues arise, the organization said.
藥物監(jiān)督總局表明，需要繼續(xù)研究藥品藥效藥效，如果發(fā)生了安全問(wèn)題，有可能會(huì)撤回批準(zhǔn)。
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.
美國(guó)制藥公司Johnson & Johnson, Merck, Pfizer 和Eli Lilly最近相繼因安全問(wèn)題而放棄了治療阿爾茲海默癥的研發(fā)項(xiàng)目，而中國(guó)突破了這一問(wèn)題。近20年來(lái)，美國(guó)已實(shí)施400個(gè)臨床實(shí)驗(yàn)，花費(fèi)上億元美金，只為找到有效治療阿爾茲海默癥的藥物。
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.
這種新藥是17年以來(lái)首個(gè)獲批的治療神經(jīng)退行性疾病的藥物。綠谷制藥指出，Oligomannate將在2019年末在中國(guó)獲批上市。在那之后綠谷公司將于2020年在國(guó)外進(jìn)行三期臨床實(shí)驗(yàn)，并希望能獲準(zhǔn)將藥物投入歐美市場(chǎng)。
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.''
阿爾茲海默癥癥協(xié)會(huì)首席會(huì)長(zhǎng)，Maria C. Carrillo博士在一份生命中回復(fù)《中國(guó)日?qǐng)?bào)》：“我代表全球成千上萬(wàn)的阿爾茲海默癥患者，阿爾茲海默癥協(xié)會(huì)表示認(rèn)可中國(guó)食品藥物監(jiān)督管理總局有條件批準(zhǔn)以海藻為原料，用于治療輕度至中度阿爾茲海默癥的Oligomannate這一舉措。
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是以褐藻提取物為原料制成的口服藥物，通過(guò)抑制腸道中導(dǎo)致大腦神經(jīng)退化和炎癥的某些細(xì)菌發(fā)揮作用。由中國(guó)科學(xué)院上海藥物研究所、上海綠谷制藥和海洋大學(xué)聯(lián)合開發(fā)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.
試驗(yàn)中，在818人身上進(jìn)行了測(cè)試，但是醫(yī)生警告說(shuō)，對(duì)于那些大腦已經(jīng)退化到無(wú)法修復(fù)，或者四處游蕩或需要幫助上廁所或洗澡的患者，可能無(wú)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.
綠谷制藥公司在聲明中提到：試驗(yàn)結(jié)果表明，僅4周，Oligomannate就在統(tǒng)計(jì)學(xué)上改善了輕度至中度AD患者的認(rèn)知功能，而且在每次隨訪評(píng)估時(shí)，這種益處都能夠維持。
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.
阿爾茨海默癥始于記憶喪失并影響認(rèn)知能力。迄今為止，還沒有治愈的方法。65歲以上的人患病風(fēng)險(xiǎn)特別大，但在65歲以下就約有20萬(wàn)人患有這種疾病。
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.
在中國(guó)，有950萬(wàn)人患有阿爾茨海默癥，而中國(guó)人口正在迅速老齡化。根據(jù)阿爾茲海默癥協(xié)會(huì)的數(shù)據(jù)，在美國(guó)，有超過(guò)580萬(wàn)人患有老年癡呆。在65及65歲以上的人群中，它是導(dǎo)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.
據(jù)路透社報(bào)道，今年8月，中國(guó)政府對(duì)藥品法進(jìn)行了全面修訂，允許對(duì)一些無(wú)法獲得治療的危及生命的疾病具有“可預(yù)見性”臨床價(jià)值的藥物進(jìn)行有條件地批準(zhǔn)。
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."
張振新教授——Oligomannate三期臨床試驗(yàn)首席研究者、北京協(xié)和醫(yī)院神經(jīng)病學(xué)教授，在北京接受《醫(yī)藥通訊》的采訪時(shí)表示“為期9個(gè)月的Oligomannate試驗(yàn)結(jié)果令人興奮"。
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.
尋找治療老年癡呆癥的方法是一條代價(jià)高昂的道路，會(huì)面臨許多失敗。但上個(gè)月，總部位于馬薩諸塞州坎布里奇的Biogen表示，明年將尋求美國(guó)聯(lián)邦藥物管理局批準(zhǔn)上市，以推銷其藥物阿杜卡奴單抗，該藥可能有助于減緩這種疾病的影響。
"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。我們對(duì)細(xì)胞水平上發(fā)生的事已經(jīng)了解得夠多了”，阿爾茨海默癥研究基金會(huì)首席發(fā)展官亨特安斯汀在接受《中國(guó)日?qǐng)?bào)》采訪時(shí)表示?！斑@并不是在試圖弄清楚宇宙是如何被創(chuàng)造出來(lái)的；這是一個(gè)合理的需要去解決和克服的事情。我們只需要投入大量資源?！?/p>
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