中国造埃博拉药物挽救生命 却卷入专利纠纷
日期:2015-06-16 12:41

(单词翻译:单击)

After a nurse who contracted Ebola in Sierra Leone was discharged Wednesday from a Rome hospital, a doctor there described the experimental treatments the patient had received as “absolutely miraculous.”
在塞拉利昂感染埃博拉病毒的一位护士周三从罗马一家医院出院,该院一位医生形容病患接受的试验治疗的效果“绝对如奇迹一般”。
They included MIL77, a product from China that was also given to a British Army nurse who recovered from Ebola at a London hospital in March. It is a near copy of what many believed was the most promising Ebola therapy: a cocktail of antibodies known as ZMapp, the result of a collaboration between the United States and Canada.
治疗中使用了中国生产的MIL77,伦敦一家医院在三月也用这个药品治疗了一位感染埃博拉的英国陆军护士,现已治愈。该药几乎原样复制了最被人看好的埃博拉疗法,也就是被称作ZMapp的抗体综合剂,后者是美国与加拿大合作的成果。



While ZMapp was mired in production delays last fall and winter and quickly became unavailable, a small private Chinese company, Beijing Mabworks, raced ahead, helping produce about 100 doses of MIL77. That means more potentially lifesaving treatments for desperate patients. But it has also led to patent infringement concerns by American officials, and to disagreements over when experimental Ebola therapies should be offered to patients only in carefully controlled studies and when they should be made more available for compassionate reasons.
ZMapp的生产在去年秋冬陷入困难,很快就断供了,一家叫作“北京天广实生物技术有限公司”的小型中国民营公司因此迎头赶上,制造了100剂MIL77。这意味着有更多绝望的病人可以得到挽救生命的治疗。但侵犯专利权的问题已经引起美国官员注意,而实验性的埃博拉疗法何时应该仅限于在严格管控的研究中施用,何时应该基于同情心提供给更多人,各方的看法也存在分歧。
Feng Li, chief executive of Beijing Mabworks, said his company was motivated to fight a global emergency and had made a licensing agreement with ZMapp’s intellectual property rights holder. “People think international collaboration could easily happen between the U.S. and Canada,” he said, “but these days, China could play a role” by making emergency response drugs “better and faster in some cases.”
天广实的首席执行官李锋表示,公司是希望去应对一场全球急难,并且与ZMapp的知识产权持有者签署了授权协议。“人们认为美加之间易于发展国际合作,”他说,“但如今,中国也可以在其中发挥作用”,有时能在应急药品的制作上“达成更好、更快的结果”。
ZMapp is being tested in a clinical trial in the United States and Sierra Leone, where the government reported nine new cases of Ebola on Thursday, one of the highest daily totals in months.
ZMapp在美国与塞拉利昂进行临床试验,后者的政府在周四有九起新病例,是数个月来单日最多的一天。
Last summer, when Ebola was raging out of control, ZMapp raised hopes after it was given to two American aid workers with the disease. Both recovered. Scientists had already shown that ZMapp could save monkeys injected with what would have been a lethal dose of the virus.
埃博拉病毒在去年夏天失控。但受到感染的两位美国救援工作者获得ZMapp后都已痊愈,因此唤起一线希望。科学家发现,ZMapp可以让注射了致死病毒量的猴子存活。
Tobacco plants were engineered to produce ZMapp, a mixture of three antibodies designed to attach to the covering of the virus, neutralize it and attract killer immune cells. That was an unusual production method, chosen in part to meet the requirements of an American government grant that promotes innovation. However, there were no facilities capable of producing large amounts of the treatment.
ZMapp使用经过改造的烟叶植物进行生产,它混合了三种抗体,可以附着在病毒令其失去效力,然后吸引杀手免疫细胞发挥效果。用烟叶制作抗体的生产方法并不常见,选择它的其中一个原因是,研发获得了美国政府的一项鼓励创新资金,因此要符合该拨款的要求。然而,现在没有设施适合制作大量药剂。
Then China jumped in. The scarcity of ZMapp was “a spark, like lightning to me,” said Boyan Zhang, chief scientific officer at Beijing Mabworks. Supported by Chinese government grants, the company had developed mammalian cells capable of quickly producing antibodies targeted against cancer and viral diseases in humans, and its leaders decided to use the same process to develop an Ebola remedy.
中国因此投入生产。天广实的首席科学顾问张博彦表示,ZMapp的稀缺“让我灵光乍现”。在中国政府的支持下,这家公司先前研发出一种哺乳类细胞,可以快速制造对抗癌症与病毒性疾患的抗体。公司高层决定利用同一方法开发埃博拉的疗法。
China, highly attuned to infectious diseases since the outbreak of severe acute respiratory syndrome in 2003, had many citizens working in West Africa. “The entire country was mobilized,” Mifang Liang of the Chinese Center for Disease Control and Prevention said at the China-U.S. Relations Conference in Houston last month.
经历2003年严重急性呼吸综合症爆发后对传染病有深刻了解的中国,有许多国民在西非工作。“整个国家都动员起来,”中国疾病预防控制中心研究员梁米芳上个月在休斯顿的中美关系研讨会(China-U.S. Relations Conference)上表示。
The Chinese government issued a directive last summer that helped inspire the production not only of MIL77 but also of an Ebola vaccine, which is currently in human safety studies; rapid Ebola diagnostic tests; and copies of antiviral drugs made by companies in other countries. Dr. Zijian Feng, deputy general director of the China C.D.C., said involvement in emergency public health assistance served to “elevate our presence in the international stage and also elevate our capabilities.”
中国政府去年夏天发布的一项命令,不仅鼓励了MIL77的制作,还促成埃博拉疫苗的研发(目前已经进展到人体安全的研究)、埃博拉病毒快速诊断测试、以及仿造其他国家药厂的抗病毒药物。疾病预防控制中心副主任冯子健表示,参与公共卫生急难协助可以“提升我们在国际层面的知名度,并提升我们的能力”。
Within three months, using information in ZMapp’s patent, Dr. Li and his colleagues had copied the active part of ZMapp and used the company’s specialized cells to produce the antibodies. A month later, with the help of the Chinese pharmaceutical company Hisun, they had 100 doses.
李锋和他的同事利用ZMapp专利的信息,在三个月内复制了ZMapp的有效部分,然后利用公司的特制细胞制造抗体。一个月后,在中国药厂海正药业的帮助下,已经生产出100剂。
But some American officials expressed concern. The United States government holds a patent on one of the antibodies in ZMapp, which was developed with support from American and Canadian military research agencies, a legacy of fears that Ebola could be used as a biological weapon by the Soviet Union or, later, by terrorists.
但是部分美国官员表达了他们的顾虑。美国政府持有ZMapp中的一种抗体的专利,其研发获得了美国和加拿大军方研究机构的支持,因为担心埃博拉可能被早前的苏联或之后的恐怖分子用作生化武器。
“If you use it, you’re supposed to get permission to do it, even for research purposes,” said Robin Robinson, director of the Biomedical Advanced Research and Development Authority, part of the United States Department of Health and Human Services. He said the Chinese scientists might have infringed patents if they tried to sell MIL77 outside China without an agreement with Mapp Biopharmaceutical, the small American company with intellectual property rights to ZMapp.
“如果你使用它,你就应该获得许可,甚至是为了研究目的”,美国卫生与公共服务部(Department of Health and Human Services)属下的生物医学高级研究和发展管理局(Biomedical Advanced Research and Development Authority)局长罗宾·罗宾逊(Robin Robinson)说道。他说,如果中国科学家试图在中国以外地区销售MIL77,却没有与拥有ZMapp知识产权的美国小型公司Mapp生物制药(Mapp Biopharmaceutical)达成协议的话,他们或许已经侵犯了专利。
Larry Zeitlin, president of Mapp, said the Chinese scientists had reached out to him after creating MIL77 and had been collaborative.
Mapp公司总裁拉里·泽特林(Larry Zeitlin)表示中国科学家已经在研制出MIL77之后与他接洽,并表现得愿意合作。
Dr. Robinson said his agency had worked with Mapp and larger companies — including Regeneron in Tarrytown, N.Y., and Genentech in South San Francisco — to use methods similar to the Chinese researchers’ to increase production of ZMapp and other antibody-based treatments for Ebola.
罗宾逊博士表示他的机构已经与Mapp和一些更大的公司合作,包括位于纽约州塔里敦(Tarrytown)的Regeneron和旧金山南部的美国基因工程技术公司(Genentech),以使用与中国研究人员类似的方法增加ZMapp和其他基于抗体的埃博拉药物的生产。
But aid groups treating patients in West Africa had trouble getting information on those efforts, said Dr. Annick Antierens, coordinator of research partnerships for Doctors Without Borders. So they began to explore using Chinese-made MIL77.
但是救援组织在救治西非的病人时,在获得有关这些努力的信息方面有困难,无国界医生组织(Doctors Without Borders)的研究伙伴关系协调员安妮克·安蒂伦斯博士(Annick Antierens)表示。所以他们开始尝试使用中国制造的MIL77。
“We said, ‘You have people dying like flies, and there’s a product that seems to be O.K.,’ ” Dr. Antierens said. But as the number of Ebola patients declined in West Africa with the waning epidemic and ZMapp finally became available, she said, American officials and scientists expressed concerns that the use of MIL77 could interfere with the clinical testing and licensing of ZMapp.
“我们说,‘人们像苍蝇一般死去,而有一种药物似乎有效’”,安蒂伦斯博士表示。但西非的埃博拉病人数量随着传播的减弱和ZMapp变得可获取而减少,她说,美国官员和科学家表达了他们对使用MIL77可能干扰了ZMapp的临床试验和批准的顾虑。
Doctors Without Borders and some other aid groups have balked at participating in the ZMapp trial because it is randomized and patients only have a 50 percent chance of receiving the treatment. That is a standard procedure in many trials so that researchers can compare patient outcomes and determine whether the treatment was effective and not harmful.
无国界医生组织和其他救援组织已经在是否参加ZMapp试用上犹豫不决,因为这是随机化的而且病人只有50%的机会得到治疗。这是许多药物测试的标准流程,这样研究人员才能比较病人的结果,并确定治疗是否是有效而无害的。
At Royal Free Hospital in London several months ago, two healthy workers with serious exposure to Ebola were given MIL77. Neither of the workers ended up developing the disease, said Dr. Michael Jacobs, who treated them.
几个月前在伦敦皇家自由医院(Royal Free Hospital),两位健康的但密集接触埃博拉的工作人员被注射了MIL77。两人最终都没有感染埃博拉,治疗他们的迈克尔·雅各布博士(Michael Jacobs)说。
When the British Army nurse, Cpl. Anna Cross, tested positive for Ebola in March, she also agreed to receive MIL77, which had shown promising results in guinea pigs and nonhuman primates at the Public Health Agency of Canada.
当英国陆军护士,安娜·克罗斯下士(Anna Cross)在三月的埃博拉测试中呈阳性时,她也同意接受MIL77治疗。而在加拿大公共卫生局(Public Health Agency of Canada),MIL77已经在豚鼠和非人类灵长类动物上显示了令人满意的结果。
The London hospital has since decided not to join the American-run clinical trial of ZMapp because of the randomizing requirement. It has opted instead to keep a supply of MIL77 for use in any Ebola patients treated in Britain or the European Union.
这家伦敦医院因此决定不加入由美国进行的Zmapp临床测试,原因是其随机化的要求。作为代替,其决定保持MIL77的供应,用以所有英国和欧盟内的埃博拉病人的治疗。
“We’ve challenged ourselves about whether that is the right decision or not,” Dr. Jacobs said. “In the end, I have to do my best for the patient in front of me.”
“我们已经在这是否是个正确决定的问题上质疑了自己,”雅各布博士说,“最后,我必须为我面前的病人做到最好。”
But Dr. H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, said it was important to test ZMapp properly to determine whether using antibodies to treat Ebola really works.
但是国家过敏和传染病研究所(National Institute of Allergy and Infectious Diseases)临床主任克利福德·莱恩博士(Clifford Lane)表示,用合适的手段测试ZMapp以确定使用抗体治疗埃博拉是否有效是至关重要的。
“There are interventions that look so logical, that should be effective, that prove not to be,” he said. “Without randomization, you have no way to control for all the different variables that come into play when you’re dealing with a patient.”
“有一些干预看起来很符合逻辑,应该是有效的,但被证明并不是,”他说。“没有随机化,你在治疗病人时就无法控制所有不同的、有影响的变量”。

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