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2014-8-12国内、国际新药信息汇总
1、国内仿制“伟哥”金戈定价尚未确定 发布日期：2014-08-12 来源：新京报
近日，广药白云山版伟哥“金戈”片剂生产批件获批，此前，广药集团董事长李楚源也曾在其微博透露，广药白云山旗下的“伟哥”名为“金戈”，系仿制药。
上市时间依审批进度而定
据悉，美国辉瑞公司的万艾可(“伟哥”)在华专利将于今年到期，国内药企也出现仿制“伟哥”热潮。根据公开报道，7月31日晚间，广州白云山医药集团发布公告称，经查询国家食品药品监督管理总局行政受理服务中心网站，该公司提交的“枸橼酸西地那非”片剂生产注册批件申请的“办理状态”已于2014年7月30日9时8分更新为“审批完毕—待制证”。
至于国产“伟哥”的具体上市时间，企业相关负责人在此前接受媒体采访时表示需要看相关部门审批进度。
依照最新的市场传闻，“金戈”将以粉红色菱形药丸面世，以区别于辉瑞旗下“蓝色小药丸”万艾可(枸橼酸西地那非)，礼来旗下“黄色小药丸”希爱力(通用名他达拉非)，以及拜耳旗下“橘色小药丸”艾力达(通用名盐酸伐地那非)。
定价尚未确定
外界曾对“金戈”价格有过诸多揣测，称“金戈”定价预计在60—70元/粒。目前万艾可售价128元/粒，希爱力售价138元/粒，艾力达售价128元/粒。这一定价被指存在价格优势。广药白云山相关媒体负责人在接受南都记者采访时曾表示，外界对金戈的传闻存在误读。“确认颜色为粉红色，但药物形状和定价存在误读。我们目前还在等‘金戈’原料药生产批件，如果获批我们将对外公告，并全面启动生产和销售工作。”
2、ZMapp抗击埃博拉病毒新药试品告罄 发布日期：2014-08-12 来源：新药汇
据美国国家广播公司11日报道，美国生物科技公司ZMapp将所有库存的，用于抗击埃博拉病毒新药的试品全部送往西非后，新药试品告罄。
世界卫生组织（WHO）表示，埃博拉疫情已经导致1013人死亡。 利比里亚政府上周五直接向美国总统奥巴马请求药物，用以治疗感染埃博拉的医生。 对此，美国卫生与公共事业部发言人表示，美国当局通过接洽药商和利比里亚当局，已经给予他们帮助。但尚不清楚药物何时会被运往当地。而Mapp也未透露新药运往了哪个国家，以及他们运送了多少新药试品。 利比里亚当局在声明中表示，世界卫生组织已经获得了用以治疗埃博拉的药物。据悉，迄今只有3人获得了ZMapp的药物，其中两人是美国人—医生和医疗救援人员；而另一位则是75岁的西班牙牧师。 世界卫生组织11日召开特别会议，讨论这种新药试品运用在人体上可能产生的伦理问题。美国疾控中心此前曾多次强调，关于新药的影响仍无从得知，需要很长时间的临床实验才能观察清楚。 世界卫生组织表示，埃博拉疫情目前已登记在案的受感染病例有1848人，包括疑似和已确诊的病例。感染埃博拉病毒的人临床反应有高烧、呕吐和出血。 第一例埃博拉病毒感染者于3月确诊，感染者来自于几内亚，随后疫情在西非多个国家蔓延。此次世卫组织发布的新感染报告，是从8月7日至9日统计而成，这段时间里有超过52人死亡，69人感染。
类似新闻：
美国公司已将埃博拉新药运往西非 不收任何费用
研发抗击埃博拉病毒新药的美国Mapp生物科技公司表示，已经将公司所有库存的新药试品全部送往西非。
该公司在网站上发布声明称，将新药试品运往西非的决定是由患者医疗服务机构所做出的，并表示新药不收取任何费用。
据报道，该公司并未透露新药运往了哪个国家，以及他们运送了多少新药试品。
8月2日和8月5日，美国政府派专机在非洲利比里亚感染埃博拉病毒的美国人布拉特利和莱特波尔接回美国亚特兰大埃默里医学院附属医院治疗。在服用了一种名为“Z-Mapp”的新药后，两人的病情都有所好转。
据此前美国媒体报道，研发“Z-Mapp”的是美国加州圣迭戈市一间只有九个人的小型生物科技制药公司。“Z-Mapp”目前仍在实验阶段，已在猴子身上进行过实验，计划明年才进行人体实验。美国食品与药物管理局特许医生将这种药用于布拉特利和莱特波尔身上。
据悉，世界卫生组织11日召开特别会议讨论这种新药试品运用在人体上可能产生的伦理问题。美国疾控中心此前曾多次强调，关于新药的影响仍无从得知，需要很长时间的临床实验才能观察清楚。
截止目前，除了尼日利亚之外，利比里亚、塞拉利昂和几内亚这几个西非国家也爆发伊波拉疫情，至今总死亡人数已将近1000人。
为了防止埃博拉病毒入境，西非国家科特迪瓦宣布，禁止所有从爆发疫情的国家飞来的航班在当地机场降落，同时禁止国营的科特迪瓦航空公司提供来往于疫区的航班服务。
科特迪瓦政府也宣布，在最大城市阿比让的机场实施防御性措施，通过红外线检测器对所有抵境乘客进行体温检测。
另一非洲国家卢旺达10日宣布，一名最近到过利比里亚的德国医科学生出现了疑似征状，当局已经将他隔离，并正在等待病毒测试结果。卫生部长比纳瓜霍说，病人发烧并证实染上疟疾，但“为了百分百安全”，卢旺达当局已经将男子隔离开来。
3、富山化学表示抗流感药法匹拉韦（favipiravir）抗埃博拉病毒有效 发布日期：2014-08-12 来源：新药汇
日本富山化学工业公司日前表示，其研制的流感治疗药物法匹拉韦（favipiravir）能有效阻止细胞内的病毒增殖，在对抗埃博拉病毒方面很可能具有一定的疗效。
富山化学工业公司的研究者说，由于流感病毒和埃博拉病毒类似，所以法匹拉韦有可能阻碍埃博拉病毒在细胞内增殖，从而遏制感染。法匹拉韦作为新型抗流感药于今年3月获批在日本制造销售。
4、西班牙“破例”使用抗埃博拉新药ZMapp 发布日期：2014-08-12 来源：新药汇 浏览次数：6
西班牙政府宣布，将对一名感染埃博拉病毒的西班牙公民使用一种依然处于试验阶段的药物进行治疗。
西班牙卫生部在声明中说，这种治疗埃博拉病毒的药物“ZMapp”已经被送到天主教神父帕哈雷斯正在接受隔离治疗的医院。
根据西班牙法律，“在病人的生命处于危险中、且无法使用已批准药物进行令人满意治疗的情况下”，允许“使用未经批准的药物”。针对帕哈雷斯的案例，西班牙药物管理部门已经允许ZMapp作为特例进口。
目前尚无针对埃博拉病毒的获批药物和疫苗。ZMapp由美国马普生物公司研制，仍处于初期试验阶段，先前仅在猴子身上做过试验。两名先前在利比里亚感染病毒的美国医务人员曾接受ZMapp治疗，随后病情出现好转。但医疗卫生部门说，眼下尚无法断定两人情况好转是否与使用这种药物有关。是否冒险大规模使用这种药物应对当前严重的埃博拉疫情，在医学界引发一场伦理争论。
帕哈雷斯现年75岁，是首名在西非感染埃博拉病毒并返回欧洲治疗的确诊患者。他先前在利比里亚的一家医院确诊感染埃博拉病毒并接受隔离治疗，西班牙军方7日派出一架装有医疗设备的飞机把他接回国。
Spain gets rare Ebola drug to treat stricken priestA Spanish priest has received one of the world's few doses of an experimental Ebola drug, raising ethical questions about how to allocate scarce medicines for a fatal disease at at time when the virus has infected at least 1,779 people in West Africa.
The drug, ZMapp, is a mixture of three antibodies engineered to recognize Ebola and bind to infected cells so the immune system can kill them. It hasn't yet been tested in humans.
ZMapp's maker, Mapp Biopharmaceutical of San Diego, has said "very little of the drug is currently available" and that it is cooperating with government agencies to increase production as quickly as possible. The drug — made available on a compassionate use basis — also takes several months to produce, meaning that it will be months before any would be available in large amounts. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has publicly said that he knows of only three or four doses.
Two American aid workers, who were infected with Ebola and flown from Africa to a special unit at Emory University Hospital in Atlanta, also have received doses.
Contrary to what many people believe, the "ultimate decision" for who gets an experimental drug is made by the manufacturer, not the government, says Arthur Caplan, head of the division of medical ethics at New York University's Langone Medical Center. Companies have drastically different policies for making unapproved drugs available, he says.
The World Health Organization scheduled a special meeting Monday to discuss how to ration scarce doses of the drug, and is expected to release a statement Tuesday. There are currently no proven medications or vaccines to treat Ebola, which has killed at least 961 people, although several therapies are in development.
The fact that three Westerners have received ZMapp has led some to criticize the manufacturer of being biased toward Americans or whites, when so many black Africans are dying. Nigerian officials say they had asked U.S. health authorities about getting the Ebola drug but were apparently not helped.
"There's no reason to try this medicine on sick white people and to ignore blacks," said Marcel Guilavogui, a pharmacist in Conakry, Guinea. "We understand that it's a drug that's being tested for the first time and that could have negative side effects. But we have to try it in blacks too."
Last week, Anthony Kamara, a 27-year-old man riding a bicycle in Freetown, Sierra Leone, said "Americans are very selfish. They only care about the lives of themselves and no one else."
He referred to ZMapp as "the miracle serum" that the U.S. has "refused to share with us to save African lives."
Caplan says he didn't question the decision to give the drugs to physician Kent Brantly and missionary Nancy Writebol. That's because the humanitarian agencies who sent them to Africa were apparently the first to ask for the drug, Caplan says.
Brantly and Writebol also were essential first-responders, who traditionally are treated first in outbreaks, says G. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center in Washington, D.C.. Both Brantly and Writebol put their lives on the line to help others, and first-responders need to stay healthy to treat the sick, Donovan says.
Few doctors, nurses or even orderlies and funeral directors will volunteer to treat infected people if they think they will be last in line for treatment, Caplan says. He notes that 80 health workers have died from Ebola since the outbreak began in March. Caplan says it's also critical to choose patients who can be followed not just for few days, but for months or years, to learn whether the treatments damage the liver or produce other side effects that can take time to appear. With drugs that are so new and experimental, doctors have an obligation to learn from every patient, he says. "If it damages your liver and causes it to shut down three months from now, that is not a cure," Caplan says.
But Caplan says it's "morally troubling" to give the drug to someone like the Spanish priest, who is not a health care professional and who is 75 years old. Older people have notoriously weak immune systems, Caplan says, so the drug may not work as well on him as in a younger person. He also may be in weaker health so it could be unclear whether any health problems that he experiences stem from the drug, or his advanced age.
Donovan argues that the Spanish priest, Miguel Pajares, was putting his life on the line, as well, even if he wasn't providing medical treatment, simply by trying to help Ebola victims. Donovan says he's troubled by the fact that Ebola and other diseases that primarily afflict developing countries have been ignored for so long.
"Given that we've known about Ebola since the 1970s, why has it taken so long to develop an appropriate response?" Donovan asks. "There just really wasn't enough interest from those who could be supporting drug development."
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