Foreign Media: outdated drugs into China drug approval still needs to be improved
Reference news, April 4, foreign media said that in the United States and other drugs in China failed to enter the market with a fresh start.
According to the United States, the Wall Street Journal, March 29, 2013, Bristol-Myers Squibb Company to stop a global test of anti-hepatoma drugs, because its efficacy as their opponents. Company called "bulinibu" (Brivanib) cancer drug, permission granted to a Chinese start-ups.
Ding headquartered in Shanghai pharmaceutical think bulinibu has great development potential in China because its opponents--Bayer AG and Onyx constraints developed sorafenib (brand name Rachel Sabrina seyvecou) – the cost of treatment is about $ 7500 a month, and not in the context of national insurance.
Du Ying, the founder of the company, said: "we want to give patients a much more reasonable price. ”
Other than the tripod, there are several companies with Western pharmaceutical companies to cooperate on drugs not yet developed in China. In China, the top international drugs needed to wait for a very long time, and regulators in China drug approval process faster.
Reported, but this new trend also begs the question: If China dumps of bad drugs?
Glenn Cowan, a Professor of medical ethics issues at Harvard Law School who has studied, he said, because of different regulatory standards throughout, a drug approved in one area of the enterprise and is not approved in another jurisdiction is not unusual nor illegal.
First of all, no need to prove a drug is superior to existing drugs in China--the United States is a difficulty, 90% die drug candidates in clinical trials.
Some industry experts say, drug companies have long been sold in China, not in other countries testing and drugs to market. "Why?" With sarcasm that answer is: because they can do it, "Asia Pacific healthcare LaOla·naerxun·Kani, an analyst at Bernstein Research said.
For example, the stroke drug cinepazide (cinepazide) in the late 80 's and 90 's out of Spain, and Italy and France, because there are reports that the drug can cause blood diseases. But Switzerland Credit Securities Research Institute data, by 2010, it has become China's top-selling drug.
Responsible for marketing the drug's sihuan pharmaceutical holdings said it produced higher purity of cinepazide maleate in generic drug cinepazide in brand-name drugs sold in Europe, its safety and efficacy are recognized by the Chinese authorities and patients.
China's State food and Drug Administration did not respond to its drug approval process and domestic drug quality, multiple requests for comment. United States food and Drug Administration (FDA) comment about drug testing in other countries.
Reports that China has been cleaning up the drug approval process. In 2007, the State food and Drug Administration Zheng Xiaoyu was investigated before, he allegedly provided by pharmaceutical companies to make drugs approved and bribery.
Zheng served as Director of the State drug administration period, more than 150,000 drug applications approved.
Reported that the problem still exists. The State food and Drug Administration said last year it announced that it would punish the company submitted fraudulent clinical trial data, pharmaceutical companies to withdraw almost four-fifths applications for drug approval.
Recent scandals around the problem vaccine have again raised concerns about drug safety.
Through partnerships with local businesses, global pharmaceutical company has a second chance to use unapproved drugs in other places to make money. The Chinese Government wants to build a competitive domestic market, thus welcomed such cooperation.
Reports for consumers in China, this trend may mean new drugs waiting time shortened, reduced costs – even if these drugs are not the best in its class.
At present, the regulatory requirements on received United States FDA approval of the drug for additional testing. Clinical trials approval process may take more than a year. By contrast, United States regulators say after 30 days of submission of clinical trials can begin.
According to IMS health consulting, as of 2013, from 2008 to 2012, only 21% of the global launch of the drug is available for sale in China, and in the United States the ratio is 68%.
For example, the revolutionary hepatitis c new drug can cure in as little as a few months over 90% patients, but had not entered the Chinese market, while China is the world's highest incidence of hepatitis c. China still relies on the old patients with therapy, often with side effects such as nausea and hair loss.
Shenyang Sun Wei, aged 46 (sound) that she had been injected with a year of interferon, hepatitis c is still not healed, her weight dropped sharply, there were severe joint pain. She said: "I look like a person who has more than 60 years. ”
Last October, she headed to New Delhi to buy three months ' worth of popular drug Sovaldi produced by Gilead science and technology company, which is still at an experimental stage in China. She said that her hepatitis c test results have been negative.
Reports said Chinese drug regulators have pledged to speed up AIDS, cancer and infectious diseases, the approval of new drugs, including those made by foreign pharmaceutical companies produce drugs.
Bristol-Myers Squibb is China's approval of its hepatitis c drug asunaprevir, and in the United States, taking into account the competitor drug is close to approval, the company canceled the application when the FDA will make a decision. Japan, and Korea and Taiwan region and Latin America and some countries in Eastern Europe's regulators have approved asunaprevir jointly with another drug for sale.
Bristol-Myers Squibb spokesman said that the company's hepatitis c treatment programs focus on the unique medical needs of various markets.
As for the bulinibu, Bristol-Myers Squibb said the drug may be particularly promising in China, because China's high incidence of hepatitis, hepatocellular carcinoma are much more common than in the West.
University of California, Los Angeles, Professor of health policy and management situerte·Shi Schweitzer says, affordable drugs will be more appealing than the medicine too expensive.
He said: "assuming that the effective, but efficacy than drugs already on the market, which can be said to be ' work '? "(Compilation/He Jine)
(Editors: Hao Long UN654)
2016-04-04 00:48:58
Reference news network
外媒：过时药物进入中国市场 药物审批仍需改进
参考消息网4月4日报道 外媒称，在美国等地未能进入市场的药物在中国获得新生。
据美国《华尔街日报》网站3月29日报道，2013年，百时美施贵宝公司停止了一款抗肝癌药物的全球试验，原因是它的药效不及对手。公司转而把这种名为“布立尼布”（Brivanib）的抗癌药的许可权授予中国的一家初创企业。
总部设在上海的再鼎医药有限公司认为布立尼布在中国有很大的发展潜力，因为其对手——拜耳股份公司和Onyx制约公司开发的索拉非尼（商品名蕾莎瓦）——的治疗费用约为每月7500美元，且不在国家保险范围内。
再鼎公司的创始人杜莹说：“我们希望给中国患者一个更加合理的价格。”
除了再鼎之外，中国还有好几家企业与西方制药公司在中国就尚未开发完成的药物进行合作。在中国市场，顶尖的国际新药需等候很长时间，而监管部门对中国药物的审批过程较快。
报道称，但这个新趋势也带来一个问题：中国是否成了劣质药的倾卸场？
哈佛大学法学院教授格伦·科恩对医德问题颇有研究，他说，由于各地监管标准不同，企业的一款药在一个辖区获得批准而在另一个辖区未获批准并不反常，也不违法。
首先，在中国无需证明一种药物优于现有药物——那在美国是一道难关，90%的候选药物在临床试验阶段夭折。
有业内专家称，制药公司早就开始在中国销售未曾在其他国家测试和投放市场的药物。“为什么？带有讽刺挖苦意味的回答是：因为他们能行，”伯恩斯坦研究公司的亚太医疗保健分析师劳拉·纳尔逊·卡尼说。
例如，中风治疗药物桂哌齐特（cinepazide）在上世纪80年代末和90年代退出西班牙、意大利和法国，原因是有报道说服用该药会引起血液疾病。但根据瑞士信贷证券研究机构的数据，到2010年，它已成为中国的畅销药物。
负责营销该药的四环医药控股集团有限公司称，它生产的桂哌齐特非专利药的纯度高于曾在欧洲出售的桂哌齐特品牌药，其安全性和有效性得到了中国相关部门和患者的认可。
中国国家国家食品药品监督管理局没有答复记者有关其药品审批流程和国内药品质量的多次置评请求。美国食品和药物管理局（FDA）不予评论其他国家的药物试验。
报道称，中国长期以来一直在整顿药物审批过程。2007年，国家药监局前局长郑筱萸被查处，他涉嫌收取制药企业为使药物获批而提供的贿赂。
郑筱萸担任国家药监局局长期间，逾15万种药品申请获得批准。
报道称，如今问题依然存在。国家药监局称，自去年它宣布将严惩提交虚假临床试验数据的公司以来，制药公司撤回了近五分之四的药品报批申请。
最近围绕问题疫苗的丑闻再度引发了人们对药品安全性的担忧。
通过与中国本地企业建立合作关系，全球制药公司有了第二次机会利用在其他地方未获批准的药品赚钱。中国政府希望建立一个竞争性的国内药品市场，因而欢迎这类合作关系。
报道称，对中国消费者来说，这个趋势可能意味着新药等待时间缩短、成本降低——即便这些药品并不是同类产品中最好的。
目前，中国监管部门要求对获得美国FDA批准的药品进行额外试验。临床试验审批过程可能会需要一年多时间。相比之下，美国监管部门表示，临床试验在提交申请的30天后即可开始。
艾美仕医药保健咨询公司的数据显示，截至2013年，2008年至2012年全球推出的药品中只有21%在中国有售，而在美国这个比例是68%。
例如，革命性的丙肝新药可在短短几个月内治愈90%以上的患者，但一直没有进入中国市场，而中国的丙肝发病率属全球最高之列。中国患者仍依靠旧的疗法，往往伴有恶心和脱发等副作用。
沈阳市现年46岁的孙薇（音）表示，她曾经注射了一年的干扰素，但丙肝仍未痊愈，她的体重急剧下降，还出现了严重的关节疼痛。她说：“我那时候看起来像60多岁的人。”
去年10月份，她前往新德里购买了三个月量的吉利德科技公司所产畅销药Sovaldi，该药在中国至今仍处于试验阶段。她表示，现在她的丙肝化验结果已为阴性。
报道称，中国的药品监管部门已承诺加快艾滋病、癌症和传染疾病新药的审批速度，包括由外国制药商生产的药物。
百时美施贵宝正在中国报批其丙肝药物asunaprevir，而在美国，考虑到竞争对手公司的药品已接近获批，该公司在FDA即将做出决定时取消了申请。日本、韩国和台湾地区以及拉丁美洲和东欧一些国家的监管机构已经批准asunaprevir与另外一种药物联合出售。
百时美施贵宝的发言人表示，该公司的丙肝治疗方案着眼于各地市场独有的医疗需求。
至于布立尼布，百时美施贵宝称，该药在中国可能会特别有前途，因为中国的肝炎高发，肝细胞癌比在西方要常见得多。
加利福尼亚大学洛杉矶分校的医疗政策与管理学教授斯图尔特·施魏策尔说，买得起的药物会比过于昂贵的特效药更受人欢迎。
他说：“假设这些药有效，但药效不如市面上已有的药，这些药能说是‘不管用’吗？”（编译/何金娥）
(责任编辑：郝龙 UN654)
2016-04-04 00:48:58
参考消息网