德国拜耳制药公司8月28日表示，其抗肝癌药索拉非尼（Nexavar）已经得到中国国家食品药品监督管理局的批准，将正式进入中国肝癌治疗市场。
抗癌药索拉非尼是由德国拜耳制药公司和美国生物技术制药企业Onyx药业共同研制开发的。拜耳对这一产品寄予厚望，预计每年将能够为公司创造20亿欧元的销售额。拜耳表示，公司极其重视庞大的中国市场，认为中国医药监管当局的批准对公司有重要意义。据估计，中国目前每年有超过34万人被诊断患有肝癌，而且这一数字还在不断增加。
目前，该产品已经获准在40多个国家和地区销售。
索拉非尼,常规治疗每个月一瓶（60片），25192.00 元，与普通老百姓无缘哪。
高级消费品！
试用过一个鼻咽癌肝转移的病人，没看出任何效果。
索拉非尼,常规治疗每个月一瓶（60片），25192.00 元，与普通老百姓无缘哪。
http://www.hly365.com/service/info/Allinfo.jsp?id=2539
建设具有中国特色的社会主义
去！中国人的钱又要被他们弄去了！
我决定暗中仿制，卖给非洲和拉美的劳苦大众！
秘鲁好像就是拉美的吧。
还没有上市吧，SFDA只批了临床啊！我们也可以做啊！
这个药有专利，大家做不了。
奢侈品哪
太贵了，老百姓那吃的起。
应该是上市了，临床试验据说效果不错。
确实已上市了，8月在广州开的中国上市会，老外来了不少，黑中国人钱啊 。
我也听说过了，不过好像效果不好，摆明了就是赚中国的钱来了嘛
JYHB0800559国 - 在审评 空 2008-8-25 19:20:26 无 无 不收费 空 --- 不需要
看样子，山寨药是必然的选择
没听说过。能真正靶向么？
没听说过。能真正靶向么？
延长寿命3个月？7.9-10.7
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01748.html
FDA Approves Nexavar for Patients with Inoperable Liver Cancer
The U.S. Food and Drug Administration today announced that it has approved Nexavar (sorafenib) for use in patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer.
"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,” said Robert Justice, M.D., director of FDA's division of drug oncology products. "This is an important new treatment option for patients who are fighting this very difficult form of cancer."
According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. This type of cancer can be difficult to remove completely using surgery. If all of the cancer cannot be removed, the disease is usually fatal within three to six months. The American Cancer Society estimates that there will be 19,160 new cases and 16,780 deaths from cancer of the liver and intrahepatic bile duct in the United States in 2007.
Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.
FDA's approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not.
A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.
The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.
The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions. In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo.
Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.
Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach.
Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.
已经在广州举行过上市的发布会会了,商品名：多吉美，适合无法手术切除的进展期肝癌患者，可以向中国红十字会申请免费治疗，其实也就是参与临床试验而已，厂家说的好听，说什么赞助什么的。
我们科也有患者吃，吃够10万，就可以免费终身吃了，至于疗效，谁也不敢说啊。多吉美~~~
我记得是每日两次口服，每次两粒
就是每盒2万5
60粒吃15天
3个月需要15万
之后就免费给药了
商品名多吉美~
这么贵，谁吃得起
"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,”
花了这么多钱也就只延长2.8个月的生命而已！
用过三个原发性肝癌病例,无效!
没什么确切疗效，不给好处谁给开？
每个月一瓶（60片），25192.00 元！！！！！！！
这么贵啊？
真不是一般的贵啊
索拉非尼在国家药监局进口药品数据查询中的信息：
注册证号 H20060296
产品名称（中文） 甲苯磺酸索拉非尼片
产品名称（英文） Sorafenib Tosylate Tablets
商品名（中文） 多吉美
商品名（英文） Nexavar
公司名称（英文） Bayer HealthCare AG
地址（英文） D-51368 Leverkusen
国家（中文） 德国
国家（英文） Germany
剂型（中文） 片剂
规格（中文） 0.2g
包装规格（中文） 60片/盒
发证日期 2006-09-12
有效期截止日 2011-09-11
产品类别 化学药品
世界上最哀伤的事莫过于没钱还得病
穷人得病就眼睁睁等死吧！
多吉美，哼！
大刀兄正解！可是手机可以用山寨的！用着呢，挺好！可是药呢？今年药业外企的生产线可不是一般的忙啊！
怎一个贵字了得!?
哎，有钱真好！
抗癌药索拉非尼是由德国拜耳制药公司和美国生物技术制药企业Onyx药业共同研制开发的。拜耳对这一产品寄予厚望，预计每年将能够为公司创造20亿欧元的销售额。拜耳表示，公司极其重视庞大的中国市场，认为中国医药监管当局的批准对公司有重要意义。据估计，中国目前每年有超过34万人被诊断患有肝癌，而且这一数字还在不断增加。
目前，该产品已经获准在40多个国家和地区销售。
索拉非尼,常规治疗每个月一瓶（60片），25192.00 元，与普通老百姓无缘哪。
高级消费品！
试用过一个鼻咽癌肝转移的病人，没看出任何效果。
索拉非尼,常规治疗每个月一瓶（60片），25192.00 元，与普通老百姓无缘哪。
http://www.hly365.com/service/info/Allinfo.jsp?id=2539
建设具有中国特色的社会主义
去！中国人的钱又要被他们弄去了！
我决定暗中仿制，卖给非洲和拉美的劳苦大众！
秘鲁好像就是拉美的吧。
还没有上市吧，SFDA只批了临床啊！我们也可以做啊！
这个药有专利，大家做不了。
奢侈品哪
太贵了，老百姓那吃的起。
应该是上市了，临床试验据说效果不错。
确实已上市了，8月在广州开的中国上市会，老外来了不少，黑中国人钱啊 。
我也听说过了，不过好像效果不好，摆明了就是赚中国的钱来了嘛
JYHB0800559国 - 在审评 空 2008-8-25 19:20:26 无 无 不收费 空 --- 不需要
看样子，山寨药是必然的选择
没听说过。能真正靶向么？
没听说过。能真正靶向么？
延长寿命3个月？7.9-10.7
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01748.html
FDA Approves Nexavar for Patients with Inoperable Liver Cancer
The U.S. Food and Drug Administration today announced that it has approved Nexavar (sorafenib) for use in patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer.
"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,” said Robert Justice, M.D., director of FDA's division of drug oncology products. "This is an important new treatment option for patients who are fighting this very difficult form of cancer."
According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. This type of cancer can be difficult to remove completely using surgery. If all of the cancer cannot be removed, the disease is usually fatal within three to six months. The American Cancer Society estimates that there will be 19,160 new cases and 16,780 deaths from cancer of the liver and intrahepatic bile duct in the United States in 2007.
Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.
FDA's approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not.
A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.
The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.
The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions. In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo.
Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.
Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach.
Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.
已经在广州举行过上市的发布会会了,商品名：多吉美，适合无法手术切除的进展期肝癌患者，可以向中国红十字会申请免费治疗，其实也就是参与临床试验而已，厂家说的好听，说什么赞助什么的。
我们科也有患者吃，吃够10万，就可以免费终身吃了，至于疗效，谁也不敢说啊。多吉美~~~
我记得是每日两次口服，每次两粒
就是每盒2万5
60粒吃15天
3个月需要15万
之后就免费给药了
商品名多吉美~
这么贵，谁吃得起
"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,”
花了这么多钱也就只延长2.8个月的生命而已！
用过三个原发性肝癌病例,无效!
没什么确切疗效，不给好处谁给开？
每个月一瓶（60片），25192.00 元！！！！！！！
这么贵啊？
真不是一般的贵啊
索拉非尼在国家药监局进口药品数据查询中的信息：
注册证号 H20060296
产品名称（中文） 甲苯磺酸索拉非尼片
产品名称（英文） Sorafenib Tosylate Tablets
商品名（中文） 多吉美
商品名（英文） Nexavar
公司名称（英文） Bayer HealthCare AG
地址（英文） D-51368 Leverkusen
国家（中文） 德国
国家（英文） Germany
剂型（中文） 片剂
规格（中文） 0.2g
包装规格（中文） 60片/盒
发证日期 2006-09-12
有效期截止日 2011-09-11
产品类别 化学药品
世界上最哀伤的事莫过于没钱还得病
穷人得病就眼睁睁等死吧！
多吉美，哼！
大刀兄正解！可是手机可以用山寨的！用着呢，挺好！可是药呢？今年药业外企的生产线可不是一般的忙啊！
怎一个贵字了得!?
哎，有钱真好！