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肝胆相照论坛 论坛 学术讨论& HBV English 存档 1 喜讯!克拉夫定在韩国批准上市
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喜讯!克拉夫定在韩国批准上市 [复制链接]

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发表于 2006-11-30 04:44
发贴心情
喜讯!克拉夫定在韩国批准上市

   克拉夫定商品名称为Levovir  ,克拉夫定是一种强力的抗乙肝病毒药物

网址 http://news.google.com/nwshp?ie=UTF-8&oe=UTF-8&hl=en&tab=wn&q=clevudine 有三条信息,看第二,三条。

补充:克拉夫定抗乙肝病毒能力超过目前任何一种药物,可以有效减少covalently closed
circular dna, 或者 cccdna。
停药后具有持续抗病毒能力,不反弹。

内容 :S. Korea's Bukwang Pharm given green light to sell new anti-hepatitis drug
   

SEOUL, Nov. 13 (Yonhap) -- Bukwang Pharmaceutical Co, a South Korean drugmaker, obtained the green light Monday from local drug authorities for the sale of its new hepatitis B treatment drug after nearly 10 years of development, the company said.

The Korea Food and Drug Administration approved the local release of Levovir in which the company has invested 90 billion won (US$96 million), Bukwang said. The company said the medicine has proved to be effective in suppressing 92 percent of hepatitis B viruses within patients.

Levovir's main ingredient is Clevudine, a powerful anti-hepatitis chemical substance developed in 1995 in the U.S., for which Bukwang won exclusive rights for development and sales.

The product is the 11th breakthrough medicine produced in South Korea.

Bukwang said clinical tests with more than 130 patients in more than six countries, including the U.S., Germany and France, have produced outstanding results with no side effects.

Despite the long-waited approval, Bukwang has yet to schedule the release of the capsules in the local market as it depends on how the drug is rated under the country's new drug insurance policy.

Seoul plans to revise its drug policy plan so new drugs will not automatically be placed on a list of "positive drugs" for which people can be reimbursed under related insurance policies.

New drugs will require strict mandatory screening by the Health Ministry to check their cost-effectiveness. More expensive products will have a smaller chance of being included on the list granting reimbursement privileges.

SEOUL, Nov. 13 (Yonhap) -- Bukwang Pharmaceutical Co, a South Korean drugmaker, obtained the green light Monday from local drug authorities for the sale of its new hepatitis B treatment drug after nearly 10 years of development, the company said.

The Korea Food and Drug Administration approved the local release of Levovir in which the company has invested 90 billion won (US$96 million), Bukwang said. The company said the medicine has proved to be effective in suppressing 92 percent of hepatitis B viruses within patients.

Levovir's main ingredient is Clevudine, a powerful anti-hepatitis chemical substance developed in 1995 in the U.S., for which Bukwang won exclusive rights for development and sales.

The product is the 11th breakthrough medicine produced in South Korea.

Bukwang said clinical tests with more than 130 patients in more than six countries, including the U.S., Germany and France, have produced outstanding results with no side effects.

Despite the long-waited approval, Bukwang has yet to schedule the release of the capsules in the local market as it depends on how the drug is rated under the country's new drug insurance policy.

Seoul plans to revise its drug policy plan so new drugs will not automatically be placed on a list of "positive drugs" for which people can be reimbursed under related insurance policies.

New drugs will require strict mandatory screening by the Health Ministry to check their cost-effectiveness. More expensive products will have a smaller chance of being included on the list granting reimbursement privileges.

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发表于 2006-11-30 22:47

有关网页http://www.drugnewswire.com/7963/

http://www.drugnewswire.com/7963/

"In this study, 31% of HBeAg+ patients and 92% of HBeAg -- patients have undetectable HBV 12 weeks after the end of treatment," stated Schaefer Price, Pharmasset's President & CEO

翻译:12周后,31%的e抗阳和92%e抗阴患者HBV(DNA?)转阴。

真是大大的优于现有的药物啊!不知道这韩国人会不会和我国人一样喜欢伪造数据。

新药多起来!

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发表于 2006-12-1 00:40
韩国人造假从那个韩国克隆技术之父可做典型了.
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