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法新社:韩国批准销售新的干细胞药物
2012-01-20 00:55:00   来源:法新社   

韩国政府药品监督管理局周四为其所谓的世界上第一个获批的医用干细胞(从其他人收集)的商业销售扫清了道路。

由汉城Medipost公司开发的Cartistem,来源于新生儿脐带血干细胞,将有助于膝盖软骨的再生,韩国食品和药物管理局说。

"Cartistem是世界上第一个获批的异体(从同一物种的不同个体采集)干细胞药物,可以为退行性关节炎患者提供新的治疗机遇,"管理局在一份声明中说。

Medipost说,从2001年以来已从私人投资者和政府基金获得27亿韩币(合2380万美元)资金用于开发Cartistem,该药物可通过手术注射到患者的膝盖。

声明中称,自去年以来,Cartistem在美国已经正在进行临床实验。

两个世界排名前十的制药公司正在洽谈寻求一个世界范围内的药品生产许可证,Medipost发言人告诉法新社记者,并补充说一个涉及一大批人的最终试验可能会于2015年在美国开展。

(c)2012法新社(生物谷bioon.com)

S. Korea approves sales of new stem cell drug

January 19, 2012

South Korea's government drug agency cleared the way Thursday for commercial sales of what it called the world's first approved medicine using stem cells collected from other people.

Cartistem, developed by Seoul-based Medipost, will help regenerate knee cartilage using stem cells developed from newborns' umbilical cord blood, the Korea Food and Drug Administration said.

"Cartistem is... the world's first approved allogeneic (taken from different individuals of the same species) stem cell drug, that can offer new opportunity for treatment of patients with degenerative arthritis," the administration said in a statement.

Medipost said 27 billion won ($23.8 million) from private investors andgovernment funds had been invested to develop Cartistem since 2001. The drug can be injected into a patient's knees via surgery.

Clinical trials have been under way in the United States since last year, the statement said.

Two of the world's top 10 drugmakers are in talks to seek a worldwide licence to make the drug, a Medipost spokesman told AFP, adding that final trials involving a large number of people would likely begin in the US in 2015.

(c) 2012 AFP

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