绿十字计划免疫球蛋白的2期试验

StephenW

Green Cross plans phase 2 trial of immunoglobulin
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Hepatitis B therapy to be tested for liver transplant patients

By Jung Min-ho

Green Cross has received approval from the Ministry of Food and Drug Safety to develop what the company says is the world's first genetically recombined hepatitis B antibiotic therapy, in the form of an artificial immunoglobulin.

Unlike existing immunoglobulin, which comes from plasma from donated blood, the new product is purer and will therefore act faster and require lower doses to achieve the same effects, the company said.

In a statement issued Wednesday, the company said it had received the green light for a phase 2 clinical trial of the new drug, Hepabig-Gene, which will involve patients recovering from liver transplants.

If the project succeeds, Green Cross will become an influential player in the world market for hepatitis B treatments.

"The initiation of the clinical trial is an important step forward," Ji Hyi-jeong, senior vice president of Green Cross, said. "If Hepabig-Gene is proven safe and effective, it will be the first recombinant Hepatitis B [immunoglobulin] and an alternative treatment choice for physicians and their patients who undergo [the most common kind of] liver transplantation."

Both the European Medicine Agency and the U.S. Food and Drug Administration granted orphan drug designation for Hepabig-Gene last year.

Orphan drugs are drugs developed specifically to treat rare conditions, making them less profitable to develop under normal market conditions, so manufacturers may be eligible for assistance in bringing these new drugs to market.

Although hepatitis B is a global public health issue, affecting up to 350 million people worldwide, patients recovering from liver transplants represent a small group who lack the purchasing power to create a new market.

Chronic hepatitis B patients face a considerably increased risk of developing cirrhosis (a disease in which scar tissue and nodules replace liver tissue) and hepatocellular carcinoma (the most common type of liver cancer).

Liver transplantation is the usual treatment for patients with liver failure and hepatocellular carcinoma. About 700 liver transplants are performed annually in Korea alone.

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StephenW

绿十字计划免疫球蛋白的2期试验
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乙肝治疗的肝移植患者进行测试

由郑民浩

绿十字已收到食品药品安全部批准制定了该公司说是世界上第一个基因重组乙肝抗生素治疗，在人工免疫球蛋白的形式。

不像现有的免疫球蛋白，它来源于从捐献血浆，该新产品是更纯的，因而将作用更快，并且需要较低的剂量，以达到相同的效果，该公司表示。

在周三发布的声明，该公司表示，它已经收到了绿灯新药，Hepabig-基因，这将涉及到病人的肝脏移植康复的2期临床试验。

如果项目成功，绿十字会成为一个有影响力的球员，在世界市场上对乙肝的治疗。

“临床试验的启动是向前迈出的重要一步，”吉HYI贞，绿十字的高级副总裁说。 “如果Hepabig - 基因被证明是安全和有效的，这将是第一个重组乙肝[免疫球蛋白]和另一种治疗选择医生和患者接受谁[中最常见的一种]肝移植。”

无论是欧洲医药局和美国食品和药物管理局核准孤儿药的Hepabig-Gene的最后一年。

孤儿药是专门开发用于治疗罕见病症的药物，使他们少在正常的市场条件下，开发利润，所以厂家可能有资格申请在将这些新药推向市场的援助。

虽然乙肝是一个全球性的公共卫生问题，影响了全世界3.5亿人，患肝移植康复代表谁缺乏购买力来创造一个新的市场一小群。

慢性乙型肝炎患者面临发展为肝硬化（一种疾病，其中疤痕组织和结节取代肝组织）和肝细胞癌（肝癌最常见的类型）的显着增加的风险。

肝移植是治疗肝衰竭和肝癌的常规治疗。约700例肝脏移植手术在韩国每年仅。

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