GC Pharma确认新的蛋白疗法治疗乙型肝炎的2/3期临床试验

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GC Pharma Confirms Phase 2/3 Clinical Trial of New Protein Therapy for Hepatitis B

First Recombinant Treatment for Most Common Liver Transplantation Risk

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YONGIN, South Korea, Jan. 17, 2018 /PRNewswire/ -- GC Pharma (formerly known as Green Cross Corporation) (KRX: 006280), a South Korean biopharmaceutical company, today announced that it will proceed with a Phase 2/3 clinical trial for GC1102 (also known as Hepabig-gene), the company's investigational recombinant hepatitis B immune globulin for preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation.

HBV infection remains a major global issue, affecting up to 350 million people world-wide. Chronic hepatitis B patients are at considerably high risk for the development of cirrhosis and hepatocellular carcinoma. Liver transplantation is the treatment option for patients with liver failure and hepatocellular carcinoma. Approximately 1400 liver transplants are performed annually in South Korea alone. In the absence of prophylaxis or treatment, HBV reinfection and hepatitis B recurrence occurs in 80% of people who undergo orthotopic liver transplantation within 6 months.

"Currently available treatments that are effective for hepatitis B recurrence following liver transplantation are hepatitis B immune globulin derived from human plasma. GC1102 - does not contain plasma-based additives - may offer innovative and more effective alternatives, as there are no other recombinant treatments available," said EC Huh, Ph. D., president of GC Pharma. "We believe GC1102 has potential to change the current treatment paradigm for hepatitis B patients."

The clinical 2/3 trial is expected to take around 5 years to complete, with patient enrollment beginning in early 2018.

About GC Pharma

GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, GC Pharma is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions more than half a century. Green Cross Corporation updates its corporate brand as GC Pharma in early 2018. Green Cross Corporation remains the company's registered, legal name.

This release includes forward-looking statements, which express the current beliefs and expectations of GC Pharma's management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE GCPharma

StephenW

GC Pharma确认新的蛋白疗法治疗乙型肝炎的2/3期临床试验

第一次重组治疗最常见的肝移植风险

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新华美通纽约永仁2018年1月17日电/新华美通/ - 韩国一家生物制药公司GC Pharma（前身为Green Cross Corporation）（KRX：006280）今天宣布，将进行2/3期临床该公司的研究重组乙型肝炎免疫球蛋白GC1102（也被称为Hepabig-gene）用于预防肝移植后乙型肝炎病毒（HBV）感染复发。
GCPharma标志
GCPharma标志

HBV感染仍然是一个重大的全球性问题，影响全球3.5亿人口。慢性乙型肝炎患者发生肝硬化和肝细胞癌的风险相当高。肝移植是肝衰竭和肝细胞癌患者的治疗选择。仅在韩国就每年进行大约1400次肝移植手术。在没有预防或治疗的情况下，在6个月内进行原位肝移植的人中有80％发生了HBV再感染和乙肝复发。

“目前可用于治疗肝移植后乙型肝炎复发的治疗方法是乙型肝炎免疫球蛋白来源于人类血浆，GC1102-不含基于血浆的添加剂 - 可能提供创新和更有效的替代方案，因为没有其他可用的重组治疗方法，“GC Pharma总裁EC Huh博士说。 “我们认为GC1102有可能改变目前乙型肝炎患者的治疗范式。”

预计2/3的临床试验将需要大约5年的时间才能完成，患者入学时间为2018年初。

关于GC Pharma

GC Pharma（前身为Green Cross Corporation）是一家生物制药公司，提供拯救生命和维持生命的蛋白质疗法和疫苗。 GC Pharma总部位于韩国，是亚洲最大的血浆蛋白制品生产商，半个多世纪以来一直致力于提供优质的医疗保健解决方案。绿十字公司在2018年初更新其公司品牌GC Pharma。绿十字公司仍然是公司注册的法定名称。

本新闻稿包含前瞻性陈述，表达了GC Pharma管理层目前的信念和期望。此类陈述仅表示自作出之日起，本公司不承担更新或修改任何前瞻性陈述的义务，无论是由于新信息，未来事件还是其他原因。

来源GCPharma