根据协议，三星Bioepis将负责临床前和临床研究、过程开发和制造、临床试验和注册，而Merck将负责商业化。 

 三星Bioepis是三星 旗 下 三 星 生 物 (SamsungBiologics)与全球生物技术产业巨擘百健艾迪 (BiogenIdec)成立的合资公司，致力于生物仿制药的发展。在生物制药领域，三 星 去年与昆泰(QuintilesTransnationalCorp.)2.6亿美元合资建厂进军生物制药业，将生产的药品拓展至类似美罗华(Rituxan)等生物制剂领域。 

甘精胰岛素注射液（来得时Lantus）是Sanofi公司销售最好的一种口服糖尿病药物。2013年Lantus的全球销售额达到78.63亿美元，然而其专利许可将在2015年到期，U300的出现可能帮助Sanofi公司继续保持在该市场的龙头位置。
 

通用名：甘精胰岛素注射液

商品名：来得时

英文名：Insulin glargine injection

汉语拼音：Gan Jing Yi Dao Su Zhu She Ye

主要成份：甘精胰岛素

化学名称：21A－Gly-30B a-L-Arg-30Bb-L-Arg-人胰岛素

赋形剂：氯化锌，M－甲酚，甘油，盐酸，氢氧化钠，注射用水

其结构式为：

分子式：C267H404N72O78S6

分子量：6063
   

  制造商 ： 安万特医药

SAMSUNG BIOEPIS AND MERCK ENTER WORLDWIDE COLLABORATION  

AGREEMENT TO DEVELOP AND COMMERCIALIZE BIOSIMILAR INSULIN

GLARGINE CANDIDATE FOR DIABETES

Seoul, Korea and WHITEHOUSE STATION, N.J. – Feb 11, 2014 – Samsung Bioepis Co., Ltd.,  

and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced  

today that they have expanded their collaboration with an agreement to develop, manufacture

and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with

type 1 and type 2 diabetes. Phase III clinical studies in type 1 and type 2 diabetes will begin soon.  

“Samsung Bioepis is very pleased to extend the biosimilar partnership with Merck to the field of

diabetes,” said Christopher Hansung Ko, Ph.D., CEO of Samsung Bioepis. “This collaboration

will bring better access to patients with diabetes worldwide.”  

“We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as

diabetes is a top priority for the company,” said Matt Strasburger, senior vice president, Diabetes,

Global Human Health, Merck. “Merck is strengthening its leadership in diabetes through our

own work and in collaboration with others, and this agreement will help build our portfolio  

across the spectrum of the disease.”  

Under the terms of the agreement, the companies will collaborate on clinical development,  

regulatory filings and manufacturing. If approved, Merck will commercialize this candidate. This  

collaboration builds on the agreement made by the two companies in February 2013 to develop

and commercialize multiple biosimilar candidates.

About Samsung Bioepis Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, aims to develop

affordable and high-quality biopharmaceutical and biosimilar products. For more information,

please visit www.samsungbioepis.com

About Merck Today's Merck is a global healthcare leader working to help the world be well. Merck is known  

as MSD outside the United States and Canada. Through our prescription medicines, vaccines,

biologic therapies, and consumer care and animal health products, we work with customers and  

operate in more than 140 countries to deliver innovative health solutions. We also demonstrate

our commitment to increasing access to healthcare through far-reaching policies, programs and  

partnerships. For more information, visit www.merck.com and connect with us on Twitter,

Facebook and YouTube,

关键词： Merck 三星 Bioepis 甘精胰岛素 Lantus 仿制药

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