AGX1009。 Agenix将文件在2012年第二季度与中国国家食品药品监督管理局批准正式申请,并预期在2012年底开始第一阶段的人体试验研究。
Sydney, June 8, 2011 (ABN Newswire)
Companies
China-focused drug development and diagnostic company Agenix (ASX:AGX) said that the Company was on track to begin clinical trials in China for its lead Hepatitis B drug, AGX 1009. Agenix will file a formal application with China's State Food and Drug Administration in the second quarter of 2012 and anticipates approval to begin Phase I human studies in late 2012.
AGX1009来自中国的医药生物技术研究所的医疗中国科学院(IMB
)北京.
AGX1009 是一种抗乙肝药物,属于一种名为类新的核苷类似物药物的逆转录酶抑制剂(NtRTI)。对AGX- 1009最接近的竞争对手预计将葛兰素史克/基列的泰诺福韦东风而获得乙肝治疗美国食品和药物管理局批准,可在2008年由中国国家食品药品监督管理局批准的2014年。身体转换成活性化合物,通过与一种酶(乙肝病毒DNA聚合酶),是对乙肝病毒复制所必需的功能干预工程AGX-1009。
AGX Australian listed company.
AGX1009 purchased from China's Institute of Medicinal Biotechnology (IMB) of the Chinese Academy of Medical Sciences in Beijing
AGX-1009 is an anti-Hepatitis B drug that belongs to a new class of drugs called Nucleotide Analogue Reverse Transcriptase Inhibitors (NtRTI). The closest competitor of AGX-1009 is expected to be GSK/Gilead’s Tenofovir DF which obtained US Food and Drug Administration approval for HBV treatment in 2008 and could be approved by China’s State Food and Drug Administration by 2014. The body converts AGX-1009 into an active compound that works by interfering with the function of an enzyme (HBV DNA polymerase) that is essential for the replication of HBV. 作者: 非东亚病夫 时间: 2011-6-8 15:41