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首页> 外文期刊>Asia-Pacific Biotech News >SFDA grants approval for clinical studies to Benapenem
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SFDA grants approval for clinical studies to Benapenem

机译:SFDA批准Benapenem进行临床研究

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摘要

Sihuan Pharmaceutical Holdings Group Ltd., a leading pharmaceutical company with the largest cardio-cerebral vascular ("CCV") drug franchise in China's prescription market, announced that the active pharmaceutical ingredients of and injection form ofBenapenem, being a Category 1.1 new drug developed by the KBP Biosciences Pharmaceutical Technical Co., Ltd, a wholly-owned subsidiary of Sihuan Pharmaceutical, received the Approval for Clinical Studies (2012L02703, 2012L02697) from the State Food and Drug Administration. Phase I of clinical studies are set to begin in the first half of this year. The drug has been patented in China and the United States. It is the third Category 1 innovative drug for which the Company has received Approval for Clinical Studies.
机译:四环医药控股集团有限公司是中国处方药市场上拥有最大心脑血管(“ CCV”)药品特许经营权的领先制药公司,该公司宣布,贝那培南的活性药物成分和注射剂形式,是由以下公司开发的1.1类新药:四环制药的全资子公司KBP生物科学制药技术有限公司获得了国家食品药品监督管理局的临床研究批准(2012L02703、2012L02697)。临床研究的第一阶段将于今年上半年开始。该药已在中国和美国获得专利。这是公司已获得临床研究批准的第三类1类创新药物。

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