Among them, 2 are new drugs and 7 are the first in China
Beijing (reporter Chen Yanfei) the State Drug Administration recently issued an announcement to verify the clinical trial data of 15 drug registration applications that have completed the clinical trial application. Among them, 2 are new drugs and 7 are the first in China.
The two new drug applications were total alkaloid tablets of Ramulus Mori and recombinant human tripatide for injection. Sangzhi total alkaloid tablets are mainly used to treat diabetes. It is reported that the product is a new traditional Chinese medicine developed by the Institute of pharmacy, Chinese Academy of Medical Sciences for 14 years and transferred to Beijing Wuhe Boao Pharmaceutical Co., Ltd. in 2010.
In addition, amlodipine atorvastatin calcium tablets of Beijing Jialin Pharmaceutical Co., Ltd. (2 specifications), salmeterol fluticasone powder inhalation (2 specifications) of Zhengda Tianqing Pharmaceutical Group Co., Ltd., exenatide injection (2 specifications) of Qinghai ChenFei Pharmaceutical Co., Ltd., and sinacasol hydrochloride tablets (1 specification) of Jiangsu Jiayi Pharmaceutical Co., Ltd. are also available The data of this clinical trial will be checked. At present, amlodipine atorvastatin calcium tablets, salmeterol fluticasone powder inhalant, exenatide injection, and cinacacet hydrochloride tablets are not on the market.
It is understood that amlodipine and atorvastatin calcium tablets are developed by Pfizer in the United States. According to public information, the sales revenue of amlodipine and atorvastatin calcium tablets of Pfizer in China was about 160 million yuan in 2015.
Salmeterol fluticasone powder inhalation was initially developed by GlaxoSmithKline. Relevant reports showed that due to high technical barriers, many enterprises failed to challenge the imitation of the drug. It wasn't until February this year that mylan announced the launch of seretide generic, wixela inhub (fluticasone / salmeterol) in the United States. In December 2018, Zhengda Tianqing's salmeterol fluticasone powder inhalation was listed in the priority review list because it was a major special project.
Exenatide injection is a product developed by AstraZeneca. In October 2018, exenatide injection of Qinghai ChenFei Pharmaceutical Co., Ltd. was listed in the priority review list.
Cinacacet hydrochloride tablets were previously produced by kylin Co., Ltd. In October 2018, sinakase hydrochloride tablets of Jiangsu Jiayi Pharmaceutical Co., Ltd. were listed as the priority review varieties.