The first batch of large varieties: Hengrui, Yiling

Source: announcement of listed pharmaceutical companies ▍ finishing: Cypress blue corn The first batch of drugs has been evaluated On November 7, Jiangsu Enhua Pharmaceutical Co., Ltd issued the announcement on clozapine tablets passing the consistency evaluation, announcing that clozapine tablets (25mg) passed the consistency evaluation (suspected to be the first) It is reported that this variety of antipsychotics is mainly used to treat refractory schizophrenia On November 6, Zhejiang Haizheng Pharmaceutical Co., Ltd issued the notice on the conformity evaluation of the company's products anatrazole tablets and letrozole tablets through generic drugs Haizheng said that it was learned through the website of the drug evaluation center of the State Food and drug administration that the company's anatrazole tablets (1mg) and letrozole tablets (2.5mg) have passed the conformity evaluation of the quality and efficacy of generic drugs It is reported that anastrozole tablet is suitable for the treatment of postmenopausal women with advanced breast cancer The original manufacturer of this product is AstraZeneca, and the commodity is raninde It was approved to be imported from China in 1998 Haizheng's anatrazole tablet (1mg) is the second one that has been evaluated, and the first one has been evaluated as Yangtze River Pharmaceutical industry According to the data, manufacturers of the same variety in China include Yangzijiang pharmaceutical, Zhejiang Wansheng pharmaceutical, Chongqing Huabang pharmaceutical and Zhejiang Haizheng In addition, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd and Beijing Yiling Bioengineering Technology Co., Ltd have applied for new category 4 According to statistics, the global sales of anastrozole tablets in 2018 is about 376 million US dollars, of which the sales in China is about 92 million US dollars; the global sales in January June 2019 is about 190 million US dollars, of which the sales in China is about 49 million US dollars (the data is from IMS database) The letrozole tablet (2.5mg) was evaluated by Haizheng The original manufacturer was Novartis, Switzerland It was first approved for listing in the United States in 1997 and approved for domestic import in 2003 Manufacturers of the same variety in China include Hengrui Pharmaceutical Co., Ltd and the company In addition, Beijing Yiling Bioengineering Technology Co., Ltd and Hainan Jinrui Pharmaceutical Co., Ltd have applied for new 4 categories, and Peili pharmaceutical has applied for 5 categories According to statistics, the global sales volume of letrozole tablets in 2018 is about $606 million, of which the sales volume in China is about $149 million; the global sales volume in January June 2019 is about $310 million, of which the sales volume in China is about $78 million (data source: IMS database) On the same day, Jiangsu Hengrui Pharmaceutical Co., Ltd released the announcement on the company's drugs passing the conformity evaluation of generic drugs It said that it had received the approval document of drug supplement application for letrozole tablets approved and issued by the State Food and drug administration, and announced that letrozole tablets (2.5mg) passed the consistency evaluation in the first batch It is reported that in May 2013, the letrozole tablets produced by Hengrui passed the US FDA certification and were approved for sale in the US market It should be noted that Haizheng's announcement shows that the approval document has been posted on the website of the State Food and drug administration, and the approval document for supplementary drug application has not yet been received on the way of mailing So according to the time of receiving the approval, Hengrui is the first On October 6th, Yiling Pharmaceutical Co., Ltd of Shijiazhuang issued the announcement on the conformity evaluation of Ciprofloxacin Hydrochloride Tablets, and received the approval of drug supplement application for Ciprofloxacin Hydrochloride Tablets (0.25g) approved and issued by the State Drug Administration The variety passed the conformity evaluation Ciprofloxacin hydrochloride tablet is an anti infective drug, which is used to treat or prevent the confirmed or highly suspected infection of sensitive bacteria It belongs to the category of national medical insurance catalogue (2019 version) and the category of essential drugs catalogue (2018 version) It was first developed by Bayer company and listed in Germany on January 30, 1987 It is reported that there are 108 domestic production approvals for ciprofloxacin hydrochloride tablets, with Lingdi as the first one On November 5, Lepu (Beijing) Medical Devices Co., Ltd issued the announcement on amlodipine besylate tablets passing the drug consistency evaluation Lepu Pharmaceutical (Beijing), a holding subsidiary of Lepu, received the approval document of supplementary application for drugs on amlodipine besylate tablets (5mg) approved and issued by the State Food and Drug Administration, which has been evaluated.