[good medicine record] the birth of the second supplementary application for injection? Jingxin and Hanyu pharmaceutical industry are famous for their unique and first imitated products

As of October 24, the acceptance number of CDE acceptance consistency evaluation reached 1523 (425 varieties of 440 enterprises) According to the supplementary application, the same below); 265 (109 varieties) have been evaluated and accepted From October 17 to October 24, 1 variety was evaluated, 18 varieties were undertaken, including the exclusive dosage form of statins in Beijing new pharmaceutical industry and the first heavy imitation of Hanyu pharmaceutical industry For details of the evaluation, 5 varieties of Tianshili have been accepted, and 1 of the 2 varieties has passed the consistency evaluation this week (October 17 to October 24), which is the right zopiclone of Tianshili Diyi Youzopiclone tablet is a new generation of non benzodiazepine sedative hypnotics According to the data of pharmaceutical intelligence, at present, there are three listed enterprises in China: Jiangsu tianshidiyi Pharmaceutical Co., Ltd., Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd and Chengdu Kanghong Pharmaceutical Co., Ltd., but the market share of sample hospitals is occupied by Jiangsu tianshidiyi Pharmaceutical Co., Ltd., accounting for 96.26% According to the progress database of consistency evaluation of pharmaceutical intelligence, at present, the consistency evaluation of this variety of three enterprises has been applied for acceptance and the be test has been completed, and Tianshi is the first to pass the consistency evaluation It is worth mentioning that up to now, only 5 varieties have been applied for conformity evaluation by tisley group, including 1 in Tianjin and 4 in Jiangsu Youzopiclone is the second one that passed the conformity evaluation Tianshili drug consistency evaluation details approval completed 5 varieties approval completed, the second supplementary application was born? This week, the consistency evaluation and approval of five varieties have been completed, among which three varieties of mannitol injection, cefaclor capsule and oral rehydration salt powder (III) have not been evaluated by the enterprise, which means that they are the first ones to be approved Details of approval of this week's conformity assessment It is worth noting that the mannitol injection of Shandong Qilu Pharmaceutical Co., Ltd was approved as soon as the technical guidance document for conformity assessment was issued, and the application for conformity assessment of the variety was accepted in July this year Now, the application status has been in the form of "certificate preparation completed - to be issued for approval", only 3 months to complete the examination and approval, confirm to pass the conformity assessment? Become the second variety evaluated according to the consistency evaluation of quality and efficacy of generic drugs? rub one's eyes and wait 18 varieties applied for acceptance have been undertaken, and the exclusive and first imitated drugs are again eye-catching This week, CDE added 20 new compliance assessment application acceptance numbers (18 varieties), among which 5 varieties were the first drugs to be applied this week, namely, pivastatin calcium dispersible tablets of Beijing New Pharmaceutical Co., Ltd., flunarizine hydrochloride tablets of Weifang Zhongshi Pharmaceutical Co., Ltd., isosorbide mononitrate sustained release capsule of Zhuhai Rundu Pharmaceutical Co., Ltd., losartan potassium hydrochlorothiazide tablets of Lepu Pharmaceutical Co., Ltd and injection specialty of Shenzhen Hanyu Pharmaceutical Co., Ltd Vasopressin Details of application acceptance of this week's consistency evaluation note: the red part is the first application of drugs this week, focusing on the exclusive dosage form of pevastatin calcium dispersible tablets and the first generic terlipressin for injection of Hanyu pharmaceutical Pivastatin calcium dispersible tablet is the third generation of statins, the latest generation of super statins, used to treat hypercholesterolemia and familial hypercholesterolemia According to the pharmaceutical intelligence data, there are only 13 market approvals (including APIs) for domestic pivastatin calcium, and only two dosage forms are tablets and dispersions In 2018, the sales volume of the domestic sample hospital of the drug was 9.4272 million yuan, and the main market share was occupied by Xinghe Co., Ltd., accounting for 77.62%, followed by China Resources Shuanghe Co., Ltd., accounting for 22.28% In addition, pivastatin calcium dispersible tablets of Beijing New Pharmaceutical Co., Ltd are the only pivastatin calcium dispersible tablets on the market in China According to the report of Beijing New Pharmaceutical Co., Ltd in the first half of 2019, the sales of pivastatin calcium dispersible tablets of Beijing New Pharmaceutical Co., Ltd reached 129 million yuan in the first half of 2019, a year-on-year increase of 153%, showing a significant volume Now the application for conformity evaluation is accepted, further improving the competitive strength of products Terlipressin for injection terlipressin is a synthetic vasopressin analogue, which belongs to vasoconstrictor in vasoactive drugs and is mainly used for hemostasis of varicose hemorrhage in cirrhosis The original research enterprise is Huiling In 2009, Hanyu Pharmaceutical Co., Ltd was listed as the first imitated company, interrupting the monopoly of the original research enterprise in China According to the financial report of Hanyu pharmaceutical, in 2018, the sales volume of terlipressin for injection reached 194 million, which is one of the main products contributing the largest revenue of the company; in the first half of 2019, the sales revenue reached 95.46 million yuan, a year-on-year decrease of 22.65%; the reason for the decline was that hanyu pharmaceutical explained that it was mainly to cooperate with provinces and regions to gradually start the bidding work in 2019 , as well as the impact of GPO centralized procurement According to pharmaceutical intelligence data, at present, only two enterprises, Huiling (China) and Hanyu, have obtained production approval documents in the domestic market of the product, among which the sales of sample hospitals are mainly occupied by Hanyu pharmaceutical industry, accounting for 89.54% Now, under the condition that the consistency evaluation is officially started and will be accelerated, the application consistency evaluation of Hanyu pharmaceutical industry is accepted If the evaluation is successful, it will further improve the competitive strength, expand the market share of the hospital terminal market, replace the original research, and change the current sales decline trend For more information about consistency evaluation, please click the link "https://news.yaozh.com/" to enter the consistency evaluation and analysis system of pharmaceutical intelligence data, one click search, intelligent analysis, clear and intuitive access to the details of each drug progress, competition situation ~ data source: Pharmaceutical intelligence data, enterprise announcement and other network public data Information source: penicillin statement of Internet public information such as yaozhi.com, enterprise announcement, Baidu Encyclopedia, etc.: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.