[good medicine record] consistency evaluation of imported generic drugs is coming, the first one has been evaluated; new application of 18 varieties, Yangzijiang, Hengrui, hausen, Yuandong Biology

Up to now, the acceptance number of CDE acceptance consistency evaluation has reached 1087 (calculated by supplementary application, the same below), involving 333 varieties of 344 enterprises, of which 195 acceptance numbers (92 varieties) have passed In the two weeks before and after May 1, 6 varieties had been evaluated, and the application of No 25 acceptance No 18 varieties was accepted The popularity of metformin hydrochloride tablets, amlodipine besylate tablets and other varieties remained unchanged More attention was paid to the anti-tumor drugs and orphan drugs of Yangzi River, Hengrui, hausen, Yuandong biology and other enterprises 01 details of review 6 varieties of review, the first imported generic drugs listed In the two weeks after the festival, from April 25 to May 8, the consistency evaluation was steadily promoted A total of 6 varieties passed the consistency evaluation, including the popular varieties such as rosuvastatin calcium tablets, metformin hydrochloride tablets and metformin hydrochloride sustained-release tablets, as well as the first evaluated varieties such as trimetazidine hydrochloride tablets and candesartan ester tablets The details are as follows: Table 1 Details of consistency evaluation in recent two weeks Among them, rosuvastatin calcium tablet produced by Sandoz (China) is the first imported drug that has passed the consistency evaluation in China, which is regarded as a milestone event of imported generic drugs in China market Meanwhile, it means that imported generic drugs also need consistency evaluation, and the country begins to re evaluate the layout of imported generic drugs Rosuvastatin is a relatively new type of statins, a selective HMG CoA reductase inhibitor, which can be used to treat primary hypercholesterolemia (type IIA, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIB) Initially developed by AstraZeneca in the UK, it was approved to be listed in the United States in 2003; in 2006, it was approved to enter China with the trade name of Crestor Domestic imitated products were first approved for listing in 2008 At present, Sanders has been included in the catalogue of Chinese listed drugs At the same time, according to the registration and acceptance data of smart drugs, the consistency evaluation of Shanghai Novartis trade, a subsidiary of Novartis group, has also been evaluated recently So far, there are seven enterprises that have passed the consistent performance evaluation of rosuvastatin calcium tablets, with fierce competition Table 2 details of consistency evaluation of rosuvastatin calcium tablets (Note: the above varieties belong to the enterprise) In addition to rosuvastatin calcium tablets, metformin hydrochloride also deserves attention recently Metformin tablets and sustained-release metformin tablets of Shanghai Xinyi Tianping Pharmaceutical Co., Ltd and Beijing Wanhui Shuanghe Pharmaceutical Co., Ltd have broken the tripartite balance of the evaluated enterprises and become the fourth through enterprise; metformin hydrochloride tablets of Shenzhen Zoomlion Pharmaceutical Co., Ltd., yuekang Pharmaceutical Co., Ltd and Tianjin Zhongxin Pharmaceutical Co., Ltd In the near future, the report was accepted According to the pharmaceutical intelligence data, at present, in addition to the four evaluated enterprises, 21 enterprises have applied for acceptance of metformin hydrochloride tablets; surprisingly, Shanghai Shiguibao Pharmaceutical Co., Ltd of China and the United States also has two acceptance number application consistency evaluation, which is the original research and development product Recently, one of the processing status is displayed as "issued document"; however, it is confirmed that the acceptance number of the issued document has not been approved for evaluation, and the specific reason is not clear Table 3 details of consistency evaluation of metformin hydrochloride tablets of Shanghai Squibb Pharmaceutical Co., Ltd of China and the United States In the past two weeks, 18 varieties (25 acceptance numbers) of conformity assessment applications from 21 enterprises have been accepted, among which 6 varieties are the first ones, namely, Paclitaxel injection from Yangtze River, caffeine citrate injection from Yuandong biology, non Brest tablet from Hengrui, voglibose tablet from Suzhou Sinochem, piracetam tablet from Jiangxi Yiyou Pharmaceutical Co., Ltd and card from Shanghai Fudan Fuhua Pharmaceutical Co., Ltd Maxipine film Table 4 details of application acceptance of consistency evaluation in recent two weeks note: red font is the first application acceptance variety, focusing on Paclitaxel injection in Yangtze River, caffeine citrate injection in Yuandong biology, and non Bustan tablets in Hengrui Paclitaxel is the largest anti-tumor drug in the world It is recognized that paclitaxel is a diterpenoid alkaloid with anticancer activity Its chemical structure is novel and complex, its biological activity is extensive and significant, its mechanism of action is brand-new and unique, and its natural resources are scarce Paclitaxel injection is widely used in the first-line and second-line anti-cancer treatment of ovarian cancer, breast cancer, lung cancer and esophageal cancer It is recommended by China Anti Cancer Association It is jointly developed by Institute of toxicants and drugs of Chinese Academy of Military Medical Sciences and Sichuan Institute of traditional Chinese medicine It is the first domestic anti-tumor drug According to the database of home-made drugs of pharmaceutical intelligence, at present, there are 65 domestic market approvals for Paclitaxel injection, 44 manufacturers, and only Yangzijiang Pharmaceutical Co., Ltd applies for acceptance of conformity assessment Caffeine citrate injection is used to treat primary apnea of premature newborn The original research company is Cayce pharmaceutical company of Italy It was approved in France at the end of 1997 for the treatment of apnea of prematurity newborn In September 1998, it obtained the qualification of orphan drug in the United States On September 21, 1999, it was approved by the FDA of the United States At present, the drug has been used as the first choice drug in clinical treatment of apnea of prematurity in Europe and the United States Foreign pediatric textbooks also use coffee citrate Because the preparation is included in the treatment of premature infants with apnea the primary drug Up to now, there are only three domestic caffeine citrate injection enterprises, including Chengdu Yuandong bio, Shanxi Guorun pharmaceutical and Guorui pharmaceutical The first application consistency evaluation of Chengdu Yuandong bio has been accepted As an inhibitor of xanthine oxidase (XO), febuxostat is suitable for the long-term treatment of hyperuricemia with gout symptoms Developed by Japanese Imperial Pharmaceutical Co., Ltd., it has been listed in more than 70 countries and regions such as the United States, Europe, Japan, etc on September 4, 2018, the domestic original research products were approved for listing, and anstar pharmaceutical won the exclusive sales right in China Although the original research began to be officially sold in China this year, three domestic generic pharmaceutical enterprises of this variety have been approved for listing, namely Hangzhou zhuyangxin Pharmaceutical Co., Ltd., Jiangsu Wanbang Biochemical Pharmaceutical Co., Ltd and Jiangsu Hengrui Pharmaceutical Co., Ltd., and the varieties of these three enterprises have been included in the national medical insurance class B drug catalog This time, Hengrui took the lead, and the first application for conformity evaluation was accepted If it goes well, it will be accepted Review, will challenge the original R & D, carve up a larger share of the market share Part of the information source: yaozhi.com, yaorongquan.com, announcement of related enterprises and other 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