[good medicine record] consistency evaluation has been done over and over, 4 + 7 competitive products are hot, the second imported generic drug has successfully passed the test, potential varieties are strong, and

As of September 12, the acceptance number of CDE acceptance consistency evaluation reached 1419 (403 of 416 enterprises are calculated as supplementary applications, the same below); the acceptance number of evaluation has reached 248 (101 varieties) This week (September 6 to September 12, the same below) another 6 varieties have been evaluated, 3 varieties have been approved, and 11 varieties have been undertaken The details of the review include 6 varieties, 4 + 7 competitive products accounted for half of this week's consistency review, 6 varieties of 7 enterprises passed the review, 4 of which are 4 + 7 winning varieties, namely olanzapine tablets, cefuroxime ester tablets, montmorillonite powder, amlodipine besylate tablets Olanzapine is the first atypical antipsychotic drug approved for long-term treatment of schizophrenia, and also the first atypical antipsychotic drug approved for treatment of acute bipolar mania Developed by Lilly, it was approved by FDA in 1996 and imported by China in 1998 At present, the product has passed FDA and EMEA certification in the United States, the United Kingdom, China and other 13 countries around the world This product, which was evaluated by Dr redI Laboratory of India this week, is sold by Pangu pharmaceutical industry as an exclusive agent in the Chinese market It is worth mentioning that this product is the second imported generic drug that has passed the consistency evaluation after the risuvastatin calcium tablet of Sandoz Olanzapine is one of the best-selling drugs in the field of psychiatry At present, the global sales volume of olanzapine has reached US $55 billion According to pharmaceutical intelligence data enterprise version of hospital drug sales data, the domestic hospital sales of olanzapine tablets reached 933 million yuan in 2018 Hausen, as the first domestic imitator of this product, broke the original research barriers, accounting for 50% of the hospital sales Source of figures: up to now, the consistency evaluation of this product has formed a three-way confrontation in the pharmaceutical intelligence data enterprise version of hospital drug sales data, which is the first one passed by hausen Qilu pharmaceutical was approved to produce 6 categories of new chemical drugs in 2018, which is deemed to have been evaluated Now, this product is the third one in India's Dr redI laboratory As a 4 + 7 bid winning competitive product, in the current situation of 4 + 7 expansion and up to three enterprises can win the bid through alliance procurement, Dr redI laboratory in India is expected to win a place by virtue of consistency evaluation Cefuroxime axetil belongs to the second generation of cephalosporin antibiotics It is suitable for upper and lower respiratory tract infections, urinary tract infections, skin and soft tissue infections caused by sensitive bacteria According to the hospital sales data of pharmaceutical intelligence data Enterprise Edition, in 2018, the domestic hospital sales of cefuroxime axetil tablets reached 241 million yuan, of which Suzhou Sinochem accounted for the largest proportion, accounting for 43.96%, followed by GlaxoSmithKline; this week's evaluation of the variety of lithopone europeani only accounted for 0.04% of the hospital sales, through the consistency evaluation, to improve competitiveness, and is expected to expand market share Source of figures: up to now, there are 7 enterprises that have passed the evaluation of cefuroxime ester tablets according to the pharmaceutical intelligence data enterprise version of hospital drug sales data Shantou Jinshi Pharmaceutical Co., Ltd and Zhengda Qingjiang Pharmaceutical Co., Ltd have completed the be test of this variety, and the evaluation may be ready in the near future Simvastatin tablet simvastatin tablet is a blood lipid lowering drug It is suitable for children with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, hyperlipidemia or mixed hypercholesterolemia, homozygous familial hypercholesterolemia, coronary heart disease with hypercholesterolemia, and heterozygous familial hypercholesterolemia Simvastatin was developed by Merck, and was approved for marketing as early as 1989; it was approved for import in 2000 According to IMS data, in 2018, simvastatin's global sales reached US $1.94 billion, of which China's sales reached US $84.6671 million According to the statistics of domestic database of pharmaceutical intelligence, there are 121 domestic market approvals for simvastatin tablets in China, involving 77 manufacturers At present, there are more than 60 enterprises with consistency evaluation reference and filing, and 5 enterprises with application accepted Among them, Haizheng Pfizer is the first to pass the consistency evaluation, and Jingxin pharmaceutical is the second In addition, according to statistics, up to now, six varieties of Jingxin pharmaceutical industry have passed the consistency evaluation Domperidone tablet domperidone tablet is a dopamine receptor antagonist It is a gastrointestinal antispasmodic and gastric motile drug in the national essential drug 2 Catalogue (2018 version), and is widely used in the treatment of nausea and vomiting Developed by Janssen (Janssen), Belgium, in 1978, it was listed in France in 1980 and in China in 1989 In 2018, the domestic hospital sales of Domperidone Tablets reached 104 million yuan, and the original research of Janssen Pharmaceutical accounted for most of the country, accounting for 96.27% Viagra accounted for only 0.08% Source of figures: at present, 22 domestic enterprises have obtained the approval number of Domperidone Tablets in the pharmaceutical intelligence data enterprise version of hospital drug sales data, only 3 of which have applied for conformity assessment Vio pharmaceutical is the first enterprise that has passed the conformity assessment of this product, and it is expected to launch an impact on the original research and expand its market share Montmorillonite powder is a kind of natural montmorillonite powder, which is mainly used for the treatment of acute and chronic diarrhea in adults and children It is the recommended drug for the clinical guide of infectious diarrhea in China This week, Zhejiang hailisheng Pharmaceutical Co., Ltd and Hunan qianjinxiangjiang Pharmaceutical Co., Ltd competed for the evaluation of this variety Up to now, there are 9 enterprises that have been evaluated in montmorillonite powder, which is the second most evaluated variety after amlodipine besylate tablets, with fierce competition Amlodipine besylate tablets amlodipine besylate tablets are mainly used in the treatment of hypertension and coronary heart disease It is the most popular variety for consistency evaluation, and the competition has become white hot Up to now, 11 enterprises have passed the consistency evaluation, no doubt, ranking first in the evaluation list In addition, in addition to the evaluated enterprises, 24 enterprises have accepted the variety by CDE, of which 18 have completed the be test, and it remains to be seen whether all of them have been evaluated The review and approval of three varieties are in the near future Two enterprises or the first one to complete the CDE approval this week have three varieties Risperidone tablets of Changzhou pharmaceutical, ranitidine hydrochloride tablets of Ruiyang pharmaceutical and Mecobalamin tablets of Nanjing Hailing Pharmaceutical Co., Ltd of Yangzi River are all in the state of "certificate preparation completed pending approval" Details of review and approval of this week's conformity assessment Among them, there are three enterprises that have been evaluated for risperidone tablets, namely, Jiangsu Enhua Pharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd and Zhejiang Huahai Pharmaceutical Co., Ltd.; ranitidine hydrochloride tablets have been approved for clinical use before, but have not been evaluated, so it is worth looking forward to whether Ruiyang pharmaceutical Co., Ltd can seize the opportunity to become the first enterprise to fight against the overtone of euripi; Mecobalamin tablets have no enterprise evaluation yet, and Yangzijiang is the first enterprise that has completed the evaluation, and will be passed soon 13 varieties have been applied for acceptance, and Chengdu Yuandong potential varieties have been listed This week, there are 18 acceptance numbers (11 varieties) for consistency assessment undertaken by CDE, among which injection is still the hot spot for application, with 12 acceptance numbers (5 varieties); in addition, there are 3 new acceptance varieties this week, including ibandronate sodium injection of Chengdu Yuandong biopharmaceutical Co., Ltd., sulfadiazine tablets of special pharmaceutical industry and chlorphenamine maleate tablets of Yunnan plant pharmaceutical industry This week's details of the application for acceptance of the conformity assessment focused on ibandronate injection Ibandronate injection is the third generation of bisphosphonates It is mainly used to treat hypercalcemia caused by malignant tumor with or without bone metastasis and osteoporosis in postmenopausal women It was developed by Roche pharmaceutical company in Switzerland and first listed in Germany in 1996 Its trade name is bondronat According to the pharmaceutical intelligence data, there are 17 domestic market approvals for ibandronate injection in China, involving 6 manufacturers At present, only Chengdu Yuandong biopharmaceutical has applied for conformity assessment and has been accepted In recent years, the prevalence of osteoporosis is increasing gradually, and the market potential of drugs is huge According to Zhongkang CMH data, the total market size of osteoporosis drugs in 2016 was 18.2 billion yuan According to the drug sales data of the pharmaceutical intelligence hospital, the sales of this kind of hospital increased year by year from 2016 to 2019 This time, if Chengdu Yuandong biopharmaceutical has passed the evaluation successfully, its market potential will be unlimited Source of figures: Pharmaceutical intelligence data enterprise version hospital pharmaceutical sales data source: enterprise announcement and other network public information statement: this view only represents the author, not the position of pharmaceutical intelligence network, welcome to exchange and supplement in the message area; 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