[good medicine] the second best-selling medicine in the world, the third one in Kelun Pharmaceutical Co., Ltd. has been appraised; Huahai 4 + 7 varieties have entered the Bureau strongly; Hengrui has made its first imitation

As of November 14, the acceptance number of CDE acceptance consistency evaluation reached 1569 (435 varieties of 447 enterprises) According to the supplementary application, the same below); 288 (116 varieties) have been evaluated and accepted This week (November 7-14), there are 5 varieties of products that have been evaluated, three of the world's best-selling drugs apixaban tablets are full, and the fourth one of the 4 + 7 varieties of escitalopram oxalate tablets in Huahai pharmaceutical industry has been evaluated; eight varieties have been undertaken, and Hengrui has made the first imitation and re listed There are 5 varieties of over evaluation details, 4 + 7 varieties and one more competitor This week, there are 5 varieties of over evaluation Among them, there are 2 first over evaluation varieties According to the approval of new chemical drug registration and listing, there are 2 approved ones They are apixaban tablets of Kelun pharmaceutical and escitalopram oxalate tablets of Huahai pharmaceutical In this week's consistency evaluation table, Nateglinide is a non sulfonylurea insulin secretion promoting agent, which can be used alone in type 2 diabetic patients who can not effectively control hyperglycemia through diet and exercise It can also be used in type 2 diabetes patients who can not effectively control hyperglycemia with metformin It can be used in combination with metformin, but it can not replace metformin Nateglinide is not suitable for the treatment of type 2 diabetes mellitus patients with unsatisfactory sulfonylureas Nateglinide tablets were jointly developed by Ajinomoto Co., Ltd and Astaire Pharmaceutical Co., Ltd and approved for listing in Japan in 1999 After that, Novartis obtained the right to hold the marketing license of the drug, which was approved by FDA in December 2000, and approved by EU in April 2001 In 2003, Beijing Novartis Pharmaceutical Co., Ltd obtained the approval of domestic market According to the data, at present, there are 36 market approvals for domestic nateglinide tablets, involving 24 manufacturers In 2018, the sales volume of domestic sample hospitals reached 107 million yuan, of which nearly 90% were occupied by Novartis and only 0.15% by Deyuan pharmaceutical However, at present, only the application for consistency evaluation of this variety in Deyuan pharmaceutical industry has been accepted and the first one has been evaluated Can we take this opportunity to launch an impact, challenge the original research and wait for the aftereffect Amoxicillin capsule amoxicillin belongs to penicillin broad-spectrum β - lactam antibiotics It is the national class a medical insurance and the national basic drug list drug in 2018 At present, there are 239 approval documents for amoxicillin capsule production in China Among them, 5 manufacturers have evaluated the consistency of the product, among which the 0.125g specification approved by Lukang Pharmaceutical this week is the first one According to the enterprise announcement, in 2018, the domestic sales of amoxicillin capsule was about 2.4 billion yuan, and the sales revenue of Lukang Pharmaceutical was 146 million yuan In addition, according to the sales data of pharmaceutical intelligence data hospital, amoxicillin capsule market share of domestic sample hospitals is the largest among Zhuhai United Laboratories and Aomei pharmaceutical factories, accounting for 27.86% and 27.36% respectively It remains to be seen whether the market pattern can be changed under the environment of five enterprises' over evaluation, centralized procurement expansion and the coming of the second round of drug volume procurement Clozapine tablets clozapine tablets are antipsychotics, mainly used for the treatment of refractory schizophrenia The original research enterprise is Sandoz, a subsidiary of Novartis, which was first launched in Europe in 1971 and listed in France in 1991 At present, there are 76 market approvals for domestic clozapine tablets, involving 58 manufacturers, 4 enterprises that have accepted the application for conformity assessment, and the first enterprise that has passed the application of Enhua pharmaceutical industry And the sales volume of domestic sample hospitals in 2018 accounted for 32.34% of Enhua pharmaceutical industry, which is the enterprise with the largest share at present Now the product has passed the consistency evaluation, the quality and efficacy are consistent with the original research drug, further improving the product competitiveness, and is expected to further expand the market share Apixaban is a reversible and highly selective direct XA factor inhibitor, which belongs to a new type of oral anticoagulant It is mainly used in adult patients undergoing selective hip or knee replacement to prevent venous thromboembolism (VTE) The original research enterprises of apixaban are Bristol Myers Squibb and Pfizer, with the commodity name of elotor / eliquis ® In 2018, the sales of eliquis reached US $9.872 billion, surpassing lenalidomine, ranking the second best-selling in the world At present, there are 3 local enterprises of apixaban tablets approved to be listed, including Kelun pharmaceutical, and the other two are Zhengda Tianqing and Haosen pharmaceutical, and the three enterprises are all registered and approved to be listed according to the classification of new chemical drugs It is deemed that they have passed the consistency evaluation Now, the tripartite situation of apixaban tablets has quietly formed, and a huge potential market in China is worth looking forward to Escitalopram oxalate tablets escitalopram oxalate tablets are mainly used for the treatment of depression Escitalopram oxalate tablets were jointly developed by H lundbecka / s and Allergan In August 2002, the drug was approved for marketing by FDA of the United States In the United States, the manufacturers of escitalopram oxalate tablets mainly include lupin, torrent, Cipla, etc In 2006, the product was approved to be listed in China Domestic manufacturers mainly include Sichuan Kelun Pharmaceutical Co., Ltd and Shandong Jingwei Pharmaceutical Co., Ltd According to the hospital sales database of pharmaceutical intelligence data Enterprise Edition, from 2016 to 2018, after the sales of escitalopram oxalate tablet sample hospital increased in 2017, the sales of escitalopram oxalate tablet decreased by 7.02% year-on-year in 2018, reaching 84.383 million yuan, which is due to the author's guess that there is a great connection with the centralized purchase of drugs Escitalopram oxalate tablet is one of the "4 + 7" volume purchased products In 2018, Kelun pharmaceutical won the bid with a price of 30.94 yuan per box In 2019, Kelun pharmaceutical won the bid again with a price of 29.89 yuan However, the price of the original research drug was high, which was a pity to be out of the competition In addition, according to the data of pharmaceutical intelligence, up to now, there are four enterprises that have been evaluated for the consistency of escitalopram oxalate tablets, and Huahai pharmaceutical is the fourth one, among which the domestic sample hospital market is mainly occupied by Shandong Jingwei, accounting for 57.4%; can the hospital market share of the drug be divided into a large share when the Kelun pharmaceutical industry wins the bid for centralized procurement and Huahai pharmaceutical enters the bureau? Eight varieties of escitalopram oxalate tablets were accepted for conformity assessment details, nine (8) new CDE conformity assessment acceptance numbers (9 varieties) were accepted for Hengrui medicine's heavyweight first imitation this week, the first application of roxithromycin dispersible tablets of Jiangsu Shenlong Pharmaceutical Co., Ltd was accepted, and the second application of kapofungin acetate for injection of Hengrui medicine was accepted More details are as follows: Roxithromycin dispersible tablet roxithromycin dispersible tablet is a new generation of macrolide antibiotics, which is used clinically for bronchitis, pneumonia, tonsillitis, five sense organs infection, urinary system infection, skin and soft tissue infection caused by sensitive bacteria From 2016 to 2018, the sales volume of domestic sample hospitals increased year by year In 2018, the sales volume of sample hospitals reached 16.9759 million yuan, a year-on-year increase of 34.41%; 78.59% of which was owned by Lizhu group Now, Shenlong pharmaceutical's application for conformity evaluation of this variety has been accepted If the evaluation is successful, it is expected to obtain policy dividend and expand market share Caspofungin acetate for injection is a kind of lipopeptide developed by fermentation semi synthesis technology It is mainly used for the treatment of neutropenia, suspected fungal infection in patients with fever, and other diseases such as invasive aspergillosis that are not effective or can not be tolerated It is recommended by the clinical guidelines of various countries for antifungal infection Kapofungin was developed by MSD, approved by FDA in 2001 and listed in China in 2002 Now it is a class B drug of national medical insurance, and was successfully included in the national basic drug catalog in 2018 According to drug intelligence data, in 2018, the sales volume of kapofen net domestic sample hospital was 238 million yuan, up 7.32% year on year At present, the original patent period of kapofen has expired In 2017, Hengrui Pharmaceutical Co., Ltd first imitated and listed the product, and Zhengda Tianqing Co., Ltd was approved as the second one in June this year It is worth noting that previously, Hengrui pharmaceutical has accepted one acceptance number application conformity evaluation and the processing status shows "issued document" This week, another acceptance number was accepted, which is expected to break the original research barrier Data source: drug intelligence data, enterprise announcement and other network public data information sources: drug intelligence network, enterprise announcement and other network public information 37