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    Home > Medical News > Latest Medical News > [good medicine record] two drugs failed to pass, creating a dramatic scene of consistency evaluation; two drugs overtake in a curve, helping anbisheng become the first R & D institution with drug listing license

    [good medicine record] two drugs failed to pass, creating a dramatic scene of consistency evaluation; two drugs overtake in a curve, helping anbisheng become the first R & D institution with drug listing license

    • Last Update: 2018-07-20
    • Source: Internet
    • Author: User
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    As of July 19, CDE has accepted 247 applications for conformity assessment (calculated by acceptance number, the same below), involving 103 varieties This week (July 13-19), there was a dramatic scene Baiyunshan and other two drugs wanted to pass the be test of overtaking exemption However, CDE thought that their data were insufficient and could not be exempted They failed to pass the consistency evaluation In addition, there was good news that five varieties of Yangzi pharmaceutical, Guoyao Zhijun, Lepu medical and Shanghai anbisheng pharmaceutical passed the consistency evaluation, which is worth mentioning Moreover, two kinds of drugs have been approved for production In addition to the name of consistency evaluation for the application of new 4 types of generic drugs to overtake in the corner, another bright spot is that anbisheng has become the first drug research and development institution in China to hold the drug listing license On July 16, Guangzhou Baiyunshan issued a notice about the company's Cefalexin capsule and Cefradine capsule failing to pass the drug consistency evaluation It is pointed out in the announcement that Baiyunshan Pharmaceutical Co., Ltd submitted the bioequivalence conformity assessment of Cefalexin capsule and Cefradine capsule exemption to the State Food and Drug Administration in December 2017 and January 2018 respectively in accordance with the relevant requirements of the announcement on conformity assessment of quality and efficacy of generic drugs (2017 No 100) issued by the State Food and Drug Administration on August 25, 2017 Supplementary application for price However, according to the evaluation report of the drug evaluation center of the State Food and drug administration, the conclusion of the two varieties of application is that "application for conformity evaluation of generic drugs will not be passed" The main reason is that the drug evaluation center of the State Food and drug administration believes that the information provided by Baiyunshan Pharmaceutical General Factory can not fully support the classification of Cefalexin capsule and Cefradine capsule as bcs1 (i.e with high solubility and high permeability), so the above products are not approved to be based on bcs1 exemption human bioequivalence research The announcement further pointed out that the reason why the two products failed to pass the conformity assessment was not the inconsistency between the quality and the efficacy, but the insufficient basis for applying for exemption from human bioequivalence study In view of the failure to pass the conformity assessment, the company actively takes actions to remedy it At present, relevant research and development work has been arranged, and it is ready to carry out be test (human bioequivalence study), and submit the application for conformity assessment again Cefalexin capsule is the first generation of cephalosporin antibiotics, which is used for the treatment of otitis media, streptococcal pharyngitis, bone and joint infection, pneumonia, urinary tract infection and other bacterial infections It is one of the first batch of basic drugs in the "289" catalogue, and it is also the second variety in the total number of reference preparations reported by the Chinese Academy of inspection Its original research enterprise is yanyeyi of Japan, which was listed in the United States in 1971 and in Japan in 1973 The cephalexin capsule of Baiyunshan Pharmaceutical General Factory was approved to be listed in China in April 1990 According to pharmarket data, the global sales volume of Cefalexin preparation in 2017 was about 482 million US dollars, and the sales revenue of Baiyunshan Pharmaceutical General Factory in 2017 was 8.1041 million yuan, accounting for 0.04% of the company's business revenue in 2017 According to the pharmaceutical intelligence data, at present, there are 349 market approvals for Cefalexin Capsules in China There are many manufacturers, including Shanghai Fuda Pharmaceutical Co., Ltd., Guangzhou Baiyunshan Pharmaceutical Co., Ltd and Hunan Kelun Pharmaceutical Co., Ltd applying for the consistency evaluation At present, Shanghai Fuda and Hunan Kelun are still in the process of review and approval, and Baiyunshan is facing the re submission, and the first dispute is still in progress Details are as follows Table 1: Table 1: application details of consistency evaluation of Cefalexin capsule Cefradine capsule is the first generation of cephalosporin, which is used to treat acute pharyngitis, tonsillitis, otitis media, bronchitis, pneumonia and other infections caused by sensitive bacteria The original research enterprise is Bristol Myers Squibb, which was listed in Ireland in 1972 and in the United States in 1982 In 1992, Cefradine capsule of Baiyunshan Pharmaceutical General Factory was approved for marketing in China According to pharmarket data, the global sales volume of cefradine customization agent in 2017 is about 73 million US dollars, and the sales revenue of Baiyunshan Pharmaceutical General Factory in 2017 is 9.1816 million yuan, accounting for 0.04% of the company's business revenue in 2017 According to the pharmaceutical intelligence data, at present, there are 246 domestic market approvals for cefradine capsules, and only Baiyunshan Pharmaceutical General Factory has applied for the conformity assessment, which has not passed the conformity assessment On July 17, Shanghai Hyundai pharmaceutical released a notice that its subsidiary, Sinopharm group Zhijun (Shenzhen) Pharmaceutical Co., Ltd., received the supplementary application approval for cefuroxime axetil tablets (0.125g) approved and issued by the State Drug Administration, which passed the consistency evaluation of quality and efficacy of generic drugs Cefuroxime axetil tablet is the second generation of classic oral antibiotics, which is suitable for the treatment of infection caused by sensitive bacteria It is one of the best-selling anti infective drugs in the world in the 1990s because of its strong antibacterial effect and safety It is reported that the global sales of cefuroxime ester tablets in 2017 was 674 million US dollars, an increase of 3.98% year on year In 2017, the sales revenue of Zhijun cefuroxime ester tablets (0.125g) was about 79.8 million yuan According to the pharmaceutical intelligence data, at present, there are 20 domestic approvals for cefuroxime axetil tablets and 5 enterprises applying for the consistency evaluation Among them, the cefuroxime axetil tablets with the specifications of 0.25g and 0.125g of Chengdu Beite Pharmaceutical Co., Ltd have passed the consistency evaluation, and the cefuroxime axetil tablets (0.25g) of China Zhijun have passed the consistency evaluation on December 29, 2017 This time, the cefuroxime axetil tablets (0.125g) of China Zhijun have passed the consistency evaluation Over consistency evaluation will further enrich the company's product specifications, be conducive to the future market sales and market competition of the product, and will have a positive impact on the company's business performance Table 2 acceptance details of cefuroxime axetil tablets consistency evaluation On July 17, Lepu medical released a notice that its subsidiary, Zhejiang xindonggang Pharmaceutical Co., Ltd., had received the approval document of supplementary application for drugs on atorvastatin calcium tablets approved and issued by the State Drug Administration The specifications of 20mg and 10mg of the drug passed the consistency evaluation of quality and efficacy of generic drugs Atorvastatin calcium tablet, as the largest drug in the field of cardiovascular disease treatment, is the cornerstone drug for blood lipid control, with a domestic market capacity of nearly 16 billion The market share of the original research group is nearly 60%, and the market is highly centralized and monopolized It is reported that in the first three quarters of 2017, Lipitor's market share accounted for about 73.84%, followed by aloe, accounting for about 17.25%, followed by Youjia and youliping, with market share of 5.88% and 1.47% According to the pharmaceutical intelligence data, at present, there are only 7 domestic market approvals for atorvastatin calcium tablets, involving Pfizer China, Beijing Jialin and Zhejiang xindonggang pharmaceutical industry Recently, Beijing Jialin's "alo" (10mg, 20mg) has passed the consistency evaluation This time, the new Donggang Pharmaceutical Co., Ltd has passed the consistency evaluation at the same time of 10mg and 20mg dosage forms, so that the company has the opportunity to start anew on the same starting line with the original research and domestic leading enterprises, and seize the stock market of Lipitor and aloe in the field of 20mg and 10mg On July 17, Yangzijiang Pharmaceutical Co., Ltd issued a notice stating that it has obtained the approval of CFDA for the production of the new class 3 drug "dexmedetomidine hydrochloride injection" According to the provisions of Document No 230 of 2015 of the General Administration, the generic drugs declared and approved for marketing after the implementation of the new registration classification will be accepted, reviewed and approved in accordance with the principle of consistency with the quality and efficacy of the original research drugs It means that the "dexmedetomidine hydrochloride injection" approved by Yangzijiang Pharmaceutical Co., Ltd is the first one to pass the consistency evaluation and enter the catalogue of Chinese listed drugs Dexmedetomidine hydrochloride injection is a relatively selective α 2-adrenergic antagonist, which is suitable for sedation of non intubated patients before or during surgery and other operations Developed by Orion and Abbott, it was approved to be listed in the United States in 1999, and Jiangsu Hengrui was approved to be listed in China as the first imitation enterprise in 2009 According to China's iqvia database, in 2017, China's anesthetic market capacity was about 11.8 billion, of which dextromethomidine accounted for 15.49% of the whole anesthetic market, and the domestic sales in 2017 exceeded 1.8 billion yuan According to the pharmaceutical intelligence data, there are 12 domestic market approvals for dexmedetomidine hydrochloride injection, including Jiangsu Hengrui, Hunan Kelun, Sichuan Guorui Pharmaceutical Co., Ltd., among which only Jiangsu Hengrui has applied for registration conformity evaluation, and it has been undertaken on June 4 This round of overtaking in the pharmaceutical industry of Yangzi River was the first one to seize a larger share of dexmedetomidine anesthesia market through consistency evaluation, while improving the product pipeline of the enterprise, laying a strong foundation for further entering the market of narcotic drugs Recently, four new drugs, montelukast sodium chewable tablets and ordinary tablets, jointly declared by Shanghai anbisheng pharmaceutical and Hangzhou Minsheng Binjiang pharmaceutical, have been approved by the State Drug Administration According to the relevant policies of consistency evaluation, montelukast sodium chewable tablets and ordinary tablets have also become the first similar drugs to pass the consistency evaluation of generic drugs; at the same time, montelukast sodium and ordinary tablets will become the first montelukast sodium chewable tablets and ordinary tablets to be marketed in China and the United States at the same time, which are sold in the United States Chewing tablets and common tablets are produced in the same production line and formula process, with the same quality and effect Montelukast sodium is a leukotriene receptor antagonist used to treat and prevent asthma in children and adults, and also to treat allergic rhinitis Developed by MSD, it was listed in the United States in 1998 and entered the Chinese market in 1999 It is reported that in 2017, the domestic hospital sales of montelukast sodium exceeded 1.6 billion yuan, and the market share of original research products exceeded 70% According to the pharmaceutical intelligence data, at present, there are only 9 domestic market approvals for montelukast sodium, with few manufacturers The main manufacturers are Sichuan Dazhong pharmaceutical and lunanbeite pharmaceutical, and there is no enterprise application for registration consistency evaluation The first montelukast sodium chewable tablet and ordinary tablet of Shanghai anbisheng pharmaceutical passed the consistency evaluation, and will be researched and developed in the original way In addition, the approval for the production of montelukast sodium chewable tablets and ordinary tablets also made Shanghai anbisheng the first drug research and development institution in China to hold the drug marketing license In the past two years, the state has vigorously implemented the drug MAH pilot, the success of anbisheng and the acceleration of the time to market of its products are gratifying cases for the implementation of MAH pilot work One drug consistency evaluation was undertaken by Harbin Pharmaceutical Montmorillonite powder on July 16th, and the consistency evaluation of two factories in Harbin Pharmaceutical Group was undertaken by CDE Montmorillonite powder, developed by Yipu pharmaceutical, was listed in France in March 1980 The clinical indications of montmorillonite powder in China are: acute and chronic diarrhea in adults and children It is used for the auxiliary treatment of related pain symptoms caused by diseases of esophagus, stomach and duodenum It is reported that in 2017, the terminal sales of montmorillonite hospital was close to 400 million yuan, and the terminal sales of drugstores were close to 500 million yuan, an increase of 18.25% year on year In 2017, the sales volume of the two terminal markets was close to 900 million yuan According to the data of pharmaceutical intelligence, there are 31 production approvals for montmorillonite powder in the domestic market, and there are many manufacturers Among them, 6 companies have applied for conformity assessment, among which Sichuan Weiao pharmaceutical and Xiansheng pharmaceutical have passed the conformity assessment one after another, which shows that montmorillonite powder has a fierce competition The details are shown in the following table: Table 3: acceptance details of montmorillonite consistency evaluation data source: drug intelligence data source: drug intelligence network, cypress blue, YanRuYu and related enterprise announcements
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