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    Home > Active Ingredient News > Drugs Articles > Analysis of Special Drug Evaluation Data in 2015: Which new drugs have caught the express?

    Analysis of Special Drug Evaluation Data in 2015: Which new drugs have caught the express?

    • Last Update: 2016-01-20
    • Source: Internet
    • Author: User
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    Source: general situation of medical economic report 2016-01-20, 2004-2015 as of January 6, 2016, the list of special approved varieties published by the drug approval center (CDE) of the State Food and Drug Administration (SFDA) is 1156 according to the acceptance number, with a time span of 2004-2015 Since 2004, the number of special approvals has been increased year by year, reaching a peak of 291 in 2013 As of the statistical time, there were 235 special approval acceptance numbers in 2015, a decrease of 8.6% compared with 2014 (Note: the data are all from CDE official website, and the statistical time is up to January 6, 2016) Among the special approved varieties over the years, the number of domestic enterprises applying for acceptance number is large, accounting for 68.1% In 2015, the application ratio of domestic and imported varieties was 2.45:1 From the perspective of application categories, domestic enterprises and import enterprises are basically concentrated on the clinical application of new chemical drugs, which accounts for 86.3% of all applications Among them, domestic enterprises have 53 applications for production of new chemical drugs, 10 applications for production of new traditional Chinese medicine and 5 applications for production of new biological products Only 8 chemical drugs have been applied for production in import enterprises, and the rest are clinical and supplementary applications In order to encourage the research and development of new drugs, the notice on printing and distributing the regulations on the administration of special examination and approval of new drug registration was issued in 2009 There are four situations of drugs enjoying special approval and special treatment: first, the effective ingredients and preparations extracted from plants, animals, minerals and other substances that have not been listed and sold in China, the newly discovered medicinal materials and preparations; second, the chemical APIs and preparations and biological products that have not been approved for listing at home and abroad; The third is to treat AIDS, malignant tumors, rare diseases and other diseases with obvious clinical treatment advantages; the fourth is to treat diseases without effective treatment The new drugs which are not included in the functional indications of Chinese patent medicine approved by the state can be regarded as the new drugs of diseases without effective treatment In the case of items 1 and 2, the applicant for drug registration may apply for special examination and approval when submitting the application for clinical trials of new drugs In case of three or four cases, the applicant can apply for special examination and approval only when applying for production According to the special examination and approval management regulations, the special examination and approval shall be set as a separate channel to give priority to the review and approval of the whole process of special examination and approval of new drug registration application, and shall be completed within the time limit specified in the drug registration management measures Specific situation of varieties in 2015 there were 235 acceptance numbers of special approved drugs in 2015, 93 by varieties, of which, chemical drugs were basically applied for, and only 2 varieties were applied for traditional Chinese medicine Only 7 varieties showed that the review had been completed, and the remaining 86 varieties were in the review status According to the analysis of the declared enterprise categories, there are 167 acceptance numbers of domestic enterprises, involving 64 varieties; 68 acceptance numbers of import enterprises, involving 29 varieties Beijing Novartis Pharmaceutical Co., Ltd., Bayer Pharmaceutical Co., Ltd and Zhengda Tianqing Pharmaceutical Co., Ltd., a local enterprise, have applied for 4 varieties Xi'an YANGSEN and AstraZeneca each applied for 3 varieties, Beijing Kangchen and other 9 enterprises applied for 2 varieties respectively, and the rest enterprises were all 1 variety (Note: enterprises applying for more than 2 varieties) according to the analysis of the indications of the declared varieties, there are 38 antitumor drugs, accounting for 40.9% of the total varieties There are seven antidiabetic drugs, which are the second largest category of application fields (Note: there are 8 indications of all kinds of drugs that have not been published by the enterprises, and they are summarized in the other varieties) The number of varieties of domestic anti-tumor drugs declared is equal to that of imported ones, 20 and 18, respectively There are 7 kinds of TiNi drugs, including furetinib succinate of Chongqing fuchuang medicine, sirotinib maleate of Shandong xuanzhu medicine, konitinib of Beijing Kangchen pharmaceutical industry, etc., as well as imported afatinib of bringlingham and lovatinib of Weicai In terms of TiNi drugs, repeat declaration mainly involves those drugs with mature targets, with limited market space Domestic enterprises can try to find new drug development opportunities for those drugs with non hot targets Bayer has declared three varieties of anti-tumor drugs, with the largest number Copanlisib for non Hodgkin's lymphoma, vilaprisan for symptomatic uterine leiomyoma, and odm-201 for prostate cancer Bayer has three OTC businesses in China, namely MSD, Dianhong pharmaceutical and Baijiahei It is expected to become the No.1 in OTC market sales in 2015, but Bayer's prescription business in China is no less than that In 2014, Bayer's healthcare prescription business grew by 15% in China The three new anti-tumor drugs will be another big chip in expanding the Chinese market The two cancer drugs declared by Lilly pharmaceutical in the United States are the breast cancer drug ly2835219 and the compound ly2157299 which can be combined with tumor immunotherapy It is worth mentioning that ly2157299 has not been listed in other countries, and has been approved for clinical application in China The application speed and review progress are relatively fast However, the Chinese clinical application of nivolumab, the PD-1 inhibitor of its compound, has not been approved yet, so it is a long time before Lilly carries out the clinical trial of immunotherapy compound in China Novartis lee011 is used to treat drug-resistant breast cancer and melanoma Lee011 is a small molecule inhibitor of CDK4 / 6 (cyclin dependent kinase 4 / 6) At present, CDK4 / 6 inhibitors are hot spots in the research and development of anti-cancer drugs Pharmaceutical giants such as Pfizer and Lilly have their own research projects in this field Baiji Shenzhou declared that the two varieties are cancer treatment drugs BGB-3111 is a specific inhibitor of Bruton 's tyrosine kinase (BTK), which is used to treat B cell malignant tumor In June 2015, it has obtained the FDA new drug research ind application and will conduct clinical research in the United States Another bgb-290 is a new type of polyadenyldiphosphate ribotransferase (PARP) inhibitor, which is an innovative targeted anticancer agent The drug is independently developed by Baiji, and signed a joint development cooperation agreement with Merck's schlandau company in Germany There is another enterprise that has applied for PARP inhibitor drug, which is the sc10914 tablet applied for by Jiangxi Qingfeng pharmaceutical PARP inhibitors can enhance the efficacy of radiotherapy, alkylating agent and platinum chemotherapy by inhibiting DNA damage and repair, and promoting apoptosis of tumor cells At present, the listed PARP inhibitors are mainly lynparza (olapani) of AstraZeneca Domestic drugs will fill the gap in this field, but there will be fierce competition between Baiji Shenzhou and Jiangxi Qingfeng Diabetes drugs and hypoglycemic drugs are the second largest application area, with 5 diabetes drugs and 2 diabetes related diseases From the perspective of domestic special review application varieties in 2015, it is mainly GLP-1 analogues, sglt-2 inhibitors, and DPP-4 inhibitors gradually return to calm application Among the diabetes drugs, the DPP-4 inhibitor repagliptin phosphate jointly declared by Jiangsu Hengrui medicine and Jiangsu Shengdi medicine is applied for production, and the other four are applied for clinical application There are two GLP-1 analogues: bpi-3016 of Beida pharmaceutical and stg-1 injection of Dalian Dean; the other two are sglt-2 inhibitors: ronggliptine pyroglutamate of Guangdong Dongguang and eigliptine tablets of Shanghai Elis pharmaceutical Sglt-2 inhibitor is a new type of diabetes drug which has been on the market in recent years However, on December 4, 2015, the FDA issued a safety communication requiring a black box warning to be added to the label of sglt-2 inhibitors, indicating that these drugs may cause serious ketoacidosis and urinary tract infection The FDA's conclusion is far more severe than the previous black box warning that DPP-4 inhibitors may cause severe disabling arthralgia, and the market prospect of sglt-2 inhibitors may face a bleak prospect Two diabetes related disease drugs are ds-5565 of No.13 Co., Ltd., which is used to treat diabetic peripheral neuralgia The other one is siliquolin of Shenzhen minsarilin Pharmaceutical Co., Ltd., which is used to treat diabetic ophthalmopathy Zhengda Tianqing has applied for 4 drugs in total, but the indications of the drugs have not been published and are in the confidential stage Zhengda Tianqing has been quiet since it applied for sulbutinib in 2011 In 2015, it applied for 4 chemicals of category 1.1 Zhengda Tianqing is a leading pharmaceutical enterprise in the field of generic drugs in China, but it has not yet been approved for listing as a new class 1.1 drug.
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