[drug Kajun] consistency evaluation: 289 clarithromycin tablets, or the first to pass? Huahai has another drug corner to overtake! Zhengda Tianqing and dongyangguang declare several important generic drugs in the week

Highlight: 1.289 clarithromycin tablets or the first to pass the consistency evaluation? 2 Donepezil hydrochloride tablets of Huahai Pharmaceutical Co., Ltd passed the car in a curve and passed the consistency evaluation for the first time 3 Zhengda Tianqing and dongyangguang declared several heavyweight generic drugs to be listed in the week 4 After Zhengda Tianqing, Jiangxi Qingfeng also declared the listing of hepatitis B drug TAF This week (October 27 - November 2) is a span week between October and November It's getting closer to the end of the year All enterprises continue to make efforts What are the important drug review and approval trends this week? Let's take a look Among the generic drugs to be reported for production, there are mainly four drugs that are "under approval" and are about to be completed; another 12 drugs that have been approved and have been certified show "prepared for approval" and nine drugs that have been approved show "issued" Let's take a look at some noteworthy drugs Data source: the registration and acceptance database of intellectual drugs of dongyangguang clarithromycin tablet on October 31, the clarithromycin tablet of dongyangguang showed "under approval", clarithromycin was a macrolide antibiotic It was invented by Japanese pharmaceutical company Taisho in 1980 and applied for patent protection Later, Taisho cooperated with Abbott, who was approved to market the drug in the United States in 1991 At present, there are 35 domestic enterprises holding approval documents of clarithromycin tablets, involving 3 specifications, of which 0.125g and 0.25g are included in the 289 directory of consistency evaluation According to the drug intelligence data, at present, clarithromycin tablets have not yet been applied for consistency evaluation by enterprises Dongyangguang's clarithromycin tablets are included in the priority review on the basis of "production in the same production line, listing in the European Union in 2016" If they are first approved for listing (according to the opinions of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs: drugs produced and listed in the same production line in China and approved for listing in the European Union, the United States and Japan are deemed to have passed the consistency evaluation) , will be in the forefront of consistency evaluation and become the first consistency evaluation enterprise Data source: on October 29, two specifications (5mg, 10mg) of donepezil hydrochloride tablets were approved for production in Huahai pharmaceutical industry Donepezil hydrochloride tablets are mainly used for the treatment of dementia symptoms of mild or moderate Alzheimer's disease The drug was developed by Eisai and launched in the United States in 1996 There are 6 domestic enterprises holding the approval documents of donepezil hydrochloride tablets, of which only Weicai (China) with the specification of 10mg holds the approval documents This time, Huahai will become the second enterprise holding the approval documents of 10mg In addition, at present, there are 5 enterprises in the consistency evaluation of donepezil hydrochloride tablets for reference and filing, and Chongqing Zhien pharmaceutical industry has applied for the consistency evaluation According to the new registration classification of generic drugs (drug quality and efficacy are the same as the original research), Huahai is included in the priority review as "the same production line is produced, and it will be listed in the United States in 2011" Therefore, approval means that Huahai is deemed to pass the consistency evaluation Data source: among the new drugs reported for production this week in the progress database of drug intelligence consistency evaluation, 2 drugs show "issued", and 1 drug shows "certificate preparation completed - pending approval" 1 the drug shows "approved production", specifically as follows: data source: registration and acceptance database of intelligent drugs Hunan Jianlang Pharmaceutical Co., Ltd class 3 new drugs were approved October 29, and olacetam for injection of Hunan Jianlang Pharmaceutical Co., Ltd was approved The drug was used in the treatment of brain injury and neurological deficit, memory and intelligent disorders caused by brain injury According to the domestic drug database of pharmaceutical intelligence, at present, 8 enterprises hold the approval documents for olacetam injection production, with the specifications of 5ml: 1.0g, 20ml: 4.0g, 20ml: 6G; 1 enterprise (Eucalyptus) holds the approval documents for olacetam for injection, with the specifications of 1.0g; in addition, 2 enterprises hold the approval documents for olacetam capsule, with the specifications of 0.4g; 5 enterprises hold the approval documents for API On October 29, the new drug type I + type III live attenuated polio vaccine sugar pill (human diploid cells) declared by the Institute of medical biology, Chinese Academy of Medical Sciences for the prevention of type I and type III poliomyelitis showed "distributed" According to the domestic drug database of Yaozhi, there are currently oral type I type III live attenuated poliomyelitis vaccine (human diploid cells) on the market, and only Beijing Beisheng research Biological Products Co., Ltd holds the production approval; there are also polio live attenuated vaccine sugar pill (human diploid cells), and Beijing Beisheng research biological products Co., Ltd and Chinese Academy of Medical Sciences Medical Biology hold the approval graduate school On the same day, Zhejiang Weixin biological group's acyw135 meningococcal polysaccharide vaccine also showed "delivered" The vaccine was used to prevent the epidemic cerebrospinal meningitis caused by a, C, y and W135 Neisseria meningitidis According to the database of home-made drugs of pharmaceutical intelligence, there are 6 enterprises holding production approval documents in the market at present 3 imported medicines were changed this week, and the O Datlow inhalation spray, which was declared by the Buling Yin Ghan, showed that it had been issued The drug was included in the fourteenth batch of priority reviews on the basis of the "obvious therapeutic advantage" compared with the existing treatment Data source: odapro is developed by bringer Ingelheim It was first approved by the UK drug and health care products Administration (MHRA) on October 10, 2013, and then approved by the US Food and Drug Administration (FDA) on July 31, 2014 The product name is strivedirespirat O Datlow inhalation spray is used to maintain airflow obstructive bronchiectasis in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema Among the generic drugs produced in this week's report, 14 drugs were accepted It is worth noting that Zhengda Tianqing and dongyangguang both applied for the listing of three important generic drugs, and Jiangxi Qingfeng applied for the listing of TAF The details are as follows: data source: within this week, Zhengda Tianqing applied for the generic listing of three important products, namely, everolimus tablets, paclitaxel for injection (albumin binding type) and traflouridine tripyrimidine tablets Everest, developed by Novartis, was approved by the US Food and Drug Administration (FDA) on March 30, 2009 under the trade name of certican It can be used in the treatment of advanced HR positive breast cancer, advanced neuroendocrine tumor, advanced renal cell carcinoma or renal angiomyolipoma with tuberous sclerosis At present, Zhengda Tianqing, Jiangsu aosaikang and Jichuan pharmaceutical have carried out the production of the old 6 categories, all of which have been approved for clinical use However, Zhengda Tianqing is the first to apply for listing in accordance with the new 4 categories, and is expected to obtain the first copy Paclitaxel for injection (albumin binding type) is suitable for the treatment of metastatic breast cancer which failed to combine chemotherapy or breast cancer which recurred within 6 months after adjuvant chemotherapy At present, only Ouyi and Hengrui hold the approval documents in China, and both have entered the catalogue of Chinese listed drugs Zhengda Tianqing is expected to become the third Trafluuridine and tipipidine tablets were originally developed for Dapeng pharmaceutical industry in Japan Approved by FDA on September 22, 2015, it is used to treat patients with refractory metastatic colorectal cancer (mCRC) who are no longer responding to other therapies (chemotherapy and biotherapy) It is reported that the drug has been approved in 21 countries and regions such as Japan, the United States, the United Kingdom, Canada and the European Union At present, the original research has not been listed in China and has been approved for clinical use Zhengda Tianqing is expected to surpass the original research institute in listing first in China Jiangxi Qingfeng fumarate tenofovir and elaphenamine tablets (TAF) were declared to be on the market After Zhengda Tianqing declared to be on the market last week, Jiangxi Qingfeng Pharmaceutical Co., Ltd also declared this week TAF (vemlidy) is a drug developed by Gilead for the treatment of chronic hepatitis B (HBV) patients with compensatory liver disease The drug was approved for marketing in the United States on November 10, 2016, and then listed in Japan on December 19, 2016 It was approved by European EMA on January 9, 2017, becoming the first new hepatitis B drug approved for marketing in Europe in recent 10 years Dongyangguang, Guangdong Province, also declared three generic drugs to be listed this week, namely, agliptin benzoate tablets, duloxetine hydrochloride enteric coated capsules and apixaban tablets Agliptin Benzoate Tablet is a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor It is the fifth DPP-4 inhibitor approved in China, which is suitable for the treatment of type 2 diabetes At present, no domestic generic drugs have been listed Shenzhen Haibin Pharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd and Ruiyang Pharmaceutical Co., Ltd have been approved for listing according to class 3.1 new drugs; 34 acceptance numbers have been approved for listing according to the old class 6 generic drugs; 14 acceptance numbers have been approved for listing according to the new class 4 generic drugs, involving 6 enterprises, with fierce competition for the first generic drugs Duloxetine hydrochloride enteric coated capsule is mainly used for depression At present, only Shanghai Shangyao Sinopharm Co., Ltd holds the approval documents, and many other enterprises have applied for generic drugs, among which Huahai Pharmaceutical Co., Ltd has been included in the 25th batch of priority review on the basis of "production in the same production line, listed in the United States in 2017" Eliquis is the best-selling drug in cardiovascular field in 2017, with annual sales of US $7.4 billion The drug is a new, oral, reversible, highly selective and direct XA factor inhibitor, which can be used to prevent VTE in adult patients undergoing selective hip or knee replacement Approved by the European drug regulatory agency in May 2011 On April 12, 2013, it was announced to be officially listed in China At present, there is no generic drug listed in China, and many enterprises have applied for the listing of generic drugs, including Jiangsu Haosen, Zhengda Tianqing, Jiangxi Qingfeng, Chengdu Beite, Sichuan Kelun, etc This week, two new drug applications were accepted They are the injection of d-camphor and edaravone d-camphor of Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd., as shown in the following figure: data source: drug intellectual drug registration and acceptance database imported drugs This week, three applications for the listing of imported drugs were accepted, namely, oxycodone naloxone sustained-release tablets of Mengdi (China) pharmaceutical, iloximab injection of Amgen biology, and oxitinib mesylate tablets of AstraZeneca Data source: pharmaceutical registration and acceptance database information source: enterprise announcement, network public information data source: pharmaceutical data statement: this point of view only represents the author, not the position of pharmaceutical network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.