[good medicine record] after the festival, Shangxin, dongyangguang's seventh over rated medicine was released; Hengrui and Kelun focused on monitoring the strong arrival of auxiliary drugs

As of October 10, the acceptance number of CDE acceptance consistency evaluation reached 1491 (418 varieties of 434 enterprises) According to the supplementary application, the same below); 263 (108 varieties) have been evaluated and accepted From September 27 to October 10, another 3 varieties were evaluated, 16 varieties were undertaken, and key monitoring auxiliary drugs of Hengrui and Kelun were listed again Details of the past evaluation: three varieties of the past evaluation, the seventh of the past evaluation drugs produced by Dong Yangguang recently, three varieties passed the consistency evaluation, one of which was approved for production by the registration and classification of new chemical drugs in four categories, deemed to have passed the consistency evaluation, and was the levetiracetam tablets of China Resources SECCO More details are as follows: levetiracetam tablets of China Resources SECCO Levetiracetam tablet is used for the treatment of partial seizures (with or without secondary generalized seizures) in adults and children over 4 years old, and for the additional treatment of generalized tonic clonic seizures in adults and adolescents over 16 years old The original research enterprise of zuelacetan tablets was Belgium's UCB company, which was listed in the United States in 1999 According to the 2018 annual report of youshibi company, its "Keppra ®" global sales in 2018 was 790 million euros According to drug intelligence data, there are 10 domestic approvals for levetiracetam tablets in China, involving 6 manufacturers However, most of the domestic market is controlled by the original research enterprises According to PDB data, the sales volume of domestic zoelacetan in 2018 was about 355 million yuan, with the original research enterprise's best time ratio accounting for 97.19%; Chongqing shenghuaxi and Zhejiang Jingxin pharmaceutical accounted for 1.55% and 1.19% respectively, followed by Shenzhen xinlitai, with a share of 0.07% Up to now, there are three enterprises applying for the consistency evaluation of this variety: Shenzhen xinlitai, Chongqing shenghuaxi and Zhejiang Jingxin Among them, Zhejiang Jingxin pharmaceutical industry is the first enterprise applying for the consistency evaluation; It is worth mentioning that the variety of China Resources Secco and Zhejiang puluokangyu pharmaceutical has been approved for production in four categories of new chemical drug registration classification, which is deemed to be passed Therefore, the consistency evaluation of the variety has become a three pronged trend, replacing the original research or will be soon Benbromarone tablet of Yichang dongyangguang is a kind of medicine to promote the excretion of uric acid Benbromarone tablet is one of the main schemes to treat hyperuricemia According to Ames data, in 2018, the market size of hospital-based antiduricemic drugs in China is about 1.21 billion yuan, of which the market share of benbromarone is about 18% According to the hospital sales data of pharmaceutical intelligence data Enterprise Edition, in 2018, the sales of domestic sample hospitals reached 3.963 million yuan, of which Changzhou CommScope pharmaceutical accounted for 98.82% of the hospital sales, and Yichang dongyangguang only accounted for 1.14% In addition, according to the announcement of dongyangguang pharmaceutical company, dongyangguang has completed the application of 37 consistency evaluation projects since 2016, ranking in the top 10 in total Benbromarone tablet is one of the key products of Yichang dongyangguang pharmaceutical industry, and it is the seventh drug that has passed the consistency evaluation Photo source: the polyethylene glycol 4000 powder of Yichang Dongyang GuangGuan Weima Yinglong is mainly used for the symptom treatment of constipation in adults and children over 8 years old (including 8 years old) The drug was initially developed by ipsenpharma company (trade name: Fusong, 10g, powder), registered in France in 1995, started clinical treatment of adult constipation in 1996, registered in China in 1999, and expanded its indications to treat constipation of children over 8 years old in 2003 At present, there are three other domestic manufacturers of polyethylene glycol 4000 powder, namely Chongqing Huasen Pharmaceutical Co., Ltd., Chongqing Sinopharm Co., Ltd and Hunan Warner Pharmaceutical Co., Ltd., all of which have passed the consistency evaluation of generic drugs Ma Yinglong Pharmaceutical Co., Ltd is the last enterprise to pass the consistency evaluation of the product According to the hospital sales data of pharmaceutical intelligence data Enterprise Edition, in the first half of 2019, the sales volume of polyethylene glycol 4000 bulk domestic sample hospitals reached 13.0418 million yuan, and in 2018, the sales volume of hospitals reached 33.4739 million yuan, of which the original research Yipu Sheng accounted for 74.69%, Huasen pharmaceutical accounted for 11.83%, and Ma Yinglong accounted for 2.47% In addition, according to its announcement, in 2018, the sales revenue of Ma Yinglong pharmaceutical was 8.5 million yuan, and polyethylene glycol 4000 powder was the first drug that passed the consistency evaluation From September 27 to October 10, the first show of auxiliary drugs of Hengrui and Kelun was held There were 23 new acceptance acceptance acceptance numbers (16 varieties) of CDE, among which the first application of 5 varieties was accepted, and the first application consistency evaluation of heavyweight injection of Hengrui, Kelun and Jingfeng pharmaceutical was accepted The sodium, potassium, magnesium, calcium and glucose injection of Hengrui medicine is an electrolyte (sodium, potassium, magnesium, calcium ion) supplement used to supplement water and maintain the electrolyte balance in the body It is the exclusive variety of Hengrui medicine, with sales volume of 179 million yuan in domestic sample hospitals in 2018 In addition, according to medicated intelligence and key monitoring drugs, sodium, potassium, magnesium, calcium and glucose injection has been listed in the list of auxiliary key monitoring drugs in Jiangsu, Henan, Inner Mongolia and other provinces It remains to be seen whether the application for conformity assessment can be accepted If it is passed successfully, it will be able to break the shackles of drug restriction brought by the key monitoring of auxiliary drugs The alanyl glutamine injection of Kelun pharmaceutical is suitable for parenteral nutrition of patients who need to supplement glutamine, including patients in catabolism and hypermetabolism The original research enterprise is fissenius kabi company, which was first listed in Germany in 1995 and is the first glutamine supplement drug in the world Since its launch, the product has been widely recommended and used by many authoritative guidelines at home and abroad, such as the 2009 European Society of parenteral nutrition surgical guidelines, 2009 European Society of parenteral nutrition ICU guidelines, 2015 China clinical pharmaceutical consensus on parenteral nutrition, 2016 China Adult perioperative nutrition support guidelines According to the pharmaceutical intelligence data, at present, there are 28 domestic market approvals for alanyl glutamine injection, involving 20 manufacturers In 2019, the sales volume of domestic sample hospitals is 423 million yuan, and in 2018, the sales volume of hospitals is 687 million yuan, of which the sales volume of domestic sample hospitals is the largest, accounting for 29.68%, followed by Chongqing Laimei pharmaceutical industry The original research enterprise only accounts for 11.42% It is worth noting that alanyl glutamine injection has been included in the list of key monitoring drugs for auxiliary drugs in Zhejiang, Sichuan, Henan, Jiangsu and other provinces Tyrofeban hydrochloride and sodium chloride injection of Jingfeng pharmaceutical tyrofeban hydrochloride is an anti platelet aggregation agent It is clinically used in adult patients with non ST elevation acute coronary syndrome (NSTE-ACS) with ECG changes and / or myocardial enzyme elevation within 12 hours of the last onset of chest pain to prevent early myocardial infarction The original research enterprise is medicure company, which was approved to be listed by FDA in 1998 and entered China in 2009 At present, there are 11 approval documents for domestic tirofiban sodium chloride injection Market, involving 8 manufacturers, among which Jingfeng pharmaceutical is the third one in China to obtain the approval documents for tirofiban sodium chloride injection production, and at the same time, it has the approval documents for its own raw material production In 2018, the sales volume of the domestic sample hospital of the drug was 65.7141 million yuan, and the main hospital market was occupied by Yuanda pharmaceutical The first application consistency evaluation of Jingfeng pharmaceutical was accepted, which is expected to break the barriers and seize a larger market share Data source: drug intelligence data, enterprise announcement and other network public data information sources: drug intelligence network, enterprise announcement, Baidu Encyclopedia and other network public information statements: this point of view only represents the author, not the position of drug intelligence 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.