[exclusive] focus on 2019 Q1 generic drugs: Hengrui's billion level products fill in domestic vacancies again; several heavyweight first imitations come, Qilu, Yangzi River, Haiyue, Qingfeng

Since the self-examination and verification of drug clinical experiment data, the consistency evaluation of generic drugs and the new registration and classification of chemical drugs in 2015, the number of drug application acceptance has dropped significantly, including generic drugs In 2016, the acceptance of imitated declaration dropped precipitously, from 1905 in 2015 to 647, a third of that in 2015, and continued to decline in 2017 Until 2018, the state accelerated drug review and approval, and the acceptance of generic drug applications gradually showed a upward trend, reaching 924, about twice of that in 2017; the first quarter of 2019 is not yet full, and the acceptance of application is half of that in 2017, and a quarter of that in 2018, according to which, the application of generic drugs in 2019 may rise further How about the acceptance of generic drug declaration in the first quarter of 2019? What are the approved varieties? See below 138 varieties were applied for acceptance According to the statistics of Qilu pharmaceutical's first generic drug registration and acceptance database, as of March 26, 2019, the number of generic drug application acceptance reached 238 (141 varieties of 128 enterprises) Among them, 235 acceptance numbers are chemical drugs; 2 acceptance numbers are traditional Chinese medicine, namely, Sanqi Tongshu capsule of Chengdu Shenhe Pharmaceutical Co., Ltd and artificial bezoar of Yangzijiang Pharmaceutical Co., Ltd.; 1 pharmaceutical auxiliary material is glycine cholic acid of Qingdao Jinfeng Pharmaceutical Co., Ltd In addition, from the perspective of drug registration and classification, chemical drug 4 is the main type of generic drug declaration, accounting for 74.79%, including 99 varieties of 178 acceptance numbers; chemical drug 3, accounting for 23.95%, including 43 varieties of 57 acceptance numbers It is worth mentioning that in the first quarter, four generic drugs were listed and registered and included in the priority review at the same time, namely, lokadipine hydrochloride tablets of Shenzhen xinlitai, ibuprofen sustained-release capsules of Nanjing Yiheng pharmaceutical, Acarbose Tablets of Zhejiang Haizheng pharmaceutical and quetiapine fumarate sustained-release tablets of Shanghai xuantai Haimen pharmaceutical Among them, lekadipine hydrochloride tablet is the third generation of high lipophilic dihydropyridine long-acting calcium antagonists, which is used to treat mild and moderate essential hypertension Developed by recordati pharmaceutical company, it was first listed in the Netherlands in 1997, and then successively listed in more than 100 countries around the world It is currently the second largest CCB drug in the European market In 2001, China realized the original research and import listing According to the domestic drug database of pharmaceutical intelligence, at present, Chongqing shenghuaxi and Zibo Wanjie pharmaceutical enterprises have market production approval documents, both of which are approved by applying for registration of chemical drugs in Category 6 Shenzhen xinlitai is the first enterprise applying for listing according to the registration classification of new chemical drugs in Category 4, and this time it has been given priority review Once approved, the market pattern of this variety may be reshaped In addition, from the perspective of the applicant, Qilu pharmaceutical once again took the lead, with a total of 6 acceptance numbers and 4 varieties accepted in the first quarter, including propofol tenofovir fumarate tablets, trifluoroauridine tipyrimidine tablets, ceftazidime avibatan sodium for injection, and aripitan capsule Four varieties are the first generic drugs in China, among which ceftazidime avibatan sodium for injection, Qilu pharmaceutical is the country The first company declared the listing of generic drugs, followed by Yangtze River Pharmaceutical industry 6 accepted numbers and 5 varieties were accepted Zhejiang Hai Zheng pharmaceutical industry and Sichuan pits medicine technology followed closely There were 5 accepted numbers 4 varieties and 5 accepted numbers 5 varieties In the first quarter of 2019, 48 varieties of top 5 review and approval of generic drug application acceptance enterprises were approved, and 10 billion products were listed Under the accelerated pace of drug review and approval, in the first quarter of 2019 (as of March 26), there were 79 acceptance numbers (48 varieties) of approved generic drugs, including 57 acceptance numbers for 6 categories of chemical drugs, 17 acceptance numbers for 4 categories of chemical drugs and 5 acceptance numbers for 3 categories of chemical drugs It has to be mentioned that according to the relevant national policies, the approved generic drugs declared for 3 or 4 categories of new chemical drugs will be It is deemed that through the consistency evaluation, there are 19 generic drugs approved according to 3 or 4 categories of chemical drugs in the first quarter, which means that the approved production of these 19 varieties means that the quality and efficacy of the original drugs are consistent Details of approved production of chemical drugs in Category 3 and 4 in Q1 2019 Among them, Jiangxi Qingfeng Pharmaceutical Co., Ltd 's laclosamide tablet, Hengrui Pharmaceutical Co., Ltd.' s temozolomide for injection, Changchun Haiyue Pharmaceutical Co., Ltd 's Tadalafil Tablets, Anhui Beck' s lamivudine tenofovir tablet, Sichuan Huiyu 's Docetaxel Injection, and Shanghai xuantai Haimen Pharmaceutical Co., Ltd.' s Metformin Hydrochloride Sustained Release Tablets, 6 varieties, which are profitable through priority review, are rapidly approved for production Temozolomide for injection, tadalafil tablets of Changchun Haiyue Pharmaceutical Co., Ltd and lakosamide tablets of Jiangxi Qingfeng Pharmaceutical Co., Ltd are the first imitated products in China Temozolomide is a standard therapeutic drug for a variety of primary malignant brain tumors It was developed by Aston University in the United Kingdom After that, Schering plough pharmaceutical in Germany obtained the only right to develop the product in most of the world's markets It has been listed in two dosage forms: capsule and injection The drug has been in capsule form since it was launched in 2004 Hengrui injection has been approved to enrich its dosage form and realize complementary advantages According to the IMS database, the global sales volume of temozolomide for injection in 2017 was about US $11.304 million Tadalafil is a long-acting phosphodiesterase 5 inhibitor developed by Lilly for the treatment of erectile dysfunction (ED) It was first approved by European EMA in 2002, approved by US FDA the next year, and entered China in 2004 According to the announcement of Hyatt pharmaceutical company, the global sales of tadalafil reached 25.46 billion yuan by 2017, occupying a leading position in the erectile dysfunction market In the European and American markets, the market share of tadalafil in PDE5 inhibitors also ranked first Lakasamide tablets are used as adjuvant therapy for partial seizures with or without secondary generalized seizures in patients over 16 years old In 2017, global sales amounted to 976 million euros The original research enterprise was UCB, which was approved by EMA in September 2008, and FDA in May 2009 The original research was just listed in China in November last year, less than three months away Jiangxi Qingfeng Pharmaceutical Co., Ltd was approved to produce this product, which competed with the original research enterprise in the domestic market In addition to the approval of 6 varieties of Hengrui pharmaceutical, Changchun hailui pharmaceutical and other enterprises, levofloxacin tablets of Guangdong Dongguang and lamivudine tablets of Shijiazhuang Longze pharmaceutical are also the approved products for priority review Therefore, in the first quarter of 2019, 11 processing numbers (8 varieties) of 8 enterprises were approved for listing through priority review, with obvious effect of priority review Details can be found in the following table See the table below: data source of approval details of priority review of generic drugs in the first quarter of 2019: Declaration of online public data such as drug intelligence data and enterprise announcement: the viewpoint of this article 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.