[good medicine record] the acceptance no. of consistency evaluation is over 700; this week, 4 varieties have passed the first customs clearance, 7 varieties have been approved, and 17 varieties have been accepted

According to the latest data of drug registration and acceptance database, at present, there are 707 acceptance numbers of CDE acceptance consistency evaluation, involving 239 varieties of 261 enterprises, of which 349 (91 varieties) are 289 catalog drug acceptance numbers; 121 acceptance numbers (59 varieties) have passed the consistency evaluation, and 32 are 289 catalog drug acceptance numbers This week, the first review of 4 varieties was completed, and the approval of 7 varieties was completed, and the application of 17 varieties (No 19 acceptance) was accepted 4 The first variety passed the consistency evaluation, and the sales volume of the two varieties exceeded 100 million This week, four varieties and five specifications of cyclosporine soft capsules, trazosin hydrochloride tablets of China Resources SECCO Pharmaceutical Co., Ltd., vitamin B6 tablets of Hangzhou Minsheng Pharmaceutical Co., Ltd and indapamide tablets of Chongqing Yaoyou passed the consistency evaluation for the first time It is worth mentioning that four varieties are all 289 varieties, and two varieties of trazosin hydrochloride tablets and trazosin hydrochloride tablets of China Resources SECCO Pharmaceutical Co., Ltd Sales volume is over 100 million In the evening of January 8, Cr Shuanghe announced that its wholly-owned subsidiary, China Resources SECCO Pharmaceutical Co., Ltd terazosin hydrochloride tablet (2mg), was the first to pass the consistency evaluation of the product Terazosin hydrochloride tablet is a quinazoline antihypertensive drug, which is a highly selective α 1-adrenoceptor blocker and belongs to the second generation of prazosin It is mainly used in the treatment of mild or moderate hypertension It can be used in combination with thiazide diuretics or other antihypertensive drugs It can also be used alone when other drugs are not applicable or invalid Oral administration is also suitable for the treatment of symptoms caused by benign prostatic hyperplasia (BPH) The drug was developed by Abbott Pharma with the trade name of "Hytrin ®" It was initially marketed in Germany in 1984, in the United Kingdom in 1986, approved by FDA in 1987 and PMDA in Japan in 1989 According to IMS data statistics, in 2017, the national sales volume of terazosin hydrochloride was 106 million yuan, 74.0% of the market share was occupied by Abbott Laboratories, the original research enterprise, and China Resources SECCO ranked third, accounting for 6.0% According to the domestic database of pharma intelligence, there are 21 approved manufacturers of terazosin hydrochloride tablets and 14 capsule manufacturers in China Among them, 2 mg of terazosin hydrochloride tablets are listed in the national basic drug catalog of China At present, there are 9 enterprises for reference and filing of tablets, among which only CR Secco is the first one to declare and have been evaluated, which is expected to impact the market share of the original research enterprise In addition, it is worth mentioning that terazosin hydrochloride capsule of Yangzi River was approved recently and was in the "issued" state On January 7, Huadong pharmaceutical announced that its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd (hereinafter referred to as "Zhongmei Huadong") produced the first cyclosporine soft capsule (50mg, 25mg) in China to pass the quality and efficacy consistency evaluation of generic drugs Cyclosporine is a powerful immunosuppressant, which also has a good effect on many autoimmune diseases It has become a recommended clinical route for a variety of autoimmune diseases It is one of the first-line drug choices to prevent graft rejection after organ transplantation in the world The original manufacturer is Novartis, Switzerland Its cyclosporine soft capsule was approved by FDA in 1990 and first imitated by China, the United States and East China in 1996 According to the announcement, in 2017, the sales revenue of cyclosporine soft capsules exceeded 400 million yuan In 2018, the market share of cyclosporine preparations in China and the United States and East China accounted for about 46.92%, exceeding the market share of the original research drugs According to the pharmaceutical intelligence data, there are 21 domestic approvals and 11 manufacturers of cyclosporine soft capsules in China At present, there are 7 enterprises that have made the consistency evaluation reference record, including 2 enterprises that have completed the application, Hangzhou Zhongmei Huadong pharmaceutical and Huabei pharmaceutical It is worth mentioning that the 2017 version of the national new medical insurance catalogue has cancelled the use restrictions of indications of cyclosporine soft capsules and tacrolimus capsules, which is conducive to their wider use in the field of immunity In addition, cyclosporine has also entered the national essential drugs catalogue of 2012 and 2018 This time, Huadong pharmaceutical took the lead and was the first to pass the evaluation, which is conducive to further improving the import substitution of the product with better cost performance, consolidating and expanding the market share On January 3, the consistency evaluation conclusion of vitamin B6 tablets of Hangzhou Minsheng Pharmaceutical Co., Ltd was "approved and supplemented" and passed the consistency evaluation Vitamin B6 tablets are used to prevent and treat vitamin B6 deficiency, such as seborrheic dermatitis and lip dryness It can also be used to reduce vomiting during pregnancy According to the pharmaceutical intelligence data, there are 483 domestic approvals for vitamin B6 tablets, 474 manufacturing enterprises, 8 enterprises for consistency evaluation reference and filing, 4 enterprises for consistency evaluation application, Hubei Guangji, Anhui Huanqiu, Hangzhou Minsheng and Yichang humanwell Pharmaceutical Co., Ltd., among which Hangzhou Minsheng Pharmaceutical Co., Ltd is the first one On January 3, Fosun Pharmaceutical announced that its holding subsidiary Chongqing Yaoyou's indapamide tablets passed the generic drug consistency evaluation Indapamide tablet is mainly used for the treatment of essential hypertension It is the base drug catalogue of 2018 version According to the latest data of iqviachpa, the sales volume of indapamide tablets in China in 2017 was about RMB 69.18 million In 2017, the sales volume of Chongqing Yaoyou in China (excluding Hong Kong, Macao and Taiwan, the same below) was about RMB 1 million 450 thousand (Unaudited) According to pharmaceutical intelligence data, at present, there are 30 domestic enterprises holding the approval documents for the production of the drug, 19 enterprises carrying out the consistency evaluation reference filing, and 10 enterprises applying for the consistency evaluation, among which Chongqing Yaoyou is the first one 7 varieties are approved, 6 varieties are about to be the first one to be evaluated this week In addition to the 4 varieties that have been evaluated, there are 8 acceptance No 7 varieties that have been reviewed and approved, and they are in the status of "issued" or "approved pending certification" In addition to tansulosin hydrochloride sustained-release capsule, which has been first evaluated by Jiangsu Hengrui Pharmaceutical Co., Ltd., the other six varieties have not been evaluated by enterprises so far If there is no accident, they may become the first enterprise breakthrough varieties In addition, vinorelbine tartrate injection from Haosen, Jiangsu Province is among them Details of approval of consistency evaluation this week 17 varieties application was accepted Kelun pharmaceutical's two pound injection launched Although the time limit for consistency evaluation of base drug catalog products has been relaxed at present, the faster the consistency evaluation is completed, the better the market share can be divided and the benefits of policies can be enjoyed This week, there was another evaluation on the consistency of application for variety No 19 and No 17, among which 289 varieties accounted for two-thirds, and the hot spots of consistency evaluation, such as metformin hydrochloride tablets, Amoxicillin Capsules, amlodipine besylate tablets, and montmorillonite powder, continued to be reported In addition, the first application for eight varieties was accepted, including the two pounds of fat emulsion amino acid (17) glucose of Kelun pharmaceutical in Sichuan Province（ 11%) and levofloxacin hydrochloride sodium chloride injection Details of application for acceptance of this week's conformity assessment note: the part marked in red is the first application for acceptance of levofloxacin hydrochloride and sodium chloride injection Levofloxacin hydrochloride and sodium chloride injection are quinolones, and they are the left-handed body of ofloxacin Their antibacterial activity is about twice of that of ofloxacin Their main mechanism is to inhibit the activity of bacterial DNA gyrase and the replication of bacterial DNA It has the characteristics of broad antibacterial spectrum and strong antibacterial effect For most Enterobacteriaceae bacteria, it is suitable for respiratory system, urinary system, skin soft tissue, intestinal medium and severe infection caused by sensitive bacteria According to the pharmaceutical intelligence data, at present, there are 95 domestic market approvals for levofloxacin hydrochloride and sodium chloride injection There are 23 manufacturers, including Sichuan Kelun, Yangtze River, Jiangsu Haosen, etc., with a relatively fierce competition pattern At present, there are no other enterprises except Sichuan Kelun Pharmaceutical Co., Ltd for reference and application consistency evaluation Fat emulsion amino acid (17) glucose (11%) injection fat emulsion amino acid (17) glucose (11%) injection is commonly known as three chamber bag, which is used for adult patients who can't or have incomplete function or are forbidden to take nutrition through mouth / intestine The original research enterprise is freseniuska, which was approved to be listed in 2004 Its commodity name is Calvin It is a national medical insurance type B product According to the announcement, the market sales of Calvin in China is about 1.33 billion yuan At present, the domestic market of the product is basically monopolized by fresenyuscapi; and in recent years, the market growth rate of three cavity bag is higher than the average growth rate of parenteral nutrition products, reaching 23% - 27%, and the market growth space is huge According to pharmaceutical intelligence data, at present, there are only two domestic fat emulsion amino acid (17) glucose (11%) injection enterprises, including Sichuan Kelun Pharmaceutical Co., Ltd and Liaoning hisico Pharmaceutical Co., Ltd.; Sichuan Kelun Pharmaceutical Co., Ltd is the first imitated enterprise, this conformity evaluation once again takes the lead, and the first application is accepted, which provides a solid barrier foundation for challenging the original research and breaking the monopoly Part of the information source: enterprise announcement, yaozhi.com and online public information data source: Yaozhi data statement: this point of view only represents the author, not the position of yaozhi.com, 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.