The 14 most noteworthy consistency evaluation varieties in 2019

Towards the end of 2018, the overall progress of consistency evaluation is not ideal It is not clear whether the country will adjust the time limit for consistency evaluation of 289 varieties However, the signal sent by the 4 + 7 volume procurement organized by the state is no more clear: only through the consistency evaluation is the passing line of generic drugs, can it be qualified to enter the field to replace the original research This is the reason why many enterprises of non 289 varieties have carried out consistency evaluation in the early days Up to now, although only 105 drugs (according to the acceptance number) have passed the consistency evaluation, there are many generic drugs for which the enterprise has submitted an application or is carrying out be, including some heavy products and no enterprise has passed the consistency evaluation, so the market competition pattern is good Today, we have selected the most noteworthy 14 consistency evaluation varieties in 2019 by using PharmaGo and PharmaBI database as tools for your reference Note: there are two situations in which no enterprise has passed the consistency evaluation of the 14 heavy-duty varieties listed in this paper: 1) a supplementary application for consistency evaluation (cyhb) has been submitted by an enterprise and has not been approved 2) Some enterprises have submitted listing application (CYHS) according to 4 categories of new registration classification After approval, it will be deemed to pass the consistency evaluation, but it has not been approved Budesonide suspension for No.1 inhalation is a kind of inhaled glucocorticoid with high local anti-inflammatory effect, which is used to treat asthma and chronic bronchitis Budesonide suspension for inhalation is the largest category of inhalation preparations in China, with domestic sales of 4.29 billion yuan in 2017 The market concentration of inhalation preparations is generally high Budesonide suspension for inhalation is monopolized by Pulmicort Lingshu, who originally researched AstraZeneca, and has been monopolized for 14 years since it entered China in 2004 No domestic generic drug has been listed in the competition In the first half of 2018, 3 companies including Zhengda Tianqing, Shenzhen Madame pharmaceutical and Changfeng pharmaceutical successively submitted listing applications according to the new 4 categories If any one of them can be approved in 2019, it will be deemed as passing the consistency evaluation, breaking the unique situation of AstraZeneca in China However, Jian Kangyuan issued a notice on November 19, saying that his wife's pharmaceutical industry had received the notice of clinical trial issued by the drug regulatory bureau, and it was expected that the be trial would be carried out again, and the listing progress would be delayed The winner will be born in Zhengda Tianqing and Changfeng pharmaceutical industry No.2 tegio capsule tegio capsule is a kind of fluorouracil derivative oral compound anticancer chemotherapy The active ingredients include tegafur, gemcitabine and otilacy, which are used for unresectable local advanced or metastatic gastric cancer In 2017, the domestic sales volume of the product was 2.8 billion yuan In addition to the original research company Dapeng, the manufacturer also includes Shandong new era, Hengrui, Qilu and Fuzhou haiwangfu (tablet) Shandong occupies nearly 60% of the market share in the new era From the aspect of be test registration, there is no competition except for the listed manufacturers Among them, Hengrui and Qilu have completed be and submitted supplementary application for conformity assessment The be test registered in Shandong new era, which occupies the largest market share, shows that the recruitment is completed, but no application for conformity evaluation has been submitted No.3 capecitabine tablet capecitabine belongs to fluorouracil, which is a TYMS inhibitor It is a commonly used oral chemotherapy drug in cancer clinic, mainly used to treat advanced breast cancer, colorectal cancer and gastric cancer In 2017, the domestic sales volume of this product is about 2.3 billion yuan, and the main manufacturers include Roche (entered China in 2007), Zhengda Tianqing, Hengrui and Qilu Hengrui first applied for conformity assessment in January this year, but it was not approved Instead, Hengrui obtained the clinical trial approval and required to do be again It can be seen that the conformity assessment requirements of this variety are quite strict Qilu pharmaceutical just submitted an application for conformity assessment on December 19 Zhengda Tianqing has not submitted the application for conformity assessment, and it is still in recruitment from the progress shown in be test In addition, although there are no new four kinds of application for this variety, Nanjing Youke (completed) and Chengdu Yuandong Biology (in recruitment) have also registered be test, which are two enterprises worthy of attention No.4 voriconazole for injection is an antifungal drug of triazole class It can induce the rupture and apoptosis of fungal cells by inhibiting the activity of 14-a-sterol demethylase dependent on cytochrome P450 In 2017, the domestic sales of voriconazole for injection reached 1.67 billion yuan, of which Pfizer accounted for 45% Domestic manufacturers of voriconazole for injection include Zhuhai Yibang, Lizhu, Sichuan meidakang Huakang and Jincheng Haisi At present, none of the four enterprises has submitted the application for conformity assessment It is noteworthy that Qilu pharmaceutical and Puli pharmaceutical are applying for the new 4 categories In particular, the injection consistency evaluation of Puli pharmaceutical is at the forefront in China Voriconazole for injection just obtained the FDA registration approval on December 2, which does not rule out the possibility of the latter No.5 sevoflurane sevoflurane for inhalation is a kind of halothane anesthetics, which is mainly used for anesthesia before surgery Sevoflurane for inhalation is currently the best selling inhalation anesthetic, which belongs to the national class B medical insurance, and has considerable difficulty in preparation technology In 2017, the domestic sales of this variety was about 1.65 billion yuan Domestic manufacturers include Hengrui, lunanbeite, Hebei Yipin, Alberta, American Baite medical and marbles pharmaceutical, of which Hengrui occupies about 60% of the market share Among the above domestic manufacturers, Hengrui has taken the lead in submitting the application for conformity assessment, while other manufacturers have not yet submitted the application It seems that Hengrui is far ahead, but what's interesting is that a company called Fujian Haixi United Pharmaceutical Co., Ltd has entered the stage of "in approval" according to the new four types of declaration If it is approved for listing, it may impact the market pattern of Hengrui's product No.6 valsartan capsule is a kind of antihypertensive drug of angiotension II receptor antagonist It can dilate blood vessels and reduce blood pressure by antagonizing the type I receptor (AT1) of angiotension II In 2017, the domestic sales volume of the product was about 1.45 billion yuan, and the original research company Novartis accounted for 96% Valsartan capsule belongs to 289 varieties, involving 10 domestic enterprises such as Changzhou No.4 pharmaceutical, Hainan aomeihua, China Resources SECCO, Tianda pharmaceutical, etc As mentioned in the previous article "progress of consistency evaluation of top 10 varieties of 289 catalog sales", Lepu is expected to be the first enterprise to pass the consistency evaluation of valsartan capsule, with a leading layout in the consistency evaluation Changzhou No.4 pharmaceutical has just completed be, and it is expected to submit supplementary application soon Yongxin, China Resources SECCO, qianjinxiangjiang, Shaanxi Dongtai and other enterprises are carrying out be test No.7 temozolomide capsule is a new imidazolidine alkylating agent, which can effectively treat newly diagnosed and recurrent glioblastoma and anaplastic astrocytoma through blood-brain barrier In 2017, the domestic sales of this variety was about 1.31 billion yuan The manufacturers mainly include MSD, Shuanglu pharmaceutical and Tishi, among which Tishi occupies nearly 60% of the market share At present, both Shuanglu and Tianshili have submitted the application for consistency evaluation In addition, Shuanglu pharmaceutical has also applied for listing in accordance with the new 4 categories, which shows the importance of this variety In addition, Shanghai huilun, aosaikang, Dongyao pharmaceutical, etc registered and carried out the be test of the variety Metoprolol No.8 sustained-release tablet is a selective β 1 receptor blocker, which is one of the commonly used drugs in the treatment of hypertension, coronary heart disease, chronic heart failure and arrhythmia In 2017, the domestic sales volume of the product was about 1.22 billion yuan, and the market share of the product was exclusively owned by the original research company AstraZeneca, and no domestic enterprise was listed Among the research enterprises, metoprolol succinate sustained-release tablets of Nantong Lianya were reported to be manufactured in September this year according to the new four categories, which were planned to be included in the priority review in November, but failed to pass the public announcement, suggesting that the enterprises behind have interests Nantong Lianya is currently in the pharmaceutical evaluation stage, and is likely to be approved for listing in 2019, breaking the exclusive situation of AstraZeneca In addition, Hefei Heyuan has just finished be, and Hainan Huayi Taikang is doing be (this is a Sino US dual newspaper enterprise with a high probability of success) No.9 repaglinide tablets repaglinide is a new type of non sulfonylurea short acting oral insulin secretion and glucose lowering drug In 2017, the domestic sales volume of the product was about 1.1 billion yuan, with Novo Nordisk, the original research company, accounting for about 80% of the share, while Jiangsu Haosen, Wansheng pharmaceutical, Beilu pharmaceutical and Kangrui pharmaceutical accounted for the remaining 20% Among the domestic manufacturers, Jiangsu Haosen is far ahead, the only manufacturer applying for conformity assessment at present, and the other three have not registered to carry out the be test of this variety Although another Tonghua Dongbao registered to conduct a be test, the recruitment has been conducted for more than a year, and it is likely to give up It's just the howsons No.10 esomeprazole enteric coated tablets Esomeprazole enteric coated tablets work by blocking the proton pump and reducing the production of gastric acid They are used to treat problems related to excessive gastric acid, including gastrointestinal reflux disease (GERD) and peptic ulcer In 2017, the domestic sales volume of the product was about 860 million yuan, and the market share of the product was monopolized by the original research company AstraZeneca, and no domestic enterprise was listed Among the research enterprises, Jiangxi Xiangshan Pharmaceutical Co., Ltd and Suzhou Teri Pharmaceutical Co., Ltd reported production according to the new 4 categories, among which Suzhou Teri won the priority review qualification, leading the way, and is expected to be approved for listing in 2019 Nanjing Youke began to do be test on December 18 and recruited patients As the be challenge of enteric coated tablets is relatively large, this variety is likely to be the first enteric coated preparation that has passed the consistency evaluation by an enterprise, so the variety remains concerned In July of this year, the office of quality and efficacy consistency evaluation of generic drugs issued the notice on soliciting the evaluation suggestions of domestic specific varieties in 289 base drug catalog 22 domestic specific varieties were designated from 289 catalog and the evaluation suggestions were given According to statistics, at present, four enterprises have submitted the application for consistency evaluation of related varieties Domestic unique varieties are usually only sold in China, with Chinese characteristics, and there is a good market base It is also worth paying attention to the consistency evaluation of domestic unique varieties Summary in this paper, oral solid preparations are mainly used in the selection of consistency evaluation varieties, but some special inhalation preparations and injections are also included At the same time, we pay attention to the progress of consistency evaluation of domestic endemic varieties Budesonide suspension for inhalation (Zhengda Tianqing), tegio capsule (Hengrui or Qilu), capecitabine tablets (Qilu), voriconazole for injection (Qilu pharmaceutical or) Puli), sevoflurane for inhalation (Hengrui medicine or Fujian Haixi Union), valsartan capsule (Lepu), repaglinide tablets (Haosen, Jiangsu), temozolomide capsules (Tianshili or Shuanglu), metoprolol succinate sustained release tablets (Nantong Lianya), esmeralazole magnesium enteric coated tablets (Suzhou trei) If approved in 2019, the existing generic market will be improved The Bureau has a significant impact.