Weekly trend of consistency evaluation: the first multi species evaluation in Ningxia to achieve "zero" breakthrough

As of November 21, the acceptance number of CDE acceptance consistency evaluation reached 1589 (436 varieties of 452 enterprises) According to the supplementary application, the same below); 294 (120 varieties) have been evaluated and accepted This week (November 14-21), there are 5 varieties that have been evaluated, and the first heavy-duty varieties have been added by Yangzijiang, Enhua, Lepu and other enterprises; 15 varieties have been undertaken, and many varieties of Shijiazhuang four drugs have been undertaken Five varieties (six specifications) passed the consistency evaluation this week, four of which were the first ones Details of this week's conformity assessment Omeprazole enteric coated capsule, a proton pump inhibitor, is used in the treatment of gastric and duodenal ulcer, reflux esophagitis and Zhuo AI syndrome Developed by AstraZeneca, it is the first proton pump inhibitor on the market It was approved by the European Union in 1988 and listed in China in the same year Omeprazole enteric coated capsule once became the international super heavyweight explosive ammunition, with sales of up to 6 billion US dollars According to pharmaceutical intelligence data, at present, there are 111 market approvals for omeprazole enteric coated capsules made in China, involving 97 manufacturers, and 5 enterprises applying for consistency evaluation, including Luoxin, Yangzijiang, Hainan Hailing chemical pharmaceutical, Changzhou No.4 pharmaceutical and Zhejiang Jinhua Kangenbei biological pharmaceutical However, as omeprazole enteric coated capsules are recognized by the industry as the most technically difficult in the 289 catalog, there is no enterprise to announce the consistency evaluation This week, Yangzijiang pharmaceutical industry took the lead in breaking through the difficulties and was the first to pass the evaluation It is believed that it has an excellent competitive advantage when the expansion of centralized drug procurement varieties is coming Up to now, there are 15 evaluated varieties in Yangtze River, 10 of which are the first to pass Photo source: Yangtze River official micro Valsartan capsule is a kind of antagonist of angiotension Ⅱ receptor, which is used to treat mild and moderate essential hypertension The original research enterprise of valsartan capsule is Novartis pharmaceutical According to the announcement of Lepu enterprise, at present, the total domestic sales of valsartan is 3-5 billion yuan, of which the original research accounts for about 75%; in addition, according to the sales data of pharmaceutical intelligence hospital, the sales of domestic sample hospitals of Valsartan capsule in 2018 reached 937 million yuan, 758 million provided by Novartis, accounting for 80.96% Now, Lepu is the first one to pass the consistency evaluation, which will definitely challenge the original Novartis and share its market share Cyclosporine soft capsule is an immunosuppressant, which is mainly used to prevent the rejection of allogeneic kidney, liver, heart, bone marrow and other organs or tissues transplantation, as well as to prevent and treat the graft-versus-host reaction (GVHD) during bone marrow transplantation; at the same time, it is also suitable for non transplantation such as endogenous uveitis, psoriasis, atopic dermatitis, rheumatoid arthritis, nephrotic syndrome, etc Plant indications Cyclosporine soft capsule was developed by Novartis pharmaceutical, and was approved to be listed in the United States by the FDA in July 1995 In 1996, it was the first imitated and listed in China by China, the United States and East China According to the pharmaceutical intelligence data, there are 11 domestic enterprises holding the production approval documents of the drug In 2018, the sales volume of domestic sample hospitals reached 331 million yuan, and the proportion of the first imitated enterprise Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd was 52.14% higher than that of the original research enterprise Huabei pharmaceutical hospital, the enterprise that had evaluated the consistency of the product varieties this week, ranked the third, 12.18% It is worth mentioning that the consistency evaluation of the product of Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd passed at the beginning of this year Therefore, this week Huabei Pharmaceutical Co., Ltd is the second enterprise in China that has ever evaluated the product Whether it will further compress the market space of the original research enterprise in China and directly replace the original research enterprise remains to be seen Calcium hydroxybenzenesulfonate capsule is the first choice drug for the prevention and treatment of diabetic retinopathy According to the data of pharmaceutical intelligence, in recent years, the sales volume of domestic sample hospitals of this variety continued to rise, with 82.5243 million yuan in 2018, up 11.76% year on year At present, there are 6 domestic calcium dobesilate capsule manufacturers, only Shanghai Zhaohui Pharmaceutical Co., Ltd and Ningxia Kangya Pharmaceutical Co., Ltd apply for conformity assessment, among which, Zhaohui pharmaceutical sample hospital accounts for the largest proportion of sales, and Ningxia Kangya Pharmaceutical Co., Ltd ranks the fourth This week, Ningxia Kangya Pharmaceutical Co., Ltd was the first one to pass the conformity assessment, and it is the first one to pass the consistency assessment in Ningxia It is expected to obtain policy dividend at the same time To achieve rapid market volume Risperidone is a commonly used drug for the treatment of schizophrenia in China, and it is the first choice of many guidelines at home and abroad At present, the original research drug has not been listed in China, and according to the pharmaceutical intelligence data, there are only three approvals for the domestic market of risperidone dispersible tablets, involving only two enterprises, Huahai and Enhua Before that, Huahai pharmaceutical has passed the consistency evaluation This week, Enhua pharmaceutical has been evaluated, and the two giants compete for hegemony Who will be the better? In addition, in addition to the evaluation of dispersible tablets, Enhua pharmaceutical's risperidone tablets have been approved and supplemented in February this year So far, three varieties of Enhua pharmaceutical have passed the consistency evaluation This week, CDE added 21 acceptance numbers (15 varieties) for consistency evaluation, and injection declaration became the mainstream A total of 14 acceptance numbers and 8 injection declarations were accepted The first declared variety is only 1, which is montmorillonite particles of taiyangshi pharmaceutical industry Details of acceptance of this week's conformity assessment declaration Up to now, there are 487 application acceptance numbers (128 varieties) for consistency evaluation of injections This week, it is worth noting that three injections of Shijiazhuang No.4 Pharmaceutical Co., Ltd have been accepted successively, namely sodium acetate ringer injection, potassium chloride injection and ambroxol hydrochloride sodium chloride injection As of November 21, there are 15 application acceptance numbers (9 varieties) for consistency evaluation of Shijiazhuang No.4 Pharmaceutical Co., Ltd, Seven of them are injections When the consistency evaluation of injections officially starts, the rush has already begun In the future, they may win a large bonus of over evaluation of injections, which can be expected to be waited Details of consistency evaluation of Shijiazhuang four drugs