[exclusive] Hengrui and Kangenbei varieties passed the consistency evaluation and exceeded 100 through the acceptance number

On October 12, Jiangsu Hengrui announced that it had received the approval document of supplementary drug application for irbesartan tablets (0.15g) approved and issued by the State Drug Administration, which passed the conformity evaluation of quality and efficacy of generic drugs Up to now, the company has invested about 8.86 million yuan in research and development of irbesartan tablet project On October 12, Kangenbei announced that its holding subsidiary Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd had received the approval document for supplementary application of amoxicillin capsule (0.25g) issued by the State Drug Administration, and the drug passed the consistency evaluation of generic drugs As of the date of this announcement, only Zhongshan branch of Zhuhai United Pharmaceutical Co., Ltd and Jinhua Kangenbei are amoxicillin capsule manufacturers that have passed the consistency evaluation of the State Food and drug administration Jinhua Kangenbei has invested about 4 million yuan in R & D for the consistency evaluation of the drug As of October 12, there are 101 acceptance numbers (see the end of the article for the specific information of 101 acceptance numbers) and 33 289 catalogues of varieties passing and deemed passing the conformity evaluation of generic drugs In terms of drug passing, there have been 5 product consistency evaluations with enterprise data reaching 3, including rosuvastatin calcium tablets (the first product to reach 3), amlodipine besylate tablets and montmorillonite, cefuroxime ester tablets, tenofovir dipivoxil fumarate tablets (including a "generic drug approved by new registration and classification of chemicals" of Zhengda Tianqing) Table 1: on October 10, 2018, Hunan health and Family Planning Commission issued the notice on ensuring the supply of new drugs and varieties through the consistency evaluation of quality and efficacy of generic drugs Three of them are worth noting: 1 The products that pass the consistency evaluation are deemed to have passed the consistency evaluation according to the national quality and efficacy consistency evaluation of generic drugs and the announcement on matters related to the quality and efficacy consistency evaluation of generic drugs (No 100, 2017) issued by the former State Food and drug administration, and the manufacturers are allowed to use the lowest average provincial price of the three provinces after passing the consistency evaluation Provinces with market price model) directly linked to the Internet for medical institutions to purchase The price collection range for price linkage of such products is the price after consistency evaluation 2 If there are more than three manufacturers of the same kind of drugs that have passed the consistency evaluation, the varieties that have not passed the consistency evaluation will no longer be included in the procurement scope of medical institutions 3 Through the consistency evaluation, varieties can be applied for the identification "through the consistency evaluation" in the provincial medicine centralized procurement platform Medical institutions should give priority to the procurement and use of varieties that have passed the consistency evaluation Briefly review the document requirements of some provinces for the drugs of the same variety that have passed the consistency evaluation, if the number of manufacturers has reached more than 3 Up to now, in addition to the provinces listed in the table, Shanghai, Fujian, Tianjin, Hebei, Jilin and other provinces have also issued documents mentioning that more than three manufacturers of the same kind of drugs have passed the consistency evaluation of quality and efficacy of generic drugs, and no more varieties that have not passed the consistency evaluation of quality and efficacy of generic drugs are selected In addition, there are 12 varieties through the number of enterprises has reached 2, is about to reach the potential of tripartite confrontation Table 2: varieties with the number of enterprises reaching two or more table 3: in terms of enterprises ranking by acceptance number, 24 enterprises have more than two acceptance numbers, and 23 enterprises have only one acceptance number Huahai pharmaceutical has passed the most, reaching 15 acceptance numbers and 10 varieties Appendix 1: data source of detailed catalog of 101 acceptance numbers through consistency evaluation: statement of progress database of consistency evaluation of pharmaceutical Intelligence: the viewpoint of this article only represents the author, not the position of pharmaceutical 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.