There are 538 acceptance numbers! Consistency evaluation over-evaluated enterprise rankings

On February 13, 2020, Zhejiang Kangenbei Pharmaceutical Co., Ltd issued a notice that tamsulosin hydrochloride sustained-release capsule, a subsidiary of Hangzhou Kangenbei, passed the quality and efficacy evaluation of generic drugs and the consistency evaluation of the original drugs The acceptance number of tamsulosin hydrochloride sustained release capsule: cyhb1950324; the approval number of the original drug: gyzz h20050285 Tamsulosin hydrochloride sustained-release capsule is a kind of drug for the treatment of benign prostatic hyperplasia It is a selective α 1-adrenoceptor blocker for the treatment of dysuria caused by prostatic hyperplasia Hangzhou Kangenbei has invested about 15.82 million yuan in R & D for the consistency evaluation of the drug As of February 13, the acceptance number of varieties passing and deemed to pass the conformity evaluation of generic drugs has reached 538, 186 varieties, of which 245 are accepted in 289 catalogue, only 75 varieties There are 420 accepted drugs, 148 varieties; 118 deemed approved drugs, 57 varieties (subject to the list of drugs listed in China) From the perspective of time dimension, it can be roughly seen that the first batch of catalog that passed the consistency evaluation was published in December 2017 (the four acceptance numbers in July and September 2017 are deemed to have passed), and there are basically all varieties passed each month, reaching the maximum in December 2018, with a total of 45 acceptance numbers From November 2019 to January 2020, a batch of approvals were obtained, with acceptance numbers of 41, 44 and 42 respectively It can be seen that the number of passes by the end of the year will increase in a centralized way Figure 1: acceptance number of conformity assessment passed in each month (including deemed pass) In terms of drug passing, there have been 54 enterprises that have passed the compliance evaluation, including Rosuvastatin Calcium Tablets (the first to reach 3 varieties), Amlodipine Besylate Tablets, Montmorillonite powder, Cefuroxime Axetil Tablets, Escitalopram Oxalate Tablets, Amoxicillin Capsules, Tenofovir disoproxil fumarate tablets, etc., reaching 3 enterprises At present, the largest number of enterprises is 5 mg amlodipine besylate tablets, reaching 17 enterprises, followed by 0.25 g metformin hydrochloride tablets, reaching 15 enterprises Table 1: according to statistics, the number of enterprises that have passed the regulations has reached 3 or more varieties, and there are still 47 enterprises that have passed the regulations, and they are about to reach the potential of tripartite confrontation Table 2: in terms of variety enterprises with 2 enterprises, Qilu Pharmaceutical Co., Ltd with the largest number of acceptance numbers has 27 acceptance numbers and 17 varieties; Ouyi Pharmaceutical Co., Ltd of Shiyao group has caught up with 23 acceptance numbers and 18 varieties; Zhejiang Huahai Pharmaceutical Co., Ltd., the former champion, ranks the third with 21 acceptance numbers and 14 varieties Table 3: the number of acceptance numbers of enterprises is calculated by the parent company Qilu Pharmaceutical Co., Ltd has the largest number of acceptance numbers, with a total of 30 acceptance numbers Next is Shiyao group, with 26 acceptance numbers Third is Fosun Pharmaceutical, with 23 acceptance numbers Yangzijiang pharmaceutical, Qilu pharmaceutical and Shiyao group have the largest number of varieties, with 19 varieties Table 4: yifeiwelun tablets (specification: 50mg, 200mg, 600mg) produced by Huahai Pharmaceutical Co., Ltd ranked by the acceptance number of the parent company are listed in the list of generic reference preparations due to the "transfer of original research technology" and listed in the list of drugs in China, which indicates that yifeiwelun tablets have passed the consistency evaluation of quality and efficacy of generic drugs This type of products include gliclazide tablets (Ⅱ) from Huajin, Tianjin and minocycline hydrochloride capsules from Hanhui Pharmaceutical Co., Ltd Table 5: data source of original research technology transfer varieties in the reference preparation Catalog: Pharmaceutical intelligence data CDE China listed drug catalog set listed enterprise announcement