Top 10 hot varieties "accepted / passed" in conformity assessment

On the eve of the proposed consistency evaluation policy, the industry is guessing whether the policy will be implemented and discussing which enterprise some varieties will eventually match; after the implementation of the policy, most enterprises wait and see, some enterprises quickly enter the state to seize resources, increase the speed of research and development, and hope to keep their own pillar varieties; now, the consistency evaluation work has entered the right track, hot varieties The phenomenon of clustering has appeared initially Is the result in line with your original expectation? 1 Consistency evaluation "accepts" top 10 popular varieties According to the statistics of drug intelligence data, as of October 21, 2019, the top 10 varieties of application acceptance number were amlodipine besylate tablets, Amoxicillin Capsules, metformin hydrochloride tablets, ceftriaxone sodium for injection, ranitidine hydrochloride capsules, montmorillonite powder, Cefalexin Capsules, paracetamol tablets, captopril tablets and parecoxib sodium for injection Among the 10 varieties mentioned above, amlodipine besylate tablets, metformin hydrochloride tablets, Amoxicillin Capsules, montmorillonite powder, ranitidine hydrochloride capsules, paracetamol tablets, indapamide tablets, captopril tablets, Cefalexin Capsules and metronidazole tablets are the top 10 enterprises The top three varieties of amlodipine besylate tablets, Amoxicillin Capsules and metformin hydrochloride tablets were reported as a whole 2 Top 10 popular varieties "passed" in consistency evaluation According to the statistics of drug intelligence data, as of October 21, 2019, the top 10 varieties of acceptance number were rosuvastatin tablets, amlodipine besylate tablets, cefuroxime axetil tablets, tenofovir dipivoxil fumarate tablets, glimepiride tablets, metformin hydrochloride tablets, metformin hydrochloride sustained-release tablets, montmorillonite powder, atorvastatin calcium tablets, Cefalexin Capsules Among the above 10 varieties, Amlodipine Besylate Tablets, Tenofovir disoproxil fumarate tablets, Montmorillonite powder, Metformin Hydrochloride Sustained Release Tablets, Cefuroxime Axetil Tablets, Metformin Hydrochloride Tablets, Levocetirizine Hydrochloride Tablets, Rosuvastatin Calcium Tablets, Glimepiride Tablets and Isoniazid Tablets are the TOP10 enterprises See the figure below for details According to the comprehensive consistency evaluation acceptance / variety information statistics, amlodipine besylate, metformin hydrochloride, Cefalexin, montmorillonite powder, four varieties are relatively more popular 3 Domestic enterprises / market statistics of popular varieties The dosage form of the product is mainly tablets, and dozens of domestic enterprises have obtained the production approval documents of the product; currently, there are 11 enterprises "pass / deemed pass", namely Jiangsu Huanghe pharmaceutical, Yangzi River, China Resources SECCO, Suzhou Dongrui, Zhejiang Jingxin, Chenxin pharmaceutical, Yabao pharmaceutical, Beijing Wansheng, Zhejiang Weikang, Guoyao Rongsheng and Chongqing Yaoyou According to the statistics of "hospital sales database" recently launched by the pharmaceutical intelligence data, the sales volume of amlodipine besylate in China in recent three years from 2016 to 2018 is more than 1 billion RMB, of which the main dosage form is 5mg According to the proportion of sales enterprises in the figure below, the proportion of original research Pfizer is still the main one ◆ metformin hydrochloride ◆ metformin hydrochloride mainly consists of two dosage forms: tablet and sustained-release tablet Among them, metformin hydrochloride tablets of six enterprises were approved, in order of Beijing Sihuan, Guangdong Huanan, Guizhou Tian'an, Beijing Jingfeng, Shanghai Xinyi balance and Shenzhen Zoomlion See the figure below for details Metformin hydrochloride sustained-release tablets of 7 enterprises were approved, in order of Jiangsu Deyuan, Shanghai Shangyao Xinyi, yuekang pharmaceutical, Beijing Wanhui Shuanghe, Nanjing Yihua, Zhengda Tianqing and Tianfang pharmaceutical See the figure below for details According to the statistics of "hospital sales database" of pharmaceutical intelligence data, the overall sales volume of domestic metformin hydrochloride tablets / sustained-release tablets in recent three years 2016-2018 is about 150-300 million RMB, and the proportion of metformin hydrochloride tablets is 3 / 4-5 / 6 The figure below shows the sales of metformin hydrochloride tablets in the past three years according to the pharmaceutical intelligence data - hospital sales database Among them, the sales proportion of original research Squibb is still the main one ◆ Cefalexin ◆ there are many dosage forms of Cefalexin, mainly including capsules and tablets At present, Cefalexin Capsules of three enterprises have been approved, including Kelun pharmaceutical, Shandong Luoxin and Shanghai Fuda See the figure below for details According to the statistics of "hospital sales database" of pharmaceutical intelligence data, the sales volume of cephalexin (including multiple dosage forms) in China in recent three years from 2016 to 2018 is less than 100 million, which is believed to be consistent with the overall situation of the antibiotic system in recent years Different from the first two varieties, the high market share is no longer the original research foreign enterprises, but the domestic Jiangsu Haosen The figure below shows the sales of Cefalexin in the past three years according to the pharmaceutical intelligence data - hospital sales database ◆ montmorillonite powder ◆ there are three specifications of montmorillonite powder At present, the montmorillonite powder of eight enterprises has been approved, in order of Sichuan vio, Xiansheng pharmaceutical, Yangzi River, Shandong hongjitang, Hangzhou Kangenbei, Harbin traditional Chinese medicine No.2 factory, Shandong LVYE, Zhejiang hailisheng See the figure below for details According to the statistics of "hospital sales database" of pharmaceutical intelligence data, the sales volume of montmorillonite powder in China in the past three years from 2016 to 2018 is about 60 million Among them, Bofu Yipu Sheng (Tianjin) pharmaceutical products occupy a huge market share The figure below shows the sales of montmorillonite powder in recent 3 years based on the pharmaceutical intelligence data hospital sales database 4 Summary to sum up, it is not difficult to find that, in addition to the relative concentration of popular varieties in the consistency evaluation, the more obvious feature is that the varieties are relatively old, which also reflects to some extent the lag of current imitated varieties in China, the high-end imitated pattern has not been formed, and enterprises still have a certain space to play For the huge cost of consistency evaluation, most of the cost invested by the enterprise again exceeds the initial R & D fund, so it is once again seen that the above-mentioned one variety is accompanied by dozens of applications, and the total R & D fund behind this is lamentable Coupled with the "4 + 7" pilot and expansion, the cost recovery of secondary development is not easy, and the profit is no longer obvious, even accompanied by a wave of layoffs However, although the industry has a lot to do with consistency evaluation, the benefits of this matter are obvious, and it is also the only way to improve the quality of generic drugs in China Therefore, quality has not yet been successful, comrades still need to work hard! Data reference: Yaozhi data