Take stock of top 10 "accepted / passed" hot varieties in conformity evaluation

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? 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 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 10 varieties mentioned above, the top 10 enterprises applying for varieties are amlodipine besylate tablets, tenofovir dipivoxil fumarate tablets, montmorillonite powder, metformin hydrochloride sustained-release tablets, cefuroxime ester tablets, metformin hydrochloride tablets, levocetirizine hydrochloride tablets, rosuvastatin calcium tablets, glimepiride tablets and isoniazid tablets 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 Follow up 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 Follow up Metformin hydrochloride mainly has 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 Follow up There are several dosage forms of Cefalexin, among which capsule and tablet are the main ones At present, Cefalexin Capsules of three enterprises have been approved, which are 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 Follow up There are three specifications of montmorillonite powder At present, the montmorillonite powder of eight enterprises has been approved They are Sichuan Weiao, Xiansheng pharmaceutical, Yangzi River, Shandong hongjitang, Hangzhou Kangenbei, Harbin traditional Chinese medicine No.2 factory, Shandong LVYE and 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 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 to some extent reflects the lag of current imitated varieties in China, the high-end imitated pattern has not yet formed, and the enterprise still has a certain space to play.