[Zhou Jun] after the aftershock of the long life biological vaccine case, 20 officials were held accountable; 25 pharmaceutical companies reported it in half a year, and Watson's net profit increased by 270.08%

Last week, after the aftershock of the long-term vaccine case, 7 drug regulatory bureaus and 13 relevant officials from Jilin Province and Changchun City were held accountable; another province issued a document, in which more than 3 manufacturing enterprises passed the consistency evaluation, and those failed were suspended from the Internet; 25 drug R & D and manufacturing enterprises released the 2018 half year report, and the net profit growth of four pharmaceutical enterprises, Watson biology, pharming biology, Saito biology and Puli pharmaceutical, were all increased More than 100%, Watson biology has reached 270.08%, nearly three times of growth, and the net profit of Tiantan biology and unnamed medicine has dropped sharply; the explosion point is continuous, let's take a look at: after the aftershock of the drug administration, five officials have been removed, and one has been reviewed and investigated On August 18, the State Administration of Market Supervision issued the accountability of relevant staff of the State Administration of market supervision and Administration for problematic vaccine cases, which removed Ding Jianhua, director of the drug and cosmetics supervision department and director of the food and drug audit and inspection center of the former State Administration of food and Drug Administration (SFDA), Dong Runsheng and sun Jinglin, deputy directors, and ye Jianhua, director and investigator of the special drug administration Guoqing and guoxiuxia were removed from their posts, and Li Bo, President (director) of CFDA, was instructed to conduct in-depth inspection On August 23, the State Food and Drug Administration announced that Wang Lifeng, former director of the Department of drug and cosmetics registration and administration of the State Food and Drug Administration (the Department of traditional Chinese Medicine National Drug Administration), was suspected of serious violations of discipline and law, and was currently undergoing disciplinary review and supervision investigation On August 22, Jilin provincial government issued a notice to remove Guo Hongzhi, the director of Jilin food and Drug Administration (the office of the provincial food and Drug Safety Committee), and Zeng Xiangdong and Yan Haijiang, the deputy director of the provincial food and Drug Administration (the office of the provincial food and drug safety committee) As early as August 16, the meeting of the Standing Committee of Jilin provincial Party committee decided to organize and deal with the relevant five cadres In addition to the three mentioned above, Bai Xugui, Secretary of the Party group and director of the Department of industry and information technology of Jilin Province, was also removed LV Feng, deputy mayor of Changchun City and director of the Municipal Public Security Bureau, made a profound inspection On the same day, the Standing Committee meeting of Changchun Municipal Committee decided to organize and deal with 8 relevant personnel in Changchun In the progress of conformity assessment, five varieties were accepted, one was declared for the first time, and one variety had been sent As of August 24, a total of 314 acceptance numbers of CDE registration acceptance were accepted, including 64 acceptance numbers, involving 34 varieties of 33 enterprises This week (August 17-24) added 5 acceptance numbers, involving 5 varieties of 5 companies (see the figure below for details) Among them, captopril tablet has been approved by Changzhou pharmaceutical factory and Ouyi, a stone drug Vinorelbine tartrate injection from Qilu Pharmaceutical (Hainan) is the first application In addition, this week, Jiangsu Hengrui's treatment status of irinotecan hydrochloride injection was updated to issued, and at present, the product has not passed the enterprise; the treatment status of niclosepam tablet of Enhua pharmaceutical was updated to approved - to be certified, and the product has not yet been declared by the enterprise except for Enhua pharmaceutical These 5 consistency evaluation varieties have already collected 3! On August 22, UL announced that cefuroxime axetil tablets (0.25g) produced by Zhongshan branch, a wholly-owned subsidiary of the company, had been approved to pass the quality and efficacy consistency evaluation of generic drugs on August 6, 2018, making it the third domestic manufacturer approved for the product consistency evaluation According to the registration and acceptance database of smart drugs, the other two are Zhijun (Shenzhen) and Chengdu Beite pharmaceutical In addition, there are 3 enterprises that have passed the consistency evaluation of 4 varieties The specific drugs and approved enterprises are: tenofovir dipivoxil fumarate tablets, 0.3g (Zhengda Tianqing, Qilu pharmaceutical, Chengdu Beite pharmaceutical); rosuvastatin calcium tablets, 10mg (Zhengda Tianqing, Jingxin pharmaceutical, Haizheng pharmaceutical); montmorillonite powder, 3G (Xiansheng pharmaceutical, Yangzijiang pharmaceutical, Sichuan vio pharmaceutical); amlodipine besylate tablets, 5mg (Jiangsu Huanghe pharmaceutical, China Resources pharmaceutical) SECCO pharmaceutical, Yangtze River Pharmaceutical, Shanghai haini pharmaceutical) Another province! On August 22, Zhejiang health and Family Planning Commission issued opinions on the implementation of reform and improvement of supply guarantee and use policy of generic drugs publicly solicited by Zhejiang medical reform office According to the consistency evaluation, generic drugs are treated equally with the original research drugs, the purchase price shall not be higher than the original research drugs, and the payment standard of medical insurance shall not be higher than the network price and payment price of other provinces At the same time, it is clear that if there are more than three manufacturers of the same kind of drugs that have passed the consistency evaluation, the online trading products that have not passed the consistency evaluation will be suspended in principle In addition to last week's Jiangxi development, more than three manufacturers of the same type of drugs have passed the consistency evaluation, and online trading products that fail to pass the consistency evaluation are suspended in principle Guangxi, Fujian, Tianjin, Hebei, Jilin, Liaoning, Shaanxi, Gansu and other provinces and cities have also issued documents to clearly stipulate the above requirements This week, 25 pharmaceutical R & D and production enterprises released the 2018 semi annual report The specific data are shown in the following figure: the 2018 semi annual report of 25 pharmaceutical enterprises (sorted by operating revenue) on the whole, the three indicators of operating revenue, net profit and R & D investment of 25 pharmaceutical enterprises, the vast majority of pharmaceutical enterprises have kept rising, with a good development trend In terms of revenue, Yunnan Baiyao, China biopharmaceutical and China Resources ranked top three, with revenue of 12.974 billion yuan, 9.72billion yuan and 6.472 billion yuan, respectively, of which the R & D investment of China biopharmaceutical reached 1.328 billion yuan, which is beyond the reach of other enterprises; in terms of revenue growth rate, the growth rate of Puli pharmaceutical, Saito bio and Yaoming bio exceeded 50% In terms of net profit, the growth rate of Watson biology, Yaoming biology, Saito biology and Puli pharmaceutical has exceeded 100%, and Watson biology has reached 270.08%, nearly three times of the growth rate Moreover, Watson biology has invested 156 million yuan in R & D, close to half of the operating revenue of 375 million yuan Among the enterprises with decline in three indicators, Tiantan bio's net profit decreased by - 72.73%, R & D investment decreased by - 31.93%; unnamed pharmaceutical's revenue decreased by - 44.60%, net profit decreased by - 96.84%, R & D investment decreased by - 0.16%; Panlong pharmaceutical's net profit increased by 71.07%, but R & D investment decreased by - 25.19% Reply of National Bureau of hot spots in other industries to break the monopoly of APIs On August 21, in response to Xiong Weizheng's proposal on further strengthening supervision and reducing access conditions for APIs submitted at this year's two sessions, the State Food and Drug Administration replied that the drug regulatory authorities do not assume the responsibility of investigating and punishing the monopoly of APIs, but will actively cooperate with the relevant work involved in the investigation and punishments of the monopoly of APIs, such as providing drug approval information At the same time, we will continue to improve the API management measures The API application is changed from being approved separately to being reviewed and approved together with the drug preparation registration application The registration and filing management is adopted to optimize the workflow and improve the work efficiency without reducing the review and approval standards Recently, the National Pharmacopoeia Committee issued the public notice on the revised version of valsartan national standard, saying that the standard of valsartan pharmacopoeia is to be revised The national pharmacopoeia committee plans to add production requirements in the Valsartan pharmacopoeia standard: the production process must be evaluated to determine the possibility of forming N-nitrosodimethylamine If necessary, the production process shall be verified to show that the content of N-nitrosodimethylamine in the finished product meets the requirements N-nitrosodimethylamine was determined by gas chromatography (general rule 0521) and mass spectrometry (general rule 0431) The limit should not exceed 3 / 10 million AXA pharmaceutical announced its listing in Hong Kong on August 20, and AXA pharmaceutical announced that it had submitted an application for listing on the Hong Kong stock exchange In the prospectus, the company has not disclosed the specific amount of capital raised Yasheng pharmaceutical obtained a round of financing of RMB 96 million in 2015, followed by a round of financing of RMB 500 million at the end of 2016, and another round of financing of RMB 1 billion in 2018, with a total estimated value of RMB 4 billion after investment At present, the company has 7 new drugs in clinical trials and 20 ongoing clinical trials Among them, apg-1252, apg-2575 and hqp1351 are the core products in its R & D pipeline Information source: State Food and drug administration, juchao.com, sepilan.com, xinhua.com, etc