[Zhou Jun] Fu Hong, Han Lin, is top of the list, and 6 bio similar drugs are in line for listing; Mr. moshadong's senior manager changes his job; Mr. Sanofi's change of command in China

This week's highlights: 1 Fuhong Hanlin is top of the list, and 6 bio similar drugs are in line for listing 2 Xinda is about to harvest 3 bio similar drugs, and adamumab or the first 3, "4 + 7" band purchase has entered the landing period The multi provincial implementation date has been announced 4 How to purchase the large varieties that have been rejected? There are also new moves in Guangzhou 5 Mr moshadong's senior executives changed jobs and brought more than 20 drugs to the market 6 Sanofi's change of command in China Or just at the beginning of the mobilization of multinational enterprises, the general administration should hear that Wu Zhen, the former deputy director of CFDA, was arrested on suspicion of abuse of power and bribery On February 26, Wu Zhen, the former deputy director of the State Food and drug administration, was suspected of abusing his power and taking bribes The investigation was concluded by the State Supervision Commission and transferred to the procuratorial organ for examination and prosecution Recently, the Supreme People's Procuratorate made a decision to arrest Wu Zhen on suspicion of abuse of power and bribery The case is under further processing Innovation and R & D Fuhong Hanlin top, 6 bio similar drugs are queuing up for listing the first bio similar drug in China! On February 25, the State Food and Drug Administration announced that it had approved the listing of rituximab (hanlikang) developed by Fuhong Hanlin It is the first biologically similar drug approved in China, mainly used in the treatment of non Hodgkin's lymphoma Although only one biologically similar drug has been approved in China, it has occupied a leading position in the number of studies It is reported that more than 200 clinical trials of biological similar drugs have been approved in China, among which, the listing application of biological similar drugs of 6 enterprises has been accepted, including 4 declared adamumumab (sumil) by Haizheng pharmaceutical, baiaotai, Xinda biology and Fuhong Hanlin, trastuzumab (Herceptin) by Sansheng Guojian, and bevacizumab by Xinda biology Antivenin Xinda is about to harvest 3 Biological similar drugs, adalimumab or the first one On February 27, according to the column of "priority review publicity" of the center for drug review, five varieties of 7 specifications of dalafeni capsule, trimetinib capsule, adamumumab injection of Cinda biology, praqusha injection of Monti (China) and patozumab injection of Roche are to be included in the priority review Among them, as the "king of medicine" in the world, adamumumab declared by Cinda bio achieved a sales volume of US $19.936 billion in 2018, and nearly 30 domestic enterprises competed to copy it At present, four applications for listing have been accepted, only Cinda and baiaotai entered the priority review, most likely becoming the first approved adamumumab manufacturer in China In addition to adamuzumab, many similar biological drugs of Cinda are also in the harvest period: bevacizumab injection has submitted an application for listing; rituximab injection has entered the clinical stage 3 Baiji Shenzhou's R & D investment in 2018 increased by 152% Two heavyweights will be listed on February 28 Baiji Shenzhou announced its financial performance for the whole year In 2018, its annual revenue was 198 million US dollars, Abraxane, Revlimid and vidaza's sales revenue in China was 131 million US dollars, and the revenue from external cooperation was 67.34 million US dollars In 2018, Baiji Shenzhou invested 679 million US dollars in R & D, an increase of 152% compared with 269 million US dollars in 2017 It is the Chinese Biomedical enterprise with the highest R & D investment According to the Chinese clinical trial database of yaozhi.com, five drugs in Baiji Shenzhou have entered the clinical phase 3 Among the five drugs, zanubrutinib and tirelizumab have submitted their applications for marketing and have been included in the priority review, according to the founder of Baiji Shenzhou The data source of Baiji Shenzhou's drugs entering the clinical phase 3 in China: China clinical trial database "4 + 7" with quantity procurement has entered the landing period, the implementation date of many provinces has been announced with the progress of time, "4 + 7" with quantity procurement should also enter the landing period from the preparation period, but the implementation progress of each province is quite different At present, Shanghai and Beijing should be at the forefront, and the two places have announced the information of distribution enterprises this week It is reported that the implementation time in Shanghai is March 20, and that in Beijing is in the middle and late March According to this progress, it should be implemented smoothly Liaoning (Shenyang, Dalian) issued two notices in succession this week to prepare for launching and promoting the pilot procurement work, and made it clear that it would be implemented uniformly on March 20; Guangzhou issued the notice on doing well the third batch of negotiation related matters of medical insurance group this week, specifically for the "4 + 7" volume procurement of failed varieties However, up to now, the specific implementation time of Guangzhou has not been determined; Shenzhen all drug network issued a notice this week, which will carry out the maintenance of the information of the selected varieties in the 4 + 7 urban drug centralized purchase, and the specific implementation time has not been determined yet In addition, Chongqing, Tianjin and Xiamen also announced the implementation time, all on March 1 The rest of Xi'an and Chengdu did not see the relevant policies and implementation time Two provincial distribution enterprises came out, and Shanghai pharmaceutical, state control and China Resources took an absolute advantage On February 26, Shanghai and Beijing released 4 + 7 information on distribution companies From the perspective of Shanghai's distribution principle, it is based on the supporting documents of "4 + 7" procurement in the early stage, following the principle that only one drug distribution enterprise is entrusted to be responsible for the distribution of a selected variety In terms of specific enterprises, the 25 winning varieties are all distributed by Sinopharm holding and Shanghai Pharmaceutical Holding Co., Ltd., of which 13 are distributed by Sinopharm Holding Co., Ltd and 12 are distributed by Shanghai Pharmaceutical Holding Co., Ltd The distribution principle in Beijing is different from that in Shanghai One product is distributed by multiple enterprises From the perspective of specific enterprises, it is still dominated by large-scale pharmaceutical businesses such as China Resources and state control, as well as cooperation with jiashitang pharmaceutical, Beijing Keyuan Xinhai pharmaceutical, Beijing Jiuzhoutong, etc In addition, on February 28, Liaoning Province also issued a notice to clarify the distribution principle: the selected drugs can be distributed directly by the selected drug manufacturers or according to the principle that each city entrusts no more than one distribution enterprise to distribute, and the drug manufacturers independently establish and change the distribution relationship on the centralized purchase platform of drugs and medical consumables in Liaoning Province before 17:00 on March 5 How to purchase the lost large varieties? New moves in Guangzhou On February 26, the Guangzhou Pharmaceutical centralized purchase platform issued the notice on completing the negotiation of the third batch of medical insurance groups The scope of negotiation is basically the unselected drugs involved in the "4 + 7" centralized purchase of "generic name + dosage form", including 23 varieties and 32 specifications, including 3 domestic pharmaceutical enterprises (Qilu, Huahai, Da'an), and the rest are all foreign enterprises, including the quotation in the "4 + 7" centralized purchase Among the top brands, Lipitor, luohuoxi of Pfizer, Keding of AstraZeneca, Plavix of Sanofi, Smecta of Epson, etc Although Guangzhou did not directly announce the procurement policy for the unsuccessful varieties, we can also learn from this move Two places, including Shanghai and Liaoning, have made clear the purchase rules for the unselected varieties In Shanghai, it is clearly stipulated that the number of products purchased and sold that are not selected shall not exceed the number of products selected, and the price shall also be reduced step by step Liaoning also issued a notice on February 25 that such varieties can continue to purchase online only after achieving gradient price reduction according to the price difference (based on the bottom price of the middle selection price) If the price difference is large, the price reduction range shall be further increased Li Zhengqing, an executive of moshadong, a hot spot in the market, jumped to Ge Li's job On March 1, Ge Li brought 20 drugs to market Ge Li announced that he appointed Li Zhengqing as chief medical officer and President of R & D in Greater China, reporting to Wu JINZI, the founder, chairman and CEO of Ge Li It is reported that before joining Geli, Li Zhengqing began to work as global vice president and general manager of China R & D center in MSD in 2011 During his tenure, more than 20 products of MSD China have been approved successfully, among which more than 10 products were approved in China from 2017 to 2018, including keytruda, zepatier, isentress, HPV vaccine (jiadaxiu and jiadaxiu 9), RotaTeq, bridion, NuvaRing and noxafil On March 1, Sanofi announced that he enling was the general manager of Sanofi China and emerging markets global business division, and the president of Sanofi China Peng Zhenke, the former president of Sanofi China, was the head of Sanofi jianzan Europe This personnel transfer is closely related to its growth rate of 12.7% in China's market in 2018, far outpacing its growth rate of 2.5% in the global market and becoming its second largest market In addition to Sanofi, the Chinese market has also become the performance engine of Roche, MSD, Novo Nordisk and other multinational enterprises in 2018 According to Roche financial report, Herceptin, the main product that has been cut price through medical insurance negotiations, had sales of US $6.929 billion in 2018, up 1% year on year, mainly driven by the US and China markets In 2018, MSD launched five drugs in China, including keytruda, a blockbuster, and nine price HIV vaccine, and achieved rapid growth In particular, its sales in China increased by 72% in 2018, which has become the main driving force for the global market growth of the product In 2018, Novo Nordisk's revenue in China reached USD 1.787 billion, up + 8% year on year, outperforming the global market by 5% The main reason is that after its main product, lilalutide, entered the national medical insurance catalog in 2017, it has a relatively significant volume in the Chinese market, and its sales revenue increased by 73% in 2018 With the new round of national health insurance catalogue to be adjusted, anti-cancer drugs, drugs for rare diseases, children's drugs, etc will be improved, and these are the "strengths" of transnational pharmaceutical enterprises It can be predicted that in 2019, the Chinese market will still be the focus of the layout of multinational pharmaceutical enterprises Accordingly, personnel adjustment and strategic adjustment will continue to be promoted Sanofi's move may just be the beginning Step up the new action of health direction 64 million yuan stepped into the field of disinfection products this week Step up has new action in the layout of health direction Chongqing yijitang and Hantong biology purchased by step up have completed the industrial and commercial change registration, and step has also formally entered the field of research, development, production and sales of disinfection products As for the reasons for entering into this field, step length means that new drugs are generally faced with high cost, high risk, long cycle and other problems when they are put on the market, while the risk of disinfection products facing such problems is relatively small, and it is easy to expand the sales of disinfection products It is reported that in order to acquire 80% of the equity of the two enterprises, step pharmaceutical invested 64 million yuan in total In fact, the legal representatives of the two Chongqing pharmaceutical companies are the same person and natural person shareholders of the two companies The main business of yijitang is mainly in the production and sales of gynecological disinfection and bacteriostasis products and wound disinfection products; Hantong biology has obtained 6 new products such as wound bactericidal liquid membrane and wet itch bactericidal liquid in the inspection report of Chongqing disease prevention and control center Official account of China official account, official account of the public, the public number of Sanofi, the official account of the Health Bureau, the official website of the General Administration of drug control and the announcement of the listed companies The statement is only for the author himself, not for the position of the drug net Welcome to exchange and supplement in the message area; if necessary, please note the author and source of the article.