[Zhou Jun] 19 "domestic specific varieties" were sentenced to death reprieve? Giant financial report is flying all over the world, who shows eye-catching performance? Prescription sharing platform is released, and separation of medicine is expected?

Announcement list of 39 priority drug registration applications On January 29, CDE official website released the public list of the 26th batch of drug registration applications to be included in the priority review procedure, involving 39 acceptance numbers, including 9 clinical applications of new drugs such as anti-cd19t cell injection of Shanghai Hengrun Dashen Biotechnology Co., Ltd., 10 applications for listing of new drugs such as polyethylene glycol losenapeptide of Jiangsu Haosen, 16 generic drugs such as Zhengda Tianqing's citrate tuofatipu tablet City application and Pfizer's pregabalin capsule and other four applications for new indications CDE: 9 medicines can be imitated! On January 29, CDE released a list of nine drugs with expired, terminated, invalid patents and no copy application, helping enterprises and R & D institutions to screen and layout new directions of drugs and guide the R & D and production of generic drugs The nine drugs are Morinda MACROL methyl butenate, irusta, ranimivir octanoate, amitripyridine phosphate, oriwanxing phosphate, lometapine mesylate, tetraquinazine, glyceryl benzoate and uridine triacetate, all of which have been listed abroad and have definite clinical value On January 30, CDE issued the notice on further completing the consistency evaluation of 289 base drug catalogue for Chinese unique varieties, which initially formed 19 "list of domestic unique varieties" It is reported that most of the above-mentioned 19 domestic unique varieties are compound preparations or no reference preparations, and most of the products are generic ones, with a small profit margin It is difficult to eliminate the cost of "big clinic" in terms of time or money, and there is great pressure to pass the consistency evaluation of generic drugs on time In addition, according to the guidance on the classification of generic drugs for quality and efficacy consistency evaluation issued by CFDA on April 5, 2017, the analysis of the guidance on "domestic specific varieties" was made Such varieties can only be proved to be safe and effective through "re conducting clinical trials", otherwise, CFDA "does not recommend the use", which is also a death sentence Jointly issued by four departments: 100 kinds of medicine in short supply will be produced centrally On February 1, the Ministry of industry and information technology, together with the health and Family Planning Commission, the development and Reform Commission and the food and drug administration, issued the notice on organizing the construction of the centralized production base of small varieties of drugs (drugs in short supply) The notice made it clear that the construction of the centralized production base of small varieties of drugs (drugs in clinical necessity, small dosage, unstable market supply and easy clinical shortage) would be organized, and 5 would be selected and identified The standard is pharmaceutical workers Top 100 enterprises in the industry, with more than 20 kinds of small product drug production number and supporting production capacity of API, meet the requirements of full dosage form of drugs (vaccines) in production, strong quality control ability, wide distribution network coverage, etc., can fulfill the responsibility of stable production and supply guarantee, and build a small product drug centralized production base By 2020, we will basically achieve the centralized production and stable supply of 100 kinds of small drugs Hot market: global pharmaceutical giants report their financial statements in 2017, with rapid growth This week, Pfizer, Lilly and AstraZeneca successively released 2017 financial statements Pfizer's total annual revenue was 52.546 billion US dollars, 1% lower than that in 2016 Innovative drugs such as ibrance (palbociclib), eliquis (apixaban), xeljanz (tofatinib) grew strongly Lilly's total annual revenue was 22.871 billion US dollars, 8% higher, mainly driven by Forteo (trapatide), basaglar (GaN Jinginsulin injection, trulicity, jardiance, etc.; AstraZeneca's total revenue for the whole year was 22.465 billion US dollars, down 2%, but in 2017, China's market showed remarkable performance, achieving a revenue of 2.955 billion US dollars, up 12% Among them, Crestor (rosuvastatin) was $373 million (+ 20%), Iressa (gefitinib) was $144 million (+ 24%) In addition to the above three enterprises, recently, Johnson & Johnson, Amgen, and semefei also published their financial statements According to the current publicity, Xinji is a fast-growing enterprise Four drugs, such as Revlimid, pomalyst, vidaza and thalidomide, contribute 81% of the sales revenue Sanofi beat Novo Nordisk to acquire Ablynx for 3.9 billion euros On January 29, Sanofi reached a final agreement to acquire Ablynx, a Belgian biotechnology company, for 3.9 billion euros (about 30.62 billion yuan), beating Novo Nordisk's proposal of 28.00 euros per share in cash at the beginning of the year to achieve the victory At present, eight nano antibodies of Ablynx have entered the clinical development stage, and its most advanced product, capracizumab, has been submitted in the European Union and is expected to be submitted in the United States in the first half of this year, which is expected to provide treatment for acquired thrombocytopenic purpura (attP) From this, it is not hard to see that Sanofi is preparing to expand the field of treatment of rare blood diseases 576 million dollars! On February 2, centuryglobal, a wholly-owned subsidiary of Shanghai pharmaceutical, completed the acquisition and delivery of Kantor Malaysia The former will hold 100% of the latter's equity and indirectly control all Kantor's business in China The acquisition price of this transaction is 576 million US dollars It is reported that after the acquisition, with the help of kantler (China) import drug distribution management service and the advantage of network all over the country, the total number of drugs imported by Shanghai Pharmaceutical will be the first in the industry In addition, kantle (China) has 30 DTP pharmacies in 22 cities, plus more than 40 owned by Shanghai pharmaceutical, which is expected to build the largest integrated DTP brand pharmacy in China Three of the hottest biomedical stocks on NASDAQ: Recently, the popular insider trading stock tool tipranks was used on Nasdaq's official website to scan the trades of nearly 40000 insiders, and three biotech stocks, Albo, bgne and corium international, were found most concerned by traders Industry highlights promote "separation of medicine"! The first prescription sharing platform for the whole country and the whole industry was released on February 2 The "national health and medical big data application sharing platform" sponsored by China health information and health care big data society was officially released At the same time, one of the first applications of the sharing platform was released, which is a prescription sharing platform for the whole country and the whole industry It is reported that the prescription sharing platform takes patients as the center, connects the distribution system and medical insurance settlement system of hospital information system, retail drugstores, drug distribution enterprises on a large scale, realizes the online verification of prescriptions, standardizes and optimizes the drug distribution supply chain, and forms a health care data resource sharing and sharing pattern through the industrial chain Take the hospital scenario as an example After face-to-face diagnosis and treatment between the user and the doctor, the doctor connects the prescription sharing platform through his system, issues an electronic prescription, and generates a two-dimensional code after being reviewed by the pharmacist After the user scans the code for payment, he can choose to pick up the medicine in the hospital, to the nearest Internet pharmacy or directly deliver it to the home by the logistics company This mode provides a variety of ways to get medicine, improves patients' medical experience, reduces the operating cost of hospital pharmacy, and promotes the separation of medicine The prescription sharing platform also established a drug traceability mechanism to complete the whole process data tracking of drugs from manufacturers, circulation, storage and distribution, so as to ensure the safety and timeliness of patients' medication The first AI to predict death approved by FDA can be warned 6 hours in advance! The FDA recently approved the first AI product to predict death, called waveclinical platform, developed by excelmedical, a medical technology company This system is a long-distance online monitoring platform, and includes all kinds of information related to patients, including medication, age, physiological condition, past medical history, family medical history, etc it can sense the subtle changes of vital signs, so as to give an early warning six hours before the occurrence of fatal events Next, wave may appear in more American hospitals When it comes to the next step, the wave platform is developing or introducing more prediction algorithms, such as those for pediatric diseases China's richest 1000 pharmaceutical and biological industries accounted for 101 seats On January 29, the interface launched the list of "2018 China's richest 1000 people" The total wealth of the 1000 rich / rich families on the list reached 12.5 trillion yuan, with a threshold of 3 billion yuan Ma Huateng of Tencent ranked the richest with 282 billion yuan of wealth; Xu Jiayin and his wife of Evergrande ranked second with 260.9 billion yuan of wealth; Ma Yun ranked third with 213.8 billion yuan of wealth Among them, there are 101 rich people in the pharmaceutical and biological industry on the list, and the top one is Fosun Guo Guangchang, with a wealth of 87.3 billion yuan; sun piaoyang of Hengrui pharmaceutical ranks the second with a wealth of 42.6 billion yuan; the third one is Ma Xingtian family of Kangmei pharmaceutical, with a wealth of 37.8 billion yuan Content source: CFDA, CDE, arterial network, quantile, e-medicine manager, medicine cloud studio, etc