[Zhou Jun] the national linkage signal of "purchasing with quantity" is emerging; another batch of "generic drugs without evaluation" is determined to be out; 20 years of clinical practice, new progress has been made in the international evaluation of innovative traditional Chinese medicine

Industry news two "major special" implementation management rules out! On December 17, the general office of the national health and Health Commission issued the detailed rules for the implementation and management of major scientific and technological special projects for major new drug creation and the implementation and management of major scientific and technological special projects for the prevention and control of major infectious diseases such as AIDS and viral hepatitis, so as to ensure the smooth implementation of the two major scientific and technological special tasks for the prevention and control of major infectious diseases such as major new drug creation, AIDS and viral hepatitis Among them, the new drug is aimed at 10 major diseases (malignant tumor, cardiovascular and cerebrovascular diseases, neurodegenerative diseases, diabetes, mental diseases, autoimmune diseases, drug-resistant pathogens infection, tuberculosis, viral infectious diseases and other common and frequently occurring diseases) that seriously endanger the health of the people in China, and attaches importance to the use of drugs for children and rare diseases The special project of infectious diseases focuses on the construction of prevention and control system for major infectious diseases such as AIDS and viral hepatitis, and the independent research and development of infectious disease diagnosis, prevention and protection products New progress of medical fee control, DRGs payment country pilot cities began to declare! On December 20, the official wechat of the State Medical Insurance Bureau issued a notice saying that in order to accelerate the pilot of DRGs, explore the establishment of DRGs payment system, and decide to organize the DRGs national pilot declaration work, in principle, each province can recommend 1-2 cities (municipalities directly under the central government as units) as national pilot candidate cities It is reported that in addition to the "package payment" mode of (DRGs), there is also a combination mode of single disease payment However, the industry believes that DRGs is more scientific and reasonable than the combination mode of single disease payment, and DRGs has been internationally recognized as the mainstream payment mode in Europe and the United States In addition, the data shows that in the pilot DRGs payment of six large-scale hospitals in Beijing, such as Beijing No.3 Medical College and Beijing People's Hospital, the medical cost of 108 selected disease groups decreased by an average of 19% Here comes the chance! There is no patent restriction on these drugs, and there is no imitation declaration Recently, CDE announced the list of drugs to be included in the second batch of patent expired, terminated, invalid and no copy application, including azanavir sulfate for the treatment and prevention of HIV / AIDS, aligiren semifumarate and tiranavir for the treatment of renin type hypertension, Mozavaptan hydrochloride, secatechin, finafloxacin and trimethoprim The selected results of "4 + 7" with volume procurement for drug procurement will be released and implemented at the end of February and the beginning of March next year? On December 17, 2018, the selection results of 4 + 7 urban drug centralized procurement was officially announced on Shanghai Sunshine pharmaceutical procurement network The final selection catalog is determined to be 25 varieties, and 43 varieties (detailed to specifications and packaging quantity) will be supplied after selection It is worth noting that the notice clearly mentions that "the specific implementation date will be announced separately" Later, according to the saibelan news, the implementation of 4 + 7 belt purchase is not the same everywhere It is probably at the end of February and the beginning of March next year All regions will be implemented before March 15, 2019, and Shanghai will implement it first On December 19, Gansu Province issued a notice that Yangzi River actively applied for price selection in the implementation of "4 + 7 urban drug centralized procurement" in Gansu Province and added another specification of hanging net Gansu Province put 2 drugs on the Internet, and pointed out that all medical institutions should open up a green channel for purchasing and using the selected drugs in "4 + 7 city drug centralized procurement" Recently, the industry frequently heard that "4 + 7 urban drug centralized procurement" will appear national linkage Although it is not clear yet, the signal is still coming In addition to Gansu, several provinces have also issued notices in response to the "4 + 7 city drug centralized procurement" variety procurement issue: Shaanxi Provincial notice shows that whether the 4 + 7 negotiation price is linked to the Internet is mainly voluntary by the enterprise, which can be listed in the price limit linked to the Internet directory preferentially Anhui mode is similar to "4 + 7", which gives "80% of the purchase quantity", requiring hospitals to ensure 80% of the purchase quantity of the products purchased with the quantity If there is a problem in the implementation process of the hospital, pharmaceutical companies can directly complain to the relevant parties Fujian Provincial notice requires to follow up the results of 4 + 7, and the purchase price of the same chemicals shall not be higher than the price of the products that have passed the consistency evaluation, otherwise the product will be disqualified Time is tight and pressure is high Another batch of generic drugs that have not been evaluated are determined to be out on December 19 Jiangsu Province issued a document saying that if more than three manufacturers of the same kind of drugs have passed the consistency evaluation of quality and efficacy of generic drugs, they will no longer choose generic drugs that have failed the consistency evaluation, and announced nine records of suspending the Internet, including three drugs from nine pharmaceutical companies These products have been publicized as early as November 22 After the official release, they will take effect officially and bid farewell to Jiangsu market temporarily In addition to Jiangsu, Jiangxi, Heilongjiang, Hubei and Guangxi also officially released the suspended product list, involving many well-known enterprises such as Sinopharm group, Guangzhou Baiyunshan and Zhejiang Jingxin Under the background of consistency evaluation policy, the "knockout" of generic drugs is becoming more and more fierce, and it is not optimistic Up to now, there are less than 10 days left from the life and death line of "289 catalog", but the clearance rate is only 8.0%, and the speed of review has not been accelerated Only 10 drugs passed the consistency evaluation this month Recently, the FDA approved and approved the special scheme review of the clinical trial of Compound Danshen Dropping Pill (the code of clinical research application of FDA is T89) At present, Tianshili will launch a multicenter, double-blind, randomized controlled clinical trial in the U.S region according to the requirements of the approval letter to verify the efficacy and safety of T89 in the treatment of chronic stable angina pectoris, so as to meet the FDA's requirements for the application of new drugs for the treatment of T89 It is reported that the compound Danshen dropping pill is a kind of modern and innovative compound Chinese medicine developed exclusively by Tianshili, which is mainly used for the prevention and treatment of cardiovascular diseases It was formally applied for the first clinical research (ind) by FDA in 1998 as a drug and again approved by FDA in 2006 It has determined the clinical indications for the treatment of chronic stable angina pectoris, and has become the first case in the world to complete the FDA The third phase clinical study of compound Chinese medicine preparation At present, only Tianshili holds the production approval documents exclusively in China, and has won the bid in 31 regions However, from 2010 to 2018, the number of regions winning the bid is gradually decreasing, and only four regions won the bid in 2018 The net profit of these companies in 2018 is expected to exceed 1 billion yuan Kelun pharmaceutical, Ruikang pharmaceutical and Lizhu group announced on December 20 that the share buyback of the company has been completed, with 4.46 million shares actually repurchased, accounting for 0.31% of the total share capital of the company at present; the actual paid capital is 99.9999 million yuan, with the highest transaction price of 22.98 yuan / share and the lowest transaction price of 21.36 yuan / share It is reported that this year's performance of Kelun pharmaceutical industry is good news all the way Recently, Kelun also released a notice It is estimated that the net profit in 2018 will be 1.16-1.385 billion yuan, an increase of 55.00% - 85.00% year on year In addition to Kelun, as of December 19, 86 pharmaceutical companies in A-share have published 2018 performance forecast, among which 64 reported good luck (increased in advance, slightly increased, continued to gain and turned loss), and 7 enterprises with expected net profit exceeding 1 billion yuan are XinHeCheng, xinlitai, Ruikang pharmaceutical and Lizhu group, while 5 enterprises with expected loss are Hengkang medical and Shanghai Laishi with loss or over 1 billion yuan 2 billion! On December 19, Wuxi Pharmaceutical Co., Ltd announced that it plans to increase its capital to Shanghai Pharmaceutical Co., Ltd in the form of cash, that is, to subscribe 2 billion yuan of new registered capital to Shanghai Pharmaceutical Co., Ltd After the completion of this capital increase, the registered capital of Shanghai Yaoming increased from 1 billion yuan to 3 billion yuan, and it is still a wholly-owned subsidiary of Wuxi apptec According to the announcement, the purpose of this capital increase is mainly to supplement the working capital of Shanghai Yaoming, repay bank loans and daily business operation Hyundai pharmaceutical sold anesthesia production business with a transaction price of 426 million On December 21, Hyundai pharmaceutical announced that its holding subsidiary Qinghai Pharmaceutical (Group) transferred 45.16% of its shares in Qinghai pharmaceutical factory through public listing, and the final transferee was Shenzhen Sanshun pharmaceutical, with a transaction price of 425625900 yuan, a premium of 2 million yuan over the listing base price After the completion of the transaction, both Hyundai pharmaceutical and Qinghai Pharmaceutical (Group) no longer hold the equity of Qinghai pharmaceutical factory According to the announcement, the purpose of modern pharmaceutical industry this time is to integrate resources and optimize the asset structure, which will not affect its narcotics business, because its wholly-owned subsidiary, Sinopharm Group Industry Co., Ltd., also has the fixed-point production qualification for narcotic drugs Information source: announcement of local drug regulatory bureaus, listed enterprises, saibelan, health and knowledge Bureau, Sina pharmaceutical and other statements: this view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.