Year end inventory 2018 policy knife point medicine stocks still ride the roller coaster

In the first year of 2018, the overall market of pharmaceutical stocks has been booming and continues to rise, becoming one of the most eye-catching industries in the stock market By the end of May, the medical stock began to adjust downward, catching up with a series of black swan events such as the falsification of the production record of the long-term biological vaccine The medical stock suffered heavy losses and continued to lead the decline, as if taking a roller coaster like a sad trend, ushering in a cold winter As one of the best defensive varieties, the performance of pharmaceutical stocks in this year can be described as vulnerable The stock market that develops first and then suppresses is obviously closely related to the policy adjustment of this year Driven by the new policies of medical reform, such as consistency evaluation and volume purchase, the life and death struggle in the field of generic drugs is inevitable, and the industry is speeding up the reshuffle The stock market is sold to unprofitable biomedical companies on the Hong Kong stock exchange“ After the "olive branch", the pharmaceutical enterprises going to Hong Kong for listing will also face the "profit" test In this regard, Sina Pharmaceutical Co., Ltd opened up the "Langyan finance and economics" plate in 2018, and continued to pay attention to the pharmaceutical stock market of this year In a flash, 2018 is coming to an end Let's review the pharmaceutical stock market of this year and sort out the policy trend of this year Key words of policy: in March 2018, the institutional setting of the State Council carried out major reforms The functions originally scattered in the drug administration, the health and Family Planning Commission and the Ministry of human resources and social security were split and reorganized, forming three new institutions: the health and Health Commission, the drug administration and the medical insurance bureau The establishment of the national medical insurance bureau is the finishing point of this institutional adjustment In this reform, the three functions of medical insurance fund payment, medical insurance catalog making and medical product pricing are integrated in the medical insurance bureau, which significantly improves the discourse power of medical insurance fund payment in the medical reform At the same time, the three tools cooperate with each other to produce a synergistic effect and a more rational and executive administrative means Micro comments: in the new regulatory era, the formation of three new institutions has ended the previous situation of "Jiulong water control" and greatly improved the administrative efficiency At the same time, it also opens a chapter for setting off a policy storm in this year Key words of policy: conformity assessment of generic drugs April 5, 2018 In order to further promote the implementation of conformity assessment, CFDA put forward 7 Guiding Opinions on the classification of varieties, including the original imported listed varieties, the original research enterprise's production listed varieties in China, the imported imitated varieties, the domestic imitated varieties, etc Micro comment: the deadline is imminent, and all parties call for "moderately relaxing" the new regulations, which is a major good for domestic generic drugs In the original document, "generic drugs according to the new classification" all need to be evaluated for consistency, but the new regulations point out that in the current year, according to the three categories of the new drug batch that have not changed the specifications and dosage forms, if there is a new drug certificate, some do not need to be evaluated for consistency This is a great advantage for pharmaceutical companies with multiple first imitations, such as Hengrui pharmaceutical, Haosen pharmaceutical, Zhengda Tianqing, etc There is no doubt that the consistency evaluation of generic drugs has accelerated the industry reshuffle As 2018 is coming to an end, the deadline for consistency evaluation is approaching, and the call for "moderate relaxation" is on the rise Key words of policy: the new rules of Hong Kong Stock Exchange came into force on April 30, including allowing biotechnology companies that fail to pass the financial qualification test of the main board to be listed, allowing companies with different voting structures to be listed, and setting up new convenient second listing channels for Greater China and international companies seeking second listing in Hong Kong This reform has brought new opportunities to listed companies in China, especially Unicorn companies to be listed, and set off an upsurge of listing Unicorn companies in the medical and health industries such as Geli pharmaceutical, Hualing pharmaceutical and Pingan good doctor have started to enter the capital market, and new three board biomedical companies such as Chengda biology and Junshi biology are on their way to listing in Hong Kong Micro evaluation: whether the biomedical industry can achieve a win-win situation remains to be seen as a rigid demand industry, with many subdivisions and investment opportunities However, the R & D cycle of new drugs is long and the required professional knowledge threshold is high Some new drugs face greater competition from multinational pharmaceutical enterprises However, the pharmaceutical industry has a large demand for capital and a high demand for stability It remains to be seen whether Hong Kong stock exchange can achieve a win-win situation between listed companies and investment institutions after offering olive branch Key words of policy: acceptance of overseas clinical data on July 6, 2018, the State Drug Administration issued the technical guidelines for acceptance of overseas clinical trial data of drugs, making clear provisions on the technical requirements and acceptance degree of overseas clinical trial data If the research and development of generic drugs abroad has complete and evaluable bioequivalence data, it can also be used for registration application It is obviously a good news for patients who are eager to wait for foreign drugs Micro review: time is the competition between money pharmaceutical enterprises, and the core competitiveness is the speed of new drug launch, that is, the speed of new product launch This is the most important core competitiveness of enterprises A period of patent protection for drugs, where the time is In 3-5 years, the economic value of drugs is huge Policy key words: Internet plus medical health September 14th, the National Health Protection Commission and the State Administration of traditional Chinese medicine jointly issued the three documents, namely Internet hospital management (Trial), Internet diagnosis and treatment management (Trial), and telemedicine service management standard (Trial), which paved the way for the development of Internet plus medical services From the perspective of supervision, Internet health care is mainly used for the follow-up of common and chronic diseases, which also means that Internet health care will only be a supplement to traditional hospitals In the short term, Internet medicine will solve the bottleneck of professional pharmacists in retail pharmacies In the long term, if the ban of online prescription drugs is lifted, it may mean that chronic disease drugs are easier to be sold online Micro comment: the opening of the policy, ushering in the opening of dawn policy, is undoubtedly a hot topic in the field of Internet health care in 2018 Internet medicine, which has been silent for two years, seems to see a new dawn The regulatory policy is gradually clear, and Internet health care has ushered in a new beginning Key words of policy: implementation of anti cancer drug negotiation of Medical Insurance Bureau On October 10, 2018, the state health insurance bureau issued the notice of the State Health Insurance Bureau on including 17 kinds of anticancer drugs into the category B scope of the national basic medical insurance, work injury insurance and maternity insurance drug catalog, which clarified the list of 17 kinds of anticancer drugs, and gave the corresponding medical insurance payment standards, requiring the implementation before the end of November Micro comments: innovative pharmaceutical enterprises and cro enterprises with strong R & D strength will continue to benefit from the National Health Insurance Bureau as a non-profit national institution The policy guidance will not suppress the overall growth of the industry, but more importantly, improve the efficiency of medical expenses, clean up the source, and accelerate the optimization of the industry structure Medical insurance negotiation will speed up the volume of high-quality new drugs, and pharmaceutical enterprises with real R & D strength will continue to launch new products and continue to benefit Cro, as a "water seller" in the process of drug innovation, also continues to benefit Key words of policy: expansion of basic drugs on November 1, the national essential drugs catalogue (2018 version) issued by the National Health Commission was officially implemented, with the number of drugs increased from 520 to 685, and the history of innovation of anticancer drugs and first-line new drugs Micro comment: the risk remains under the new opportunity Increasing the coverage of the base drug catalogue is expected to promote the large quantity of new drugs included in the base drug catalog The innovation of new drugs included in the base drug catalog will encourage innovation Hengrui pharmaceutical, Huadong pharmaceutical, Kelun pharmaceutical, Changchun hi tech, China biopharmaceutical, Shiyao group, Sansheng pharmaceutical, etc ushered in new opportunities, but there are still risks of too large price reduction and less than expected dosage of drugs Key words of policy: tacit clinical trial system on November 5, CDE website launched the column of "publicity of tacit clinical trial license" The administrative license mode of clinical trial has changed from approval system to tacit license system On November 7, CDE issued a notice saying that in order to further improve the efficiency of the review of priority review applications, experts will be organized to review the priority review applications put forward by the applicants in the form of "on the spot review" from now on to determine the types of priority review Micro review: "nodding system" has become "shaking head system", and the pace of new drug listing has accelerated The tacit approval system of clinical trials marks the administrative permission of clinical trials of new drugs in China, which has changed from "nodding system" to "shaking system", entering a more efficient "shaking system" era On the one hand, it further accelerates the research and development process of the overall pharmaceutical enterprises, on the other hand, it accelerates the application progress of new drugs in China, catches up with the global synchronous listing progress, so that Chinese patients have the opportunity to use them earlier New drugs For innovative pharmaceutical companies and multinational pharmaceutical companies, it is significant good news Key words of policy: on November 23, the Ministry of Commerce issued a notice on public solicitation of opinions on Guiding Opinions on classified and classified management of national retail pharmacies (Draft for comments), which is intended to further guide and standardize the classified and classified management of retail pharmacies, which means that the retail pharmacy industry is about to start a new great change It is clearly pointed out in the opinions that by 2020, the classification and classification management system of retail pharmacies in most provinces and cities will be basically established; by 2025, the unified regulation and policy system of classification and classification management of retail pharmacies nationwide will be basically established Micro comments: the key to improve the industry concentration and the classification of chain drugstores is the requirements for pharmacists As of September 2018, the number of licensed pharmacists registered in domestic drugstores is 405600, while the number of drugstores is about 450000 at present, and the number of licensed doctors is still relatively tight, which will limit some small drugstores, which is conducive to the merger and acquisition of leading enterprises The standardized management of drugstores and the evaluation of grading standards have improved the professional service ability of high-grade drugstores, prepared for the outflow of prescription drugs, and may enjoy preferential policies in the future Key words of policy: the custody of public hospital pharmacy was suspended on November 26 The national health and Health Commission and the State Administration of traditional Chinese medicine jointly issued the opinions on accelerating the high-quality development of pharmaceutical care, proposing to adhere to the public welfare of public hospital pharmacy Public hospitals are not allowed to contract, rent or trust the pharmacy to for-profit enterprises As soon as the opinion was released, it attracted a lot of attention in the industry This is the first time in recent years that all parts of the country have expressed their opposition to the trusteeship of pharmacies At the national level, they have a clear and strict attitude towards the trusteeship of public hospitals Micro comment: before the ban, the trusteeship of drugstores with capital ebbing was meant to dance on the tip of the knife Before the national health and Health Commission issued the above notice, the enterprises had already changed This year, SHP made it clear that what the company did was not traditional pharmacy trusteeship, but an extension of the supply chain Step pharmaceutical also released a notice that the company plans to adjust the custody business model of medical institution pharmacy in the original proposal (including centralized distribution of drugs, consumables, traditional Chinese medicine, etc.) to the professional pharmacy business model While Kangmei pharmaceutical industry is making great efforts to layout the "smart + big health industry" ecosystem, the pharmacy trusteeship mode will become the development foundation of smart pharmacy Now the pharmacy trusteeship has been stopped and Kangmei pharmaceutical industry has been severely damaged Key words of policy: "4 + 7" volume procurement on December 6, the national "4 + 7" volume procurement bid winning varieties were significantly reduced, including 75% price reduction of AstraZeneca's gefitinib; 93% price reduction of Zhengda Tianqing's entecavir The price reduction is much lower than