[week king] 4 + 7 expansion coming! Is 34 + 1000 far away? Lilai, Novartis and Johnson & Johnson staged the "Three Kingdoms killing"; Yongtai's strength was impressive but it kept a low profile?

1.4 + 7 expansion is coming this week! Is 34 + 1000 far away? 2 Lilly, Novartis and Johnson & Johnson staged "three kill"; 3 70 new drugs entered the new progress of national health insurance negotiation, and 7 varieties were not allowed to enter the market; 4 Yongtai's biological strength was impressive but it kept a low profile, and it was only 13 years since its establishment that it went to Hong Kong for IPO? The 4 + 7 expansion is coming! Is 34 + 1000 far away? On September 1, the joint procurement released the centralized document of drug procurement in the alliance region, which clearly defined the type, scope, quantity, specification and time of procurement, marking the official opening of the "4 + 7" national expansion Except for 4 + 7 cities, the alliance area includes 25 provinces and cities such as Shanxi and Inner Mongolia In principle, it should not be higher than the lowest price of provincial centralized procurement for the same variety of the enterprise in 2019 (as of July 31) in the alliance region Compared with the first batch of volume procurement, this time there are still some differences: 1 It is no longer an exclusive bid winner This time, more than one bid winner can win at most three enterprises, and one, two and three bid winners can obtain 50%, 60% and 70% shares respectively In this way, we can find a balance between price and supply guarantee, avoid the problem of insufficient capacity of the exclusive bid winning enterprises, ensure reasonable competition and avoid monopolization 2 Expand the scope of pilot hospitals This procurement is no longer limited to the implementation of public medical institutions, but also includes some military and social medical institutions 3 The procurement cycle is no longer a single one year, and the number of enterprises selected in this centralized purchase is no more than 3 The procurement cycle is one year in principle for the varieties of 2 (including 2); the procurement cycle is two years in principle for the varieties of 3 selected enterprises In general, the cancellation of exclusive bid winning and the exaggeration of scope cycle all indicate that the centralized mining pays more attention to the capacity and market planning of bidding enterprises Although the "4 + 7" expansion seems to focus on only 25 selected varieties, the actual radiation range has a great impact, because the intention of the state is obvious enough, and it is only a matter of time before the continuous promotion of the national collection of multiple varieties, and the pattern of China's drug market will also change Of course, for the single round of this centralized mining operation, the original research of no more than three varieties is likely to expand even if the price is quoted according to last year's 4 + 7 median price But for these kinds of domestic enterprises, the degree of competition will not be comparable to last year New members of close county medical and health community On September 2, the basic health department of the national health and Health Commission issued the notice on printing and distributing the list of pilot provinces and counties for the construction of close county medical and health community According to the relevant requirements of the notice on promoting the construction of close county medical and health community issued by the National Health and Health Commission and the State Administration of traditional Chinese medicine (Guo Wei basic level letter [2019] No.121), all counties (cities, districts, under the (the same as) voluntary application, examination and approval of the administrative departments of health and health at prefecture level and provincial level and the competent departments of traditional Chinese medicine determined that Shanxi Province and Zhejiang Province are the pilot provinces for the construction of close county medical community, and 567 counties such as Xicheng District of Beijing are the pilot counties for the construction of close county medical community 70 new drugs entered the new progress of the national health insurance negotiation 7 varieties were not allowed to enter the market on the morning of September 2 A communication meeting minutes of the national health insurance catalog drug negotiation enterprises organized and held last Saturday was out According to the relevant content, no accident occurred In November this year, the negotiation of the 2019 version of the medical insurance catalog will officially start! In 2017-2018, according to the common name, there are 128 new drugs on the market, 10 of which have been negotiated and admitted in 2018, 18 of which have added the 2019 regular catalogue, 70 of which have entered this round of negotiations, and 30 of which have not been admitted Seven varieties are not ready to sell in the Chinese market due to supply reasons, and the market strategy refuses to negotiate The main contents of the negotiation are as follows: first, the drugs successfully negotiated are included in class B (the local governments cannot transfer out, change the payment standard or limit the payment, and determine the regional payment proportion as a whole); second, the validity of the payment standard determined by the negotiation is 2 years (2020-2021), and generic drugs automatically belong to the catalog, and medical insurance can adjust the payment standard according to the price level of generic drugs Generic drugs can be purchased in different ways, such as centralized purchase In case of major changes in the policy, the payment standard can be re negotiated The third is to explore the feasible way to "officially announce" the final payment standard At present, the definition of confidentiality needs to be negotiated with enterprises All enterprises need to reach an agreement on whether they need to keep confidentiality Shanghai follows the U.S practice of confidentiality, and the State Food and drug administration does not advocate it If the state allows local governments to keep confidentiality in the later stage, the enterprises may be able to give it to a certain extent More concessions Is there cooperation in the industry? 172 drugs in Guizhou have been removed from the Internet! On September 2, the notice on suspending the online purchase of some winning drugs was publicized on Guizhou drug centralized purchase network The list includes 172 drugs from 112 manufacturers, of which "Sichuan Tongyuan Pharmaceutical Co., Ltd." has seven products removed from the network, and "Sichuan Kelun Pharmaceutical Co., Ltd." has six products removed from the network, all of which are ranked in the top Previously (August 26), Guizhou drug centralized purchase network published the notice on providing some price materials related to the winning drugs as soon as possible, requiring 1045 drug manufacturers to submit the ex factory price of each drug before June 1, 2019, the price of each drug to Guizhou drug distribution and retail enterprises, and the price of winning the bid for the platform, and winning the bid for the platform Explain the price difference The online purchase of drugs that fail to provide the checklist and commitment letter within the time limit will be suspended from September 2, 2019 Sure enough, the removal of 172 drugs from the Internet is a punishment for dishonest operation In today's turbulent medical market, the government will not allow any practice contrary to the direction of medical reform The strengthening of supervision also means that drug manufacturers should pay more attention to production and operation issues, so as to actively implement them After Danshen ligustrazine injection was not covered by medical insurance, new adverse reactions were added On September 3, the official website of the State Food and Drug Administration issued a notice on Revising the instructions of Danshen ligustrazine injection, and decided to revise the product instructions [adverse reactions] and [precautions] According to the revised requirements, the warning words that should be added to Danshen and ligustrazine injection are: "this product can cause serious allergic reactions (including anaphylactic shock), the patients should be closely observed during the administration period, and the drug should be stopped and treated in time in case of allergic reactions or other serious adverse reactions." In fact, the recent life of Danshen and ligustrazine injection has been difficult Since July 1 this year, the first batch of national key monitoring and rational drug catalog (chemical and biological products) was officially published, and Danshen and ligustrazine was included; it was originally a class B variety in the supplementary catalog of medical insurance in 18 provinces However, it was excluded from the 2019 version of the medical insurance catalogue on August 20 According to the interpretation of the national basic medical catalogue, "except for the special provisions, the local government will not adjust class B drugs In principle, the original added varieties should be gradually digested within three years, and the varieties that are included in the national key monitoring scope should be digested first." It means that in three years at most, Danshen and ligustrazine will disappear from the local medical insurance catalog Whether it can be persisted for three years or not is unknown How much remains in the 4 billion market at the end of the year is also unknown? Enterprise information Lilly, Novartis and Johnson & Johnson staged "three kill" on September 4, Lilly Pharmaceutical (China) announced that Tuozi ® (iqzumab injection) for the treatment of adult patients with moderate to severe plaque psoriasis suitable for systematic treatment or phototherapy was approved by the National Drug Administration (nmpa) for listing This drug is the third il-i inhibitor for psoriasis treatment in China, which was approved to be listed in April after the approval of the treasurer of Novartis (trade name "keshanting") and the ulinumab injection (trade name "hidano") of the domestic subsidiary of Johnson & Johnson in June At present, the application of il-mab such as ulinuzumab injection and he Sujin mAb in foreign countries has been for 10 years Since the market in 2019, il-mab has been recommended as the first-line treatment of moderate and severe psoriasis vulgaris Il-mab has a sudden rise, a smaller adverse reaction (almost no tuberculosis infection), a better effect (80% of patients improve skin lesions by 28 weeks 80% %) has a better application prospect, and its long-term effect is the best nuclear weapon for the treatment of psoriasis Innovative therapies for psoriasis are rapidly iterating, from TNF - α inhibitors, IL-12 / 23 inhibitors, to IL-17 inhibitors and other biological agents aiming at different targets are on the market, which has the hope to change the current treatment status of psoriasis The market competition of psoriasis is more and more intense So at this moment, as a new generation of psoriasis drug, the main consideration is how to make the majority of patients accept its expensive price Of course, if we can quickly enter the medical insurance, I believe that it is hopeful to completely seize the market of the old generation of psoriasis drugs According to the latest announcement of the Hong Kong stock exchange, immunetech biopharm has submitted an application for listing on the main board on September 2 The co sponsors are CCB international and Guoxin Securities (Hong Kong) Yongtai biopharmaceutical plans to raise $100 million to $200 million, according to people familiar with the matter In addition, Yongtai biology said: "Yongtai biology has always been strong, but acting in a low-key way." Founded in 2006 in Beijing, Yongtai biology is mainly engaged in the development and commercialization of cell immunotherapy drugs Its product chain covers non gene modified cells, gene modified cells, tumor multi-target treatment cells, tumor single target treatment cells and other major tumor cell immunotherapy products In addition to its own patented cell therapy product eal ® - expanded activated lymphocytes (EAL), the company's main research products include car-t cell series, tcr-t cell series, etc In terms of past performance, the company has not generated any revenue, while the loss mainly comes from the company's R & D and administrative expenses In 20172018 and the first half of 2019, the total amount of the company's loss and comprehensive expenditure during the period was 16.62 million yuan, 34.89 million yuan and 50.53 million yuan respectively; the R & D expenditure was 11.93 million yuan, 31.17 million yuan and 23.38 million yuan respectively The net cash used in operating activities continued to be negative, which were - 12.08 million yuan, - 44.08 million yuan and - 35.29 million yuan respectively in the reporting period However, as of August 2019, there are 10 kinds of cell immunotherapy products in Yongtai biological in China under clinical trials There are two products for solid tumors and seven for blood system cancer At present, there is no cell immunotherapy product listed or submitted for NDA in China, and eal ® which has entered the phase II clinical trial has a relative first mover advantage to some extent Source: yimaike, Sina medical news, Yaozhi news, sepilan, e-medicine manager, Zhitong financial network, etc Statement: this opinion 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.