[Zhou Jun] real world evidence helps drug research and development, and a large number of rare disease drugs are rushing to the "battlefield"; green leaf pharmaceutical spent 1.4 billion to announce its presence in biomedicine; Shiyao and Shenzhou terminal

Highlights: real world evidence helps drug research and development A large number of rare disease drugs are rushing to the "battlefield" to control the pharmacy profits by 15%, or will effectively reduce the pharmacy drug price Green leaf pharmaceutical spent 1.4 billion to announce the reality of entering biomedicine! On January 7, a large number of rare disease drugs are rushing to the "battlefield" The Circular of the State Food and Drug Administration on Issuing the guiding principles of real world evidence supporting drug development and evaluation (Trial) (No 1 in 2020) is online (hereinafter referred to as "guiding principles") The documents provide evidence of effectiveness and safety for the registration and listing of new drugs, evidence for the change of specifications of listed drugs, evidence for post market requirements or re evaluation of drugs, human experience summary and clinical research and development of famous traditional Chinese medicine empirical formulas and preparations of traditional Chinese medicine medical institutions, as well as guidance for clinical research design and accurate positioning of target population Brief comment: as the National Drug Administration (nmpa) issued the first document in 2020, this is a milestone event, because it is a great change from the regulatory concept Drugs are approved with new indications through real world data After the policy, people will be more convenient, or more early to discuss the use of real world evidence, patients with rare diseases or drug students with rare diseases Enterprises are most likely to benefit, which will provide a strong support for drug evaluation Vaccination procedures have changed! On January 6, the national health and Health Commission issued the notice on the adjustment of immunization procedures of polio vaccine and vaccine containing measles component in the national immunization plan (hereinafter referred to as the notice) It is suggested that the vaccination procedures of the two kinds of vaccines have changed from the original: "one injection of three sugar pills" to "two injections of two sugar pills"; the first dose of mumps vaccine, i.e the first dose, i.e the second dose, i.e the second dose, i At the same time, it is emphasized that there are new requirements for vaccination record and abnormal reaction monitoring Brief comment: in the new era of basic and medical conditions, vaccination procedures should also change accordingly, which is beyond doubt, and related manufacturers will also have a series of changes On January 8, Zhejiang Medical Insurance Bureau issued the proposal for improving the centralized purchasing function of drugs and promoting the full coverage reform of medical insurance drug payment standards (Draft for comments) (hereinafter referred to as the proposal) Among them, the plan clearly points out that all designated retail pharmacies in the province implement the unified payment standard for medical insurance drugs, which is 15% higher than the determined payment standard for medical institutions (excluding national and provincial negotiated drugs), and the maximum is no more than 200 yuan (calculated by the minimum package) Brief comment: on the whole, this is not surprising, because this is not the first case, and there have been many similar policies implemented before, so it seems that the trend has been formed This time, Zhejiang province again sent a message about the 15% increase in price, which no longer affects Zhejiang Province, but the national designated zero sale drugstores Shandong: without price reduction, the market will be lost On January 6, the Shandong provincial drug centralized purchase platform issued the notice on publicizing the price adjustment of non selected drugs in centralized purchase organized by the state It shows that the price adjustment of non selected drugs (the first batch in 2019) in the centralized procurement of national organizations in Shandong Province has been sorted out, of which 55 products have not been adjusted It can be seen that on January 13, if "the adjusted price of the products without evaluation is higher than the selected price products" and "the products without price adjustment have not been reduced", the purchase will be suspended and the market will be lost For the drug companies that are not selected, they will face the double blow of recruitment and medical insurance payment In the future, with the second batch, the third batch and the fourth batch of 4 + 7 With the development of the nth batch, there will be more and more unselected varieties, ushering in brutal price pressure It is also a key task to ensure the supply of non winning drugs! On January 7, Zhejiang Medical Insurance Bureau issued the notice on doing a good job in the work of centralized purchase of selected drugs and the rational use of non selected drugs, which requires that in the process of implementing the national drug centralized purchase and expansion, all medical institutions should also guarantee the rational use of non selected drugs purchased and used by the hospital, if the masses have the demand for rational use of drugs It is forbidden to complete the agreed purchase volume of selected drugs, There is a simple way to purchase and use only the selected drugs and to stop the supply of non selected drugs It is emphasized to guide the patients to use the selected drugs after price reduction preferentially, and to ensure the supply of the non selected drugs that the patients really need Brief comment: does this guarantee the market proportion of some non selected drugs to some extent, at least unify the drugs under the general name, how to use them, and the right to choose belongs to the patients! Enterprise information LVYE pharmaceutical spent 1.4 billion yuan to announce its entry into biomedicine On January 6, LVYE pharmaceutical released a notice on the disclosure, related party transactions and special general meeting of shareholders concerning the acquisition of Shandong Boan's equity Shandong LVYE has the conditions to agree to purchase, while LVYE Investment Group has the conditions to agree to sell 98% of its shares in Shandong Boan After the acquisition, in addition to obtaining 9 innovative antibody drugs under Shandong Boan, green leaf pharmaceutical complements the core advantages of the original products, and the three antibody discovery platforms of Shandong Boan will also be under green leaf pharmaceutical Before that, green leaf pharmaceutical's business was mainly composed of four parts, namely, drugs in the field of tumor, central nervous system, digestion and metabolism, and cardiovascular medicine "Small molecule preparation innovation" and "internationalization" are widely recognized by the industry, but in the field of biological medicine, the strength of green leaf pharmaceutical is not very prominent The acquisition of Shandong Boan by LVYE pharmaceutical on the one hand shows the firm determination of LVYE pharmaceutical to add bio pharmaceuticals, and on the other hand reflects the optimistic degree of many traditional pharmaceutical industries on bio pharmaceuticals After all, this is not the first news of acquisition of bio pharmaceutical enterprises this year The issue pricing of the first unprofitable enterprise attracted much attention On January 6, Zejing pharmaceutical officially launched the offering, which also means that it entered the most critical issue pricing link before listing As the first enterprise applying for listing with the fifth set of standards, the listing process of Zejing biology has always been concerned by the market The opening of the IPO also marks the first unprofitable enterprise that has passed the meeting on the science and technology innovation board Zejing Pharmaceutical Co., Ltd is an innovation driven new drug R & D enterprise focusing on tumor, hemorrhage, blood disease, hepatobiliary disease and other treatment fields At present, it has 11 innovative drugs under research, including donafinil toluene sulfonate (zepusen), recombinant human thrombin (zepusen) and jaketinib hydrochloride (zepusen) with multiple indications in phase II / III clinical trials It is the company's biggest star product and hope Because all the products of Zejing pharmaceutical are in the stage of R & D, have not yet carried out commercial production and sales, have not yet realized sales revenue, have not yet made profits and have accumulated losses that have not been made up, the product risk level is self-evident After all, we do not know how many new drug researches are "dead in the womb", the low success rate is obvious to all, but there are two sides to everything, the other is On the other hand, the higher the investment risk, the greater the return How to choose is still different from person to person Reality! On January 6, 2020, Sinopharm and Shenzhou terminal "broke up" due to their interests Shenzhou cell, an innovative pharmaceutical company, disclosed in the reply to the second round of inquiry on the science and technology innovation board that it had previously reached a commercial agreement with the group on sct400, a product under research Based on the changes of pharmaceutical policy and market environment in the past year, Shiyao group proposed to Shenzhou cell to modify the commercialization agreement, but the two sides did not reach an agreement on the modification of the agreement in the future Just a week ago, Sinopharm group and another innovative pharmaceutical company, Junshi bio, terminated their cooperation In order to avoid the potential conflict caused by the clinical research and future commercialization of another anti-PD-1 monoclonal antibody in the research and development of the group, the company and Junshi signed the cooperation on the research, development and commercialization of breast cancer drugs on December 30, 2019, which was agreed by both parties Brief comment: in fact, the root cause may be the gap between the initial intention and the result of cooperation Compared with the innovative pharmaceutical enterprises, the local large pharmaceutical enterprises have more mature experience in drug commercialization, sales network and more abundant cash flow, while the innovative pharmaceutical enterprises have more innovative varieties, stronger early R & D ability and talent pool Both sides with their own advantages can complement each other and make common progress It's a pity that they all cut their backs because of conflicts of interest or unsatisfactory results of research and development This is because the current market situation in China determines that, unlike foreign countries, at present, large-scale pharmaceutical enterprises in China and emerging bio pharmaceutical innovation enterprises are more likely to compete on the same track If the two sides of the cooperation can't devote themselves to cooperation, it's not a matter of time before they fail or break up! As of January 1, 2020, there are 7343 Chinese listed companies listed on 15 global exchanges including Shanghai, Shenzhen, Hong Kong and New York It is understood that this year, the market value threshold of the top 500 has reached a new high, 7.7 billion yuan higher than the previous year A total of 37 enterprises in the pharmaceutical and biological industry have entered the latest China's top 500 listed companies by market value in 2020, of which Hengrui pharmaceutical ranks 25th in the total list with 387.1 billion yuan, ranking first in the pharmaceutical and biological industry Meirui Pharmaceutical (221.1 billion yuan, ranked 65) and Wuxi Pharmaceutical (150 billion yuan, ranked 102) ranked second and third in the pharmaceutical industry From the perspective of market value change, there are 10 enterprises with an increase of more than 90%, which are Changchun hi tech (up 203.85%), Kangtai Biology (up 147.92%), tiger medicine (up 121.37%), Tongce medical (up 115.99%), China biopharmaceutical (up 115.64%), Yaoming Biology (up 112.18%), Pingan good doctor (up 110.58%), Hengrui medicine (up 99.29%) ）, antuobio (up 97.14%), Aier Ophthalmology (up 95.51%) Brief comment: there is no doubt that Biopharmaceutics has become the exclusive pronoun of 2019 pharmaceutical industry Basically, all fast-growing enterprises are linked with biopharmaceutics Many emerging pharmaceutical enterprises are gradually surpassing the tradition, achieving the leading position in the industry, and also greatly improving the overall medical market position Congratulations! 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