[Zhou Jun] the recognition of Hongmao pharmaceutical industry has been revoked; is the "consistency evaluation" of vaccine coming? Anhui Province announced

Is this week's focus on vaccine "consistency assessment"? Anhui Province announced the official arrival of volume procurement, who can "fight" to the end? The association of traditional Chinese medicine officially responded: the recognition of Hongmao pharmaceutical industry was revoked Boya's acquisition of Luo Yi, entering the vaccine industry or going further, the "consistency evaluation" of vaccines in the general administration is coming? On December 24, the State Food and Drug Administration issued the technical guidelines for clinical comparability research of vaccines for prevention, which will further standardize and improve the level of clinical research and development of vaccines and strengthen the supervision of vaccine quality and safety The guiding principles include six parts: preface, consideration before clinical trial, general consideration of clinical trial design, statistical consideration of clinical trial design, data management and quality assurance, and evaluation of clinical trial results In the content, it emphasizes the consideration of clinical research and development, pharmacy and non clinical research and development before clinical comparability research; it also elaborates the selection of control vaccine in clinical comparability research, the specific requirements of research vaccine management and immunogenicity substitution index, and reiterates the consideration of safety evaluation and the general principle of statistical treatment in clinical comparability research And so on At the same time, it is pointed out that the production capacity of common vaccines in China is over capacity, there is homogenization in vaccine production, and there is still a lack of innovative vaccines In addition, the quality and level of clinical research and development are uneven, which brings many challenges to the evaluation of vaccine effectiveness and safety For preclinical research, it is usually necessary to carry out a pharmaceutical and non clinical comparative study between the candidate vaccine (or trial vaccine) and the same vaccine (or control vaccine) which has been put on the market The comparative data is used to evaluate the comparability of the two vaccines in combination with the results of clinical trials For clinical research, vaccine clinical comparability research usually adopts non inferiority experimental design, and the consistency evaluation between clinical batches (Times) of vaccine adopts equivalence test The guiding principles will promote the development of innovative vaccine companies Brief comment: in fact, we all have a sense of the coming of this day There are oral solid preparations of generic drugs before and injections after This time it's a vaccine It's nothing more than integrating all pharmaceutical markets, reducing the emergence of homogeneous products, advocating innovative product discovery, comprehensively interpreting the principle of "valuing rare products", and once again emphasizing that the future belongs to innovative products! Industry hot news Anhui Province announced the official arrival of volume procurement, who can "fight" to the end? On December 24, 2019 and December 23, the official website of Anhui Medical Insurance Bureau issued the notice on the implementation plan of negotiation and negotiation (pilot) for the centralized purchase of some commonly used drugs and the second batch of anticancer drugs in public medical institutions of Anhui Province in 2019 (hereinafter referred to as the plan) After the implementation of the first batch of anti-cancer drugs, the second batch of anti-cancer drugs procurement was officially launched, and antibiotics with a relatively high purchase amount were added simultaneously From the perspective of procurement scope, the procurement categories are mainly antibiotic drugs and anti-tumor drugs, with large procurement area, and the varieties with high procurement volume and amount are expected to be selected The expert group will negotiate with the shortlisted enterprises on the basis of factors such as clinical use and quality type of drugs, so as to form a negotiated price for volume purchase At the same time, on the basis of the purchase volume submitted by the provincial public medical institutions, the total purchase volume is estimated to be 60% - 70% of the total annual consumption of drugs successfully negotiated by the provincial public medical institutions, and the volume purchase is carried out And ensure clinical priority, no "second bargaining", adhere to "two vote system" and encourage "one vote system" The provincial public medical institutions should pay for the drugs within 90 days Brief comment: Generally speaking, the enterprises involved may face a new round of consideration of "price and quantity game", and the enterprises not selected will also face the pressure of key monitoring of products The chess game has been laid out, and now we are waiting for all players to enter the game The winner is the king, the fittest and the survival of the pharmaceutical industry are consistent rules The profit of drugs has declined, but the quality of drugs must also be qualified! On December 26, Shaanxi Provincial Drug Administration issued a drug quality announcement, announcing that 10 batches of drugs from 7 pharmaceutical enterprises, including KangBo pharmaceutical, Yixiang pharmaceutical and Renze pharmaceutical, were unqualified In order to strengthen drug supervision and ensure the drug safety of the public, the Provincial Drug Administration organized drug regulatory departments at all levels to carry out drug sampling The 10 batches of drugs found in the sampling inspection that do not meet the requirements are announced The items that do not meet the requirements are mainly properties, inspection, content determination, etc On the same day, Qinghai provincial drug administration also released a list of unqualified drugs For the above-mentioned non-conforming pieces of traditional Chinese medicine, control measures such as sealing up and detaining have been taken, and the illegal use of suspected fake pieces of traditional Chinese medicine by the hospital has been investigated and handled make a concise evaluation Although drug profits have been greatly reduced, this does not mean that, in order to save costs, fake drugs and substandard drugs are used instead The purpose of the state to reduce drug prices is to benefit the people on the one hand, and on the other hand, to integrate the market, improve the ability of enterprises to control costs and resist risks Enterprises without such ability are doomed to fail in the last place, not better Get out early and have a better ending! Many drugstores are audited by the medical insurance bureau, and the drug traceability system is expected to be completed as soon as possible! On December 26, Hebei Medical Insurance Bureau posted a notice on its official website, requiring 94 designated pharmacies at the provincial level to transfer the electronic account of purchase, sale and deposit and the balance table of financial end level subjects from January 2018 to December 2019, requiring designated pharmacies to submit relevant data before January 15, 2020 For drugstores that cannot provide relevant data accurately and completely on time without proper reasons, they will be handled according to relevant regulations At present, enterprises upload more data In the future, if medical insurance carries out intelligent monitoring work under the provincial centralized mode, the monitoring efficiency will only continue to improve In addition, it is worth noting that Hebei provincial drug administration is comprehensively promoting the construction and operation of drug traceability system in the province, requiring all drug wholesale enterprises and retail chain enterprises to join the drug traceability system in Hebei Province, and formally reporting drug traceability data from December 1, 2019 Industry insiders pointed out that because the collected data are not completely coincident, the requirements of retail pharmacy compliance may be upgraded to a new stage under the joint action of multi sector linkage and big data analysis Brief comment: once the drug traceability system is fully established, this problem should be solved to a large extent The transfer out of non-medical insurance drugs started, 352 in Beijing! On December 26, the Beijing Municipal Medical Security Bureau issued the document notice on adjusting the reimbursement scope of drugs for basic medical insurance, work injury insurance and maternity insurance in this Municipality This notice shall be implemented as of January 1, 2020 According to the notice, 281 Western medicines and 71 Chinese patent medicines, such as rhubarb sodium bicarbonate oral regular release dosage forms, were deleted from the reimbursement scope of basic medical insurance, work injury insurance and maternity insurance of this city, including 352 drugs deleted from the national medical insurance drug catalogue and drugs under the state key monitoring scope A notice of Hebei Medical Security Bureau and Hebei human resources and social security department on printing and distributing the directory of drugs for basic medical insurance, work injury insurance and maternity insurance (2019 version) has been circulated in the industry Priority should be given to transferring out the drugs included in the key monitoring scope of the state and our province to form the catalogue of supplementary drugs temporarily retained in our province, which will be gradually digested by the Provincial Medical Security Bureau within three years Brief comment: no doubt this is a commonplace problem When the medical insurance catalog was issued, it was clearly stated that drugs that did not enter the medical insurance will be severely hit, and those that really play a leading role in the disease will also be included in the medical insurance The direction has been clear, that is to let enterprises do valuable and innovative products; only when enterprises embrace national policies, do consistency evaluation for consistency evaluation, and do innovation for innovation, can they win the competition In addition, because it is difficult to have a large amount of space for drugs not included in the medical insurance, and enterprises will no longer invest in resources and human resources, it is bound to involve career changes of medical representatives and other related issues, which is also a key consideration for industry personnel Official response of enterprise information and traditional Chinese Medicine Association: the recognition of Hongmao pharmaceutical industry was revoked On December 21, the "2019 China traditional Chinese medicine innovation and development forum and China traditional Chinese medicine corporate social responsibility report conference" hosted by China traditional Chinese Medicine Association was held in Beijing Hongmao Pharmaceutical Co., Ltd and vice president of Hongmao Pharmaceutical Co., Ltd won the honorary titles of "star enterprise of fulfilling social responsibility in 2018" and "person award of fulfilling social responsibility in 2018" On December 26, the China Association of traditional Chinese Medicine issued a letter of apology on its official website, announcing the cancellation of the recognition of Hongmao medicinal wine, correction of mistakes, and standardization of management; and expressing sincere apology for the adverse social impact caused and the trouble caused to the development of the traditional Chinese medicine industry People's Daily Comments: public order and good customs should be considered in the evaluation and commendation In the evening of December 23, 2019, Boya biology announced the report on issuing shares, convertible corporate bonds and paying cash to purchase assets and related transactions (Draft), and spent nearly 1 billion yuan to purchase 60.55% shares of Boya biology Officially announced to settle in the vaccine industry Open the double strategic support of blood + vaccine According to the analysis of relevant securities companies, the overall valuation of Luoyi biology is RMB 1.574 billion, which is also reasonable At present, the overall profitability of Luoyi is good, and the market prospect of AC vaccine, a heavyweight product, is also very good However, in combination with the "vaccine consistency evaluation" policy published by the state, it points out that the lack of innovation in the vaccine industry and the serious homogenization is a challenge and an opportunity for Luoyi bio With the financial support of Boya bio, if we can cure the vaccine innovation party A breakthrough will be a great advantage Source of information: Sina Pharmaceutical News, sepiland, e pharmaceutical manager, pharmaceutical economic news, China Pharmaceutical News, etc.; responsible editor | penicillin this article is the integrated content of yaozhi.com, the copyright belongs to the original author, and the purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.