Exclusive analysis: China's pharmaceutical industry in 2020

2020, with the national implementation of volume procurement; In 2020, the key drug monitoring mechanism will be fully established; In 2020, DRG will operate in 30 pilot cities; The implementation of 20202019 version of medical insurance catalogue, and the three-year transition period of provincial medical insurance catalogue reduction; Under the new situation of medical reform, the growth mode of Chinese pharmaceutical industry will change from public relations and sales driven to cost and technology driven, and form a pharmaceutical production and distribution pattern with large-scale backbone enterprises as the main body and small and medium-sized enterprises as the supplement On November 29, 2019, the notice on several policies and measures to further deepen the reform of the medical and health system with the centralized purchase and use of drugs as the breakthrough issued by the leading group for deepening medical reform of the State Council required that the centralized purchase of drugs should be taken as the breakthrough to promote the linkage of three medical services On December 29, 2019, the national drug centralized procurement document (gy-yd2019-2) issued by the national centralized procurement union marked the official promotion of the 4 + 7 pilot experience of national volume procurement to the whole country The initial trial 4 + 7 and 4 + 7 expansion reduced the average drug price by 52% and 25% respectively, and the lowest price of the minimum specification also decreased from "Jiao" to "Fen", from 0.149 yuan (5 mg of amlodipine besylate tablets in Jingxin) at 4 + 7, to 0.049 yuan (1 mg of risperidone tablets in Qilu) at 4 + 7 expansion, and then to 0.022 yuan (rock drug Collection) through consistency evaluation in Hebei centralized mining Group captopril tablets 25mg) and 0.012 yuan (nifedipine tablets 10mg of Shandong Luxi Pharmaceutical Co., Ltd.) failed to pass the consistency evaluation The second batch of national volume procurement has not yet started, and only the lowest price of the highest effective quotation has been as low as 0.1 yuan (paracetamol 0.5g and metronidazole 0.2g) On November 20, 2019, the executive meeting of the State Council proposed "promoting the substantial reduction of drug price by purchasing with quantity" It can be seen that price reduction has become the main theme of this round of reform, but even if willing to bear the price reduction, a considerable number of evaluated enterprises will certainly not be selected, because although the second batch of purchasing with quantity has been relaxed to a maximum of 6 at the same time, but the number of evaluated enterprises such as amoxicillin has been increased Far more than six In addition, as the premise of participating in volume purchase, consistency evaluation must be done first, and a huge cost will be paid for consistency evaluation According to the statistics of medical magic cube, from January 2, 2018 to October 23, 2019, the expenses of consistency evaluation of 65 varieties (excluding deemed pass) were disclosed, with the lowest of only RMB 1.54 million and the highest of RMB 2011.09 million, of which 18 enterprises with RMB 1.54-5 million accounted for 28% and 2 enterprises with more than RMB 15 million accounted for 3%, while those with less than RMB 5 million were the return of international enterprises with joint production at home and abroad For those who have passed the green channel assessment after declaration, for example, Huahai has 7 products with the cost between 159-3.02 million yuan, so this non ordinary enterprise can enjoy it, and more will pay at least the median of 6.78 million yuan 76% of the pharmaceutical enterprises in China have an annual revenue of less than 20 million yuan (China Pharmaceutical Industry Information Center, China Health Industry Blue Book 2018) Although many places have also issued subsidy policies, "tens of billions of original research drugs, or being squeezed out by consistency evaluation drugs", most of them are just flowers on the brocade, so at least 76% of the enterprises are unable to bear the cost of consistency evaluation by themselves In view of the huge cost of consistency evaluation, after the evaluation, there will be another 4 + 7 bargaining, and it is not sure to win the election Therefore, the number of consistency evaluation applications plummeted from 207 in January 2019 before the 4 + 7 bid opening to 73 in February Now, the number of applications has changed from profit to consideration of both profit and survival Last December, the number of applications was 110 On November 15, 2019, the notice of the leading group of the State Council on deepening the reform of the medical and health system on further promoting the experience of deepening the reform of the medical and health system in Fujian Province and Sanming City (Articles 2 and 9) pointed out that "before the end of December 2019, each province shall formulate and issue the provincial key monitoring and rational drug catalog (chemical and biological products) and publish it, and comprehensively establish the key by the end of December 2020 Drug monitoring mechanism " According to the statistics of pharmaceutical cloud studio, as of December 29, 2019, there have been 22 provinces, 16 cities and 11 hospitals that have published the list of key monitoring drugs, involving 203 varieties, among which 14 provinces / municipalities such as Inner Mongolia are consistent with the national version, 9 provinces such as Jiangxi Province have increased the number on the basis of the national version, some local versions have increased the number more, and most of them are Chinese medicine injections For example, in Weihai, Shandong Province, 98 kinds of drugs have been added, including 44 traditional Chinese medicines, most of which are traditional Chinese medicine injections The impact of 4 + 7 is on chemical preparations, and the focus of monitoring impact is not to make consistency evaluation or participate in 4 + 7 traditional Chinese medicine and biochemical medicine, which will be a double blow to local pharmaceutical enterprises, because foreign enterprises do not have traditional Chinese medicine and biochemical magic medicine Before the introduction of the national key monitoring catalogue, the sales volume of these 20 key monitoring varieties has declined significantly, and the decline will increase after the introduction of the key monitoring catalogue 8 charts: a systematic analysis of the latest progress of medical reform On October 16, 2019, the notice on printing and distributing the technical specifications and grouping schemes of DRG paid national pilot projects issued by the State Medical Security Bureau cleared the obstacles for the development of DRG industry in China Although DRG is not specifically for drugs, under the background of "completely abolishing the new medical reform based on drugs" (report of the 19th National Congress of the Communist Party of China) and taking drug price reduction as a breakthrough, it will be difficult to avoid drug sales, which takes up a large share of medical insurance funds On the premise of DRG prepayment, hospitals and doctors, for the sake of not overdraft, have large prescriptions, unnecessary inspections and drugs with low cost performance It will be limited and the level of rational drug use will be greatly improved DRG can be described as the key monitoring of the extended version According to iqvia Statistics (≥ 100 beds of hospitals), in the context of oral administration without injection, local auxiliary drug catalogue and anti drug restriction, the second quarter of five consecutive years from 2015 to 2019 compared with traditional Chinese medicine (mainly traditional Chinese medicine injection), large infusion, auxiliary drug and anti biotic decreased by 3.9%, 1.3%, 4.9% and 1.1% respectively, while therapeutic drug increased by 11.1%, cage lifting and replacement Bird effect is obvious In terms of the above non therapeutic drugs (temporarily referred to as this), local pharmaceutical enterprises accounted for 99.7%, 85.4%, 88% and 77.6% respectively (2017) After DRG implementation, the above changes will be more amplified It can be seen that DRG will have a greater impact on drug sales, especially on local pharmaceutical enterprises 3 strategies for pharmaceutical enterprises under DRG Under the influence of 4 + 7, key monitoring, DRG and other policies, as well as the fact of Indian generic medicine under the covetous eyes of Indian pharmaceutical enterprises, the profit model of Chinese pharmaceutical industry based on public relations and sales will gradually be ended, and the era of high profit margin of generic pharmaceutical enterprises will become a history, but it will be in line with international standards, and enter the era of low profit margin relying on scale and cost On November 6, 2019, the order of the national development and Reform Commission of the people's Republic of China (No 92) issued by the national development and Reform Commission and the Guiding Catalogue of industrial structure adjustment (2019 version) clearly restricted 6 and eliminated 13 pharmaceutical projects On November 29, 2019, the leading group of deepening medical reform of the State Council issued several policies and measures on further deepening the reform of the medical and health system with centralized purchase and use of drugs as a breakthrough, which required to promote the cross regional and cross ownership merger and reorganization of drug production and distribution enterprises, cultivate a number of large-scale enterprise groups with international competitiveness, and accelerate the formation of large-scale backbone enterprises As the main body, small and medium-sized enterprises as the supplementary pattern of drug production and circulation The number of drug approval documents and pharmaceutical enterprises in Japan decreased from 100000 and 1359 before the consistency assessment to 19000 and 300 after the consistency assessment, respectively, while only 20 of the 300 produced generic drugs The scale of the US pharmaceutical market is about four times that of China, but there are more than 800 pharmaceutical companies that actually sell their products, while there are 3262 pharmaceutical companies in China (China Pharmaceutical Enterprise Management Association), and only 47.8% of the top 100 companies (2017) Previously, attempts to use GMP and other policies to deal with minor disorder, but the effect is not significant This time, it's not about GMP certificates, but about approval documents Without conformity evaluation, an enterprise can't be regarded as a pharmaceutical factory In the face of huge expenditure and 4 + 7 price reduction environment of conformity evaluation, compared with more than 100000 chemical approval documents, there will be a few enterprises that have been evaluated Therefore, this small-scale disorder will be managed, and the corresponding concentration will be greatly increased, so as to achieve the official goal of "accelerating the formation of drug production and distribution pattern with large-scale backbone enterprises as the main body and small and medium-sized enterprises as the supplement" The new version of "Drug Administration Law" introduces the drug listing holder system (MAH), which realizes the separation of drug ownership and production, provides legal protection for the professional division of labor in the pharmaceutical industry, and avoids the construction of unnecessary repetitive production capacity The all-round pharmaceutical factory with all functions of research, production and marketing can only be a few large-scale enterprise groups, while the small and medium-sized enterprises have a way out only by focusing on the subdivision of the field and making it more precise and strong All aspects of drug research and development, production and marketing will also appear in the form of specialized division of labor of cro, C (d) Mo and CSO respectively Due to the low cost, abundant university students and the increasingly perfect capital market, especially the reform of drug review and approval system and the accession of a large number of returned scientists in recent years, the cro and C (d) Mo in China have been growing at a rate of about 20%, and the proportion of cro and C (d) Mo in the world will rise from 11.6% and 6.9% in 2013 to 26.8% and 10% in 2021 (1) Innovation Since the State Council issued No 44 document in 2015, China has opened a big scene of medical innovation connecting with the world In particular, China's accession to the ICH, the promulgation of the new drug administration law, the adjustment of the 2019 version of the medical insurance catalogue and the establishment of the science and technology innovation board have created an unprecedented good environment for China's medical innovation At the same time, China's pharmaceutical innovation has indeed made gratifying achievements According to the authoritative Gen website statistics, in terms of the closing market value on October 30 this year, China, the world's top 25 biotech companies in market value, accounted for 5 seats Hengrui, Wuxi apptec and Hansen, who are good at R & D, ranked 7th (398.8 billion yuan), 14th (135.5 billion yuan) and 16th (139.5 billion Hong Kong dollars) respectively (2) Imitation The 4+7 led national procurement plan aims to accelerate the substitution of generic drugs and reduce the burden of patients In December 29, 2018, the twelve ministries and commissions of the State Health Commission and other ministries and commissions jointly issued the notice on Issuing the plan to accelerate the implementation of the supply and use of generic drugs We should issue a catalogue of drugs that encourage imitation by the end of 2020 33 kinds of drug catalogue have been released by the national health and Health Commission on October 9, 2019 As a big country of generic drugs, China's generic drugs have not been able to replace the original research, 4 + 7 declared the end of this history With the continuous improvement of the innovation environment and the comprehensive promotion of volume procurement, the proportion of innovative drugs and generic drugs will rise from 5% and 0% in 2010 to 45% and 25% in 2030, respectively, while the proportion of other non therapeutic drugs will drop significantly, and the drug use structure in China will be greatly optimized For example, Zhejiang Huahai Pharmaceutical Co., Ltd., represented by the internationalization of raw materials, ranked first in a row when expanding 4 + 7 and 4 + 7, respectively, among the 12 lowest prices less than 1 yuan at 4 + 7 The number of varieties involved in 4 + 7 is not large, and the consistency evaluation