10 years of innovation: China's pharmaceutical industry ushers in a major turning point

Since 2005, after more than 10 years of development, China's pharmaceutical industry has bred drugs such as yisaipu (etanercept), exetane, sidabamide, ibowetai, treprizumab and so on The listing of each drug has opened a new page in the development of China's pharmaceutical industry, with special milestone significance! However, up to now, it is still undeniable that there are no multinational giants in Chinese pharmaceutical enterprises, and the heavyweight products whose sales volume can reach the level of heavyweight bomb (annual sales volume > 1 billion US dollars) have not yet appeared The important business of pharmaceutical enterprises is still chemical generic drugs (first generic varieties) or APIs, and most innovative drugs or biological similar drugs have not yet become enterprises The core business of the exhibition 1、 10 years of innovation: the innovation ability of China's pharmaceutical industry is rapidly improving This paper only focuses on chemical drugs and biological products, excluding traditional Chinese medicine Since 2005, China has been approved to launch a number of innovative drugs or bio similar drugs, all kinds of wonderful factors, There are also many kinds of drugs The development and commercialization of drugs have certainly attracted the efforts of scientists, enterprises and the country The author has selected more than 20 representative drugs, such as yisaipu (enacep), exetane, conbercept, sidabamide, ibovetai and trepril monoclonal antibody The development and marketing of drugs have almost received the national major special support 10 years' innovation represents drug information summary: these 25 drugs are the epitome of 10 years' innovation and development of Chinese medicine The innovation ability of Chinese medicine enterprises is rapidly improving From yisaipu to tuoyi and Dabusu, Chinese medicine enterprises are changing from fast followers to original research product developers with innovation ability Fast following Chinese medicine: most of the innovative drugs from yisaipu to hanlikang that have been approved for listing by the State Administration are based on the results of the rational design of the listed drugs, some of them are license in varieties, and few of them are heavy original innovative drugs in China See the table below for details Except for some drugs (such as conbercept), the Chinese market of drugs is later than the international market for 7-16 years Time difference between individual drugs and international first in class drugs: innovative Chinese medicine: tuoyi, dabushu, etc set a new milestone In the list of 25 drugs, the proportion of drugs approved for marketing in 2018 is not small At the same time, the innovative drugs represented by tuoyi and dabushu have opened a new milestone Although drugs are not first-in-class drugs, the level of drug innovation, development and commercialization has reached the world-class level The time difference between the drugs and the first-in-class drugs has been shortened to 4 years, and the drugs are on the market It has significantly impacted the imported products (odevo, coreda) and greatly improved the accessibility of Chinese patients' medication The first PD - (L) 1 monoclonal antibody to enter the Chinese market will become the real blockbuster drug in China in the future! 2、 Innovative drugs have not yet become the core driving force of China's pharmaceutical industry If we talk about the varieties with sales volume of 2 billion yuan in China, we may only think of Zhengda Tianqing Runzhong and dongyangguang Pharmaceutical Co., Ltd., all of which are generic drugs Among more than 20 representative drugs, the author collected the sales volume of several drugs in 2018 from the company's annual report, and calculated the contribution of innovative drugs The sales of products and companies can be seen from the above list that products such as Kemena, epsilon and tebio have relatively high contribution A product supports an enterprise, so that an enterprise can be listed However, the overall sales revenue of the company is not ranked in the top among Chinese pharmaceutical enterprises, and the global ranking of the company is even less Relatively speaking, innovative drugs such as Sinopharm group and Shanghai pharmaceutical, which rank top in domestic sales revenue, have a very low contribution to their sales, which can almost be ignored The contribution of artesunate, one of the core products of Fosun medicine, is less than 3%; the contribution of aitan, one of the core products of Hengrui medicine, is also less than 3% In a certain sense, the operating revenue of Chinese pharmaceutical enterprises is less than 100 billion yuan, and there are no multinational giants The heavyweight products whose sales volume can reach the level of heavyweight bomb (annual sales volume > 1 billion US dollars) have not yet appeared The important business of pharmaceutical enterprises is still chemical generic drugs (first generic drugs) or APIs, and most innovative drugs or biological similar drugs contribute It is very low and has not yet become the core business of most enterprises 3、 Everything is changing With the deepening of drug review and approval reform, the improvement of health insurance payment environment, especially the obvious change of financing environment, China's pharmaceutical industry is entering a turning point, and 2018 is the beginning! Chemical generics: Conformity evaluation of integration, reorganization and transformation, "4 + 7" centralized procurement has profoundly changed the chemical Generics Industry The traditional value of the first generics and chemical generics is rapidly fading High quality and high requirements are the basic standards of the future Generics Industry For such varieties as Runzhong and Kewei, the sales volume will surely be surpassed by innovative drugs, far beyond! Bioequivalent drugs: Fuhong Hanlin hit the line to kill in the field of bioequivalent drugs Sansheng pharmaceutical and Fuhong Hanlin have taken the lead in completing the listing of bioequivalent drugs, among which the market share of lisep of Sansheng pharmaceutical occupies an absolute advantage; In the next few years, from the perspective of late clinical products, Fuhong Hanlin, baiaotai, Xinda, Zhengda Tianqing, Jiahe biology, Shenzhou cell, tianguangshi, Hualan, etc have obvious advantages, and will be the main force in the biological similar drug market for many years to come! Innovative medicine is the core driving force to support the formation of multinational pharmaceutical enterprises innovation! Innovation! Innovation! With the improvement of financing environment, medical insurance payment, innovation accumulation, review and approval, the innovation of China's pharmaceutical industry in the next few years will be blooming everywhere The potential heavyweight varieties can be seen in the table below: potential heavyweight varieties: Of course, the enterprises and drugs in the above table are only from the perspective of individuals, and there are still many potential varieties that the author has not listed Other 3-stage clinical PD - (L) 1 monoclonal antibodies, 4-generation EGFR-TKI, PARP inhibitors, GK activators, CD4 / 6 inhibitors, etc Although the innovative drugs listed in the table are still not the original innovation of first in class, they have been able to keep up with the world-class development level The new generation of innovative products represented by Pd - (L) 1 monoclonal antibody have been listed in the world-class market, and are shortening the time difference with the first in class drug market! Baiji Shenzhou, Xinda biological, Junshi biological, Hualing pharmaceutical and cornerstone pharmaceutical are typical representatives of China's new generation of innovative enterprises Domestic innovative pharmaceutical enterprises are developing rapidly, and innovation in the future will be the core driving force to support the formation of multinational pharmaceutical enterprises! From 2018, everything is changing!