166 Class I new drugs have been approved. Which products are the most representative in the 40 years of reform and opening up? Chinese pharmaceutical companies are marching into the world?

Source: e pharmaceutical manager 2018-05-08 for China's pharmaceutical industry, the fortieth anniversary of reform and opening up is actually the forty years of industrial development At this stage, China's pharmaceutical industry has developed from scratch, from small to large, and finally from imitation based to imitation based, which has led to the birth of new drugs On the occasion of the 40th anniversary of reform and opening up, statistics have been made on a class of new drugs approved in China in the past 40 years Let's take a look at what new drugs are worth remembering in China's pharmaceutical industry According to the figures provided by China Pharmaceutical Enterprise Management Association, at the end of 1978, the sales volume of the national pharmaceutical industry was 7.28 billion yuan This is the first year of reform and opening up Forty years later, by the end of 2017, that figure had become an astonishing 2.96 trillion In the past 40 years of reform and opening up, the overall scale of China's pharmaceutical industry has grown by more than 400 times! In terms of quantity, this is an earth shaking change At the same time, in terms of "quality", the internal changes are also surging In order to understand this "qualitative change", the manager of E medicine has sorted out 166 class a new drugs (mainly chemical drugs and biological drugs, which are not listed yet) approved in China since 1978 From the earliest artemisinin suppository produced by Baiyunshan Pharmaceutical Factory in Guangzhou to the recombinant Ebola virus vaccine rapidly approved due to the emergency epidemic in 2017, in fact, the approval of new drugs has been enough to reflect a time line of the development of China's pharmaceutical industry These 18 kinds of new drugs have been selected from over 160 new drug products since 1978 (full list is attached at the end of the article) 1 in fact, if we look back on the history, it will be easy to find that the start of new drugs in China is actually not in line with the emergence of reform and opening up In 1978, the state began to set things right It was in this year that the State Council approved and transmitted the regulations on Drug Administration (Trial Implementation) issued by the Ministry of health at that time, and made special provisions on clinical identification and approval of new drugs Then, in 1979, the Ministry of health revised the relevant provisions of the drug administration regulations, organized the formulation of the new drug administration measures (Trial), and put forward comprehensive and specific regulations on the definition, classification, scientific research, clinical, identification, approval and production of new drugs It is worth noting that this is the beginning of legislation and management of new drug evaluation in China The real approval of new drugs took place in the first decade of reform and opening up, namely 1978-1988 The first approved new drug is closely related to artemisinin, which Tu youyou claimed won the Nobel Prize in the future In 1986, the first new drug certificate of artemisinin was issued by the Ministry of health to the Institute of traditional Chinese medicine of the Chinese Academy of traditional Chinese medicine with the number of (86) Wei Yao Zheng Zi x-01 In the same year, the artemisinin suppository produced by Guangzhou Baiyunshan Pharmaceutical factory also obtained the new drug certificate with the number of (86) Wei Yao Zheng Zi x-04 The next new drug is also closely related to artemisinin In 1987, artesunate developed by Guilin pharmaceutical factory, Shanghai Pharmaceutical Industry Research Institute, Institute of microbial epidemiology of the Academy of Military Medical Sciences, Institute of traditional Chinese medicine of the Chinese Academy of traditional Chinese medicine, Institute of medicine of the Chinese Academy of Medical Sciences, Shanghai Institute of medicine of the Chinese Academy of Sciences, Guangxi Medical College and Guangxi College of traditional Chinese medicine obtained the new drug certificate Artesunate injection, which was jointly developed by Shanghai Pharmaceutical Industry Research Institute, Guilin No.2 pharmaceutical factory and Guangzhou College of traditional Chinese medicine, also obtained new drug certificate It was also in 1987 that artemether and its injection developed by Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences and Kunming Pharmaceutical Factory obtained new drug certificate Among them, artemether oil injection was listed in the 9th edition of "basic drug catalogue" by who in 1997 Therefore, the first era of new drug development in China can be called "artemisinin era" Artemisinin, a scientific discovery of Chinese people, is even considered to be the greatest medical innovation in the second half of the 20th century It has been used for 15 years from artemisinin to derivative series, from artemisinin single drug to compound drug, from artemisinin laboratory extraction to industrial scale production, and then to the mass production and market of artemisinin antimalarial new drugs, which has been innovative drugs The miracle of R & D efficiency and speed in China at that time 2 the second decade: the injection era was set to 1989-1997 Compared with the previous decade, the biggest difference is the number of new drug approvals in this period According to incomplete statistics of e drug managers, there are 71 new drugs approved in this decade alone, which can be called explosive growth However, the characteristics of this stage are very obvious First of all, in terms of dosage form, most of the products belong to the scope of injection, for example, hepatocyte growth promoting factor for injection produced by Beijing No.1 biochemical pharmaceutical factory in 1995, or recombinant human interleukin-2 for injection produced by Beijing Sihuan biological engineering products factory in 1997 It is worth noting that at this stage, there are often multiple production units for the same variety, such as Shanghai Huaxin biology, Changchun Institute of biological products of the Ministry of health and other units, in addition to the four ring biology, and Shanghai Yan'an pharmaceutical factory, Wuxi No.1 pharmaceutical factory, Sichuan Changzheng pharmaceutical factory, Sichuan antibacterial pharmaceutical factory Many units, such as pharmaceutical factory of Institute of vegetable industry, have participated in the research and development of rifapentine capsule, and they are also production units The other obvious feature is that from the perspective of the production subject, the application subject of new drug research and development in this period is still dominated by the subordinate enterprises or state-owned enterprises and institutions of the relevant administrative organs of the state, such as China Medical Keyuan, Chinese Academy of Sciences, Nanjing University, Zhejiang Medical College, etc., which had drug research institutes or pharmaceutical enterprises at that time, which are also at this stage He participated in the application of new drugs At that time, private enterprises were rare, such as Lizhu Pharmaceutical Group Co., Ltd., the predecessor of Lizhu pharmaceutical, Zhuhai Special Economic Zone The third decade: the number of new drugs approved by the joint venture company began to appear The third decade (1999-2008) was not so good, only 46 in total However, compared with the previous 20 years of reform and opening up, China's new drug R & D and innovation in this stage has taken on a new look The first is the emergence of a large number of private enterprises Under the encouragement and call of reform and opening up, more and more people are engaged in the construction of pharmaceutical enterprises A large number of pharmaceutical enterprise restructuring also takes place at this stage, such as Qilu pharmaceutical In 2003, Qilu pharmaceutical became a pilot enterprise of property right restructuring of state-owned enterprises in Shandong Province Since then, Qilu pharmaceutical has completed the transformation from its predecessor, a state-owned pharmaceutical factory to a star pharmaceutical factory Also in 2003, Qilu Pharmaceutical Co., Ltd The new drug "Juhe Granule" was approved successfully It is at this stage that EBP, a heavy-duty product of Sinopharm group, is officially launched Similarly, there is the recombinant human endostatin (endu) of medezin biology in Yantai, which is the earliest anti-cancer drug independently developed in China At the same time, shinzaisheng (recombinant adenovirus-p53 anti-cancer injection), which once caused a long-standing lawsuit, also happened at this stage On the other hand, the new drugs applied by the joint venture companies began to appear At this stage, many Sino foreign joint ventures, such as Shanghai Shiguibao, Glaxo Weikang Suzhou Pharmaceutical Co., Ltd and shikebicheng Tianjin Co., Ltd., have been approved as new drugs in China It is worth noting that before and after 2003, the "landmark to national standard" which had a deep influence in the pharmaceutical industry was carried out in succession Before that, many local standards for the implementation of new drugs were actually put on the market After that, local standards were no longer implemented, and all new drugs were unified as national standards Fourth decade: compared with the emergence of real heavyweights, the number of products approved in the latest period is not too much, only 45 However, the biggest feature of this stage is that new drugs with real weight and original value begin to enter the stage of history One of the most typical is the new drug, exetinib hydrochloride, which was approved by Beida pharmaceutical in 2011 As a special landmark achievement of national "11th Five Year Plan" major new drug creation, the emergence of Kemena makes China become the third country with completely independent intellectual property rights to target anticancer drugs after the United States and the United Kingdom; Kemena also breaks the situation that lung cancer targeted treatment has been monopolized by imported drugs for a long time, becoming the third in the world and the first targeted anticancer drug in Asia Academician Chen Zhu, then Minister of health, even praised Kemena as "two bombs and one star" in the field of people's livelihood The other is xidaban, which is developed by Shenzhen micro core Institute This is the world's first subtype of selective histone deacetylase oral inhibitor, which belongs to a new mechanism of action - epigenetic regulatory anti-tumor drugs It is also the first original small molecule drug developed synchronously in the world in China As a result, xidaban has also won the 11th Five Year Plan "863" molecular design project and the national "major new drug creation" innovative drug incubation base and other project branches Yes, it has been rated as a major scientific and technological special achievement of the Ministry of science and technology during the 11th five year plan At this stage of time, we see that new drugs independently developed by China can be put on the world stage Similarly, conbercept of Chengdu Kanghong biological Co., Ltd., until now, has also been regarded as the benchmark of domestic biological drug R & D and innovation The process of pharmaceutical innovation in China has begun Entrepreneurs, scientists and investors in the pharmaceutical industry have been involved in the wave of innovation in China Chinese excellent enterprises and entrepreneurs have begun to aim at the world From the perspective of 40 years' development, although there are no less than 100 approved innovative drug products, there are not many products that can be recognized by other global markets Attachment: Class 1 new drugs approved in China since 1978 (Note: incomplete statistics, Chinese medicine is not included temporarily)