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    Home > Active Ingredient News > Drugs Articles > Huang Peijie: China has a lot of lessons to fill if it wants to become the main battlefield of new drugs in the world

    Huang Peijie: China has a lot of lessons to fill if it wants to become the main battlefield of new drugs in the world

    • Last Update: 2017-05-20
    • Source: Internet
    • Author: User
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    [expert opinion of chinapharma.com] on May 18, at the 2017 Pujiang pharmaceutical health industry finance innovation development summit, Huang Peijie, chairman of Greater China region of Boston Consulting Company (BCG), raised the question on the spot: "can China, which has become the second largest pharmaceutical market in the world, become the largest pharmaceutical innovation source in the world as its economic scale?" (Huang Peijie: China has many lessons to fill to become the main battlefield of new drugs in the world.) it is reported that the conference with the theme of combination of industry and finance, which is a hot topic at present, is sponsored by China Pharmaceutical Enterprise Management Association and China Chemical Pharmaceutical Industry Association, and jointly organized by e-drug manager and Shanghai Pharmaceutical Huang Peijie first gave a number that surprised the scene: China's investment in application and later stage research has surpassed that of the United States in 2013 It is optimistic to estimate that China will maintain the compound growth rate from 2003 to 2013 and double that of the United States in 2018, reaching US $658 billion; It is conservatively estimated that even if only half of the compound growth rate between 2003 and 2013 is maintained, China will reach US $434 billion, while the US will reach US $313 billion This is a powerful and exciting number, but it also points to a real problem facing China's innovation Can China become an innovation? In line with the current policy orientation and industry sentiment, Huang Peijie believes that China has the potential to become a biomedical industry At the policy level, in the next five to 10 years, the reform of China's medical system will promote innovation and efficiency He believes that China's medical reform will go through three stages: from 2009 to 2011, focusing on expanding the coverage of medical insurance; now, focusing on controlling the growth of medical expenses and improving the quality of medical care; in the future, focusing on encouraging innovation and improving the quality and efficiency of medical care Specifically, in the policy of pharmaceutical industry, Huang Peijie emphasized two key aspects: the reform of registration and approval system and the MAH Compared with the previous reform of registration and approval, the clinical registration application (ind) and new drug listing application (NDA) have been shortened to less than 12 months Ind has shrunk from 33 months in 2011 to 8 months in 2016, and NDA has also dropped from 35 months in the same period to 11 months now In particular, CFDA's recently released draft on the reform of clinical trial management is seen as a major positive The opinion clearly states that CDE shall complete the review of phase I and phase III clinical trials within 60 days, otherwise, it shall be deemed to agree the application, and the qualification of clinical trial institutions shall be changed from approval system to record management At present, MAH pilot in ten provinces and cities in China is aimed at upgrading the fundamental reform of innovative drug research and development in China According to Huang Peijie, MAH has three characteristics: the separation of drug R & D and production, encouragement of small and medium-sized pharmaceutical enterprises focusing on R & D and innovation; the holder's responsibility in the whole life cycle of drugs, rather than drug manufacturers; optimization of production resource allocation, reduction of repeated construction and overcapacity The MAH pilot program will be implemented until 2018 For the practice proved feasible, relevant laws, regulations and departmental rules will be revised and improved, and implemented nationwide In terms of biomedical technology, in the past decade, the number of biotechnology-related enterprises registered in China has been significant, and the clinical research related to biopharmaceuticals has grown rapidly According to the statistics of nature index1, China is a country with an increasing trend in the number of life science papers published In 2015-2020, the growth rate of biopharmaceutical related clinical trials in China is 18.1%, which is far higher than 7.6% in the United States, 5.2% in Europe and 5.0% in Japan To speed up the registration and approval of new drugs, the major beneficiary will be innovative drug enterprises In the past five years, 102 new biomedical R & D enterprises have been established in China In addition to Baiji Shenzhou's landing in the U.S stock market, Cinda's total financing has exceeded $400 million But China, which wants to become the main battlefield of new drug innovation in the world, still has many important courses to be supplemented First of all, the emerging biomedical innovation and R & D in China is still lack of creativity Only 10% of the biological preparations in the declared clinical trials belong to class I biological products, while only part of these 10% are "me better" products for known targets, and the rest are "me too" Huang Peijie, for example, said that more than 15 enterprises are applying for the "me too" product of rituximab This is closely related to the weakness of China's frontier basic research According to Huang Peijie, China's R & D capital has been heavily invested in application and later research Among the top ten frontier topics, the number of citations of Chinese papers in the core paper field is zero In terms of the number of Frontier indicators, China is only 6, while the United States is as high as 26 Although the number of papers published has been increasing positively, there is still a huge gap between China and the United States in terms of number In 2016, the number of life science papers in the U.S declined but still reached 7048, compared with 789 in China In the United States, the government funds two-thirds of basic research, three times as much as China According to 2014 data, the total amount of US government funded basic research is US $32 billion, while China's is only US $10 billion, and the funding source is only the government Huang Peijie pointed out that in promoting basic research, the government should continue to increase financial support for academic research and innovative entrepreneurs In addition, for innovative drugs, China needs to make its healthcare market more attractive The key to this is to allow innovative therapies to enter the coverage more quickly, and further implement measures to encourage commercial medical insurance What China needs to do more is to provide better IP protection and business environment for innovation Although China's IP environment is showing signs of improvement, such as the establishment of China's special court for intellectual property rights; the introduction of relevant policies to strengthen the protection of intellectual property rights, and clear that trade secrets are also intellectual property rights; from 2011 to 2016, the number of IP applications increased by 20% - 30%, indicating that the overall IP awareness of Chinese enterprises is improving However, the situation of infringement in China is still serious Therefore, China ranks 27th among the 38 major contributors of global GDP in terms of IP environment status, that is, IP protection is "weak" or "very weak", ranking behind Chile, Russia, Mexico and other countries "What we need to think about when we have a sense of innovation is the systems and elements needed to foster innovation The Chinese government should invest more money and make more efforts," Huang said
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