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    Home > Active Ingredient News > Drugs Articles > A new chess game of R & D for multinational pharmaceutical enterprises: mature products are not old, and it's reasonable to weigh on new drugs

    A new chess game of R & D for multinational pharmaceutical enterprises: mature products are not old, and it's reasonable to weigh on new drugs

    • Last Update: 2016-05-06
    • Source: Internet
    • Author: User
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    Source: from May to June, 2016, the weather in the medical economics Daily was suddenly warm and cold, just like the air in the circle of new drug research and development: hope is just around the corner, but it's not so easy to reach that end When it comes to drug research and development in Asia, China must be the inevitable focus of attention China has experienced great changes in the past two decades Multinational pharmaceutical companies have set up R & D centers in China "We encourage cross-border talent exchanges, such as researchers from domestic R & D centers to work in Berlin or the United States The whole R & D is oriented to the world, and new drugs will not only be listed in China, but also in other parts of the world " At Bayer center in Beijing, the reporter met with Lang Zhihui, vice president of Bayer prescription medicine in China and director of medical department The doctor, who previously worked as a clinician in foreign countries and then served as a clinical research and development position in many famous pharmaceutical companies around the world, expressed great enthusiasm and expectation for the research and development field in China China R & D center: how to open it correctly? [background board] with such a high risk, new drug research and development is still the most important exploratory science for human life, but it takes a long time and costs a lot to develop a new drug, and the road to success is unknown (uncertain) and accompanied by risks Every new drug research and development has great uncertainty, and there are many cases that cost more than one billion dollars to enter the stage III clinical practice, but are still floating "If you're not lucky, you may never be able to develop new drugs, or you may fail in the end." Dr Zheng Yiman, vice president of MSD China and head of the Chinese medical department, told reporters about the risks of R & D From the perspective of investment output ratio, pharmaceutical industry is actually a very high-risk enterprise: about 10000 new drugs are under development, only 10 of which can finally enter the clinical practice, and only one "heavy bomb" that can actually sell more than $1 billion may be sold This kind of probability is even more "terrible" than gambling "According to the latest figures, it takes an average of 12 years and 1.2 billion US dollars to develop a new drug At the macro level, a new drug or a new drug will go through several stages in clinical application The first is scientific research Without the support and efforts of laboratories, universities and research institutes, new scientific discoveries and exploration of disease mechanism, the research and development of new drugs would be impossible Second, after the research results are obtained, there will be a process of transformation, that is, a group of experts will transform the research results into productivity In other words, after understanding the mechanism of the disease, the therapeutic effect can be achieved by intervening in the pathological or physiological process Then, the pharmaceutical factory may have to pay more than $1 billion and 10 years of long waiting, go through several phase I to phase III clinical trials, and finally put the drug to the market " In Lang Zhihui's view, these links are closely linked Beijing! Shanghai! Behind the unknown and risks, innovation is still the engine to promote the business growth of pharmaceutical enterprises The long-term competitiveness of the world's top pharmaceutical enterprises is still in the reserve of new drug research and development: more and more enterprises are interested in China's research capacity, and multinational pharmaceutical giants are trying to develop new drugs in Chinese laboratories, or set up R & D centers in China In a table of international pharmaceutical companies setting up R & D institutions in China, the reporter noticed a detail: Beijing and Shanghai are the most preferred places For example, Lilly China R & D center in Shanghai, (Shanghai) AstraZeneca East Asia clinical research center, Shanghai Roche (China) R & D center; Novartis (China) biomedical research Co., Ltd., Bayer China drug discovery innovation center, Merck xuelanuo China R & D center, MSD R & D (China) Co., Ltd in Beijing, etc "In 2011, MSD established the China R & D center in Beijing At present, it has more than 400 scientific researchers and employees, and has various abilities to do later R & D, that is, product R & D It can be said that our R & D investment in China is gradually increasing " According to Dr Li Zhengqing, general manager of MSD R & D (China) Co., Ltd., in the past two years, China's national policy development has been in a positive direction, such as the country's more standard and strict requirements for drug quality, and the reform of drug audit system makes it possible for innovative drugs to be approved and listed quickly So why Beijing and Shanghai? The views expressed by a researcher at the clove forum may be representative:“ The reason is very simple In Beijing, there are national regulatory authorities, evaluation centers, and intermediate inspection centers, which are convenient for business processing and communication Not only foreign enterprises set up R & D centers here, but also good domestic R & D pharmaceutical enterprises usually have a special office in Beijing for approval, or R & D centers of similar levels Shanghai is the center of the whole Yangtze River Delta Many domestic high-quality pharmaceutical enterprises gather here, and the degree of internationalization of Shanghai is also very good For example, Zhangjiang has shown the aggregation effect As for the central and western regions, it is difficult to keep pace with Beijing and Shanghai in terms of market, talent and other aspects The president of global clinical development, a foreign company that will locate a Chinese R & D center in Beijing, said publicly: it is more about considering the research area of concern and its corresponding partners, including some universities and their affiliated biotechnology companies For example, Tsinghua University and Peking University have attractive R & D capabilities in related fields In addition to the pharmaceutical giants in Europe and the United States, the pharmaceutical companies in Asia also aim at Chinese R & D Recently, the project signing ceremony was held in China for the "global production base and R & D center of Korean American drugs" invested by the largest pharmaceutical enterprise in South Korea with a total amount of US $500 million The core of the enterprise is long-acting protein, polypeptide drug technology and oral drug technology China's children's medicine ma mi AI is the R & D and production of Beijing company invested by it No lab, just an office? On the one hand, China is constantly integrating into the global drug R & D system The establishment of R & D centers in China by international pharmaceutical companies gives domestic pharmaceutical companies the opportunity to have close contact with international advanced pharmaceutical R & D technologies But on the other hand, for most foreign enterprises, the role of China's R & D center is relatively weak: it is mainly aimed at supporting development of foreign existing new drugs to be listed in China, such as clinical trials, application to drug regulatory authorities, etc., and it is difficult to reach the core of research and development of multinational companies In addition, the cost advantage of R & D centers in China has been increasingly diluted "The R & D center set up in Beijing has no laboratory, just an office, which is mainly responsible for the work of documents and materials, application and registration of laws and regulations." A global top 10 foreign enterprise related person told reporters Even so, there is a positive side It is pointed out that one of the final results of these multinational pharmaceutical companies' investment in setting up R & D centers in China is to cultivate a large number of middle and senior talents who are proficient in R & D technology and R & D management in China several years later It is also a good foundation and hope for improving the ability of independent innovation in the future China is the heavy angle clinical trial of clinical trials, and China also plays an important role "Bayer has brought more and more Chinese patients into global clinical trials At present, 107 clinical trials have been completed or are in progress in China, nearly three times the number eight years ago " Such is Lang Zhihui's introduction In fact, not only drug companies, but also clinicians show great concern and interest in the participation of Chinese clinical trials Professor Li Jin, Cancer Hospital Affiliated to Fudan University, gave an example to the reporter: a phase III randomized trial on colorectal cancer in Europe and America showed that the median survival time of the new drug group was 29% better than that of the placebo group "Whether these European and American research data can be directly used for the treatment of patients in China remains to be confirmed Therefore, we carried out relevant research in Asia, especially in China to further prove it " Li Jin believes that Chinese doctors are growing and maturing, and many experts are gradually showing their talents on the international stage China's clinical research is different from that of 10 years ago It is no longer just a participant or a bystander Today, it has the ability to lead these large-scale or even transnational clinical trials "The participation of Chinese doctors is getting higher and higher, and the quality of clinical trials conducted by various centers is also improving, and the data of clinical trials are gradually recognized internationally." Maintain speed and passion: without the Red Sea, all we see is the blue sea! [background] in recent years, the "pressure mountain" of old brand original research drugs in China's pharmaceutical policy has become frequent: reduce drug prices; support domestic drug innovation and other trends, which seems to make the "price gap" of original research drugs gradually change At present, almost all multinational enterprises are facing the challenge that many products are mature products, so the differentiation of products in the market is decreasing; at the same time, the consistency evaluation work being carried out in China has promoted the quality of domestic generic drugs to continue to rise For a large number of patent expired drugs, we need to fight against the erosion of market share by generic drugs Traditional business: inescapable pricing trade-off from a strategic point of view, multinational pharmaceutical enterprises need not only to obtain stable growth from traditional business, but also to re explore the feasible mode of profit generation of traditional business continuity The previous "sales driven" mode is slowly transforming into "innovation driven" At this moment, it is necessary to control costs, seek differentiation and maintain innovation passion For the slightly sensitive drug price issue, in an interview with reporters, some heads of multinational companies in China also frankly said that the price composition may be two parts, one is to adhere to high quality, the other is to encourage innovation The next thing we must insist on is to promote the innovation of internal processes and pay attention to cost control, so as to continuously reduce costs and strive to provide patients with better products while maintaining more competitive prices In a recent interview with the media, a senior manager of a foreign pharmaceutical company said, "the mature prescription drug market will not give up, because the total volume is still very large And the bidding policy and the whole trend of new medical reform will make this mature market more and more difficult to do " Therefore, the pricing and marketing strategies of foreign pharmaceutical companies for traditional drugs are changing Heavyweight new drugs: it's reasonable to "squeeze" hot fields Now, on the whole, the strategy of many foreign pharmaceutical companies is that mature products are not old, but attention is gradually shifted to heavyweight new drugs Looking at the global R & D field, drug innovation, especially for the research and development of innovative drugs in cancer, diabetes and other fields that do not meet the clinical needs, has always been the hot spot pursued by pharmaceutical companies, at the same time, it is also the difficulty in the research and development field "For example, diabetes is a public health problem in the world, which is not only difficult to cure, but also expensive to invest in medical treatment Therefore, it is necessary for many pharmaceutical companies to focus on the research of diabetes " Zheng Yiman said that the hot areas of cancer and diabetes are concerned because medical problems have not been solved and medical needs have not been met as
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