Encouraging new drug research and development: cooperation is the general trend

Source: Bio Valley / Zhang Yixin 2015-08-28 pharmaceutical device evaluation system ushered in the first major adjustment in the past five years On August 18, the State Council issued the opinions on reforming the review and approval system for pharmaceutical and medical devices The opinions clearly pointed out that the definition of new drugs should be adjusted from the current "drugs not listed and sold in China" to“ "Drugs that are not listed and sold in China and abroad" also stipulates that researchers of research and development institutions can hold the new drug listing license, optimize the approval procedures of innovative drugs, and allow overseas unlisted new drugs to carry out clinical trials in China after approval In this regard, the industry has gradually formed such a consensus that new drug research and development will occupy an increasingly important position in the development of Chinese pharmaceutical enterprises According to the public data, the R & D investment of the top ten pharmaceutical enterprises in China is only 1% of the sales volume, about US $300 million In 2013, the R & D investment of the top ten pharmaceutical enterprises in the world accounted for 17.8% of the sales volume, accounting for us $60.39 billion In the 2014 global R & D expenditure ranking of pharmaceutical companies by Gen website, Roche's R & D investment ranked first even reached as much as $10 billion Large pharmaceutical enterprises can maintain such a high investment cost by virtue of their huge size and complete industrial chain For Chinese pharmaceutical enterprises, which take small and medium-sized enterprises as the main force, to independently undertake the high cost tests such as pharmacokinetics, drug safety evaluation, etc., the enterprises must pay the cost of the decline in R & D efficiency So in today's innovation oriented policy environment, how can small and medium-sized pharmaceutical enterprises carry out low-cost and efficient research and development of new drugs? On August 26, the strategic cooperation signed by Wuxi apptec and Lishi Pharmaceutical Co., Ltd gave the answer: on the basis of maintaining certain independent R & D capability, small and medium-sized pharmaceutical enterprises can improve R & D efficiency and focus on innovation through different forms of cooperation According to Dr Li Xiaoyi, executive director and chief executive officer of Li Shida Pharmaceutical Co., Ltd., Li Shida Pharmaceutical Co., Ltd is currently developing more than 40 varieties, including more than 10 national class 1.1 new drugs "The company invests 10% of its revenue in R & D every year, but its scale is not large and its resources are limited," said Dr Li Xiaoyi frankly "Cooperation with platform enterprises like Wuxi apptec can achieve twice the result with half the effort." In fact, it is common to share the risks and benefits of the project in a strategic cooperation mode, so that the drugs can be put on the market faster with less money For example, AstraZeneca and Kuntai, Astaire and inc research, Sanofi and Covance, etc In the future, the cooperation between pharmaceutical enterprises will be more and more frequent, especially for the enterprises with strong desire in the field of R & D, cooperation may even bring new ideas and breakthroughs for the development of enterprises At present, the vast majority of domestic pharmaceutical enterprises are still in the state of manufacturing "drugs" behind closed doors, and the cooperation between local enterprises in the field of R & D is few As a cro enterprise that has accumulated rich cooperation experience with AstraZeneca and other multinational pharmaceutical enterprises, Wuxi apptec has opened the path of local R & D cooperation Not long ago, it reached strategic agreements with Yuheng pharmaceutical and Zhongsheng pharmaceutical, respectively, to jointly develop chemical medicine and biological medicine This in-depth cooperation between Wuxi apptec and Li's big pharmaceutical Co., Ltd runs through the whole process of early drug discovery, new drug application for research and new drug listing application, even including some SMOs Dr Liu busjun, chief operating officer of Wuxi apptec's testing department, said that he would further cooperate with innovative enterprises in the future, especially providing one-stop new drug research and development services for small and medium-sized enterprises Liu and Li praised a series of policies issued by the national government to encourage new drug research and development This has created a policy environment for the research and development of new drugs in China At the same time, it has put forward higher requirements for Chinese enterprises to improve their innovation ability and drug quality New drug research projects with clinical value will continue to emerge It can be predicted that innovation will become the main theme of Chinese pharmaceutical industry "Chinese medicine ushered in the spring More than 20 years ago, the FDA greatly improved its innovation ability after raising the application fee and solving the backlog problem." So says Dr Li Xiaoyi Some insiders believe that large pharmaceutical enterprises may outsource drug R & D registration, clinical application and other projects to a third-party organization for the purpose of avoiding interests and dispersing R & D risks, while small and medium-sized pharmaceutical enterprises will explore different forms of cooperation from the perspective of improving R & D efficiency Behind this subversive reform, a large number of industry opportunities are ready to take off, and cro enterprises undoubtedly ushered in good news But in Liu busjun's view, "the CFDA's policy is of milestone significance, is to really encourage innovation, it is a decisive step for China to move towards the international stage, and the whole Chinese pharmaceutical industry will move towards a new era of healthy development, which is the greatest good."