New drug development in China: How close are we to the first original drug?
Release time：2015-08-26
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According to a data provided by the Tufts Center for Drug Development Research, the average cost of developing a new drug is about $2.6 billion. In 2013, the R & D investment of the world's top ten pharmaceutical companies accounted for 17.8 percent of sales, up to $60.39 billion, while the R & D investment of the top ten domestic pharmaceutical companies was only 1% of sales, about $0.3 billion.
This is the embarrassing situation facing China's new drug research and development: although we occupy a huge market advantage and have 4700 pharmaceutical companies, the vast majority of companies are small and scattered, and sales profits are low; companies have no capital and are unwilling to invest capital in new drug research and development; The level of innovation is mainly in the stage from imitation to the combination of imitation and creation, and the proportion of generic drugs is as high as 96%. Due to the lack of innovative drug research and development capabilities and a complete development chain, Chinese pharmaceutical companies are rushing to research hot targets, and repeated product declarations have led to serious homogeneity of enterprises, which is basically a state of disorderly competition, and sustainable development is unsustainable. So far, China's first real new drug is still still holding the pipa and half covering the shy face, and it has not come yet.
On the one hand, with the improvement of comprehensive national strength, the requirements of the international market for China's innovation ability are increasing day by day. On the other hand, chronic diseases such as tumor and diabetes have become the most important diseases threatening national health. There is an urgent demand for new drugs with good curative effect and high price. From July 30 to 31, 2015, at the "Professional Information Leading Innovation and Internationalization of Chinese Pharmaceutical Enterprises-The Second Thomson Reuters China Pharmaceutical Industry Conference" hosted by Thomson Reuters, Academician Sang Guowei, Chairman of the Chinese Pharmaceutical Association, Dr. Lu Qiang, Vice President and Chief Scientific Officer of Yuheng Pharmaceutical, Dr. Zhang Lianshan, President of Global R & D of Hengrui Pharmaceutical, Dr. Hu Shaojing, Vice President and Chief Scientific Officer of Betta Pharmaceutical, and other top experts in the industry, the three themes of "new drug research and development in China", "internationalization of Chinese pharmaceutical enterprises" and "professional information and Chinese pharmaceutical enterprises" are discussed and prospected.
From the perspective of the whole market environment, overseas generic drug companies are paying more and more attention to innovative drugs. Teva, the world's largest generic drug company, is increasing the proportion of research and development of patented drugs year by year. Aljian sold generic drug business after merging with Atvis and intends to enter the field of innovative drugs. Domestic drug companies are also in step with the global market. A group of local drug companies represented by Hengrui, Zhengda Tianqing and Hazheng have strengthened their R & D investment, first-in-class is becoming a new trend in the research and development of global pharmaceutical companies, and innovative drugs have become an important means to enhance the competitiveness of enterprises.
In addition, many industry insiders present also said that how to develop new drugs that make Chinese people affordable is the focus of research by domestic pharmaceutical companies. For the development of innovative drugs in China, basic research, capital investment and policy guidance play a pivotal role.
basic research
In the final analysis, the discovery of a successful new drug is inseparable from the support of basic research, such as the discovery of new targets and the elucidation of the mechanism of action. Hu Shaojing, vice president and chief chemist of Betta Pharmaceuticals, said, "Investment in basic research is a crucial point, which determines whether China can occupy a place in the global research and development of new drugs in the future. "At the same time, the communication between basic scientists, pharmaceutical company R & D personnel and clinicians is also very important. Through clinical feedback, more reasonable drug design is carried out on the basis of disease markers and targets, so that the designed new drugs are more effective and have fewer adverse reactions, so as to better realize personalized medicine and precision medicine.
In recent years, the level of basic research in China has improved significantly. In the 2015 Nature Index ranking, China ranked second in the world, and the Chinese Academy of Sciences even ranked first in the world's universities and research institutes. However, the current domestic basic research mainly focuses on the number of papers. And quality, which brings limitations to fully promote the development of new drugs.
Capital input
For innovative drugs, the greater the breakthrough, the greater the investment risk, especially for the exploration of new targets. The reluctance of private capital to invest in highly risky and uncertain areas has led to insufficient support for early development of new drugs. The traditional domestic concept is that drugs must be made on the market to be valuable, but in the view of Guo Ming, general manager of Yasheng Medicine, as long as the drug has sufficient potential value, it can be realized at any time. Academician Sang Guowei pointed out that the most difficult problem in new drug research and development is funding. At the same time, he also proposed a solution, that is, to realize the company's value-added and early investment exit in the early stage of drug development, build a successful business model, and create an investment atmosphere for early innovative projects.
government guidance
For a long time, the approval of new drugs in China and other related systems have been criticized: long clinical access time, registration and binding production license, long market bidding and procurement cycle, different processes in different provinces, innovative drugs can not enter the medical insurance or bidding procurement catalogue in time, in addition, the intellectual property rights of new drugs also lack protection. Sang Guowei said that the concept of "government, industry, university, research and application" should be introduced in the field of pharmaceutical innovation in China. On the basis of industry, university and research, we should improve the top-level design and increase the government's support and investment. At the same time, we should also put more emphasis on the importance of translational medicine model in the research and development of innovative drugs, and strive to promote the new mode of collaborative innovation among enterprises, research institutes and universities.
In recent years, the state has encouraged innovation, setting up special review and approval channels for some innovative drugs and clinically urgently needed drugs, and tilting review resources towards innovative drugs. At the end of July, CFDA issued intensive documents, successively issued the "Announcement on Carrying out Self-examination and Verification of Drug Clinical Trial Data" and the "Announcement on Soliciting Several Policy Opinions on Accelerating the Resolution of the Backlog of Drug Registration Applications", which also marked China's new drug approval A milestone reform in the system.
In 2014, we were honored to witness the approval of new drugs in important therapeutic fields independently developed by China, such as apatinib mesylate tablets, chidarbenamine tablets and sabin strain inactivated polio vaccine. They have injected a shot in the arm into China's new drug research and development. Although this is still a long way from First-in-class, a solid step has been taken. The growth of Chinese pharmaceutical enterprises needs time and patience, please also look forward to the birth of China's real original medicine!
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