According to a data provided by Tufts Center for Drug Development Research, the average cost of developing a new drug is about US$2.6 billion. 17.8% of the global top 10 pharmaceutical companies invested in R&D as a percentage of sales in 2013, amounting to US$60.39 billion, while the top 10 domestic pharmaceutical companies invested only 1% of sales in R&D, about US$300 million.
This is the embarrassing situation facing China's new drug R&D: although we have the advantage of a huge market with 4,700 pharmaceutical companies, the vast majority of them are small and scattered, with low profitability in sales; they do not have capital and are unwilling to invest capital in new drug R&D; the innovation level is mainly at the stage of generic-based to combined generic-innovation, with the proportion of generic drugs reaching 96%. Due to the lack of innovative drug research and development capabilities and a complete development chain, Chinese pharmaceutical companies are swarming to research popular targets and repeatedly declare their products, resulting in serious homogenisation of enterprises and basically disorderly competition, making sustainable development unsustainable. To date, a new drug in the true sense of the word is still a pipa and a half, a thousand calls have not yet come.
On the one hand, with the improvement of comprehensive national power, the international market is increasingly demanding China's innovation capability, and on the other hand, chronic diseases such as oncology and diabetes have become the most important diseases threatening national health, and the people have an urgent demand for new drugs with good efficacy and good price. At the 2nd Thomson Reuters China Pharmaceutical Industry Conference, academician Sang Guowei, Chairman of the Chinese Pharmaceutical Society, Dr. Lu Qiang, Vice President and Chief Scientific Officer of Yu Heng Pharmaceutical, Dr. Zhang Lianshan, President of Global R&D of Hengrui Pharmaceutical, and Dr. Hu Shaojing, Vice President and Chief Scientific Officer of Baida Pharmaceutical, discussed and discussed the three themes of "New Drug R&D in China", "Internationalization of Chinese Pharmaceutical Enterprises" and "Professional Information and Chinese Pharmaceutical Enterprises". The conference will be held in Beijing, China.
In terms of the overall market environment, overseas generic pharmaceutical companies are paying more and more attention to innovative drugs, global generic pharmaceutical companies Teva are increasing the proportion of patent drug research and development year by year, Allergan is selling off its generic business after the merger with Actavis in order to enter the field of innovative drugs, while domestic pharmaceutical companies are also in line with the global market, a number of local pharmaceutical companies, represented by Hengrui, Zhengda Tianqing, Haisheng, etc., are strategically developing new drugs by strengthening R&D investment and cooperating with multinational pharmaceutical companies. First-in-class is becoming a new trend in global pharmaceutical R&D, and innovative drugs have become an important means to enhance the competitiveness of enterprises.
In addition, a number of industry insiders also said that how to develop new drugs that are affordable to the Chinese people is the focus of research by domestic pharmaceutical companies. For the development of innovative drugs in China, the three major factors - basic research, capital investment and policy guidance - play a pivotal role.
The discovery of a successful new drug is ultimately dependent on the support of basic research, such as the discovery of new targets and the elucidation of mechanisms of action. Shaojing Hu, Vice President and Chief Chemist of Baida Pharmaceuticals, said, "Investment in basic research is a crucial point that will determine whether China can take its place in global new drug development in the future." At the same time, communication between basic scientists, R&D staff of pharmaceutical companies and clinicians is also crucial to develop more rational drug design based on disease markers and targets through clinical feedback, so that the new drugs designed will be more effective and have fewer adverse reactions, thus better enabling individualised drug use and medical treatment.
In recent years, the level of basic research in China has increased significantly, with China ranked second in the world in the 2015 Nature Index rankings and CAS even ranked among the world's universities and research institutes. However, basic research in China is currently focused on the quantity and quality of papers, which has brought limitations to fully promote new drug development.
For innovative drugs, the greater the breakthrough, the greater the investment risk, especially for new target discovery. The reluctance of private capital to invest in highly risky and uncertain areas has led to a lack of support for early stage R&D of new drugs. The traditional domestic perception is that a drug must be made to market before it has value, whereas in the view of Guo Ming, General Manager of Asheng Pharmaceuticals, a drug can be realised at any time as long as it has sufficient potential value. Academician Sang Guowei pointed out that the most difficult aspect of new drug research and development at present is the funding problem. He also proposed solutions, namely to achieve value-added companies and early investment exits in the important early stages of drug development, to create a successful business model and to create an investment climate for early stage innovation projects.
Leading the way
For a long time, the domestic system related to the approval of new drugs has been subject to criticism: long clinical access time, registration tied to production licenses, long market bidding and procurement cycle, different processes in different provinces, innovative drugs cannot enter the medical insurance or bidding and procurement catalogues in a timely manner, in addition, the intellectual property rights of new drugs are also lacking protection. Sang Guowei said that China should introduce the concept of "government, industry, academia, research and application" in the field of pharmaceutical innovation, improve the top-level design based on industry, academia and research, increase the support investment from the actual national situation, and also put more emphasis on the importance of the translational medicine model in innovative drug development, and strive to promote the new model 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 drugs in urgent clinical need, and tilting review resources towards innovative drugs. at the end of July, the CFDA issued intensive documents, successively releasing the Announcement on the Self-checking and Verification of Drug Clinical Trial Data and the Announcement on the Solicitation of Opinions on Several Policies to Accelerate the Resolution of the Backlog of Drug Registration Applications, which also marked a milestone in China's a landmark reform in China's new drug approval system.
In 2014, we were honoured to witness the approval of new drugs in important therapeutic areas developed independently in China, such as Apatinib Mesylate Tablets, Cetapenem Tablets and sabin strain inactivated polio vaccine, which have injected a shot in the arm for new drug development in China. The growth of Chinese drug companies needs time and patience, and we look forward to the birth of truly original Chinese drugs!
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