logo

您当前的位置:
Home page
>
>
>
New Drug Development in China: How Far Are We from the First Original Drug?
新闻资讯

New Drug Development in China: How Far Are We from the First Original Drug?

  • Categories:Industry news
  • Author:
  • Origin:
  • Time of issue:2019-12-18 19:36
  • Views:5

(Summary description)According to data provided by the Tufts Drug Development Research Center, the average cost of developing a new drug is about $ 2.6 billion. In 2013, the R & D investment of the top ten global pharmace

New Drug Development in China: How Far Are We from the First Original Drug?

(Summary description)According to data provided by the Tufts Drug Development Research Center, the average cost of developing a new drug is about $ 2.6 billion. In 2013, the R & D investment of the top ten global pharmace

  • Categories:Industry news
  • Author:
  • Origin:
  • Time of issue:2019-12-18 19:36
  • Views:5
Information
According to data provided by the Tufts Drug Development Research Center, the average cost of developing a new drug is about $ 2.6 billion. In 2013, the R & D investment of the top ten global pharmaceutical companies accounted for 17.8% of sales, up to 60.39 billion US dollars, while the R & D investment of the top ten domestic pharmaceutical companies was only 1% of sales, about 300 million US dollars.
This is the embarrassing situation facing China's new drug research and development: Although we occupy a huge market advantage and have 4,700 pharmaceutical companies, most of them are small and scattered, with low sales and profit; companies have no capital and are unwilling to invest capital in new drug research and development. ; The level of innovation is mainly at the stage of combining imitation-based to imitate innovation, and the proportion of generic drugs is as high as 96%. Due to the lack of R & D capabilities and a complete development chain for innovative drugs, Chinese pharmaceutical companies have been researching popular targets and repeated product declarations, leading to serious homogeneity of enterprises, which is basically a state of disorderly competition and sustainable development is difficult to sustain. So far, China's first truly new medicine is still half-hiding the pipa, and it has yet to come.
On the one hand, with the improvement of comprehensive national strength, the international market has increasingly demanded for China's innovation capabilities. On the other hand, chronic diseases such as tumors and diabetes have become the most important diseases that threaten the health of the people. People have proposed new drugs with good curative effects and good prices. Urgent needs. July 30-31, 2015, at the "Professional Information Leads Chinese Pharmaceutical Companies Innovation and Internationalization-The Second Thomson Reuters China Pharmaceutical Industry Conference" hosted by Thomson Reuters, Sang Guowei, Chairman of the Chinese Pharmaceutical Association Academician, Dr. Lu Qiang, Vice President and Chief Scientific Officer of Yuheng Pharmaceutical, Dr. Zhang Lianshan, Global R & D President of Hengrui Pharmaceutical, Dr. Shaojing Hu, Vice President and Chief Scientific Officer of Beta Pharmaceuticals, and many other top experts in the industry. The three themes of "R & D in China", "Internationalization of Chinese Pharmaceutical Enterprises" and "Professional Information and Chinese Pharmaceutical Enterprises" were discussed and prospected.
From the perspective of the overall market environment, overseas generic drug companies are paying more and more attention to innovative drugs. Teva, the world's largest generic drug company, has increased the proportion of patented drug R & D year by year. Aijian sold its generic drug business after it merged with Atves. In the field of innovative drugs, domestic pharmaceutical companies are also keeping pace with the global market. A group of local pharmaceutical companies represented by Hengrui, Chia Tai Tianqing, Hisun and others have strategically deployed new pharmaceutical fields by strengthening research and development investment and cooperating with multinational pharmaceutical companies. 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, a number of industry insiders also said that how to develop new medicines that are affordable to Chinese people is the focus of domestic pharmaceutical companies' research. For the development of innovative drugs in China, the three major factors of basic research, capital investment and policy guidance play an important role.
  basic research
发现 The discovery of a successful new drug cannot be achieved without the support of basic research, such as the discovery of new targets and the clarification of the mechanism of action. Hu Shaojing, vice president and chief chemist of Betta Pharmaceuticals, said, "Investment in basic research is crucial, which determines whether China can have a place in global new drug research and development in the future." At the same time, basic scientists, pharmaceutical companies The communication between the R & D personnel and the clinician is also very important. Through clinical feedback, a more rational drug design based on the markers and targets of the disease is carried out, making the designed new drug more effective, with fewer adverse reactions, and thus more To achieve personalized medicine and precision medicine.
In recent years, the level of basic research in China has increased significantly. In the 2015 Natural 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. Quantity and quality, which have brought limitations to fully promote the development of new drugs.
Capital investment
创新 For innovative drugs, the greater the breakthrough, the greater the investment risk, especially for the mining of new targets. Private capital is reluctant to invest in highly risky and uncertain areas, which has led to insufficient early research and development support for new drugs. The traditional domestic concept is that drugs must be marketed to be of value. In the view of Guo Ming, general manager of Yasheng Medicine, as long as the drugs have sufficient potential value, they can be realized at any time. Academician Sang Guowei pointed out that the most difficult problem in new drug research and development at present is funding. At the same time, he also proposed a solution, namely to realize the company's value-added and early investment exit in important stages of drug development, create a successful business model, and create an investment atmosphere for early innovation projects.
Government-led
For a long time, related systems for the approval of new drugs in China have been criticized for a long time: long clinical access time, registration binding production licenses, long market bidding and procurement cycle, different procedures in different provinces, and innovative drugs cannot be entered into the medical insurance or bidding procurement directory in time. The intellectual property rights of new drugs also lack protection. Sang Guowei said that China ’s pharmaceutical innovation field should introduce the concept of “government, industry, research, and research”. Based on the industry, university, and research, improve the top-level design based on the actual conditions of the country, increase government support, and also emphasize the transformation of the medical model. The significance of innovative drug research and development, and strive to promote new models of collaborative innovation among enterprises, research institutes and universities.
In recent years, the state has encouraged innovation, and set up special review and approval channels for some innovative drugs and clinically needed drugs, and review resources are tilted towards innovative drugs. At the end of July, the CFDA issued intensive documents, and successively released the "Announcement on the Self-examination of Drug Clinical Trial Data" and the "Announcement on Soliciting Several Policy Opinions to Accelerate the Resolution of the Backlog of Drug Registration Applications", which also marked the approval of new drugs in China Landmark reform in the system.
In 2014, we are honored to witness the approval of new drugs in China's independent research and development of important therapeutic fields, such as apatinib mesylate, cetabine amine tablets, and sabin strain polio vaccine. A dose of strong needle was injected. Although this is still a long way from First-in-class, a solid step has been taken. The growth of Chinese pharmaceutical companies requires time and patience. Please also look forward to the real The birth of original medicine!

Scan the QR code to read on your phone

Copyright©2019 Wuhan Wuyao Pharmaceutical Co.,ltd

鄂ICP备11004909号   Power by 300.cn