Per reporter Li Biao Intern reporter Li Mingming Jiangsu Taizhou photographic report per editor Chen Xu
Innovative drugs are the eternal theme of pharmaceutical companies, and it is also the fundamental way for enterprises to obtain high profits and improve market competitiveness. What is the overall R&D capability of China's pharmaceutical companies at present? At what stage is China's pharmaceutical innovation? What are the barriers to new drug development? How can China truly leapfrog from imitation innovation to original research innovation?
Recently, the 2021 China (Taizhou) Pharmaceutical Summit was held in Taizhou, Jiangsu Province. At the meeting, Li Jia, director of the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, made a systematic report on the above problems.
He said that China's new drug innovation is currently facing a rare period of opportunity, the next 5 to 10 years, the global pharmaceutical industry will be reorganized and transformed and upgraded, only by always adhere to scientific and technological innovation, independent innovation, firmly grasp the core technology in their own hands, in order to achieve the core competitiveness of pharmaceutical companies.
<h2>Talk about the status quo: The proportion of China's first innovative drugs is still very low</h2>
In 2018, a survey by consulting firm McKinsey showed that China's contribution to global pharmaceutical research and development rose to 4% to 8%, which also marked that China's ability to innovate drugs basically jumped to the ranks of the second echelon in the world.
"China has moved from tracking generic drugs to imitative innovation, and now it is necessary to pay attention to the original innovation. In 2019, the first innovative drug (FIRST IN CLASS) drugs in the United States were as high as about 20, while China only had two, and the proportion of China's first innovative drugs in recent years was very low, and many of them were not based on new drugs, but on natural products or the first innovative drugs that came out of traditional Chinese medicine and ethnic medicines. Li Jia introduced.
According to the FDA(U.S. Food and Drug Administration), a drug that is granted the First-in-class refers to a drug that uses a completely new, unique mechanism of action to treat a disease. It is a radically innovative approach and is the first drug capable of treating the disease.
Talking about why she is the first innovative drug, Li Jia said that because it represents the most profitable part of the entire pharmaceutical field, it can also best solve the unmet needs of the clinic.
Taking PD-1 (an immunotherapy drug) as an example, China has been on the market for 4 years slower than other countries, the first and second PD-1 drugs account for 85% of the market, while the last three drugs account for about 10%, and all the drugs after that will not add up to more than 5%. Although there are 5 PD-1s listed in China, they account for less than 5% of the world market.
Is there an opportunity for original drug innovation in China? Li Jia believes that there is currently a rare period of opportunity, because the five landmark research of new target discovery, new biomarker discovery, new molecular entity discovery, combination drug research and rapid druggability research are advancing, and it is a good path to overtake in the corner.
"In the next five to ten years, the global pharmaceutical industry will be reorganized and transformed, and many large pharmaceutical companies will begin to put many businesses such as research and development into China, and this field is facing a period of strategic opportunities." At the same time, biomedicine is not only about new drug creation, but also includes all-round transformation of translational medicine, regenerative medicine, intelligent medicine, and new materials, so it is a leader, and grasping it may make the entire biomedical industry different. Li Jia said.
<h2>Talk about challenges: the success rate of new drug research and development is only 5% Research and development funds are getting higher and higher</h2>
Driven by China's "major new drug creation" science and technology major projects, from 2008 to 2018, 41 new Class I drugs were born in China, and in 2019 and 2020, 12 and 15 new Class I drugs were added, respectively.
Although in 2017, China's pharmaceutical market has ranked second in the world, and it has become the world's first in terms of the number and weight of drug production, most of them are generic drugs, the value is relatively low, while the proportion of innovative drugs is relatively low, and the market value is very different from the international comparison.
"New drug research and development and the entire biomedical industry are facing great pressure to innovate, because the cost is getting higher and higher, the cycle is getting longer and longer, and at the same time, the gold content and efficacy of new drugs are also declining." Even the largest companies are currently struggling to afford to develop new drugs. ”
Li Jia introduced that the failure rate of new drug research and development is very high, often 20 new drugs enter the clinic, and in the end, only one new drug can be produced, in other words, there is only a 5% success rate, and it may not be able to become a blockbuster new drug.
"At present, major pharmaceutical companies are not only doing new drug research and development, but also doing the ultimate in open innovation, and every large company has invested in China. People like Novartis and Eli Lilly Pharmaceuticals have set up Investment Funds in China. Collaboration with small businesses and academia is also increasing. ”
The so-called blockbuster new drugs are used by the pharmaceutical industry to refer to innovative drugs with annual sales of $1 billion, that is, sales of about 6 billion to 7 billion yuan, and as a measure of the success of a drug development.
Li Jia said that in 2001, the average cost of developing a new drug was about 800 million US dollars, and by 2014 it had reached 2.6 billion US dollars, of which AstraZeneca had the highest investment and spent 12.4 billion US dollars to make a new drug.
<h2>On countermeasures: establish a public platform and industrial incubator for new drug research and development in the country</h2>
Li Jia said that the crux of the current industry lies in the lack of original technology for new drugs, and all the new concepts, new methods and new technologies used in drug research and development are not from China.
He introduced that many large domestic pharmaceutical companies have their own R&D centers overseas, not only for research and development, but also to discover and purchase good projects. But now that the U.S. has begun to tighten sales in this regard, it is unlikely that a good new drug program will be bought directly from the United States.
From the field of new drug discovery, how to achieve from pathogenesis research, to target discovery, to lead molecular discovery, to clinical and finally to the market? Li Jia said that China has the best contract research organizations and medicinal chemistry, and many new drugs in the world are made by China's contract research organizations.
Li Jia believes that China's new drug research and development is still weak in two aspects, on the one hand, from pathogenesis to target discovery and then target confirmation. For example, in the field of life sciences, China has a large number of papers related to research, but most of these new research progress has not been transformed, scientific research institutes, universities can not find funds to do this, investors do not dare to invest. Another weak link is that there are very few drugs that really go out of the clinic to the market to make money.
According to Li Jia's analysis, the first vulnerable aspect can be sought to be done well through the national laboratory, because only by grasping the target can it be possible to seize the entire industry behind.
Another weak aspect of the solution is to establish a public platform and industrial incubator for new drug research and development in the country, integrate some platforms in the new drug research and development chain, and then promote the landing of some good projects, transform the research results from pre-clinical to listing, and combine capital, parks and platforms more closely.
"I think within 20 to 30 years, There will be its own big pharmaceutical companies in China, we have 6,000 local pharmaceutical companies, and there are a lot of returnees who have established biotechnology companies, so these are all possible." Li Jia stressed.
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