China's pharmaceutical innovation has entered a stage of leapfrog development
Observations from the 2nd China Pharmaceutical Development Conference and the 65th Anniversary Forum of the Institute of Materia Medica, Chinese Academy of Medical Sciences.
At present, the scale of China's biopharmaceutical market ranks second in the world, pharmaceutical innovation ranks among the top of the world's second echelon, and China's drug research and industrial development is entering a new stage of innovation and leapfrogging.
This is the latest news obtained by the reporter from the 2nd China Pharmaceutical Development Conference and the 65th Anniversary Forum of the Institute of Materia Medica, Chinese Academy of Medical Sciences.
A number of academicians and experts attending the meeting said that thanks to the strong support and promotion of the pharmaceutical industry by the state, as well as the active investment and research and development of pharmaceutical enterprises, and with the unremitting efforts of groups of scientific research workers, the high-quality development of China's pharmaceutical industry has achieved remarkable results. But at the same time, experts also pointed out that China's biomedical industry is in the critical stage of "climbing over the hurdles", and the next step is to strengthen the layout of national strategic scientific and technological forces, optimize the top-level design, put the improvement of original innovation capabilities in a more prominent position, increase talent training, and strive to achieve more breakthroughs from "0" to "1".
The pharmaceutical industry has changed from a lack of medical treatment to a global layout.
From 1950, more than 90% of chemical APIs relied on imports from abroad, to about 40% of the world's bulk API production
From the early 80s, the total output value of medicine was less than 10 billion yuan, to the operating income of enterprises above designated size in the pharmaceutical industry exceeded one trillion yuan
From the lack of medical treatment and poor equipment, to the original innovative drugs represented by artificial musk, dicyclic alcohol, mulberry branch total alkaloids, etc., ...... continue to emerge
China's pharmaceutical industry is integrating into the global innovation network and industrial system at a higher level.
According to the latest data, there are more than 10,000 pharmaceutical industry enterprises above designated size in China, and the added value accounts for about 4% of the total industrial added value. From the perspective of output value, data from the China Pharmaceutical Enterprise Management Association shows that in 2022, the operating income of enterprises above designated size in the pharmaceutical industry has reached 33,633700 million yuan.
Wang Rui, academician of the Chinese Academy of Engineering and executive director of the Institute of Materia Medica, Chinese Academy of Medical Sciences, said that the Institute of Materia Medica, which has a history of 65 years, as a member of the "national team" of China's pharmaceutical innovation and research and development, has also confirmed the vigorous development of China's pharmaceutical industry. Over the past 65 years, generations of pharmaceutical researchers have forged ahead and moved forward bravely, promoted the listing of hundreds of new drugs, and obtained 132 new drug certificates and drug registration approvals, including 22 original innovative drugs represented by artificial musk, dicyclol, mulberry branch total alkaloids, etc.
The reporter learned at the scene that, according to preliminary statistics, since China launched a major new drug creation science and technology project in 2008, more than 90 chemical drugs and biological drugs have been approved as Class 1 innovative drugs, and more than 40 traditional Chinese medicine innovative drugs have been approved. In addition, about 200 varieties have entered the clinical stage, more than 160 varieties have entered the clinical stage, and more than 200 varieties have entered or completed phase clinical trials.
Liu Dengfeng, Inspector of the Department of Science and Education of the National Health Commission, pointed out that the country attaches great importance to pharmaceutical innovation, and major new drug creation spans three five-year plans, builds a full-chain ecosystem for new drug research and development, and realizes the leap from "generic" to "innovative" in China's new drug creation.
According to the data of the Ministry of Industry and Information Technology, since the "14th Five-Year Plan", the average annual growth rate of the main business income of China's pharmaceutical industry has been 93%, the average annual growth rate of total profit is 113%, the development foundation is more solid, the industrial system is further optimized, and the pharmaceutical industry continues to improve quality and efficiency. During the same period, the industry's R&D investment increased by more than 20% annually, and original breakthroughs were made in basic research. Innovative achievements in the fields of innovative drugs and high-end medical devices are constantly emerging, and the pharmaceutical reserve system is constantly improving.
New drug research and development is on the rise.
Driven by policies, talents, environment and capital, China has opened the era of innovative drugs. Chen Kaixian, an academician of the Chinese Academy of Sciences and a researcher at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, said that the number of new drugs approved in China has increased significantly, and the proportion of domestic new drugs has increased rapidly after 2018, and the number of clinical trials has also shown a rapid upward trend. At present, there are about 20 to 30 Class 1 new drugs developed in China every year, which have occupied a certain proportion in the world.
Specifically, in 2017, only 4 domestic chemical drugs and 2 domestic biological drugs were approved in ChinaIn 2021, 18 domestic chemical drugs and 11 domestic biological drugs were approved that year, achieving a big jump.
In recent years, China's pharmaceutical R&D market has been increasing. The reporter learned from the meeting that the R&D investment of some innovative new drug R&D biotechnology companies has exceeded that of large traditional comprehensive pharmaceutical companies, and the pipeline under research has been continuously enriched. In 2022, China's listed pharmaceutical companies will invest more than 10 billion yuan in annual R&D.
According to PharmaProjects' April 2023 data, China currently has a total of 5,402 drug pipelines, which is 23 more pipelines than in 202222%, accounting for 236%, far exceeding the global pipeline 589% growth. At the same time, China is also catching up in the research and development of innovative drug candidates, ranking second with a total of 1,457 drug candidates in 2022.
Experts pointed out that with the support of major national scientific and technological programs such as major new drug creation, China's biomedical field has established a national drug innovation technology system with close connection of R&D chain, industrial chain, and deep integration of "production, education, research and application". For example, during the new crown epidemic, more than 10 anti-new crown vaccines and small molecule drugs such as azvudine have been approved for marketing.
In this context, China's pharmaceutical innovation is becoming more and more important in the international arena. According to the supplementary report "New Active Substances Launched in 2022" (New Active Substance) in 2022, a total of 73 new drugs were launched globally in 2022, including 74 new active substances, which is the top three years in global pharmaceutical history. Among them, tumors have once again become the position with the largest number of NAS launches in 2022. It is worth noting that as of March 2022, the share of NAS in China has been increasing, with a total of 16 NAS launches, accounting for 21 of the number of new drugs6%。
In this regard, the above-mentioned report said that it can be seen that the Asia-Pacific region is constantly demonstrating vigorous R&D and innovation, and the global innovation force is also shifting to the Asia-Pacific region.
Focus on personnel training and accelerate the incubation of key technologies.
Through unremitting efforts, China's new drug creation has achieved a breakthrough from "0" to "1", from "following" and "running", and then to gradually "leading" in some fields, providing strong support for promoting the construction of a healthy China. At the same time, however, experts have also pointed out that compared with the world's advanced level, there is still a clear gap between us and us, and we are in the critical stage of "climbing over the hurdles."
Experts said that the basic research in the field of biomedicine in China is relatively weak, and the supply and transformation of original innovation knowledge are insufficientThere are shortcomings in some links of the technology chain, industrial chain and innovation chain;The quality and level of scientific and technological innovation are not high, and there is a relative lack of major original drugs and leading medical technologies with independent intellectual property rightsThere are relatively few R&D institutions, leading talents and large companies with international influence.
Various factors restrict the rapid development of China's pharmaceutical industry. How to break through the "barrier" and face new development opportunities and challenges?
Academician Wang Chen, Vice President of the Chinese Academy of Engineering and President of the Chinese Academy of Medical Sciences and Peking Union Medical College, pointed out that pharmacy occupies an important position in the cause of medicine and health, and it is necessary to carry out scientific and technological layout from the national strategic height to plan and grasp the overall development of pharmacy in China. Clinical pharmacy plays a key role in health care. Under the new situation, clinical pharmacy should focus on cultivating compound pharmaceutical talents who understand medicine, medicine, management, communication, keen scientific research thinking and rich humanistic qualities.
Sun Xianze, chairman of the Chinese Pharmaceutical Association, said that as a multidisciplinary, knowledge-intensive and capital-intensive high-tech industry, the biomedical industry should adhere to the new development concept, optimize the top-level design, strengthen reform and innovation, deepen cooperation, and strengthen the construction of pharmaceutical research platforms and bases guided by national goals and strategic needs.
It is necessary to cultivate basic research talents who can sit firmly on the 'cold bench', accelerate the incubation of more key technologies from '0' to '1', and cultivate an environment that encourages original innovation. For the development of frontier fields, Wang Rui said that nuclear medicine, as a new medical method, plays a huge role in the clinical diagnosis and treatment of tumors, and has a wide range of application prospects. He called for an expert consensus to be formed as soon as possible to fill in the gaps.
Xie Chengrun, CEO of China Biopharmaceutical, said that pharmaceutical companies should focus on the layout of core industries, and open up the basic research innovation chain and clinical transformation and application path through multi-party collaboration and cooperation among production, academia, research and medicineStrengthen the layout in emerging fields such as digitalization and artificial intelligence;We strive to build a global innovation platform, strengthen cooperation with multinational pharmaceutical companies, and continuously explore the international market. (Reporter Liang Qian, Deng Jie).
*: Economic Information Daily.