The innovation of biopharmaceutical technology and industrial development are related to national economy, people's livelihood, and national security, and are inevitable requirements for building an innovative country and developing new quality productive forces. We need to strengthen the construction of basic scientific research and technological innovation capabilities in biomedicine, firmly grasp the lifeline of the development of the biopharmaceutical industry in our own hands, and make more and greater contributions to improving human health and well-being. The momentum towards independent innovation development is gradually strengthening. After years of persistent efforts, China's biopharmaceutical development has achieved outstanding achievements, realizing a historic transformation from basic dependence on generic drugs to independent research and development of innovative drugs, and showing an increasingly strong development momentum. The level of basic scientific research in biomedicine has significantly improved. According to statistics, in 2023, the number of articles published by Chinese scholars in the three top global academic journals in the field of biomedicine, Cell, Nature, and Science, will jump to the second place in the world, second only to the United States. Among the "Top 10 Clinical Breakthroughs in the Medical Industry in 2024" selected, four are from China. Significant progress has been made in drug research and development. According to a recent evaluation by global management consulting firm McKinsey, the United States dominates the top tier of global drug research and development, accounting for over half of the world's new drug research and development; China is at the forefront of the second tier. A few years ago, Japan and developed countries in Western Europe occupied the second tier, while China had long hovered in the third tier and ranked behind countries such as South Korea and Israel. The above evaluation by McKinsey is based on two indicators: firstly, the number of new drugs under development in the country, with the United States accounting for 49.1% of the global share of the drug pipeline (a series of steps and processes taken by pharmaceutical companies or research institutions in developing and researching new drugs), and China's share rising to 26.7%, becoming the second largest drug development destination in the world after the United States; The second is the number of new drugs approved for market each year in China (including self-developed and those developed by other countries), ranking third after the United States and Japan. McKinsey's comprehensive evaluation believes that China's position in new drug research and development has entered the forefront of the global second tier; China and the United States rank among the top two in the world in terms of the number of clinical studies conducted in cutting-edge fields such as stem cell therapy and gene therapy. The innovation system of biomedicine has been formed. From the design and screening of new drugs, preclinical research, safety evaluation, clinical research to evaluation, China's biopharmaceutical innovation system has a complete layout and is in line with international standards. At present, China is further improving and optimizing its biopharmaceutical innovation system, and making it a top priority to strengthen forward-looking layout, cultivate at the source, and promote original innovation. Give full play to the advantages of the system and continue to awesome to support China's achievements in the development of biomedicine, thanks to the continuous awesome support of the Party and national policies. Shortly after the founding of the People's Republic of China, a 12 year national plan for the development of science and technology was formulated and released. For the first time, life sciences were included in the national strategy, and institutional advantages were fully utilized to focus on drug research and development. A number of professional drug research institutions, such as the Beijing Institute of Biological Products, were established, laying the foundation for China's biopharmaceutical research and development. Under the promotion of these measures, China has achieved important achievements such as the development of vaccines for polio, artificial synthesis of bovine insulin, and discovery of artemisinin. After the reform and opening up, with the advancement of the scientific and technological system reform, China launched initiatives such as the "Spark Program," "863 Program," and "973 Program," prioritizing genetic engineering and biotechnology and promoting the integration of industry, academia, and research. Since entering the new era, multiple "Five Year Plans" and related national science and technology major projects implemented by the country have made innovation and industrial development of biomedicine a major focus, and have introduced a series of strong measures to support the development of biomedicine, promoting China's biomedicine to enter the stage of innovation driven and high-quality development. Especially the "Healthy China 2030" plan outline released in 2016 further strengthens the layout in cutting-edge fields such as precision medicine and cell therapy. In 2019, the system of drug marketing authorization holders began to be implemented, encouraging biopharmaceutical companies to lead research and development and result transformation, further accelerating the process of drug development and innovation. These measures work together to promote the development and commercialization of innovative drugs in China to a new level. According to statistics, in 2023, there will be 40 Class 1 innovative drugs approved for market in China, including 35 chemical and biological drugs. As of the end of 2024, more than 40 Class 1 new drugs have been approved for market in China, and there are also 81 non imported new drugs currently under review and approval by the Drug Evaluation Center of the National Medical Products Administration. It is predicted that by 2025, China is expected to have 53 new drugs approved. Strengthening basic research and enhancing originality. While we see the tremendous achievements in the development of Chinese biopharmaceuticals, we also need to pay attention to the challenges we face, the most prominent of which is the lack of originality, that is, the original innovation in new mechanisms, targets, and treatment strategies of drug action is still lacking. In recent years, although a number of innovative drugs have been independently developed in China, the vast majority are not original innovations, but belong to tracking innovation or imitation innovation. Often, foreign counterparts complete innovation from 0 to 1, 1 to 2, while Chinese pharmaceutical companies and drug developers achieve tracking innovation from 3 to 5, 5 to 8 based on this foundation. The lack of original innovation seriously restricts the development of China's pharmaceutical industry. Taking the new drugs for tumor immunotherapy (PD-1, PD-L1 antibodies) as an example, there are a total of 7 approved drugs in foreign markets. Among them, Merck's pembrolizumab (referred to as K drug) sold nearly 30 billion US dollars in the international market in 2024, while the nivolumab (referred to as O drug) developed by two pharmaceutical companies, Bristol Myers Squibb and Ono Pharmaceuticals, sold over 10 billion US dollars in 2023. The O and K drugs account for 73% of the total marketing of the global tumor immunotherapy antibody market. More than 10 drugs of this type have been approved for market development in China, but their market share in the global market is only 4%. The original innovation cycle is long, the investment is large, and the risk is high, especially in the development of innovative drugs. The Nobel Prize in Physiology or Medicine in 2023 is awarded to scientists who discovered microRNAs and their critical role in post transcriptional gene regulation. This is the result of decades of exploration in this field, during which they encountered numerous setbacks and repeated failures before finally achieving success. How to improve the ability and level of drug basic research? How should researchers engaged in original drug research be assessed? The research and development cycle of new drugs is long, and there is a delay in seeing results. Does the unit where the researchers work have enough patience? Who will invest in the development of innovative drugs with long cycles and high risks? To solve these problems, it is necessary to establish a set of effective, scientific and reasonable institutional mechanisms. The importance of drug basic research for innovative drug development is self-evident, but drug basic research faces too many unknown situations and uncertain factors, and the driving force of market mechanisms is relatively limited (strong leading pharmaceutical companies may also participate appropriately). The main body of drug basic research is mainly supported by national universities and related research institutions, especially the implementation of major basic science research plans at the national level. Only when the basic research of drugs has achieved certain results and progress, the possibility of successful drug development has increased, and the prospects for market launch are relatively clear, will the investment and participation enthusiasm of pharmaceutical companies increase. The innovative thinking and persevering spirit of drug researchers who can withstand loneliness are important conditions for the success of innovative drugs and original research drugs. This requires researchers to sit on the bench for ten years and devote themselves wholeheartedly to the entire innovation process, while also requiring relevant parties to create a relaxed and tolerant support environment, allowing for imaginative ideas, avoiding blame for everything, and providing effective incentives. At the same time, we should also pay attention to the current trend of declining support for new drug research and development in the capital market, which has led to a decrease in the innovation willingness of pharmaceutical companies. To encourage innovation enthusiasm, investors need to have confidence in returns. Innovative drug development has the characteristics of high investment, high risk, long cycle, and high return. Internationally, statistics show that the average cost for each new drug to be launched is 2.6 billion US dollars. The pricing of original drugs cannot ignore the "cost of failure". A pharmaceutical company developing 10 drugs can only achieve an average of one or two successes, and most of them are failures. So we need to work hard from all aspects and vigorously create a relaxed environment that tolerates and allows failure, so that drug innovators have the courage and ability to constantly explore and create, in order to continuously develop more innovative drugs and improve human health. Improving the approval system to achieve a safe and efficient drug approval system is the core mechanism for safeguarding public health. The relevant departments ensure that the effectiveness and safety of drugs meet national standards through technical audits, expert reviews, and other processes, prevent unqualified drugs from entering the market, and play an extremely important role in ensuring drug safety and accessibility, optimizing resource allocation, and promoting high-quality development of the pharmaceutical industry. Since the beginning of this century, especially since 2015, the reform of China's drug approval system has been continuously deepened. A series of policy documents such as the "Opinions on Reforming the Drug and Medical Device Evaluation and Approval System" have been implemented to improve drug approval standards, promote the consistency evaluation of generic drug quality, accelerate the evaluation and approval of innovative drugs, significantly shorten the application review time limit, and improve approval efficiency. Further improving the drug approval system can provide stronger impetus for accelerating the development of innovative drugs, especially original new drugs. It is understood that currently, some new drugs in China, especially those with strong innovation and no mature precedents, often need to be approved for market abroad before they can easily obtain market approval domestically. Some countries implement an "emergency use permit" system for drugs, which, through strict procedures, can open up special channels for the rapid development and clinical application of certain new drugs in special circumstances. In fact, China has also practiced and accumulated relevant experience in this area in recent years. We need to constantly summarize our experience, comprehensively balance the relationship between strict supervision, ensuring safety, promoting innovation, and driving development, and promote the continuous improvement of the drug approval system. At the beginning of this year, the DeepSeek-R1 artificial intelligence model from a Chinese company was launched, achieving significant breakthroughs in natural language processing, multimodal understanding, and other fields. Through technological innovations such as MoE architecture, low training costs, lightweight, and localized deployment advantages, the global development of artificial intelligence has ushered in the "DeepSeek moment" in China. We believe that as long as we continue to strengthen policy guidance and support, consolidate basic research, increase technological breakthroughs, focus on ecological synergy, and fully unleash market vitality, we will definitely usher in the "DeepSeek moment" of China's innovative drugs, and accelerate the transition from a "pharmaceutical giant" to an "innovative drug powerhouse". Chen Kaixian is an academician of the CAS Member, a researcher and former director of the Chinese Academy of Sciences Shanghai Institute of Materia Medica, the former president of Shanghai University of Traditional Chinese Medicine, and a pharmaceutical expert; Compiled by Li Hongbing and Liu Shi'an based on oral accounts. (New Society)