A brain cell protection innovative drug developed by a Chinese research team over 8 years was approved for market at the end of last year, aimed at improving neurological symptoms, daily living activities, and functional impairments caused by acute ischemic stroke; Two innovative drugs in Pudong New Area of Shanghai have been approved for listing recently, respectively for the treatment of ovarian cancer and adult type 2 diabetes...... According to the data of the State Food and Drug Administration, in 2024, 48 innovative drugs will be approved for listing in China, 8 more than the previous year. China ranks second in the world in terms of the number of new drugs under development, with multiple domestically produced innovative drugs being launched globally. In the past 10 years, China's pharmaceutical industry has developed rapidly, and the innovation vitality of pharmaceutical research and development has significantly increased. More and more innovative drugs have been approved for market Yang Yue, a researcher and doctoral supervisor at the School of Pharmacy, Tsinghua University, said. Targeting clinical needs, deep collaboration between industry, academia, research, and medicine. 18 years ago, Su Weiguo returned to China and devoted himself to the field of independent innovative drugs for only two years. In a caf é in Zhangjiang Science City, Pudong New Area, Shanghai, after experiencing countless "failures," he suddenly had an inspiration and drew a new chemical structure on a napkin, which became the prototype of fipronil. Fruquintinib is an innovative drug developed by Hehuang Pharmaceutical after 12 years of research and development in China, 5 years of global clinical trials, and over 2 billion yuan of investment in research and development. It was approved for market in China in September 2018 and is the first independently developed new anti colorectal cancer drug in China. As of the end of 2024, it has been approved for listing in 12 global markets including China (including Hong Kong and Macau), the United States, the European Union, and Japan. In its first year of overseas listing, the sales revenue of Fruquintinib reached 290 million US dollars, indicating great potential for global clinical demand. Since 2006, Hehuang Pharmaceutical has always adhered to its goals and strategies in research and development, which is to lay out a pipeline covering major tumor products Su Weiguo, who serves as the CEO and Chief Scientific Officer of Hehuang Pharmaceutical, said that for example, colorectal cancer has always lacked effective treatment drugs globally, and fipronil provides a new treatment strategy to solve this medical problem. In the existing product pipeline of Hehuang Pharmaceutical, the research products cover most of the tumor and combination indication studies, and more than 15 studies of 7 innovative drugs will support the submission of new drug market applications. How to choose a direction for drug research and development? "First, we should focus on the unmet clinical needs, that is, what drugs patients need, and our innovative research and development will focus on these areas." Wang Xingli, CEO of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and CEO of the Global Research and Development Center, said that Fosun Pharmaceutical aims at clinical needs, and has launched more than 10 innovative drugs, providing more treatment options for patients with breast cancer, lung cancer and other diseases. Carrying out innovative research on the integration of industry, academia, research, and medicine is an important secret to the success of He Huang Pharmaceutical. At present, more than 100 pre - and post clinical and real-world research projects covering 12 independently developed pipelines are being conducted in multiple medical institutions with support from multiple industry university research and medical joint research projects in Shanghai. The emergence of innovative drugs for brain cell protection is also a result of focusing on clinical needs and adhering to collaborative innovation among industry, academia, research, and medicine. Stroke, commonly known as "stroke", is divided into ischemic stroke and hemorrhagic stroke. More than 60% of stroke patients in China are ischemic stroke. The neuroprotective treatment of acute ischemic stroke has been a global challenge for half a century. The more brain cells die, the higher the risk of future disability, "said Wang Yongjun, Director of the National Center for Quality Control of Neurological Diseases and Dean of Beijing Temple of Heaven Hospital affiliated with Capital Medical University. Xianbixin, jointly developed by the National Key Laboratory of Neurological and Tumor Drug Research and Development, Beijing Temple of Heaven Hospital, and Xiansheng Pharmaceutical Group Co., Ltd., is a Chinese solution for Chinese researchers to creatively solve the global problem of brain cell protection. There is no fixed model for drug development, the key is to start from clinical needs Yang Yue believes that from the experience of international drug development, original drugs all start from clinical trials. The lack of effective drugs for doctors in treating diseases is the direction and driving force of drug development. Currently, large hospitals are placing increasing emphasis on clinical trials, and their clinical trial capabilities are constantly improving, providing greater opportunities for innovative drug research and development cooperation. Increasing R&D investment and attracting global R&D talents "Innovation is the lifeline of Hengrui. Without technological innovation, there would be no Hengrui today," said Sun Feifeng, Chairman of Jiangsu Hengrui Pharmaceutical Co., Ltd. Thanks to technological innovation, Hengrui Pharmaceutical has grown from a small pharmaceutical factory producing purple medicine to a leading enterprise in China's pharmaceutical industry. Since 2011, Hengrui Pharmaceutical has approved 18 new molecular solid drugs (Class I new drugs) and 4 other innovative drugs (Class II new drugs) for sale in China. In addition, more than 90 independent innovative products are under clinical development, and about 400 clinical trials are being conducted both domestically and internationally. Innovative drug research and development is both costly and time-consuming. Usually, with a research and development investment of 1 billion yuan, the success rate is only 10% after 10 years. New drug research and development requires large investment, long cycles, and high risks of failure, posing significant challenges for pharmaceutical companies. Since its establishment, Hengrui Pharmaceutical has always regarded technological innovation as its top development strategy, continuously increasing investment and accumulating over 40 billion yuan in research and development. Among them, R&D investment exceeded 6 billion yuan in 2021, 2022, and 2023, accounting for over 20% of revenue. In the first half of 2024, the cumulative R&D investment was 3.86 billion yuan, a year-on-year increase of 26.23%. Fosun Pharma also spares no effort in research and development investment. In 2023, Fosun Pharma invested a total of 5.937 billion yuan in research and development, and 3.915 billion yuan in research and development in the first three quarters of 2024. Wang Xingli introduced that while investing in self research, Fosun Pharma implements an open research and development model, incubating and investing in research and development projects through the establishment and management of industry funds, ensuring the sustainability of drug innovation research and development. Among them, the participants of the New Drug Innovation Fund include social capital and local governments, with an initial scale of 1.5 billion yuan, incubating 10 innovative pharmaceutical companies. Talents are the fundamental force of research and development. While increasing investment, pharmaceutical companies are also constantly strengthening the construction of their R&D talent teams. Hengrui Pharmaceutical has established 14 R&D centers in countries such as China, the United States, and Switzerland, with a global R&D team of over 5500 people, accounting for more than 1/4 of the company's total workforce. Nearly 60% of them hold a master's degree or above, and many of them have work experience in multinational pharmaceutical companies and research institutions. Fosun Pharma has over 3400 R&D personnel, of whom over 1800 hold master's degrees or higher. Fosun Pharma has established a global R&D center to coordinate and manage the innovative drug R&D team and product pipeline. How to motivate R&D talents? On the basis of ensuring the continuity and stability of innovative drug research and development, Hengrui Pharmaceutical has established a management system that encourages innovation, forming a clear orientation that supports bold exploration and encourages responsibility. Fosun Pharma has developed incentive mechanisms for innovative drug research and development, generic drug CMC (chemical composition production and control) research and development, and employee stock ownership plans based on the characteristics of its R&D business, to continuously motivate and retain key core R&D personnel. Universities need to further improve their training mechanisms to provide high-quality research and development talents for pharmaceutical companies Yang Yue suggests that the School of Pharmacy should optimize its curriculum by adding courses such as clinical trials and drug regulation to traditional pharmacology, pharmaceuticals, and drug chemistry research and development courses, in order to enhance students' practical abilities in clinical trials; Medical schools can increase drug development courses to enhance the theoretical foundation of pharmacy among medical students. Strengthening policy support and stimulating enterprise innovation vitality. At 9:00 am, tens of thousands of biopharmaceutical practitioners began their busy work in Zhangjiang Science City, Shanghai. After more than 30 years of development, Zhangjiang Science City has gathered more than 2300 innovative biopharmaceutical enterprises, becoming one of the most complete and innovative regions in the national biopharmaceutical industry chain. The implementation of a series of policies supporting drug innovation is an important reason for the rapid development of the biopharmaceutical industry in Zhangjiang Science City. In 2011, Zhangjiang Science City was the first to propose the reform of drug marketing authorization holders. In 2015, Shanghai became a pilot city for drug marketing authorization holder reform. At present, more than 20 Class I new drugs have been approved for market as drug marketing authorization holders in Zhangjiang Science City. The system of drug marketing authorization holders separates drug marketing authorization from production authorization, allowing innovative drug research and development companies to outsource production to other enterprises, which greatly solves the investment problem of many innovative drug companies in the start-up stage He Huang Pharmaceutical's Executive Vice President Cui Yang said. A series of innovative systems, such as the medical device registrant system, the import "whitelist" system for biopharmaceutical research and development products, and the reform of entry quarantine for special biopharmaceutical products, have been piloted in Pudong New Area. Relying on the pioneering efforts of Pudong New Area, Zhangjiang Science City continuously draws policy dividends, encourages innovation, and accelerates the development of the biopharmaceutical industry. Good policies provide strong support for the development of innovative pharmaceutical companies, and the introduction of the drug marketing authorization holder system allows for the entry of fipronil into the market at least three years in advance Cui Yang said. Optimizing the review and approval services is also conducive to stimulating the innovation vitality of pharmaceutical companies. For pharmaceutical companies, if the review and approval speed is too slow, innovative products may not be able to enter clinical trials and be launched in a timely manner, which may miss market opportunities. Wang Xingli said that in the past 10 years, the reform of China's review and approval system has achieved significant results, with increasingly strong service professionalism and higher efficiency. The implementation of Hengrui Pharmaceutical's innovative achievements cannot be separated from the assistance of the drug regulatory department Sun Feifeng said that in recent years, the drug regulatory department has established a standardized full process communication and exchange system to guide enterprise research and development, avoid detours, and improve research and development efficiency and success rate. For example, Hengrui Pharmaceutical has an average of about 150 communication and exchanges with the Drug Evaluation Center every year, receiving a lot of business guidance. In January of this year, the General Office of the State Council issued the "Opinions on Fully Deepening the Reform of Drug and Medical Device Supervision and Promoting the High quality Development of the Pharmaceutical Industry", which proposed that "in accordance with the requirements of 'early intervention, one enterprise, one policy, full process guidance, and research review linkage', more evaluation and approval resources should be tilted towards key innovative drugs and medical devices urgently needed in clinical practice"; After the provincial drug regulatory department submits an application and the National Medical Products Administration approves it, a pilot program for optimizing and innovating clinical trial review and approval of drugs will be launched in some areas, shortening the review and approval time from 60 working days to 30 working days. How to further optimize the review and approval services for the increasing number of clinical trial applications and market applications for innovative drugs in China? Yang Yue believes that the key is to improve the efficiency of review and communication, and provide more targeted services for innovative drug approval applications. On the one hand, strengthen the identification of innovative drugs and tilt the review and approval resources towards the most valuable innovative drugs, especially original new drugs; On the other hand, we will vigorously develop regulatory science and apply advanced tools such as artificial intelligence to improve the efficiency of review and approval. (New Society)