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Recently, the team of Professor Xu Ruihua from the Cancer Center of Sun Yat-sen University was invited to publish an expert review entitled "China's Anti-tumor Drug R&D and Clinical Research: Challenges and Opportunities" in the international academic authoritative journal Cell.
In recent years, the innovation capability of China's biopharmaceutical industry has been rapidly improved, the level of clinical research has also been in line with international standards, and the development of new drugs has moved towards the direction of original research and innovation in the true sense, but there are still some problems to be solved. Through this special review, the research team hopes to make the world pay more attention to the development and contribution of China's oncology clinical research, and also face the existing problems and challenges and how to solve them, so as to further promote the healthy development of China's new anti-tumor drug R&D and clinical research, and bring more hope and opportunities to cancer patients around the world.
The Cancer Center of Sun Yat-sen University is in a leading position in the clinical research of anti-tumor drugs, especially the clinical research of high-incidence tumors in China such as digestive tumors and nasopharyngeal carcinoma, and the clinical research results have been adopted by the NCCN international guidelines 48 times in the past five years, and the number of papers published in four major clinical medical journals ranks among the best in the world. As a leader in the clinical research of anti-tumor drugs in mainland China, Professor Xu Ruihua has led a number of international multi-center clinical studies, realized the innovation of colorectal cancer diagnosis and treatment system, solved the problem of poor efficacy of immunotherapy for digestive tumors, and made the diagnosis and treatment of digestive tumors reach the international advanced level. Recently, a number of clinical trial projects led by Professor Xu Ruihua have been verified by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and have successfully passed (no major finding, no minor issue), which has been highly praised by international peers.
In view of the outstanding contributions of the team in the field of global anti-tumor clinical research, on the occasion of the 50th anniversary of the founding of the journal Cell, Professor Xu Ruihua's team was invited to write a special review of the clinical research of new anti-tumor drugs in China for Cell. This is the first time in the 50-year history of the journal that a special review of the field of oncology clinical research in China has been published.
Malignant tumors are a major threat to human health. In China, there are 4.57 million new cancer patients and 3 million deaths every year, accounting for 23.7% and 30% of global cancer patients, respectively. Effective treatment is an important way to control tumors, so the research and development of anti-tumor drugs is urgent.
China's pharmaceutical industry is currently entering a new stage of drug innovation and has become the world's second largest drug R&D market. Over the past decade, China's clinical development and regulatory review have undergone significant changes to encourage the development of innovative medicines, especially for rare, serious, or life-threatening major diseases. As shown in Figure 1, from 2018 to 2022, the clinical research applications (INDs) of innovative drugs in China have been increasing year by year, but the applications for registration and marketing (New Drugs The number of applications (NDAs) is still relatively small, anti-tumor drugs are the main therapeutic category approved for the first IND application, China accounts for nearly one-third of the world's clinical trial activity, and the proportion of clinical trials in the field of oncology is also rising, but there is still room for further improvement in the innovation capacity of China's pharmaceutical industry.
Figure 1: Current status of innovative drug applications and clinical trials in China
There is still the problem of target homogeneity in the development of new drugs in China. As we all know, there are problems such as high cost, long lead time and low success rate in new drug research and development. Many local biopharmaceutical companies will choose to develop mature targets with fewer risks or faster generic drugs due to input-output considerations, resulting in domestic drug development facing the problems of target duplication and overlapping adaptation scope (Figure 2). Effective communication and collaboration between clinicians and basic scientists is still insufficient, and most of the anti-tumor drugs developed in China come from companies, with relatively small contributions from universities and academia, and limited exploration of biomarkers or scientific questions in enterprise-led clinical research. China's physician training system lacks systematically trained medical scientists who are proficient in both clinical and basic research. In addition, the international competitiveness of domestic enterprises and the allocation of medical resources between regions still need to be further improved.
Figure 2. Target distribution of innovative drugs
Despite the challenges, there are huge opportunities in the field of anti-tumor drugs in China. We have a large patient population, a unique distribution of tumor types, and a constantly improving healthcare system, which provides very favorable conditions and sufficient resources for the conduct of clinical trials. At the same time, China's drug R&D and clinical research environment has gradually converged with global standards, and the government has formulated a series of policies and measures to support the development of the pharmaceutical industry and promote clinical research of innovative drugs. China's clinical research capabilities are also improving, and more clinicians have received scientific training, realized the importance of clinical trials, and incorporated translational study design and biomarker exploration into early clinical research.
More and more clinical studies and anti-tumor protocols conducted in China or led by Chinese researchers are being recognized and promoted internationally. In 2023, four original Chinese anti-tumor drugs were approved overseas: tislelizumab (TEVIMBRA) by the European Medicines Agency (EMA), and avatinib (AYVAKIT), toripalimab (LOQTORZ) and fruquintinib (FRUZAQLA) by the US FDA. Although the number of first-in-class (FIC) drugs in China is still small from a global perspective, our drug development model has shifted from "me-too" to FIC. Domestic pharmaceutical companies are actively promoting new products to overseas markets, and overseas licensing is also a favored choice for domestic pharmaceutical companies in the mode of innovative drugs going overseas.
Today, China has become an important player in the field of oncology clinical research and is regarded as one of the most promising biopharmaceutical markets in the world. In order to overcome the challenges and seize the opportunities, we still need to:
- Strengthen cooperation and communication between the government, academia and industry, improve the R&D capabilities and international competitiveness of enterprises, and increase support for innovative drug R&D;
- Strengthen the cooperation between basic science and clinical medicine, establish a translational medicine platform, and train more medical scientists who can combine scientific research and clinical practice;
- Promote cooperation between innovative individuals and form a diversified cooperation model between colleges, research institutions and enterprises.
We believe that in the future, more Chinese original drugs will enter the global market and continue to contribute China's wisdom and strength to anti-tumor treatment.
Expert Profile
Xu Ruihua
Member of the Faculty of the Chinese Academy of Medical Sciences, Doctor of Medicine, Director of the Cancer Prevention and Treatment Center, Hospital President and Director of the Research Institute of Sun Yat-sen University, Director of the National Key Laboratory of Malignant Tumor Prevention and Treatment in South China, Professor and Doctoral Supervisor.
Chairman of the Chinese Society of Clinical Oncology, Vice Chairman of the Chinese Anti-Cancer Association, Chairman of the First Targeted Therapy Committee of the Chinese Anti-Cancer Association, Chairman-designate of the Chemotherapy Committee of the Chinese Anti-Cancer Association, Chairman of the Colorectal Cancer Committee of the Chinese Society of Clinical Oncology, Editor-in-Chief of Cancer Communications, Editor-in-Chief of the Graduate Textbook Oncology, and Editor-in-Chief of the Undergraduate Textbook Clinical Oncology.
He has published more than 200 SCI papers in top international journals such as JAMA, Nature Medicine, Nature Materials, Cancer Cell, Lancet Oncology, etc., as a corresponding author or the first author, and has been selected as a global highly cited researcher by Clarivate Analytics and continuously selected into the list of highly cited researchers in China. As the first completer, he has won 2 second prizes of the National Science and Technology Progress Award, 1 National Innovation Award, 6 first prizes of the Provincial and Ministerial Awards, the Ho Leung Ho Lee Foundation Science and Technology Progress Award, the Wu Jieping Pharmaceutical Innovation Award, the Tan Jiazhen Clinical Medicine Award and the CSCO Annual Achievement Award. He has been selected into the National Millions of Talents Project, the National Advanced Worker, the State Council Special Allowance Expert, the Nanyue Baijie Talent Training Project, and the National Health and Family Planning Outstanding Contribution Young and Middle-aged Experts.
Expert Profile
Wang
Assistant to the Dean of the Cancer Center of Sun Yat-sen University, Director of the Department of Internal Medicine, Professor, Researcher, Chief Physician, PI of the National Key Laboratory of Malignant Tumor Prevention and Treatment in South China, and Doctoral Supervisor. It focuses on the precision treatment of digestive tract tumors and the synergy of immunotherapy. He is also the vice chairman of the Youth Council of the Chinese Anti-Cancer Association, the vice chairman of the Youth Committee of the Tumor Targeted Therapy Professional Committee of the Chinese Anti-Cancer Association, and a member of the Standing Committee of the Colorectal Cancer Special Committee of the Chinese Society of Clinical Oncology. He has won the Young Scientist of the China Anti-Cancer Association, the People's Good Doctor, the Famous Doctor of the Country, and the May Fourth Youth Award of Guangdong Province. As the last/co-corresponding author, he has published many papers in journals such as Nature Medicine, Cancer Cell, Journal of Clinical Oncology, Gut, The Lancet Gastroenterology and Hepatology. The relevant results have been adopted by many domestic and foreign guidelines such as NCCN, ASCO, CSCO and CACA guidelines in the United States, and the results have been selected as important medical advances in China in 2022. It has obtained 5 national invention patents, and won 4 provincial and ministerial awards such as the second prize of the National Science and Technology Progress Award (the second completer).
Expert Profile
Nguyen Dan Yun
He is the deputy chief physician, doctor of medicine and master's supervisor of the first phase of the clinical research ward of the Cancer Prevention and Treatment Center of Sun Yat-sen University, a standing member of the Youth Committee of the Tumor Targeted Therapy Special Committee of the Guangdong Anti-Cancer Association, a member of the Tumor Immunotherapy Expert Committee of the Guangdong Pharmaceutical Association, and a member of the Digestive Tumor Committee of the Guangdong Women Physicians Association. He is mainly engaged in clinical research and medical oncology treatment of new anti-tumor drugs, with research interests in phase I clinical trials and translational research, and individualized treatment of digestive tract tumors. As a number of new anti-tumor drug clinical research projects Key Sub-I. He has presided over and participated in a number of National Natural Science Foundation of China and provincial and ministerial scientific research funds.
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Source of this article: Sun Yat-sen University Cancer Prevention and Treatment Center Subscription Account Editor: Sheep
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