“Clinical research is the source of the entire pharmaceutical innovation chain, with high-quality source innovation depending on first-class research design, trial implementation, and organizational work. This is the starting point for our products to gain approval, achieve market launch, go international, and benefit patients, and it is also a crucial responsibility that pharmaceutical innovators must undertake.”

At the Clinical Research and Collaborative Innovation Forum of the 2024 China BioMed Innovation and Investment Conference (CBIIC), Song Ruilin, Executive President of China Pharmaceutical Innovation and Research Development Association (PhIRDA), first outlined the forum’s main significance. He further emphasized that China’s pharmaceutical innovation, in pursuing global development, needs to establish an internationalized standard system starting from clinical research, strictly implement International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, and provide internationally recognized clinical evidence for Chinese innovative drugs and medical devices going global. 

Song Ruilin

Zhang Shuyang, Chairman of PhIRDA and President of Peking Union Medical College Hospital (PUMCH), pointed out in her speech that Chinese enterprises’ participation in global pharmaceutical R&D has significantly increased, and the clinical and market value of China’s innovative drugs is gaining global recognition.

However, there are still too few cases where clinical researchers discover new mechanisms, initiate clinical trials, launch new products through industry-academia-research cooperation, benefit patients, and continuously expand drugs’ clinical value. There remains a notable mismatch between China’s pharmaceutical innovation level and the enormous patient needs, as well as medical resource supply. This requires efficient integration and joint efforts from multiple parties including government, medical institutions, research institutes, companies, and investors, with clinical research taking the lead to cultivate new quality productive forces in pharmaceutical innovation.

Zhang Shuyang

Clinical Research Quality and Efficiency Enhancement: From Policy Implementation to Industry Drive

The nation’s deepening reform of the review and approval system has opened a new chapter in China’s pharmaceutical innovation industry development. The “Pilot Program for Enhancing Clinical Research and Achievement Transformation Capabilities in High-level Hospitals” further grants hospitals policies equivalent to those supporting universities and research institutes in innovation achievement transformation. As a high-level clinical institution, Peking Union Medical College Hospital “has established a new development pattern of medical research innovation transformation from basic research to clinical application through research ward construction.” Han Xiaohong, Vice-Chairman of Clinical Trial Research Specialty Committee of PhIRDA and Director of the Clinical Pharmacology Center at PUMCH, highlighted how under the guidance of full-chain policies, they have built research platforms, achieved digital management of the entire clinical trial process, enhanced quality control and services, promoted product clinical transformation, and ultimately realized the complete process of patient benefit. Finally, Han pointed out that how to further stimulate clinicians’ enthusiasm for engaging in clinical research is a crucial issue facing institutions currently. Under a series of quality and efficiency enhancement initiatives, clinical trial standards and monitoring requirements are becoming increasingly stringent. Clinical research can provide more guidance and support for pharmaceutical innovation, thus requiring policies to provide broader and better development space and incentive environment for clinical researchers. In this process, clinical institutions also need to actively transform and proactively connect with industry demands.

Han Xiaohong

“The clinical value of drugs is not immutable; it needs to be continuously expanded and enhanced through more detailed clinical evidence, higher-quality clinical research, and broader clinical practice.” Professor Tang Yu, Executive Director of Clinical Trial Center (GCP Center), National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, detailed the approaches and steps for clinical research to lead innovative industry development from an industrialization perspective: First, accurately describe clinical needs based on extensive high-standard clinical data and connect them with R&D challenges; Second, prioritize research by screening and identifying clinical issues that are cost-effective, efficient, and implementable from a feasibility standpoint; Third, encourage clinicians to take initiative in launching investigator-initiated trials (IIT) and actively engage with pharmaceutical companies, data companies, and other partners to transform clinical problems into achievements. Clinical needs of patients are at the core of this process. Through active exploration of differentiated innovation and deepening understanding of drug mechanisms and disease areas, research questions will become increasingly clear, collaboration between medical research and industry will grow closer, and the clinical value of drugs will continuously improve throughout this process, ultimately achieving a win-win situation where both patients benefit and the industry develops.

Professor Tang Yu

Industry Development Bottlenecks and Internationalization Demands: New Challenges, New Opportunities

On one hand, there are substantial unmet clinical needs among patients; on the other hand, China’s pharmaceutical innovation industry faces development challenges. Dr. Wang Yinxiang, Chairman of the Board and CEO of Jacobio Pharma, outlined the “three mountains” currently challenging China’s innovative drug industry development: the payment environment, financing difficulties in both mainland and Hong Kong capital markets, and the challenges of getting innovative drugs into hospitals. He pointed out that financing for China’s innovative drugs has been declining since 2021, and the conservative R&D strategy across the industry has led to numerous “homogeneous” research projects, creating bottlenecks in pharmaceutical innovation development. Innovative pharmaceutical companies are facing increasingly tight budgets for clinical research. This situation does not align with the development needs of the “new three driving forces” of economic development—basic scientific research, applied technology transformation, and financial services—and contradicts China’s rapidly growing global share of clinical trials. The Chinese innovative drug market requires more policy support for innovative clinical research to achieve sustained and deepening development.

Dr. Wang Yinxiang

Meanwhile, the international market has raised higher requirements for both the quantity and quality of clinical research in China. Dr. Zhou Shuhua, Principal Analyst at Citeline, analyzed global and Asia-Pacific clinical trial development trends, finding that even amid challenges in international cooperation, the number of clinical trials in the Asia-Pacific region maintains rapid growth. In 2022-2023, the Asia-Pacific region was the only area globally showing positive growth in clinical trial initiations, with a growth rate reaching nearly 30%. In 2023, 55% of global clinical trials were conducted in the Asia-Pacific region, with China accounting for 62% of these, a figure still growing at an remarkable rate. In 2023, China ranked first globally in clinical trial initiations across all therapeutic areas except ophthalmology. Dr. Zhou also pointed out that further opening up clinical data access and fully utilizing real-world data to support pharmaceutical innovation products will help further expand the international market for China’s innovative drugs and medical devices.

Dr. Zhou Shuhua

Breaking the Deadlock: Institutional Innovation Leads Scientific Research Innovation, New Ecosystem Nurtures New Achievements

Against the backdrop of improving clinical research quality and efficiency, and facing the development challenges and internationalization demands of the pharmaceutical industry, coordinated development across the entire pharmaceutical innovation chain has become crucial, particularly requiring synergistic advancement from all participating entities. The forum specially invited representatives from government, healthcare, research, enterprise, and investment sectors for panel discussions on collaborative innovation. The first panel discussion was moderated by Professor Tang Yu, with participating guests including Liu Hui, Director,Beijing Pharma &Biotech Center, Beijing Municipal Science & Technology Commission, Administrative Commission of Zhongguancun Science Park; Yin Yongmei, Associate Dean & Jiangsu Province Hospital; Feng Chen, Vice President of Gobroad Healthcare Group, Executive President of Shanghai Gobroad Cancer Hospital; and Shen Zhirong, Vice President and Global Head of Translational Discovery, Research and Medicine, BeiGene. The participating experts analyzed the main issues in clinical development from their respective perspectives. Yin Yongmei, as a clinical physician, emphasized the significance of continuously understanding patient needs and clinical benefit information throughout the research process. Dr. Shen Zhirong pointed out from an industry perspective that scientific research uncertainty, clinical trial design, and homogeneous target development are the challenges facing current clinical translation.

Meanwhile, innovations in policy and hospital management mechanisms have provided new approaches to breaking the deadlock. Liu Hui introduced Beijing’s innovative initiatives: establishing a medical and health joint conference mechanism led by the mayor, involving 18 committees and bureaus across various sectors of the entire chain, achieving seamless integration of administrative services with industry needs, and promoting medical-engineering cross-integration based on clinical demands; establishing a 20-billion-yuan Beijing Medical and Health Industry Investment Fund to serve key project transformation in the pharmaceutical field; exploring cooperation models where senior technology transfer personnel from Beijing’s benchmark incubators serve as consultants and station at hospitals, assisting clinical physicians in achievement transformation. Feng Chen introduced Gobroad Hospital’s management system innovations, such as pioneering a results-oriented payment system for clinical trials to address sponsors’ concerns and promote researchers’ trial quality; establishing a one-stop integrated service mechanism of “clinical design-process management-regulatory requirements” to resolve mismatches between enterprises and PIs, patients and clinical trials, and information asymmetry, thereby improving the quality and efficiency of later-stage clinical trials.

The participating experts agreed that accelerating the integration of advantageous resources and encouraging innovative institutional cooperation methods are important paths to breaking through current clinical research challenges. On one hand, clinical institutions need to improve their organizational operation and management capabilities, proactively engage with enterprises in conducting clinical research, and enhance research efficiency through multiple efforts. On the other hand, policies should create a favorable atmosphere for medical research and development, encourage multiple entities to exercise their initiative, and promote innovation in cooperation mechanisms and systems.

Tang Yu, Liu Hui, Yin Yongmei, Feng Chen, Shen Zhirong (From Left to Right)

Expectation: Connecting the Entire Chain, Enabling Patients to Share in the Benefits of Industry’s Innovative Development

The second panel discussion was moderated by Bai Hua, Vice Director of Department of Scientific Research at PUMCH, with participating experts from Chen Yanming, Vice President of the Third Affiliated Hospital and President of The Eighth Affiliated Hospital of Sun Yat-sen University; Du Yang, Assistant Dean of School of Medicine, Director of Institute of New Medicine, the Chinese University of Hong Kong, Shenzhen; Zhang Yong, Managing Partner of LYZZ Capital; and Fu Xin, Head Medical Affairs Oncology Shenzhen Chipscreen Biosciences Co., Ltd.

The panel discussion focused on two key stages of clinical research participation in the full-chain pharmaceutical innovation process: the drug development stage - how to motivate clinical researchers to raise clinical questions, connect basic research to build technology platforms, leverage capital support, and  have enterprises lead product commercialization; and the post-marketing stage - how to enable patients to access innovative drugs better and earlier, accelerating innovation benefits for the public, while simultaneously optimizing product usage and enhancing clinical value through post-marketing clinical research.

The participating experts noted that there are still multiple “disconnections” in the entire chain of innovative drug and device clinical research and use, such as disconnections between laboratory discoveries of drug mechanisms and clinical design and development processes, between enterprise-driven drug development and clinical needs and target patients, between clinical value assessments by various participants before and after drug marketing, and between product launch and hospital adoption. The journey of any innovative product from successful development to patient benefit is a continuous process of bridging these “disconnections.”

How to streamline the innovation chain? The guests offered suggestions and solutions based on their perspectives and experiences: From a practical perspective, firstly, the clinical value of innovative drugs and devices should be comprehensively considered without being constrained by performance assessments such as “drug proportion ratio,”actively introducing and training doctors on innovative products, and encouraging their clinical application; secondly, innovative drugs tested through hospital clinical institutions should have access to fast-track channels for hospital adoption after marketing approval, avoiding multiple layers of approval and accelerating patient benefit; thirdly, innovative IIT research is crucial for enhancing drug clinical value, and it is recommended that high-level clinical institutions maintain a more open attitude towards IIT research, especially for pre-market products, to further stimulate original innovation. From a long-term development perspective, it is recommended to actively develop platforms integrating “basic research + clinical institutions + transformation centers,” promoting deep exchanges among clinical doctors, scientists, and entrepreneurs, and focusing on cultivating interdisciplinary talents who understand both clinical practice and industry transformation, which will be crucial for the industrialization of clinical research.

Bai Hua

Chen Yanming

Du Yang

Zhang Yong

Fu Xin

Through three hours of in-depth discussion, representatives from various institutions including government, medical, research, enterprise, and investment sectors exchanged views on the challenges and solutions facing clinical research and the entire pharmaceutical innovation chain, reaching corresponding consensus. It is expected that these constructive ideas and opinions will be continuously implemented throughout the pharmaceutical industry development chain, converging into a torrent of mechanism and industry innovation, achieving dual success in patient benefit and industry development.

This forum was organized by Peking Union Medical College Hospital and the Clinical Trial Research Specialty Committee of PhIRDA.