On September 21, 2019, China Pharmaceutical Innovation and Research Development Association (PhIRDA) together with China Association for Medical Devices Industry (CAMDI), Chinese Hospital Association (CHA), Hong Kong Exchanges and Clearing Limited (HKEX) and the Research and Development International (RDI) held the 2019 China BioMed Innovation and Investment Conference (2019 CBIIC) in Suzhou Industrial Park.

As an annual international conference with high profile in pharmaceutical industry and investor community, 2019 CBIIC based on the successful experience of the previous three conferences and stuck to the principle of promoting the linkage between social capital and pharmaceutical innovation, and improving the innovation capability of pharmaceutical industry to give the detailed analysis of the policies of pharmaceutical innovation and investment, to show the trends of investment in China. 2019 CBIIC is also an authorized, diversified and high-level platform to support communication and cooperation among innovative projects, entrepreneurs, investors, industry leaders, experts and media.

2019 CBIIC was also supported by Chinese Academy of Medical Sciences, Southern Medicine Economic Research Institute, Suzhou Industrial Park, Zhongguancun Private Equity & Venture Capital Association (ZVCA), People’s Government of Pingshan District of Shenzhen Municipaliy, Natioanl Foundation for Cancer Research (NFCR), HongKong Bio-Med Innotech Association (HKBMIA), Institute for Biotechnology and Medicine Industrial (IBMI), Japan Pharmaceutical Manufacturing Association (JPMA), BioCentury, China Association of Enterprises with Foreign Investment R&D-based Pharmaceutical Association Committee (RDPAC) and J.P. Morgan. Leaders and officials from national pharmaceutical regulatory, domestic and foreign academicians and experts, leaders from the world top 4 stock exchanges-HKEX, NASDAQ, LSEG and SSE and KOLs worldwide participated in the 2019 CBIIC.

Ren Jinsheng, 2020-2021 Annual Chairman of PhIRDA, Chairman and CEO of Simcere Pharmaceutical Group moderated the welcome remarks session in the opening ceremony. Liu Qian, Vice-Chairman of Education, Science, Culture & Health Committee of the NPC, President of Chinese Hospital Association and Lu Chunyun, Vice Mayor of Suzhou Municipal People’s Government addressed in the session and expressed warm welcome to the participants.

Chair of Welcome Remarks Session: Ren Jinsheng, 2020-2021 Annual Chairman of PhIRDA, Chairman and CEO of Simcere Pharmaceutical Group

President Liu Qian pointed in his speech that as a national supported emerging industry, pharmaceutical industry concerns the issues of public health. Party Central Committee with Comrade Xi Jinping at its core pays close attention to the people’s livelihood, especially the food and drug safety problems. This year, the Standing Committee of the National people's Congress has approved the revised Drug Administration Law and the Vaccine Management Law. Meanwhile, it plans to accelerate the approval progress of Laws on Promotion of Basic Medical and Healthcare and initiate the working plan of revising the Law on Medical Practitioners. Reviewing, revising and approving so many laws with high standards in such a short time, it aims to promote the implementation of those laws, to improve China’s medical and healthcare law system, to facilitate China healthcare development reach a new level.

Lu Chunyun, Vice Mayor of Suzhou Government, introduced the progress and achievements of Suzhou supporting the development of biopharmaceutical industry. By the end of 2018, there were more than 3,000 pharmaceutical companies with outstanding innovative results, and total output value over 100 billion RMB, forming a pharmaceutical industry ecosystem with Suzhou Industrial Park (SIP) as its core.

President Liu Qian Gave a Welcome Remark

Vice Mayor Lu Chunyun Gave a Welcome Remark

On behalf of PhIRDA and SIP, Song Ruilin, Chairman of PhIRDA and Ding Lixin, Director of SIP Administrative Committee, signed a 10 years’ strategic cooperation agreement to jointly facilitate the innovative transformation of pharmaceutical industry in China.

Song Ruilin, Chairman of PhIRDA (Left) and Ding Lixin, Director of SIP Administrative Committee (Right) signed the Strategic Cooperation Agreement.

The keynote speeches and panels of the opening ceremony focused on 3 themes.

1. Impact of New Drug Administration Law on the Future Development of Pharmaceutical Innovation

Song Ruilin, Chairman of PhIRDA, moderated the speech and panel in the second session.

Moderator: Song Ruilin, Chairman of PhIRDA

Liu Pei, Director-General of Department of Policies and Regulations, National Medical Products Administration, made a speech named “Impact of New Drug Administration Law on the Future Development of Pharmaceutical Innovation”.

Director-General Liu Pei thoroughly analyzed the new revision of the Drug Administration Law (DAL) from 5 aspects: First, it clarify the mission of drug administration. Through scientific definition of drugs, accelerating review and approval, standardized clinical trial management and sustaining evaluation on supervision. Meanwhile, strengthening the basic principle of risk management on the whole drug lifecycle, including holders, full process control and production behaviors. Second, encourage drug R&D. By explicitly encouraging the direction of drug R&D and production, supporting clinically value-oriented and therapeutic effect pharmaceutical innovative projects, optimizing clinical trial management. Meanwhile, prioritized innovative drug review mechanism, implementing the associated approval of APIs, excipients and packing materials, and establishing a system for conditional approval. Third, clarify and refine the system. Systematically refine the clinical trials in pharmaceutical R&D, quality standards of pharmaceutical products in production processes and process change management, etc., and establish drug traceability system for market authorization holder (MAH), pharmaceutical manufacturers, drug distributors and medical institutions. Meanwhile, establishing a national drug reserve system, essential drug system, drug shortage lists, and a monitoring system for drug supply to ensure the production and supply of drugs. Fourth, to ensure the entity responsibility of the MAH, and clarify that the MAH is the subject of corresponding responsibility for the whole life cycle of the drug. Fifth, severe and well-placed punishment for serious violations of the law. Redefining the scope of counterfeit drugs and inferior drugs precisely and scientifically according to its drug efficiency, increase penalties for the illegal act of producing and selling counterfeit and inferior drugs, and to ensure that the strike on the violation of these illegal acts is more precise and powerful.

Director Liu Pei pointed out that with the issue of Opinions on Reforming the Review & Approval System for Drugs and Medical Devices (the State Council [2015] No. 44) and Opinions on Deepening the Reform of Review & Approval System to Encourage Innovation in Drugs and Medical Devices (General Office [2017] No. 42), drug regulatory reform measures were introduced constantly, and the acceleration of new drug approval has greatly promoted the enthusiasm and investment of new drug research and development in China. Although drug regulatory reform and industrial development have made great achievements, in comparison with the people's growing needs for a better life, there are still problems of inequitable and inadequate development. Recently, the escalation of international trade friction has forced us to accelerate innovation and core technology R&D. While modifying the patent law, study implementation of patent linkage system and patent term extension, and strengthen data protection systems, to implement the “Four Most Stringent” requirements of the Party Central Committee and the State Council. In order to meet the needs of the public demands for drugs, adhere to the problem-oriented strategy, and improve the law in a targeted manner.

Liu Pei, Director-General of Department of Policies and Regulations, National Medical Products Administration made a keynote speech

KOLs of pharmaceutical policy makers, industry experts and well-known entrepreneurs, they are Song Ruilin, Chairman of PhIRDA, Liu Pei, Director-General of Department of Policies and Regulations, NMPA and Chen Qiyu, 2012-2013 Annual Chairman of PhIRDA, Executive Director & Chairman of Shanghai Fosun Pharmaceutical Group, Wu Xiaobin, BeiGene China GM & Company President, Shao Rong, Professor, Vice Executive Director of the Research Center of National Drug Policy & Ecosystem of China Pharmaceutical University, jointly discussed the implementation of the new Drug Administration Law promotes pharmaceutical innovation. All of the panelists recognized that the new Drug Administration Law incorporates reform measures such as the MAH system and the implied license for clinical trials reflects that China's drug regulation is in line with the international standards, and provides legal protection for medical innovation, which will greatly improve pharmaceutical development and production efficiency. Leaders and experts agreed that the pharmaceutical industry should seize the opportunities of development and facilitate China's independent innovation and R&D capabilities with an open and international vision. At the same time, actively carried out the Regulations for Implementation of the Drug Administration Law, Provisions for Drug Registration and the related supporting documents, and ensured the implementation of the Drug Administration Law to promote the pharmaceutical innovation.

Top left: Director-General Liu Pei

Top Right: Chairman Chen Qiyu

Bottom left: President Wu Xiaobin

Bottom Right: Professor Shao Rong

2. Global Pharmaceutical Innovation Development

XU Tian, Vice President of Westlake University, moderated the second keynote report and discussion session.

Moderator: Xu Tian, Vice President of Westlake University

Liu Yongjun, Global Head of Research, Sanofi, made a keynote speech on the theme of “Translating Human Immunobiology to Life Changing Medicine”.

Dr. Liu Yongjun started from the research experience of autoimmune and its transformation, and systematically introduced the significant impact and contribution of basic immunology research on drug development and innovation. Thymic stromal lymphopoietin (TSLP) is a multifunctional cytokine that plays an important role in the development of T cells and B cells. TSLP can regulate and control tumors’ development. Through long-term research on TSLP, Dr. Liu Yongjun first discovered and isolated a new innate immune cell, Plasmacytoid Dendritic Cells (pDC), and developed a DC vaccine targeting breast cancer and melanoma; he also discovered the mechanism and function of TSLP in the allergic immune response in human. He was the first to discover that the stimulation of OX40 can prevent immunosuppressive T-cell function (Treg) in tumors, and developed humanized antibodies against OX40. Regarding the transformation of basic research on immunization, he focused on three important targets for immunobiological drug discovery: CD40/CD40L in B/T cells, mDC in bone marrow derived dendritic cells and pDC in plasmacytoid dendritic cells. Dr. Liu Yongjun pointed out that good basic research and target screening are important foundations for drug research and development, and the development of combined drug therapy is also very important. In January 2018, Science Translational Medicine published a series of new cancer vaccines developed by researchers at Stanford University, using a short DNA immunostimulant to increase OX40-activated receptors on the surface of T cells, and then use another type of antibody binds to the OX40 receptor and successfully activates T cells to attack cancer cells. The vaccine can kill cancer tumors in a single injection and it open up new ideas for the development of immunotherapy.

Liu Yongjun, Global Head of Research of Sanofi, gave a keynote speech

KOLs of leading experts and entrepreneurs, they are Vice President Xu Tian, Dr. Liu Yongjun, Jiang Hualiang, Academician, Chinese Academy of Sciences, 2015-2016 Annual Chairman of PhIRDA, Professor, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Liu Dianbo, 2018-2019 Annual Chairman of PhIRDA, President of Luye Life Sciences Group, Cai Dajian, Vice-Chairman of PhIRDA Pharmaceutical Innovation Investment Specialty Committee, Founder & Chairman of GTJA Investment Group, had a fruitful panel on how the enterprises should follow the scientific sense, in accordance with international standards and focus on the companies' own advantages to carry out research and develop, as well as strengthening the basic research capabilities and improving the efficiency of transformation into clinical research to promote the pharmaceutical innovation capabilities.

Panel: Global Trends on Pharmaceutical Innovation R&D

Top left: Professor Jiang Hualiang

Top right: Dr. Liu Yongjun

Bottom left: President Liu Dianbo

Bottom right: Chairman Cai Dajian

3. The Development and Future of Global Innovation Financing Platform

Jiang Feng, Executive Vice President of CAMDI, moderated the third session.

Moderator: Jiang Feng, Executive Vice President of China Association for Medical Devices Industry

John Whittaker, Managing Director of J.P. Morgan Healthcare Investment Banking, made a keynote speech on the theme of Healthcare in Global Markets

John Whittaker pointed out that healthcare spending is the fastest growing expense in countries around the world. Biotechnology and pharmaceutical R&D are capital-intensive industries, and obtaining sufficient capital resources is the key to success. In the medium and long term, China's medical and health expenditures will continue to grow, and the emergence of innovative therapies is an important factor driving the development of China's medical industry. As for investing in China's healthcare market, pharmaceutical innovation is a good chance to catch.

John Whittaker said that the global healthcare market will show a growing trend, but the US and Hong Kong healthcare industry markets perform differently. The growth rate and speed of the healthcare stocks in Hong Kong's are higher than those of other sectors, which perform best in the entire supply chain. The biotechnology sector accounts for half of the listed capital. This is in stark contrast to the United States. In the US, healthcare sector owned a lower ranking in the capital market. In 2017, there were almost no pre-clinical companies listed. Now, not only biotechnology-driven companies in the life sciences are listed, but also some diagnostic, pharmaceutical, healthcare, and IT companies are listed this year. And the performance after the IPO is rather good. Healthcare will become a core industry in the United States, which may be a change in the risk appetite of the US investors over the past few years. The valuation of the capital market is still a good indicator for comparing biopharmaceutical companies listed in the US and Hong Kong.

John Whittaker also talked about mergers and acquisitions activity in the pharmaceutical industry. He pointed out that medium- and long-term income growth is the premise of M&A, and innovative treatment is its main concern, large bio-tech companies are paying more attention to M&A of R&D pipelines in the fields of cancer and rare diseases.

John Whittaker, Managing Director, J.P. Morgan Healthcare Investment Banking, made a keynote speech

Charles Li, Chief Executive of Hong Kong Exchanges and Clearing Limited, made a keynote speech named Big Medical + Big Healthcare + Big Data: Around the Corner, or Nowhere Near?

Charles Li noted how exchanges could support the extensive use of medical big data by deploying leading edge technology to deal with issues such as privacy protection and pricing difficulties. The integration and sharing of big data can speed up medical innovation and enhance the quality of human health, Li notes. Li said that the large-scale use of medical data will face four major obstacles: data is difficult to standardise, difficult to confirm, difficult to protect and difficult to price. He notes if the issues of data protection and pricing are resolved, the government and society at large would be more incentivized and have the ability to sort out the other challenges.

Charles Li, Chief Executive of Hong Kong Exchanges and Clearing Limited made a keynote speech

Houston Huang, Managing Director, Head of China Global Investment Banking, J.P. Morgan moderated the panel of The Development and Future of Global Innovation Financing Platform.

Senior management from the four major stock exchanges, Wilfred YIU, Managing Director, Head of Markets of HKEX, Robert H. McCooey, NASDAQ Global Head of Capital Market & Chairman of Asia Pacific Region, Robert Barnes, Global Head of Primary Markets and CEO Turquoise of London Stock Exchange Group, Peng Yigang, Deputy Director of Offering & Listing Center of Shanghai Stock Exchange, introduced the latest developments in biotech listings and discussed on how can capital better facilitate the development of global pharmaceutical innovation.

Panel: The Development and Future of Global Innovation Financing Platform

Middle: Managing Director Wilfred Yiu

Top Left: Managing Director Houston Huang

Top right: Chairman Robert H. McCooey

Lower left: Dr. Robert Barnes

Bottom right: Deputy Director Peng Yigang

The conference was held in the background of the revised new Drug Administration Law and the Vaccine Management Law were issued, policies of drugs, medical insurance, and healthcare regulation were intensively released as well as the new IPO regulation of the HKEX and the launch of SSE STAR Market. The opening ceremony focused on the high-level exchanges and dialogues on the impact of the revised Drug Administration Law on China's future pharmaceutical innovation, the development trend of global pharmaceutical innovation and global innovative financing platform. More than 700 institutions and more than 3,000 industry professionals from domestic and foreign pharmaceutical innovation companies, research institutes and investment institutions attended the opening ceremony.

The success of the opening ceremony has deepened the industry's understanding of the importance of the new Drug Administration Law to promote the development of China's pharmaceutical innovation, grasped the development trend of global pharmaceutical innovation investment, and optimistic about the prospect of China's pharmaceutical innovation investment, it promoted the R&D cooperation and contributed to the efficient integration of domestic and international social capital and innovation, and will also have a more positive and important impact on promoting the transformation and upgrading of China's pharmaceutical industry and innovation. The opening ceremony has received high attention and praise from the medical and investment circles at home and abroad. Springer Nature Group, one of the most influential media in the field of international scientific research, and nearly 100 reporters from more than 40 traditional/new media in China and abroad, such as the Pharmaceutical Economics News, the Menet, and the NEJM followed and reported the opening ceremony.