Bi Jingquan on China’s pharmaceutical evolution and int'l cooperation
Former Director of the China Food and Drug Administration & reformer behind China’s biopharma transformation highlights the power of global partnerships and best practices to advance innovation.
Bi Jingquan, currently Chairman of the China Center for International Economic Exchanges (CCIEE), a state-affiliated thinktank, has been widely acclaimed for his transformative leadership and bold policy reforms during his 2015-2018 tenure as the head of China Food and Drug Administration (CFDA) and later the State Administration for Market Regulation (SAMR), which evolved from the CFDA. His policies that enhanced the quality of generic drugs and expedited the introduction of new medicines in China earned him the title "变革者毕井泉" or "Bi Jingquan the Reformer."
Bi delivered the following keynote on May 17, 2024, at the 2024 DIA China Annual Meeting held in Suzhou, Jiangsu Province, in which he candidly admitted that “the contributions of Chinese scientists have been limited” in modern medicine and the “significant challenges regarding drug innovation and equitable accessibility in China.”
Nonetheless, he recounted the tremendous progress China thus made and highlighted the vital role of international cooperation in promoting China's biopharmaceutical progress. Training exchanges and technical cooperation with the U.S. FDA and China's accession to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have been critical in modernizing China's capabilities in drug evaluation, production, and quality assurance, as well as facilitating the entry of Chinese drugs into global markets, he said.
At the time of the United States’ withdrawal from the World Health Organization under President Donald Trump’s second administration and the emerging controversy within China over generic drugs, we have decided to spread Bi’s fact-based, openness-informed speech in English.
A transcript is available on the official WeChat blog of DIA China. DIA, founded as the Drug Information Association, is a leading global multidisciplinary life science membership association based in the United States. - Yuxuan JIA and Zichen WANG
For background, Bi Jingquan's achievements, along with an overview of China's accession to the ICH, were briefly summarised by the WeChat blog 知识分子 The Intellectual. The translated text is provided below.
On December 19, 2024 in Washington, D.C., the Drug Information Association (DIA) awarded Bi Jingquan the DIA Lifetime Achievement Award in recognition of "a lifetime of exceptional leadership and steadfast courage in advancing public health through innovation and international cooperation".
Bi Jingquan, Chairman of the China Center for International Economic Exchanges (CCIEE) and former Director of the China Food and Drug Administration (CFDA), has been highly praised within the industry as the most successful CFDA director in many years and is regarded by many as one of the key figures driving the development of China's innovative pharmaceutical industry.
The Drug Information Association (DIA), which presented the award to Bi Jingquan, is a globally recognised interdisciplinary academic platform with a strong reputation in pharmaceutical research and development. In 2017, during China's efforts to join the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the DIA played a crucial role as a communication bridge between the two parties.
The ICH, an international non-profit organisation, aims to achieve greater harmonisation in global technical standards, streamline drug development, and eliminate unnecessary duplication of clinical trials. Its mission supports the efficient, cost-effective development, registration, and production of safe, effective, and high-quality medicines.
China's accession to the ICH represents a pivotal step toward aligning its clinical trial practices with international standards, facilitating the entry of international drugs into China while enabling Chinese innovative drugs to access global markets.
Under the coordination of the DIA, Bi Jingquan and Dr. Theresa Mullin of the U.S. FDA reached a consensus on several critical issues related to China's accession to the ICH, ultimately paving the way for the country's membership. This milestone marked a turning point in the internationalisation of China's pharmaceutical industry. The current structure of the pharmaceutical sector and the surge in innovative drugs in China can largely be traced back to that pivotal moment.
In January 2015, Bi Jingquan was appointed Director and Party Secretary of the China Food and Drug Administration (CFDA). Initially, expectations for Bi's leadership were low due to his lack of prior experience in the pharmaceutical sector. However, just months later, the release of the Opinions of the State Council on Reforming the Drug and Medical Device Evaluation and Approval System signalled the beginning of the most significant transformation in China's drug regulatory framework in a decade.
During his three-year tenure, Bi Jingquan implemented transformative measures to address long-standing challenges in drug regulation, new drug registration, and clinical trials. He directly confronted the persistent issue of a regulatory system prioritising licensing while neglecting process oversight. To enhance the quality of generic drugs, he also actively advanced their consistency evaluation.
While elevating the benchmarks for both generic and innovative drugs, Bi streamlined review processes and significantly increased evaluation capacity. Under his leadership, the pace and volume of new drug approvals improved dramatically, effectively eliminating the backlog of pending approvals. These reforms greatly expedited the entry of international drugs into the Chinese market and accelerated the development and commercialisation of innovative Chinese drugs. The subsequent wave of pharmaceutical innovation in China can be attributed, at least in part, to these initiatives.
加强国际合作 推动生物医药产业发展——在国际药物信息大会的发言
Enhance International Cooperation to Promote the Development of Biomedicine Industry
— Speech at the 2024 DIA China Annual Meeting
Distinguished guests, ladies and gentlemen, friends, and comrades:
Good morning! I am very pleased to be in Suzhou to attend the 2024 DIA China Annual Meeting!
First of all, I would like to extend my congratulations on the convening of the DIA China Annual Meeting and express my gratitude to the chairman for inviting me to this prestigious event. This year marks the seventh anniversary of China's joining the ICH.
Seven years ago, thanks to the DIA China Annual Meeting held in Shanghai, I had the opportunity to meet Dr. Theresa Mullin, who was then the Chair of the ICH. Dr. Li Zili, then Chair of the DIA China Regional Advisory Council, facilitated and participated in the meeting alongside me. At the time, Dr. Li was responsible for global affairs in the U.S. FDA's Office of Generic Drugs. The meeting yielded a significant milestone: a consensus on several key issues concerning China's joining the ICH.
On June 1 of that year, the ICH formally passed a resolution granting China membership, marking the start of a new era in international cooperation on drug regulation for the country. Since then, all ICH pharmaceutical development guidelines have been adopted as guiding principles in China, significantly accelerating the alignment of China's regulatory framework with international standards. This alignment has provided essential institutional support for the development of China's biopharmaceutical industry.
Without the DIA meeting in Shanghai, Dr. Mullin might not have come to China; without Dr. Li Zili's dedicated efforts, I might have missed the opportunity to meet Dr. Mullin. As someone who witnessed this historical moment firsthand, I take this opportunity to express my deep respect and sincere gratitude to Dr. Mullin and Dr. Li Zili. I also extend my heartfelt appreciation to all member organisations that supported China's accession to the ICH!
I recount this history to illustrate that international cooperation in biopharmaceuticals is extremely important for China, for countries around the world, and for promoting scientific progress and human health.
Modern medicine was born in Europe. With Western learning spreading to the East, modern medicine was introduced to China. Many big multinational pharmaceutical companies have entered China for over a century. Last year, when I met with the CEO of Eli Lilly and Company in the United States, he showed me a picture of the first insulin prescription issued in July 1923 at Peking Union Medical College Hospital. At that time, Eli Lilly's insulin had just been launched in the United States. Bayer's aspirin entered the Chinese market after World War I and began local production in China in 1936.
After China's reform and opening up, large multinational pharmaceutical companies began entering the market on a large scale. At that time, Otsuka Pharmaceutical became the first Sino-foreign joint venture pharmaceutical company in China, while BMS Shanghai was the first Sino-American joint venture. In 1989, Merck transferred the production technology for its newly launched RECOMBIVAX HB vaccine technology to China, enabling local production. This move made the hepatitis B vaccine affordable to the Chinese population, significantly curbing the widespread transmission of hepatitis B and sparing billions of people from the suffering caused by the disease. The Chinese people have always remembered this contribution.
The entry of large multinational companies brought modern pharmaceutical concepts, technologies, and products, improving the health status of the Chinese people and driving the improvement of China's clinical trial standards and technological advancements in the pharmaceutical industry.
In the late 1980s and early 1990s, China's pharmaceutical industry experienced significant growth. At that time, domestic companies were only capable of producing generic drugs. Their understanding of generics was limited—that as long as the generics passed testing, their efficacy was guaranteed. After 2000, scientists who had studied abroad returned to China to start their own businesses or took up academic positions in fields like biology, chemistry, and medicine. Additionally, some scientists with experience in multinational companies joined domestic Chinese enterprises. Meanwhile, traditional Chinese pharmaceutical companies began to research and develop innovative drugs.
The rapid development of the industry necessitated reforms to the regulatory system. In 1998, China began to explore a regulatory framework that aligned with the needs of the modern pharmaceutical industry. This included dismantling the industry management bureaus from the planned economy era and establishing the National Medical Products Administration, which separated drug registration from the Ministry of Health. The introduction of regulations such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Supply Practice (GSP) marked key milestones. Over time, drug quality supervision upgraded from mere testing to comprehensive quality surveillance programmes.
Following the 18th National Congress of the Communist Party of China in 2012, reforms to the drug evaluation and approval system were initiated. These reforms began with addressing the backlog of market applications and clinical data falsification, focusing on raising approval standards, implementing a marketing authorization holder system, and conducting consistency evaluations of the quality and efficacy of generic drugs. Additionally, patent term compensation and patent linkage systems were established, and China joined the ICH. These reforms reflect lessons drawn from international best practices and the outcomes of global cooperation.
Each year, China's drug regulatory agencies send professionals to the United States for training and invite U.S. FDA experts to China to provide training for drug reviewers and inspectors. In September 2015, during my visit to Europe, Pfizer invited Dr. Peter Stein, former Director of the Office of New Drugs (OND) at the U.S. FDA's Center for Drug Evaluation and Research (CDER), to present on the organisational structure of the CDER. In November 2015, the China Food and Drug Administration (CFDA) invited Dr. Murray Lumpkin, former Deputy Commissioner of the U.S. FDA, to deliver two half-day lectures on the evaluation of both innovative and generic drugs.
With the support of the Gates Foundation, the CFDA hired four senior reviewers who had previously worked at the U.S. FDA to serve as chief scientists at the CFDA's Center for Drug Evaluation. In 2014, CFDA and the U.S. FDA reached an agreement on drug regulation, which included mutual dispatching of inspectors for on-site inspections of drug quality for products exported to each country, as well as the sharing of regulatory information. Right before the "722" clinical trial data verification in 2015 [a regulatory initiative by the CFDA to ensure strict authenticity and reliability of clinical trial data for drugs under review], I attended the graduation ceremony of the drug quality inspector training class established by Peking University with the support of the U.S. FDA's China Office.
In the context of globalisation, pharmaceutical R&D, clinical trials, and market sales extend beyond national borders. Every innovative drug will face competition from other international companies and must be prepared for market approval applications in multiple countries. Once a promising drug is developed, it becomes a global necessity. As a result, drug regulatory agencies in each country must manage new drug approval applications from innovative drug companies worldwide.
Strengthening international cooperation among drug regulatory agencies across countries and promoting the unification of regulatory standards are crucial for reducing companies' R&D costs, improving R&D efficiency, and enhancing drug accessibility.
Ensuring the safety, stability, and resilience of the drug supply chain is a top priority for governments worldwide. Drugs are essential commodities that save lives, and even in exceptional circumstances, countries must safeguard the stability of the drug supply and humanitarian materials to prevent greater harm. Restricting drug R&D and supply hampers the global distribution of resources for drug development and production, raises R&D costs, reduces R&D efficiency, and undermines the availability of drugs. China produces drug intermediates and active pharmaceutical ingredients, which are sold to India for formulation and then exported to developed markets like the United States. This is a result of global resource allocation. In the era of globalisation, no country can enhance the safety and stability of its drug supply by isolating itself. A secure and stable global drug supply chain must be maintained with collaborative international efforts.
The collaboration between China and the United States to combat fentanyl abuse is a prime example of international cooperation. Chemical raw materials produced by Chinese companies are exported to Mexico, where they are processed into fentanyl and smuggled into the U.S. market. Tackling such transnational crimes requires coordinated efforts between China, the United States, and other countries to address and combat drug abuse at its source.
Drug shortages are another global challenge, with different countries experiencing unique issues. According to the latest data from the American Society of Health-System Pharmacists (ASHP), the U.S. faced a shortage of 323 drugs in the first quarter of 2024. Meanwhile, the European Union identified 400 critical drugs in short supply at the end of 2023. In China, shortages affect both generic and innovative drugs. Prior to 2016, two-thirds of drugs approved in the U.S. had not been launched in China, many of which were needed by Chinese clinical practice. Regulatory authorities worldwide share concerns: excessively low prices for generics can undermine long-term supply efforts by enterprises, while low prices for innovative drugs may stifle innovation, hinder technological progress, and limit the ability to address unmet clinical needs. There is significant potential for cooperation between China, the U.S., and the European Union to address these shortages.
Distinguished guests!
In the history of biopharmaceutical development, Chinese scientists have made significant contributions to medical progress, such as the discovery of the pharmacological effects of ephedrine, the synthesis of crystalline bovine insulin, the development of artemisinin, and the use of arsenic trioxide and all-trans retinoic acid for the treatment of acute and chronic myeloid leukemia. Among them, ephedrine, artemisinin, and arsenic trioxide were derived from traditional Chinese medicine. However, overall, the contributions of Chinese scientists have been limited.
In recent years, China has become an important part of global drug innovation. From 2015 to 2023, China approved 451 innovative drug classes for market entry, with domestic enterprises accounting for one-third of these innovations. Among the 13,537 drugs in clinical research worldwide, Chinese enterprises have initiated or participated in the development of 4,774, accounting for 35% of the global total.
In the past three years, the number of new drug out-licensing deals by Chinese companies has grown significantly. According to Pharmcube statistics, there were 45 deals worth $14 billion in 2021, 61 deals worth $27 billion in 2022, and 96 deals worth $42.1 billion in 2023. Since 2019, 11 drug classes received the U.S. FDA Breakthrough Therapy Designation, with the same number also approved for market entry in the United States.
An important aspect of China's 2015 drug evaluation and approval system reform was raising the standards for generic drug market entry, requiring generics to demonstrate consistent quality and efficacy with the brand-name drugs. This led to consistency evaluations for previously approved generics based on this new standard. As of now, China has approved 9,423 generic drugs through these evaluations or under the new standards, covering 1,218 drug classes.
The accessibility of Chinese drugs is gradually improving. The quality and efficacy of commonly used generic drugs produced in China have reached a level where they can effectively substitute brand-name drugs. China has established a basic medical insurance system covering nearly 1.4 billion people. Since 2018, the time required for innovative drugs to be included in the medical insurance catalogue has been shortened from five years to just over one year, with many innovative drugs being added in the same year they are approved for market entry.
There are still significant challenges regarding drug innovation and equitable accessibility in China. For instance, most innovative drugs are follow-on drugs or imitations, with few best-in-class drugs and even fewer breakthrough therapies on clinically significant endpoints. Prices of innovative drugs are often too low, and some hospitals are not proactive in procurement, leading to both lower sales prices and volumes than expected. This, to some extent, dampens enterprises' enthusiasm for innovation and reduces investors' willingness to invest.
Since 2023, President Xi Jinping has repeatedly emphasised the importance of developing biopharmaceuticals and encouraging biopharmaceutical innovation. The State Council's executive meetings have called for comprehensive support for innovative drugs. The Government Work Report 2024 highlights the need to develop new-quality productive forces, accelerate the growth of the innovative drug industry, and explore new areas in life sciences. Relevant Chinese government departments and local governments are actively developing policy measures to support innovative drugs throughout the entire biopharmaceutical lifecycle, including R&D, production, usage, and payment. These efforts aim to improve market expectations and address challenges such as financing difficulties and hospital entry barriers faced by innovative drug companies.
Currently, global life sciences and information sciences are increasingly integrated and evolving rapidly, with emerging technologies continuously surfacing. The application of multi-omics technologies is becoming more widespread, and various drug conjugates are advancing quickly. Cell therapies and gene-editing drugs are entering clinical use, while artificial intelligence and data technologies have made disruptive breakthroughs in the biopharmaceutical field. These advancements are driving new paradigms in life science research and drug development, ushering biopharmaceuticals into a new era of data explosion. The world is entering an era filled with transformation and promise.
The theme of this meeting is "Embracing Innovative Technology, Expanding Health Horizons." It is indeed essential to further emancipate minds, dismantle institutional and systemic barriers, promote coordinated development and governance across medical insurance, healthcare, and pharmaceuticals, and strengthen intellectual property protection. It is crucial to establish a robust foundational system that supports innovation and work toward creating the world's most competitive ecosystem for the growth of the innovative drug industry.
China sincerely hopes to engage in extensive communication and exchanges with all countries, jointly build an open and inclusive pharmaceutical market, contribute Chinese wisdom and strength to the development of global health endeavours and accelerate the construction of a community of common health for mankind.
Finally, I wish the meeting a great success! Thank you all!