"At the Forefront of the Wave, We Move Forward": Innovation Chronicle of Peking University People's Hospital's Research-Oriented Ward

In late 2009, Dr. Chen Genghui, General Manager of Tianji Pharmaceutical, approached Peking University People’s Hospital with a proposal to jointly conduct registrational clinical studies on a non-hormonal small-molecule chemical drug (cream formulation) for the treatment of psoriasis.

At that time, new drugs were not yet a hot concept pursued by capital; the relevant regulations and guidelines were not as robust as they are today, and new drug development was still regarded within the industry as a high-risk, low-return outlier.

The requirements proposed by Dr. Chen Genghui present a challenge fraught with uncertainties for Peking University People's Hospital.

However, Dr. Fang Yi, Director of the Phase I Clinical Trial Research Office at Peking University People’s Hospital, and Dr. Zhang Jianzhong, Director of the Department of Dermatology, decisively undertook this clinical study, driven by their original aspiration to advance indigenous innovation in China’s pharmaceutical industry. At that time, they were yet to realize that this forward-looking exploration would give rise toA once-in-a-decade blockbuster product--Benvitimod, andA Significant Milestone in the History of China’s Innovative Drugs。

Peking University People's Hospital Research Ward was developed based on the Clinical Pharmacology Base of Peking University People's Hospital.As one of the first clinical pharmacology bases in China established in the 1980s, Peking University People’s Hospital is among the earliest hospitals in the country to conduct clinical trial research. Its scope has evolved from early clinical verification of generic drugs and bioequivalence studies to its current comprehensive involvement in Phase I, II, III, and IV clinical trials across the entire innovation drug development pipeline.

Meanwhile, another seed was taking root and sprouting. In 1998, Pfizer began preparing to introduce Viagra into the Chinese market, with its initial clinical trials conducted at Beijing’s 301 Hospital.Director Fang Yi, who was serving at the 301 Hospital at that time,witnessed firsthand the disruptive allure of the new generation of global first-in-class drugs.He developed a strong interest in the novel possibilities of clinical trials.

As one of the earliest cohort of formally trained clinical pharmacology graduates in China, Dr. Fang Yi, upon graduating from West China University of Medical Sciences, served as an intern physician in clinical settings and gained frontline experience at the university-affiliated pharmaceutical factory. This background undoubtedly fostered the bridging mindset characteristic of a new generation of clinical pharmacology experts represented by him. After witnessing the promise of innovative therapeutic products—including Viagra, GLP-1 receptor agonists, and TNF-α monoclonal antibodies—at the 301 Hospital,Reevaluating the Significance of Generic Drugs Based on Bioequivalence

At the end of 2008, Director Fang Yi joined Peking University People's Hospital to assist in establishing the Phase I Clinical Trial Research Unit and applying for the construction of a GCP platform under the National "12th Five-Year Plan" Major Special Project on "Major New Drug Development."With nearly RMB 30 million in funding support from the Ministry of Science and Technology, the National Health Commission, and Peking University People’s Hospital, a clinical research demonstration platform has been established at Peking University People’s Hospital, featuring specialized focus on malignant tumors, hematologic disorders, cardiovascular diseases, hepatitis, and autoimmune diseases.

With the launch of a series of Phase I clinical trials for biotechnological drugs at Peking University People's Hospital beginning in 2012, leaders from numerous specialized departments, drawing on their years of frontline experience in cutting-edge diagnosis and treatment, keenly perceived the emergence of a new field. Supported by many scientists within the hospital, including Professor Huang Xiaojun, Professor Li Zhanguo, Professor Zhang Jianzhong, and Professor Ji Linong,Peking University People's Hospital Initiates Transformation and Upgrading in the Early-Stage Clinical Research of Innovative Drugs.

In 2021, in response to the needs of Beijing’s biomedical industry development, Peking University People’s Hospital leveraged its Phase I clinical trial ward as a foundation and, after nearly one year of comprehensive relocation, structural renovation, and information technology upgrades, completed the establishment of a fully equipped research ward with complete staffing and comprehensive disciplinary coverage.With this, the new journey of clinical research in the research-oriented wards of Peking University People's Hospital has officially begun.

The remarkable achievements of the Research Ward at Peking University People's Hospital, under the overall leadership of Director Fang Yi, are inseparable from the unique strengths and robust capabilities of the hospital’s other specialized departments.

Peking University People's Hospital boasts a hematology team of top-tier national caliber.Its department and the Peking University Institute of Hematology constitute one of the largest comprehensive hematology research institutes in China, integrating medical care, teaching, and scientific research. The robust hematology department signifies that Peking University People's Hospital possesses a powerful R&D platform to support the development of oncology drugs. Coupled with the hospital’s domestic leadership in thoracic tumors, bone tumors, liver tumors, gastrointestinal tumors, breast tumors, gynecological tumors, and hepatobiliary tumors, this enables its research wards to develop in sync with the latest global trends in drug R&D.

The Department of Rheumatology and Immunology at Peking University People's Hospital is also among the top-tier in China, being one of the earliest established rheumatology and immunology specialties in the country., a National Key Clinical Discipline, an Innovative Team of the Ministry of Education, the Beijing Key Laboratory of Rheumatology, and an Asia-Pacific Center for Rheumatology. Under the leadership of Professor Zhang Guoli, the clinical achievements of its medical, educational, and research team of over 120 members have been incorporated into more than 30 national textbooks, and the team has obtained 16 national invention patents. It ranks among the international leaders in the diagnosis and treatment as well as mechanistic research of rheumatoid arthritis, immunotherapy for systemic lupus erythematosus, and early diagnosis of Sjögren's syndrome, having become one of the internationally renowned centers for rheumatic and immune diseases.

Also highly distinctive is the team led by Professor Ji LinongDepartment of Endocrinology, Peking University People's Hospital, leading the research and development and clinical studies of metabolic disease drugs in China, bringing more treatment possibilities to patients suffering from diabetes and its complications.

Experts from leading departments have formed research partnerships with clinical trial wards, establishing a mechanism for collaborative research in these settings:Phase I clinical trials of innovative drugs provide strategic support for Phase II clinical trials in specialized departments, while the distinctive expertise of these subspecialties, in turn, informs the design of Phase I studies, creating a mutually reinforcing synergy.

Throughout the development of the research ward, Director Fang Yi has been carrying out construction work and planning for future development under the guidance of hospital leadership.Given the inherent multi-year lag in new drug development, the ward, under the leadership of Director Fang Yi, operates like a well-equipped light vessel, constantly identifying and assessing which fields will see growth over the next 5–10 years and moving forward decisively.Under this strategy, the ward has remained at the forefront of domestic innovation for an extended period, accurately aligning with emerging trends.

Prior to the approval of benralizumab cream for marketing in China in 2019, there had been a nearly 30-year gap in innovative topical therapies for mild-to-moderate psoriasis, both in China and in Europe and the United States.The groundbreaking launch of benmoximod not only cemented Dr. Chen Genghui’s status as the “King of Drugs,” but also validated the forward-looking insights of the Research-Oriented Ward and the Department of Dermatology at Peking University People’s Hospital.

By the end of 2010, after discussions with Dr. Zhang Jianzhong, Director of Dermatology, Director Fang Yi jointly decided to advance the registration clinical trials of benvitimod: Dr. Fang Yi would oversee Phase I, while Dr. Zhang Jianzhong would be responsible for Phases II and III.

Due to the lack of sufficient procedural regulations and guidelines in the field of innovative topical drugs for psoriasis to support reasonable, compliant, and evidence-based clinical trials,Director Fang Yi and Director Zhang Jianzhong engaged in prolonged, iterative discussions with experts from the Center for Drug Evaluation (CDE), ultimately developing a feasible clinical trial protocol through their collaborative exchanges.

After nearly a decade of concerted efforts by multiple parties, and with the support of the National Major Science and Technology Project for Significant New Drug Development during the 12th Five-Year Plan period,Benvitimod Cream was approved for marketing in China in 2019, three years earlier than its launch in the United States. It was successfully selected as one of the "Top Ten Innovative Drugs in China 2019" and among the "Major Medical Advances in China 2019." In 2020, it was included in the National Reimbursement Drug List and incorporated into the Chinese Expert Consensus on the Diagnosis and Treatment of Psoriasis.Since its market launch, benvitimod has alleviated the suffering of more than 150,000 psoriasis patients, bringing significant benefits to the broader psoriasis community.

In addition to benralizumab,The Research Ward at Peking University People's Hospital has also enhanced the value of early-stage clinical studies for multiple products through various approaches.

Genor BiopharmaAmong the 10 monoclonal antibody drugs in early-stage research and development, six of which were conducted in collaboration with the Research Ward of Peking University People's Hospital. After optimizing clinical research strategies, all were advanced to Phase II clinical trials in a rapid, cost-effective, rigorous, and scientific manner. Notably, early-stage clinical studies for one TNF-α monoclonal antibody biosimilar saved nearly several million RMB, helping GeneThera Biopharmaceutical secure China’s first marketing approval for a TNF-α monoclonal antibody biosimilar.Luye Pharma's RANKL Monoclonal AntibodyWith the strategic optimization guidance from Peking University People’s Hospital’s research-oriented ward during the initiation of clinical trials, we accelerated our progress and outpaced competitors who had launched their trials earlier, ultimately becoming the first RANKL monoclonal antibody approved for market launch in China.

Research wards remain an emerging concept in China. Nevertheless, even within the brief span of their development in the country, Director Fang Yi has already formulated his outlook for the future, consistent with the forward-thinking approach that has long characterized his leadership of the research wards at Peking University People’s Hospital.

Director Fang Yi believes that the national initiative to establish research-oriented wards, and the drive for their vigorous development, is not merely about building a public platform for numerous enterprises. The ultimate goal is to serve a community of scientists specializing in integrated medicine, pharmacology, statistics, quantitative pharmacology, analytical methodology, and pharmaceutical formulation R&D. This enables the earliest possible identification of issues in clinical research, facilitates problem-solving guided by these findings, and ensures the effective advancement of translational medicine and drug development.Research wards are an R&D platform, not just a clinical one.

Regarding the future potential of research-oriented wards, Director Fang Yi pointed out that such wards have, to a certain extent, alleviated the challenges posed to clinical research by objective factors within hospitals, including fixed bed staffing quotas, bed occupancy rates, and bed turnover rates. In the longer term, the goal is to align with globally leading research hospitals, dedicating the majority of inpatient beds to patients enrolled in various clinical studies, thereby leveraging cutting-edge technologies to accumulate first-hand data.Only in this way can research-oriented wards/hospitals transcend the role of mere service providers, possessing self-sustaining capabilities to develop products and transform into scientific teams that truly shift from development to discovery.