Source: People's Daily Health APP

2017 is called the "First Year of Innovative Drugs" by the pharmaceutical industry in China.

According to the CPM database of the China Pharmaceutical Industry Information Center, in that year, the Center for Drug Evaluation (CDE) of the National Medical Products Administration handled 199 applications from enterprises for clinical studies of Class 1 chemical drugs, up 42% year-on-year; similarly, in the same year, 48 drug varieties were approved for marketing in China, with the number of anti-tumor drugs ranking first.

It was also in that year that Junlin Wang, who had been deeply involved in the pharmaceutical industry for more than a decade, resolutely chose to give up his position as the "leader" of a well-known pharmaceutical company and founded Shanghai UnionClin Co., Ltd. Since then, he has focused on the third-party services (CRO) for clinical studies in new drug development in the field of oncology and become a veritable entrepreneur.

On August 6, in an exclusive interview with the People's Daily Health APP, Junlin Wang said that as the cost of new drug research and development continues to rise and the difficulty continues to increase, the need for collaboration between biopharmaceutical companies and third-party clinical research service enterprises is becoming increasingly prominent. An efficient third-party clinical research service company can enhance quality and accelerate every stage in clinical research during drug development.

Junlin Wang, Chairman of UnionClin, at the Innovative Drug Clinical Study Summit Forum

Focus on Oncology: New Drug Development Needs to Break Through Bottlenecks

Before 2017, Junlin Wang had been working in the field of drug development for more than a decade. He had gone through processes like drug development, animal testing, clinical studies, and drug approval multiple times, not only personally experiencing the torment brought by the lengthy development cycles of new drugs but also savoring the joy brought by the success of new drugs. It was precisely this accumulation over more than ten years that allowed Junlin Wang to grasp the bottleneck in China's new drug development—the clinical study.

Clinical study work includes the formulation of drug development strategies, protocol design, clinical monitoring, clinical pharmacology, biostatistics, data management, subject recruitment, bioanalysis, and third-party medical imaging evaluation, etc. According to data from the drug clinical trial institution filing management information platform, as of November 19, 2021, there are a total of 1,165 drug clinical study institutions in China, among which 1,117 are in the filed status, and 48 are drug clinical study institutions have their filing status canceled.

"Clinical trials are a very complex process, which can take as short as two to three years, or as long as seven to eight years. Currently, although the number of clinical study institutions in our country has increased, only a top portion of clinical study centers can participate in global multicenter clinical studies. This is the pain point in our country's new drug R&D work and also an important reason for the birth of Youlin," said Junlin Wang.

In 2015, the State Council issued the "Opinions on Amending and Reforming the Review and Approval System for Drugs and Medical Devices", which initiated a reform aimed at "resolving the backlog of registration applications" and primarily focusing on "improving drug clinical study approvals" and "encouraging the research and creation of new drugs." Subsequently, the introduction of a series of policies such as the "Opinions on Implementing Limited Review and Approval for Drug Registration Applications", the "Opinions on Encouraging Drug Innovation and Implementing Priority Review and Approval", and the "Announcement on Adjusting the Procedures for Drug Clinical Study Review and Approval" has more directly promoted new drug research and development.

The arrival of a rapid development period for China's innovative drug R&D has also brought excellent development opportunities for UnionClin. However, Junlin Wang did not want to swallow the entire "cake" in one bite, instead, he focused his attention on the R&D of innovative drugs in the field of oncology.

"The R&D of new anti-tumor drugs accounts for about 60% of the innovative drugs in China, and the clinical studies of oncology products are relatively complex. They require not only familiarity with the entire workflow but also a professional understanding of the diseases. It can be said that clinical studies of innovative oncology drugs are the most specialized and most in need of a professional third-party organization to help sponsors improve trial efficiency," said Junlin Wang.

He also takes early clinical studies as an example: "The early clinical stage of new drugs is particularly important. Continuous attempts must be made to find a viable path. This is a dynamic trial-and-error process and is the stage most prone to losing control and failure, where many companies expend enormous resources. This is precisely where UnionClin's expertise and strengths lie. For example, although some products have the same target, they are still different drugs, and the corresponding clinical strategies are also different; or if the same drug aims to develop multiple indications, deciding which one to do first and which one to do later greatly tests the planning ability of the clinical study team."

Aligning Goals in the Clinical Study Ecosystem is Very Important

In the interview, Junlin Wang mentioned "efficiency" multiple times. He believes that efficiency is the core of the business and is the original motivation for innovative drug sponsors to seek cooperation with third-party clinical service enterprises.

"Whether we can truly improve the efficiency and professionalism of clinical studies, and whether we can help sponsors control R&D costs while enhancing R&D efficiency—this is the value of Youlin," said Junlin Wang.

Currently, the vast majority of clinical study scenarios are still in hospitals, and traditional clinical studies mostly rely on manual data entry and manual monitoring management, making it difficult to improve efficiency. UnionClin first targets this issue, solving the problem of efficiency improvement on the hospital side through informatization methods.

UnionClin has proposed solutions from two directions: the Clinical Research Intelligent Management System and Embedded Clinical Research Site Services (SMO). The Clinical Research Intelligent Management System allows many tasks previously performed manually to be handled by the system. It can update and adjust the work progress of clinical studies in real-time and dynamically to enhance the advancement of the entire clinical study. The Embedded Clinical Research Site Services provide hospitals with dedicated clinical service teams, modularizing in-hospital clinical study processes, with each module managed by a professional team.

"In the past, clinical studies on the hospital side might have been a relatively uneven road, requiring investigators to overcome obstacles step by step. What we aim to do is to flatten this uneven road, allowing the 'car' to run faster and smoother on it. Currently, nearly 30 hospitals in China have adopted our Clinical Research Intelligent Management System in their Phase I clinical wards or research wards, and this number will further expand in the future," said Junlin Wang.

In Junlin Wang's view, pharmaceutical R&D companies, hospitals, and clinical third-party service enterprises together form a clinical study ecosystem. Only when the three parties share the same goals and their workflows are interconnected can the efficiency of the entire ecosystem be effectively improved.

Reflecting on Past and Future: Making the CRO Better

According to Frost & Sullivan's forecast, China's CRO market size is expected to reach approximately $13 billion in 2022, with a compound annual growth rate of 25.85% from 2015 to 2022; the segmented clinical CRO market is expected to reach approximately $7.5 billion in 2022, with a compound annual growth rate of 28.45% from 2015 to 2022.

"However, compared with Europe and the United States, the penetration rate of third-party clinical service companies in new drug R&D in China is still relatively low, about 40%. Most sponsors still choose to conduct clinical studies themselves. To increase the penetration rate in the future, we need to improve the professionalism and proficiency of CRO companies," said Junlin Wang.

In the more than ten years before founding UnionClin, Junlin Wang mastered the entire process from early R&D to clinical studies and product commercialization. This enables him now, in providing clinical study services, to both "look forward" and "look backward."

"Looking forward to seeing where this new drug comes from and why it comes, and looking backward to understand its future clinical value. This aligns with our original intention: we hope to make clinical study services more professional and holistic, to stand more from the sponsor's perspective, from the standpoint of each drug, to provide them with more appropriate and differentiated services," Junlin Wang told the People's Daily Health APP, "currently, there is no clear leading company among China's third-party clinical research service enterprises, and we hope to root deeply in the oncology field and become the best and most efficient in this area."

UnionClin originated from "Only the world's utmost sage can possess the intelligence and wisdom sufficient to govern" in The Doctrine of the Mean, Part 31, but Junlin Wang has his understanding of this name, "I just hope to plan the overall situation with wise people and do meaningful and valuable things together. The essence of third-party clinical research services is a human resource service industry, and what is most needed is a solid and capable team to make this work better and better."