Mr. Wang Junlin

Founder and Chairman of Shanghai UnionClin Co., Ltd. 

Graduated from Fudan University. With over 20 years of experience in the pharmaceutical industry, he has full-chain operational experience in innovative drug R&D, clinical research, production and quality management, and commercialization. Since 2004, he has led teams in conducting multiple Phase I-III clinical studies for new drugs in China, possessing extensive experience in new drug clinical development and has established strong relationships of trust and cooperation with highly influential clinical experts in the domestic industry. 

From 2002 to 2016, he co-founded Shanghai CP Guojian Pharmaceutical Co., Ltd. and served as its President. CP Guojian focuses on the R&D, pilot-scale production, and industrialization of antibody drugs, holding a leading position in China’s antibody pharmaceutical sector. In 2005, he promoted the launch of Yisaipu, the first monoclonal antibody drug in China for the treatment of rheumatic disorder. In 2017, he founded UnionClin, focusing on new drug clinical trials in the fields of neoplasm, autoimmune diseases, infection, neurology, and cardiovascular diseases. Leveraging a network of clinical research centers and digital tools, it provides full-cycle solutions for Phase I-III new drug clinical research. 

“Focusing on the specific areas of neoplasm, autoimmune diseases, and infection, and focusing on innovative molecules with leading progress”

Pharmaceutical Industry Hall of Fame: Hello, Mr. Wang! It’s a pleasure to meet you. As a clinical research organization (CRO) company based in China and serving the globe, how do you define UnionClin’s differentiated positioning? Compared to your peers, what are UnionClin’s core competitive advantages? 

Wang Junlin: New drug clinical trials require constantly challenging new heights. Only with a deep understanding and accumulation of knowledge about the drug itself and disease treatment can the demands of innovation be met. UnionClin’s strategy is to focus: focusing on the specific areas of neoplasm, autoimmune diseases, and infection, and focusing on innovative molecules with leading progress.

UnionClin’s core competitive advantages lie in the following aspects:

1.A closed-loop, full-process service. From Investigational New Drug (IND) strategy to New Drug Application (NDA) submission, we provide one-stop services for Phase I-III new drug clinical research. Service modules include: strategic consulting, regulatory submission, medical affairs, clinical operations, data management and statistics, clinical pharmacology, pharmacovigilance, independent imaging assessment, and bioanalysis. This structure meets the need for dynamic decision-making in new drug clinical trials, effectively reduces communication costs, and ensures on-time delivery.

2.An ecosystem of mutual empowerment centered on clinical resources. We have established deep cooperative relationships with multiple national medical centers, over 100 clinical research consortia, and more than 1,000 hospitals covering a wide geographical area. The collaboration includes developing digital tools for sites, holding regular strategic seminars, cooperating on translational platforms, and communicating to resolve trial project issues in real time.

3. Driven by intelligent platforms. We have developed tools such as eDISC (Digital Investigation Site Center), MuXiaoZhu (Intelligent Patient Matching System), U-ORBIT (Intelligent Imaging Assessment System), and ClinIQ (Intelligent Site Selection System) to enhance the scientific basis of decision-making and execution efficiency during clinical trials. We are developing Artificial Intelligence (AI) tools to improve the quality and success rate of clinical trial data.

4. Bolstered by international service capabilities. Relying on our experience with dual submission in China and the US and our global multi-center trial data management system, we help domestic companies go abroad and assist overseas companies in conducting clinical trials in China. For China’s first independently developed original Dendritic Cell (DC) vaccine (covering 8 indications for both neoplasm and non-neoplasm, applicable to all age groups), UnionClin completed the writing of IND submission materials for both the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) within one month, helping the sponsor obtain simultaneous approvals from China and the US.

“Continuously building an intelligent clinical research system to empower efficient clinical research”

Pharmaceutical Industry Hall of Fame: Regarding one of the core competencies you just mentioned—digital tools (such as Electronic Data Capture (EDC), AI-assisted analysis)—how do they empower UnionClin’s efficient clinical research? Have you already formed standardized solutions? 

Wang Junlin: Technology drives efficiency transformation. Since the founding of UnionClin, we have been continuously building an intelligent clinical research system to empower efficient clinical research. The AI intelligent strategy systems (clinBEST, clinIQ) use target libraries, protocol libraries, and site databases to shorten the clinical design cycle and accurately recommend sites; we have introduced and locally deployed the international TrialMaster Electronic Data Capture system (EDC and e-solutions), adapting it to the practical needs of clinical research in China and ensuring data compliance for dual China-US submissions; the eDISC clinical research platform enables multi-center collaboration, real-time dynamic decision-making, and rapid protocol adjustments to reduce trial-and-error costs; the MuXiaoZhu recruitment management platform accelerates enrollment and ensures quality by leveraging a national patient resource pool of over 20,000.

The core value of digital technology lies in freeing up the energy of clinical experts and research teams and expanding management boundaries—liberating them from repetitive tasks to focus on high-risk, high-value decisions.

“Four core capabilities—professional teams, cost control, risk prediction, and clinical resource synergy—support and ensure professionalism in cross-therapeutic area research”

Pharmaceutical Industry Hall of Fame: In terms of indications, UnionClin Pharmaceutical focuses on new drug clinical trials in the fields of neoplasm, autoimmune diseases, and infection. How does UnionClin ensure professionalism in research across these therapeutic areas? Have you established and equipped dedicated teams, technology platforms, or clinical resources for different disease areas? 

Wang Junlin: To ensure cross-domain professional competence, we have built a support system based on four core capabilities:

Team service capability. Each therapeutic area is led by experts, and medical teams are divided according to disease focus. Team members have an average of over 10 years of experience in new drug clinical development and have led the design of nearly 100 clinical protocols.

For example, in a Phase I-III project for a small molecule drug targeting a rare mutation, our medical, operations, and data management & statistics teams collaborated across all modules. We overcame a series of enrollment challenges caused by the low mutation rate, ultimately achieving the NDA goal within four years and establishing the project as a national leader, helping the client seize a first-mover advantage in the market. This kind of vertically integrated capability cannot be replaced by fragmented services.

Cost control capability. In areas such as clinical trial drug management, sample size calculation for large-scale clinical projects, international standard data management, and embedded Site Management Organization (SMO) services at some sites to reduce intra-hospital coordination costs, we significantly help sponsors save R&D expenses and avoid detours.

Risk prediction capability. We have established a risk assessment system with specific contingency plans and countermeasures for 7 types of clinical research risks, allowing us to identify potential issues (such as subject dropout risk) in advance and provide solutions. Our database integrates regulatory guideline requirements (such as NMPA/FDA/Center for Drug Evaluation (CDE) guidelines and frequently asked questions), significantly improving submission efficiency.

Clinical resource synergy capability. We transform the clinical resources accumulated in fields like neoplasm, autoimmune diseases, and infection into a capability for precise matching of research sites and investigators. Our network of over 1,000 partner research sites in more than 100 cities nationwide, along with deep cooperative relationships with over 2,000 core Principal Investigators (PIs) in multiple fields, extends further to resource pools of special patient populations, significantly enhancing the feasibility and execution quality of innovative protocol designs.

“Phase II-III projects account for about 40% of UnionClin’s services, with over 20 projects having completed Biologics License Application (BLA)”

Pharmaceutical Industry Hall of Fame: It is widely believed in the industry that Phase II-III clinical studies have higher requirements for resource integration and risk control. When supporting clients in mid-to-late-stage clinical development, how does UnionClin help sponsors reduce costs and accelerate progress through clinical design optimization and operational efficiency improvements? 

Wang Junlin: Phase II-III projects account for about 40% of UnionClin’s services, with over 20 projects having completed BLA. The key to early-stage clinical research lies in the dynamic decision-making capabilities, and the data accumulated provides crucial support for later-stage studies. Phase II and III clinical trials, on the other hand, focus on the professionalism of the registration strategy, enrollment efficiency, and the execution performance of research sites.

A Phase II trial for a hyperuricaemia drug was delayed by 4.5 months due to the Spring Festival holiday, adverse weather, and adjustments to new regulations from the Human Genetic Resources Administration Office. After we took over the project, we decisively changed the lead unit, ensured rapid response from site resources, optimized the enrollment strategy, and made dynamic plan adjustments. We completed the enrollment of 120 subjects within 2.5 months, shortening the enrollment period by 50% compared to the original plan, successfully making up for the previous delay and reaching the milestone.

In an international Phase III trial for a programmed cell death protein 1 (PD-1) monoclonal antibody for hepatic cancer, we successfully addressed five major challenges: intense enrollment competition, significant population differences, quality requirements for dual China-US submission, pandemic risks, and lessons from failures of similar studies. By dynamically coordinating the regulatory requirements of the FDA, European Medicines Agency (EMA), and CDE, managing over 50 Chinese hepatic cancer experts bilingually to optimize the protocol, and collaborating with 55 research sites to complete 70% of the enrollment task in the China region, we ultimately enrolled 482 cases within 34 months (with a dropout rate controlled below 10%). We ensured the smooth progress of the study under special circumstances (the pandemic), laying the foundation for the NDA submission.

“True dual submission capability is not about translating documents, but about converting time costs through an understanding of policies”

Pharmaceutical Industry Hall of Fame: UnionClin’s “China-US dual submission” capability has received much attention. When simultaneously meeting the regulatory requirements of the FDA, NMPA, and others, how does the company achieve “one trial, two submissions” through data management and protocol design? For pharmaceutical companies planning to pursue China-US dual submissions, what forward-looking advice can UnionClin offer? 

Wang Junlin: By leveraging China-US dual submission strategies, international multi-center clinical trial systems, and data mutual recognition mechanisms, the time-to-market for drugs can be significantly shortened. For example, an oncolytic virus project, through a coordinated China-US strategy, successfully shortened the approval cycle by 12 months; high-quality data from an Investigator-Initiated Trial (IIT) in China was directly recognized by the US FDA, leading to the initiation of a Phase II clinical trial in the United States.

The essence of UnionClin’s “China-US dual submission” capability is translating the regulatory logic of both regions into the language of protocol design. To give an example, a cell therapy project originally planned to conduct separate trials in China and the US. We redesigned it with a “dual-endpoint protocol” and established an independent review committee. This led to simultaneous approvals from China and the US, saving time and tens of millions in costs. True dual submission capability is not about translating documents, but about converting time costs through an understanding of policies.

For companies planning for dual submissions, I have three suggestions:

1. Leverage momentum in target selection: While ensuring the innovativeness of the target, it is necessary to also consider its global recognition. For potential blockbuster products, one should plan ahead.
2. Maintain flexibility in endpoint design: Based on the differences in clinical trial requirements between regulatory systems, the design must consider the regulatory requirements of both parties and the drug’s characteristics, leaving room for adjustment in endpoint selection to increase the success rate and reduce risks.
3. Ensure a robustly compliant data system: To address the data standards and traceability requirements of different regulatory systems, ensure high compliance in all aspects—from database certification and collection processes to data entry guidelines—to meet the requirements of each system.

“In the next ten years, UnionClin will implement the ‘China Solution, Global Delivery’ strategy”

Pharmaceutical Industry Hall of Fame: How do you view the changing demands on clinical CROs from Chinese innovative pharmaceutical companies “going global”? How will UnionClin further strengthen its global service capabilities? 

Wang Junlin: Currently, the globalization of China’s innovative drugs is transitioning from a demand for “single services” to “ecosystem co-construction.” The “going global” of innovative drugs has moved beyond the scope of individual products or companies, evolving into a holistic internationalization process for China’s entire pharmaceutical innovation system.

As a key supporting force, UnionClin is systematically building its global service capabilities: by deeply understanding international regulatory systems and establishing dynamic tracking mechanisms, restructuring business processes according to international standards to solidify the foundation of compliance, and forming strategic partnerships with pharmaceutical companies to achieve full-process collaboration. We must both practice the top-level design philosophy of “beginning with the end in mind” and achieve technology empowerment through an intelligent clinical research operating system.

In the next ten years, UnionClin will implement the “China Solution, Global Delivery” strategy—leveraging local innovation advantages to export efficient clinical research models through digital means, becoming a core force in safeguarding the globalization of China’s innovative drugs.

About UnionClin

Founded in 2017 and headquartered in Shanghai, UnionClin Pharmaceutical focuses on new drug clinical research in the fields of neoplasm, autoimmune diseases, infection, neurology, and cardiovascular diseases. Leveraging its AI-empowered digital system platform, professional clinical resources, and team advantages, it has built an intelligent service system covering the entire new drug R&D cycle: from IND strategy to NDA submission, providing one-stop solutions for Phase I-III new drug clinical research. Services include: medical affairs, clinical operations, data management and statistics, clinical pharmacology, pharmacovigilance, independent imaging assessment, bioanalysis, SMO, and professional talent secondment. It possesses capabilities for China-US dual submission, innovative trial design experience, and global multi-center clinical research services. It in-licenses high-quality overseas products and promotes the internationalization of local innovative products. 

It has a service team of over 500 people, stationed in more than 100 cities nationwide, and has established effective collaborations with over 2,000 clinical experts in core fields and more than 1,000 research centers. It has provided services for over 200 new drug clinical research projects. 

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