HLT Pharma Debuts with Digital Solutions for Clinical Drug Research, Files IPO Prospectus
Digital transformation in pharmaceutical companies has become a recent focal point of the industry, with new technologies reshaping the landscape of the pharmaceutical sector: artificial intelligence is being applied to drug discovery and crystal form design, big data technology is utilized in clinical research, internet-based healthcare is transforming diagnosis and treatment models, and digital marketing is establishing new market relationships...
Efficient and continuous new drug development is key to gaining core competitiveness in the pharmaceutical industry. Global top-tier pharmaceutical companies are at the forefront of digital transformation; Pfizer, Novartis, Roche, and Merck & Co. have all applied new technologies to every aspect of new drug development, giving rise to representative companies such as Flatiron Health and Science 37. As for domestic pharmaceutical enterprises, although a significant gap remains in overall new drug R&D capabilities, they are catching up rapidly, driven by policy support and local innovative companies.
VCBeat (WeChat ID: vcbeat) interviewed Dr. Peng Tao, Chief Data Scientist at HLT Pharma. Making his company’s debut appearance, Dr. Peng outlined HLT Pharma’s core strengths, business layout, and development roadmap, and discussed how the company will deliver innovative solutions to the pharmaceutical industry amid the wave of digital transformation.
Dr. Peng Tao, Chief Data Scientist at HLT Pharma. Photo provided by the interviewee.
Clinical trials are the most costly and time-consuming phase in new drug development. The high cost of clinical trials does not stem from absolute technical complexity, but rather from the substantial resources required to ensure long-term, stable, and high-quality collaboration among various roles and stakeholders across the industry. Electronic Data Capture (EDC) systems have gradually evolved over the past two decades in response to the growing scale and increasing complexity of clinical trial demands within the pharmaceutical R&D sector.
HLT Pharma is not targeting the single market of merely providing EDC products to pharmaceutical companies. Dr. Peng Tao told VCBeat, “EDC is far from sufficient.” HLT Pharma aims to process data from more sources and dimensions in clinical research, offering clinical research organizations and pharmaceutical companies a more comprehensive perspective and real-world insights to control research risks and improve efficiency. “New drug development must be a highly regulated industry, with stringent requirements for data clarity, accuracy, timeliness, completeness, and attributability. Collecting data at a single point is insufficient; therefore, facilitating the flow of information among different stakeholders is of great significance.”
HLT Pharma’s logic is clear: among the various stakeholders in clinical trials, hospitals (clinical trial sites) represent the scarcest resource. The capability and capacity of these clinical trial sites constitute a critical bottleneck for the entire industry. By integrating various platforms within clinical trial sites—such as Electronic Medical Records (EMR)—with Electronic Data Capture (EDC) systems and other platforms, information can flow rapidly from the sites to pharmaceutical companies’ clinical research programs, thereby enhancing the efficiency of clinical research and alleviating this bottleneck.
Integrating diverse data sources provides additional dimensions for observation and analysis: clinical trial institutions can perform real-time analysis of clinical and research data, thereby enhancing participant protection; project managers in clinical research can gain visibility into previously inaccessible “black box” processes, enabling effective management and mitigation of trial risks. More comprehensive data can also be repurposed after trial completion, improving the institution’s scientific research and clinical capabilities, as well as strengthening corporate experimental management capacities. “This constitutes foundational infrastructure for the entire industry, akin to building bridges and highways, making clinical trials faster and safer.”
In fact, this is also the direction currently being promoted by major regulatory agencies worldwide. For instance, in early July, the U.S. FDA released the Guidance on the Use of Electronic Health Record Data in Clinical Trials, recommending the use of EMR data within EDC systems. The aim is to leverage more clinical data to unlock greater medical value and support the research, development, and application of safe and effective drugs. Diverse data sources include clinical records, physician orders, medical imaging, laboratory data, medication records, demographic data, and vital signs. These data can be merged, aggregated, and analyzed, encompassing both electronic medical records (EMRs) and clinical data warehouses that integrate EMR data.
Peng Tao pointed out that the FDA’s issuance of guidance stems from the 2016 ICH Good Clinical Practice (GCP) guidelines, aiming to ensure the efficiency and quality of clinical research amid increasingly large-scale and complex conditions. “While adhering to GCP principles, the FDA hopes investigators will focus on the most critical aspects, reduce excessive attention to non-core details, encourage the pharmaceutical industry to embrace technological innovation, leverage new technologies to control trial risks, and enhance subject protection.” This development is favorable for the clinical research technology industry. It also indicates that systems, including Electronic Data Capture (EDC), should not operate in isolation; instead, they must integrate with upstream and downstream processes to stand out.
“HLT Pharma may not be widely recognized, but our strong technical capabilities are our advantage. This is not a market being built from scratch, but one evolving from existing foundations toward greater excellence. Previously, policy support and corporate attention were insufficient; now the opportunity has arrived. Industrial demand is driving technological upgrades, providing an excellent entry point,” said Peng Tao. He noted that smaller vendors in this market had previously been limited to IT services and struggled to establish systematic layouts, which presents an opportunity for HLT Pharma.
Prioritizing resources where they matter most, HLT Pharma has also adopted a focused approach in its product portfolio. Peng Tao told VCBeat that EDC products are the key focus of HLT Pharma’s recent strategic layout.
Electronic Data Capture (EDC) is a computer network-based technology used for data collection in clinical trials. Compared to the more traditional paper-based data collection, EDC also involves manual entry by clinicians or Clinical Research Coordinators (CRCs), with the only difference being that the medium of entry has shifted from paper to the web. Once entered, the data can be directly transmitted and aggregated.
According to a white paper published by Medidata, 75% of new clinical trials utilized Electronic Data Capture (EDC) systems by 2013. Today, this figure is even higher, particularly among global pharmaceutical companies, Phase III clinical trials, and trials conducted in the United States, Europe, and Japan. Nevertheless, EDC has not yet achieved 100% penetration across the industry. The situation in China is less optimistic; according to data from Probe Capital, the adoption rate of EDC among Chinese pharmaceutical companies is below 50%. Currently, major global EDC vendors include Oracle, Medidata, and Veeva, whereas the Chinese market remains fragmented, with numerous service providers offering diverse products and services.
Typically, EDC vendors price their services based on the number of enrolled participants and the duration of the drug study. The larger the participant pool and the longer the trial, the higher the product price. The average market price for a standard EDC system ranges from RMB 50,000 to RMB 200,000. In complex and demanding scenarios (e.g., Phase III oncology trials that may last over five years), the product price can exceed RMB 1 million.
For pharmaceutical companies, Electronic Data Capture (EDC) systems are the most critical tools in clinical trials, yet they have limitations: physicians document medical histories and issue orders within Electronic Medical Record (EMR) systems, only to re-enter this data into EDC systems. As a result, physicians become the sole conduit between these two major systems. HLT Pharma collaborates with clinical trial institutions to address this challenge.
With the advancement of information technology, Electronic Data Capture (EDC) systems can now interconnect with Interactive Web Response Systems (IWRS), pharmacovigilance systems, data analysis and reporting systems, and investigational product management systems. This integration enables real-time provision of subject information and status during clinical trials. Consequently, various interactive terminals within institutions—such as tablets, computers, and physician workstations—can serve as interfaces for EDC platforms. A single operation by physicians can simultaneously meet both clinical care and research requirements, enabling seamless collection of trial data. In this process, the EDC system itself is relatively straightforward due to its high degree of standardization (e.g., CDISC standards). The complexity lies in the diversity of Electronic Medical Record (EMR) systems across research institutions, which presents a significant barrier to data integration within clinical research organizations.
Having accumulated extensive experience in system integration within clinical research institutions, HLT Pharma’s EDC product is a natural extension of its core business. HLT Pharma began strategically developing its EDC product line two years ago, continuously engaging in product development, testing, and optimization. While typical EDC products only need to provide relatively simple web services, those deployed in clinical research institutions must bridge hospital intranets with external networks, imposing stringent requirements on connectivity, stability, and security. Adhering to high standards and rigorous criteria, HLT Pharma’s EDC product matches internationally renowned vendors in data capture and data security. It has successfully passed validation by NNIT, an international professional organization—a distinction rarely achieved among domestic EDC products.
In addition to its core capability of connecting with clinical research institutions, HLT Pharma has adhered to its own principles in developing the foundational features of its Electronic Data Capture (EDC) system, with the primary objective of enhancing the efficiency of frontline operational staff. The product also includes comprehensive training functionalities. Furthermore, HLT Pharma’s EDC solution emphasizes system “interoperability.” It enables direct exchange of visit information and Case Report Form (CRF) data without additional development with platforms compliant with the CDISC Operational Data Model (ODM) standard, such as Medidata Rave. For pharmacovigilance databases compliant with the ICH E2B standard, individual case safety reports of adverse events can be transmitted directly.
Currently, pharmaceutical companies such as Chia Tai Tianqing, Innovent Biologics, and Harbour BioMed are already utilizing the HLT Pharma EDC product.
In terms of integration with upstream and downstream partners, in addition to achieving “interconnectivity” with various Electronic Data Capture (EDC) systems, HLT Pharma also collaborates extensively with medical institutions, networks of medical experts, industry associations, and clinical trial and research service partners. Together, they build disease and patient models, conduct in-depth mining of core data, and drive greater insights across the continuum from clinical care to rehabilitation.
“We are a cross-disciplinary team, with members hailing from large pharmaceutical companies, CROs, and internet enterprises. All of us have many years of industry experience, understand the actual needs of enterprises, and can therefore target our product and service design precisely,” Peng Tao told VCBeat. He stated that HLT Pharma positions itself as a “leader in innovative pharmaceutical solutions,” providing pharmaceutical companies with full lifecycle product services. “The EDC product is merely one component and supporting tool within our service offerings.”
Specifically, aligned with the progress of pharmaceutical product development, HLT Pharma’s services focus on three stages: pre-market clinical research, market approval submission strategies, and post-market real-world studies. Specifically, these services include clinical trial protocol design, clinical trial data management, pharmacoeconomic evaluation, rational drug use evaluation, clinical pathway evaluation, pharmacovigilance solutions, and real-world evidence/studies.
Different types of enterprises have varying needs. HLT Pharma’s clients primarily fall into three categories: innovative pharmaceutical companies, CROs and traditional domestic pharmaceutical companies, and multinational corporations (MNCs). The innovative drug market has gained significant momentum in recent years, characterized by high-level and ambitious R&D efforts focused on original drugs. For these clients, HLT Pharma provides end-to-end services ranging from clinical trial design, regulatory registration, and commercial strategy to post-marketing studies. CROs and traditional local enterprises place greater emphasis on cost-effectiveness. HLT Pharma enters this segment by offering high-quality services at reasonable prices. Multinational pharmaceutical companies mainly conduct international multi-center clinical trials, requiring globally synchronized data management capabilities, along with specific regulatory submission needs.
Regarding HLT Pharma’s development strategy, Peng Tao stated, “Driven by favorable policies—such as state encouragement of innovation in pharmaceuticals and medical devices, the consistency evaluation of generic drugs, and the return of a large number of overseas biomedical innovation talents—the domestic pharmaceutical industry presents significant growth opportunities. This creates an excellent opportunity for providing pharmaceutical enterprises with informatization and data intelligence services. Leveraging its strong technological advantages, HLT Pharma aims to rapidly expand its market share in China in the short term. In the long run, as innovative drug R&D upgrades and expands globally, HLT Pharma aspires to become a mainstream provider of informatization solutions for the global pharmaceutical industry.”