Sipai Health Recognized as China's Sole Representative in CB Insights' Digital Health 150 for Real-World Evidence Innovation

In early October 2019, CB Insights released its inaugural list of the 150 Most Promising Digital Health Companies (Digital Health 150). From a pool of over 5,000 startups, CB Insights industry analysts selected 150 high-potential companies that are providing disruptive emerging technology solutions to the healthcare industry through innovative primary care models.

According to CB Insights, the Digital Health 150 list is evaluated based on factors such as patent applications, investor composition, public sentiment, market potential, partnerships, competitive landscape, team strength, and technological novelty. The 150 selected startups cover a wide range of sectors, spanning from disease diagnosis to technology-driven health insurance platforms and AI tools for drug discovery.

Notably, in the “Drug R&D: Real-World Evidence” category of the Digital Health 150 list, CB Insights selected eight high-potential companies worldwide, with Medbanks being the only Chinese company shortlisted. In fact, Medbanks has a long-standing presence in the field of Real-World Study (RWS).

Real-world studies originated from pragmatic clinical trials. They refer to studies that, based on a large sample size, non-randomly select treatment measures according to patients’ actual clinical conditions and preferences, and conduct long-term evaluations. In real-world studies, researchers focus on the effectiveness and adverse reactions observed in routine clinical practice, thereby further evaluating the external validity and safety of the interventions.

According to industry experts, like other clinical studies, real-world studies must be conducted around relevant scientific questions. However, a major feature of real-world studies is that data collection comprehensively applies multidisciplinary methods and techniques from clinical/pharmacoepidemiology, biostatistics, evidence-based medicine, and pharmacoeconomics, integrating multiple data resources to carry out the research. Since the study data are derived from real-world settings, the results of such studies are more representative than those of traditional randomized controlled trials (RCTs), and the research objectives are more flexible and diverse.

In practice, the key component of real-world studies (RWS) is the systematic collection and analysis of real-world data generated from routine clinical practice. RWS differs from randomized controlled trials (RCTs), which produce the highest level of evidence-based medicine, in terms of data collection logic, with the two approaches being complementary. In recent years, RWS has become an increasingly important trend in clinical research. According to statistics from Yaowu Guanlan, as of May 2019, more than 1,000 real-world studies had been registered on ClinicalTrials.gov, including nearly 150 studies conducted in China.

In April 2019, the FDA approved a new indication for Pfizer’s Ibrance (palbociclib) based on real-world data: in combination with an aromatase inhibitor or fulvestrant, it may be used to treat male patients with HR-positive, HER2-negative metastatic breast cancer. According to Pfizer’s official announcement, this FDA approval was primarily based on post-marketing real-world medication data from male patients recorded in the IQVIA insurance claims database, Flatiron Health’s breast cancer database, and Pfizer’s global safety database, rather than on clinical trials or assessments of clinical performance.

Previously, in December 2018, the FDA appointed Amy Abernethy, CMO of Flatiron Health, as its Principal Deputy Commissioner. At that time, former FDA Commissioner Scott Gottlieb stated that a key reason for this appointment was Abernethy’s extensive experience in the application of real-world evidence and in conducting efficient, innovative clinical trials, which would help the FDA improve its review policies for clinical drugs and accelerate the review process.

In 2018, China’s first real-world study guideline—the “2018 Chinese Real-World Study Guideline”—was jointly released by the Wu Jieping Medical Foundation and the Chinese Thoracic Oncology Group. In the same year, a Chinese multicenter observational real-world study led by the Chinese People's Liberation Army General Hospital was presented at the 2018 ASCO Annual Meeting. Real-world studies have been receiving increasing attention in China.

“The General Manager of Medbanks told VCBeat that since 2016, Medbanks has invested substantial personnel and financial resources to deepen its engagement in the field of real-world evidence (RWE), and has thus become a key participant in real-world studies related to oncology in China.”

Founded in Beijing in 2014, Medbanks has long been dedicated to the oncology sector. It currently operates four core business segments: pre-market clinical study management for new oncology drugs (SMO), post-market real-world evidence studies (RWE), specialty pharmacy services (DTP), and health insurance services and management (PPO/PBM). Its operations cover 28 provinces and municipalities and more than 330 cities across China.

A spokesperson for Medbanks highlighted that Medbanks (Beijing) Medical Technology Co., Ltd. (hereinafter referred to as “Medbanks Medical”) positions itself as a practitioner of real-world data (RWD) in oncology. The company has long focused on the curation and analysis of big data related to cancer care, accumulating extensive high-quality, multi-layered datasets and building a robust network of researchers with strong collaborative ties. Leveraging these integrated resources, Medbanks Medical rapidly launched its real-world study (RWS) services in oncology, gradually establishing a distinct competitive advantage.

Specifically, Medbanks has developed the capability to acquire real-world data (RWD) by leveraging its commercial team, Site Management Organization (SMO) team, and hospital/physician resources. The company has accumulated a vast amount of oncology-related RWD through disease-specific cohort data accumulation, external data collaborations, and data flows across its various business divisions. Undoubtedly, the operational expertise Medbanks has gained from its previous activities in RWD analysis, real-world studies (RWS), and patient management will benefit its RWS business.

As a critical component of its full-lifecycle drug commercialization management, Medbanks has collaborated with multiple multinational pharmaceutical companies to conduct numerous real-world studies and real-world-based patient management programs.

To date, Medbanks has conducted numerous retrospective studies to support the clinical-exemption market approval and indication expansion of medical products, completing over 60,000 real-world studies. In addition, Medbanks has launched patient management programs and charitable assistance initiatives. “Looking ahead, Medbanks will leverage its inclusion in the Digital Health 150 list as an opportunity to deepen its expertise in oncology real-world research, thereby benefiting more physicians and patients,” said a representative from Medbanks.