RELX successfully registers China’s first domestic e-cigarette clinical trial
On August 4, RELX (RLX Technology) announced that its application for an e-cigarette clinical trial has been successfully registered with the China Clinical Trial Registration Center (ChiCTR) and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP).
This is the first e-cigarette clinical research project in China that has passed ethical review and expert approval, filling a gap in domestic e-cigarette clinical research.
It is reported that the project will last for three months and will study the metabolic dynamics of nicotine in the subjects' bodies, as well as the impact of replacing cigarettes with RELX products on human biomarkers. The research team has basically completed the methodological validation of biomarkers in the human body.
According to the World Health Organization's requirements, all global clinical research must be registered before implementation. Through the WHO International Clinical Trials Registry Platform, the public can learn about all planned, ongoing, and completed clinical research. This not only ensures that the public can trace the results of each clinical trial but also helps reduce unnecessary duplicate research.
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In previous preclinical studies, mice exposed to e-cigarette aerosol through their mouths and noses for three weeks showed only minor microscopic structural changes in their respiratory tracts, which were relatively small compared to the molecular and microscopic changes associated with smoking-related diseases. In another 28-day study of e-cigarette inhalation toxicity in mice, only weak biological effects related to aerosol inhalation were observed. These findings provide foundational support for this clinical trial.
Prior to this, RELX ensured product quality by independently establishing strict standards for e-liquid. In 2021, RELX published two SCI papers that not only verified the inhalation safety of the cooling agent WS-23 but also demonstrated the harm reduction potential of e-cigarettes at the cellular level. The initiation of this clinical research will further provide evidence for the safety of RELX products.
The project leader, Zhong Guoping, deputy director of the Zhongshan University-RELX Technology Research Center for Atomization Science, stated: "This is a groundbreaking scientific research in China's e-cigarette industry, which will break the long-standing reliance on foreign clinical research data."
"This clinical research will provide more scientific basis for us to explore the harm reduction degree of e-cigarettes, and the relevant research results can also serve as a reference for the public's objective understanding of e-cigarettes," said Wen Yilong, co-founder and head of R&D and supply chain at RELX.
In 2020, RELX announced its "1+4" scientific research path: while ensuring product quality, it established four major modules for physical and chemical research, toxicological research, clinical research, and long-term impact assessment, comprehensively conducting scientific evaluations of e-cigarette atomizers.
Currently, RELX has established various professional research platforms, including physical and chemical laboratories and life sciences experiments, and has established cooperative projects with eight universities, two hospitals, and ten research and commissioned research institutions at different levels.
At present, the domestic atomization science research system is still incomplete, and clinical research is not a "must-have" before product launch. As the first e-cigarette brand to utilize modern medicine, toxicology, and other methods to conduct physical and chemical safety and clinical research on its products, RELX's continuous investment in research is, on one hand, responsible to consumers, and on the other hand, promotes the sustainable development of the industry.
