Jingyi Hesheng Launches Hospital-Formulated Trial of Standardized TCM Protocol for Type 2 Diabetes, Targets TCM Standardization Challenge

The macroeconomic backdrop of the post-pandemic era, combined with the inaugural year of the 14th Five-Year Plan, has provided a potent remedy for the “development journey” of traditional Chinese medicine.

At the top-level design, the 14th Five-Year Plan explicitly states that it is necessary to improve the Traditional Chinese Medicine (TCM) service system and leverage the unique advantages of TCM in disease prevention, treatment, and rehabilitation; strengthen the organization and excavation of the essence of classical medical texts, build a scientific and technological support platform for TCM, reform and improve the review and approval mechanism for traditional Chinese medicines, and promote the research, development, protection, and industrial growth of new TCM drugs.

In terms of implementation, the State Council issued the "Notice on Several Policy Measures for Accelerating the Characteristic Development of Traditional Chinese Medicine," which established implementation measures across dimensions such as TCM talent development, traditional Chinese medicine industry management, and the TCM development environment. The notice also mentioned the establishment of 10 to 20 national clinical medical research centers specializing in traditional Chinese medicine to vigorously promote scientific research and development in the field.

In response to the national call to promote the development of Traditional Chinese Medicine (TCM), many TCM enterprises are actively exploring solutions, committed to addressing challenges such as market education and inconsistent diagnostic and treatment standards on the path of TCM inheritance and innovation.

Supreme Life is one such example, focusing on scientific research in traditional Chinese medicine (TCM) and targeting the challenges of standardization and normalization in TCM.

Supreme Life is dedicated to the standardization, scientific research, and commercial translation of specialized clinical treatment protocols in Traditional Chinese Medicine (TCM). Its team brings together a large group of professionals, including postdoctoral fellows from the Perelman School of Medicine at the University of Pennsylvania, postdoctoral fellows from Beijing University of Chinese Medicine, and research experts from top-tier (Grade A tertiary) hospitals in Beijing.

After six years of in-depth research, Supreme Life has achieved phased results in the diagnosis and treatment of type 2 diabetes. He Jian, Founder and CEO of Supreme Life, introduced that the company has developed a standardized Traditional Chinese Medicine (TCM) treatment protocol for type 2 diabetes, which differs from conventional therapies, and has commenced the development of proprietary Chinese medicines and hospital preparations.

He Jian, Founder of Supreme Life

He Jian also serves as the Chairman of TCM Online. TCM Online is currently a highly influential online platform dedicated to the heritage and education of Traditional Chinese Medicine (TCM). Built upon internet technologies, the platform has been committed to clinical TCM heritage education and boasts an extensive pool of expert resources.

Actual Images of Select Courses on the TCM Online Platform

"Many diagnostic and treatment protocols in Traditional Chinese Medicine (TCM), particularly those developed by TCM masters, require systematic excavation and inheritance." He Jian has developed his own theoretical framework for understanding the inheritance of TCM.

He Jian stated, “The essence of Traditional Chinese Medicine (TCM) education is not to run training courses, but to deliver solutions. National Medical Masters, renowned veteran TCM practitioners, and clinical experts distill decades of specialized experience through their teaching. They categorize this expertise according to TCM theoretical frameworks into several scenarios, providing specific solutions for each along with data on treatment prognosis. This process essentially represents the experts’ self-directed deep learning in the clinical management of certain disease categories accumulated over decades of medical practice. The role of TCM education is twofold: it facilitates the learning and inheritance among TCM professionals, and it provides exploitable opportunities for optimizing TCM clinical treatment protocols and advancing scientific research.”

In the course of inheriting clinical education in Traditional Chinese Medicine (TCM), He Jian also led a small team to explore the scientific basis of TCM treatments, striving to align the methodological framework of TCM clinical practice with the scientific explanations of modern medicine.

Supreme Life was established against this backdrop. In 2020, He Jian and his team embarked on a new journey by founding Supreme Life, dedicated to the standardization, scientific research, and commercial translation of specialized clinical treatment protocols in traditional Chinese medicine (TCM). The team brings together a large group of professionals, including postdoctoral fellows from the Perelman School of Medicine at the University of Pennsylvania and Beijing University of Chinese Medicine, as well as research experts from top-tier (Grade IIIA) hospitals in Beijing.

In March 2021, Supreme Life completed a RMB 25 million angel financing round, jointly invested by IDG Capital and Jiadao Capital, which is held by renowned investor Gong Hongjia.

Since 2015, He Jian’s team has conducted clinical efficacy observations on a total of 112 experts and teams treating diabetes with Traditional Chinese Medicine (TCM). These expert teams come from diverse backgrounds, including not only those who teach on online TCM platforms but also some of the most renowned expert teams across China.

After excluding individual cases and other factors, He Jian’s team conducted an in-depth scientific analysis of 17 teams with a sufficient number of cases and demonstrated therapeutic efficacy. In December 2017, they identified the “Biao Ben Ni Cong Method” (a TCM approach for treating diabetes) developed by Hu Tianbao’s team in Qujing, Yunnan Province, as their focal point. Using this methodology as a prototype, they carried out multi-center, large-sample clinical trials at multiple hospitals and community health centers in Beijing and other locations. Meanwhile, Supreme Life established a big data platform for scientific research to enable comprehensive scientific monitoring of each patient, thereby optimizing prescriptions and developing Supreme Life’s “Standardized TCM Treatment Protocol for Eliminating Insulin Resistance and Restoring Pancreatic Function.”

In 2020, the diabetes team from Supreme Life randomly enrolled 138 patients with diabetes at multiple community health service centers, including the Beijing Tieying Community Health Service Center. Of these, 101 patients adhered to the treatment regimen. The enrolled patients voluntarily accepted Traditional Chinese Medicine (TCM) treatment. On the first day of enrollment, they discontinued oral hypoglycemic agents. For patients using insulin, the dosage was gradually reduced based on blood glucose levels monitored throughout the treatment course. The treatment duration was five months.

Clinical trials demonstrated that 58% of patients discontinued insulin therapy within the first month, and 79% did so within two months. These patients exhibited improved glycemic control, with better hemoglobin A1c (HbA1c) levels and pre- and postprandial (2-hour) blood glucose values compared to baseline. Among patients who had not previously used insulin, 89% showed improved clinical indicators after five months of standardized Traditional Chinese Medicine (TCM) treatment. Notably, 59% of these patients achieved HbA1c levels below the WHO diagnostic threshold for diabetes (6.5%) after discontinuing both TCM and conventional Western medications. Six-month follow-up data for patients who ceased all treatments revealed that 78% maintained target glycemic levels. Furthermore, a significant proportion of patients experienced substantial improvements in lipid profiles and blood pressure compared to baseline.

The remarkable therapeutic efficacy has also garnered recognition from government authorities. In May 2020, Hu Tianbao was honored as a “Renowned Senior Traditional Chinese Medicine (TCM) Practitioner of Beijing” by the Beijing Administration of Traditional Chinese Medicine. With government funding, Supreme Life established the “3+3” Flame Legacy Grassroots Inheritance Studios for Renowned Senior TCM Practitioners of Beijing in multiple community centers, dedicated to scientific research on TCM treatments for diabetes.

Furthermore, favorable policies regarding clinical trials and regulatory approvals for Traditional Chinese Medicine (TCM) have also accelerated the product development process at Supreme Life.

The National Medical Products Administration’s 2018 “Provisions on Simplified Registration and Approval Management of Traditional Chinese Medicine Compound Preparations Derived from Ancient Classical Formulas” states that traditional Chinese medicine (TCM) compound preparations derived from ancient classical formulas (Category 3.1) may submit only non-clinical safety study data; for TCM compound preparations based on modifications of ancient classical formulas (Category 3.2), if the extraction involves decocting the entire formula with water and human use history data are provided, pharmacodynamic studies and clinical trials may be waived.

In February 2021, the State Council issued the Several Policy Measures on Accelerating the Characteristic Development of Traditional Chinese Medicine, which stated that the review and approval process for new traditional Chinese medicine (TCM) drugs with human use experience should be optimized. For eligible innovative TCM drugs, improved new TCM drugs, classical ancient prescriptions, and drugs with the same name and formulation, a management mechanism should be studied and implemented in accordance with laws and regulations to exempt them from non-clinical safety studies and certain clinical trials.

Supreme Life has partnered with a CRO specializing in Chinese patent medicines to extend its standardized methodology for traditional Chinese medicine (TCM) treatment into the development and clinical trials of proprietary Chinese medicines and hospital preparations, with filing for hospital preparation registration expected by the end of 2022.

Supreme Life Laboratory

He Jian lamented that while the state is vigorously promoting the inclusion of proprietary Chinese medicines (PCMs) in the National Essential Medicines List, there remains a notable lack of PCMs with proven efficacy for major chronic conditions such as diabetes. In the coming years, Supreme Life’s PCM-based treatment regimen for diabetes will continue to be optimized, facilitating its rapid entry into the PCM market and ultimately benefiting patients.

Leveraging China’s national clinical education resources in Traditional Chinese Medicine (TCM), Supreme Life is actively exploring TCM treatments for conditions where it holds therapeutic advantages, including hyperlipidemia, hypertension, sleep disorders, breast nodules, and early-stage breast cancer. The company is committed to continuously developing highly effective, standardized solutions and new proprietary Chinese patent medicines. “We believe that as long as we uphold an objective and scientific approach, and continually tap into the treasure trove of our ancestors’ wisdom using modern technology and methodologies, the future of TCM will be boundless,” shared He Jian.