The launch meeting of Nanjing Tianyinshan Hospital, the team leader of the national multi-center real-world research on the modern Chinese medicine Tongguan Teng preparation (Shengnai®) for the treatment of digestive system tumors, was successfully held

On May 19, 2025, the launch meeting of Nanjing Tianyinshan Hospital of the "National Multi-center Real-World Study of Modern Chinese Medicine Tongguan Teng Preparation (Shengnai ®) for the Treatment of Digestive System Tumors" sponsored by Nanjing Sanhome Pharmaceutical Co., Ltd. was successfully held. This project is led by the Anti-tumor Drug Clinical Research Committee of the China Medical Innovation Promotion Association and the Beijing Xisike Clinical Oncology Research Foundation as academic guidance units. Professor Qin Shukui serves as the leader of the academic guidance expert group. Professor Li Jin, Academician Fan Jia, Professor Zhou Jian, Professor Liang Jun, Professor Nan Kejun and many other well-known oncology clinical experts serve as members of the academic guidance group to jointly guide the project in clinical development. Shanghai Lingxian Pharmaceutical Technology Co., Ltd., as a CRO company, fully supports the implementation of this study. All research parties attached great importance to the kick-off meeting. Professor Qin Shukui, leader of the project academic guidance group, Dr. Wang Yong, chairman of Shenghe Pharmaceutical, and Mr. Sun Zhongliang, chairman of Lingxian Pharmaceutical, attended the meeting.

Research highlights: Integration of traditional Chinese and Western medicine, focusing on clinical pain points

• Policy response: Traditional Chinese medicine is an outstanding treasure of Chinese civilization and plays an important role in safeguarding the health of the Chinese people and all mankind. The party and the government have long attached great importance to the development of traditional Chinese medicine. The "14th Five-Year Plan for the Development of Traditional Chinese Medicine" and the "Action Plan for the High-Quality Development of Traditional Chinese Medicine" and other policy guidance promote the integration of clinical value assessment of traditional Chinese medicine with evidence-based medicine.
• Innovative design: Real-world study (RWS), as a powerful supplement to randomized clinical controlled trials, can provide more information derived from clinical practice and relevant to actual situations. As China's first clearance rattan preparation (Shengnai) RWS, it covers multiple scenarios such as single drug, combined systemic treatment and local treatment (such as TACE, radiotherapy), and comprehensively evaluates clinical effectiveness and safety.
• Big names gather to explore the value of research

The meeting began with an opening speech by Professor Qin Shukui, a well-known oncology clinical expert. He pointed out that real-world research (RWS) is a key bridge connecting clinical practice and evidence-based medicine. Especially in the field of traditional Chinese medicine, scientific and standardized data collection is needed to provide high-level evidence support for the modern application of traditional medicines and promote the innovative development of the integration of traditional Chinese and Western medicine in tumor treatment. Professor Qin emphasized that this study is not only a verification of the clinical value of Tongguanteng preparation (Shengnai®), but also an exploration of innovative models of integrated traditional Chinese and Western medicine in the treatment of tumors.

Professor Qin Shukui, Professor Chen Yingxia, Professor Zhang Yu and other participating experts conducted in-depth discussions around research design, efficacy evaluation and the anti-tumor mechanism of traditional Chinese medicine. They affirmed the clinical efficacy of Tongguanteng preparation (Shengnai®) in single use and combination treatment, and pointed out that its safety and effectiveness need to be further verified through real-world large sample data.

Dr. Wang Yong, Chairman of Nanjing Sanhome Pharmaceutical Co., Ltd., shared his analysis of the mechanism of action of Tongguandeng Teng Preparation (Shengnai ®) from a pharmacological perspective. Tongguan Teng preparation (Shengnai ®) is an anti-tumor drug that follows the scientific logic of Western medicine, is based on substances, and has clear targets and mechanisms of action. It is also an anti-tumor drug that combines the medication theory of monarch, minister and assistant with Chinese characteristics. Perhaps this drug can find another new mechanism and new path for the clinical treatment of tumors. Tongguanteng preparation (Shengnai ®) promotes apoptosis through C21 steroid glycosides, promotes differentiation with chlorogenic acid, and enhances immunity with polysaccharides. The three of them cooperate with multiple targets to fight tumors, playing a 1+1+1>3 role. Dr. Wang Yong said that if the real-world study of Tongguanteng preparation (Shengnai®) is successful, it will further confirm the establishment of the pro-differentiation mechanism, open up a new channel for tumor treatment, and prove that the clinical medication theory of traditional Chinese medicine, in which the monarch and his minister serve as assistants, may be based on the synergistic effect of active substances with differentiated mechanisms of action. At the same time, drugs with completely different mechanisms for the same indication, especially difficult and complicated diseases, can often have good synergistic effects.

As the CRO partner of this study, Director Guo Axuan, head of post-marketing research at Lingxian Pharmaceuticals, systematically elaborated on the research plan at the kick-off meeting from the four core modules of project establishment basis, research background, plan design, and implementation path:

Research design: Prospective, non-interventional observational study, covering esophageal, gastrointestinal, hepatobiliary and pancreatic and other digestive tract tumors;

Inclusion criteria: Patients who received Tongguan Teng preparation (Shengnai ® ) as a single agent or combination therapy were included to evaluate the safety, tolerability and efficacy;

Research progress: This research has obtained ethics approval from Tianyinshan Hospital, the team leader's unit, and has been registered in the National Medical Research Registration Information System.

Ethics and Quality Control:

• Strictly follow ethical review, protect the rights and interests of patients, and purchase insurance for subjects participating in the project;
• Tongguanteng (Shengnai ® ) oral syrup is provided free of charge by the sponsor, reducing the financial burden on patients;
• Establish a multi-center collaboration mechanism to ensure data authenticity and reliability through regular training and audits. The Lingxian Pharmaceutical team stated that it will rely on its rich experience in real-world research to provide technical support for the project and help generate high-quality evidence-based evidence.

Looking to the future: Empowering evidence-based medicine to promote the development of modern traditional Chinese medicine preparations

The existing standard treatment options for digestive system tumors have not yet met clinical treatment needs, and problems such as poor treatment effects, toxic side effects, and drug resistance need to be solved urgently. Tongguanteng preparation (Shengnai®) relies on active ingredients such as C21 steroid glycosides, chlorogenic acid, and polysaccharides. It has good anti-tumor treatment efficacy and high safety in clinical use, but it still lacks high-level evidence support. Through the collaboration of multiple centers across the country, this study will prospectively observe the efficacy and safety of Tongguanteng preparation (Shengnai®) alone or in combination, accumulate real-world data, provide high-level evidence-based medical evidence for clinical practice, and provide new treatment options for the treatment of digestive tract tumors.

The successful holding of this kick-off meeting marks that the real-world research on Tongguan Vine Preparation (Shengnai®) has officially entered the implementation stage. Lingxian Medicine will rely on its rich project management experience and work closely with sponsors, research centers and academic guidance units to help Tongguanteng preparations (Shengnai®) transform from "clinical experience" to "clinical evidence", and contribute to the innovative development of modern traditional Chinese medicine preparations in the field of anti-tumor!