The Expert Consultation Meeting on the Clinical Trial Protocol for the Post-Marketing Evaluation of Shuganning Injection was successfully held in Beijing.

On April 3, 2026, the expert consultation meeting on the clinical trial protocol for the post‑marketing evaluation of Shuganning Injection was successfully held in Beijing. The meeting brought together leading experts from the industry to conduct an in-depth discussion on the scientific design and systematic optimization of the clinical trial protocol for Shuganning Injection, providing crucial support for establishing a high‑level clinical evaluation framework for traditional Chinese medicine injections and strengthening the evidence base of evidence‑based medicine.

The meeting was co-chaired by Researcher Sun Xiaobo of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, and Chief Researcher Xie Yanming of the China Academy of Traditional Chinese Medicine. Also in attendance were leading experts in the field of liver diseases, including Professor Xu Xiaoyuan from Peking University Health Science Center, Director Li Xiuhui of Beijing You’an Hospital affiliated with Capital Medical University, Professor Xu Chunjun of Beijing Traditional Chinese Medicine Hospital affiliated with Capital Medical University, Professor Nan Yuemin of the Third Hospital of Hebei Medical University, Professor Ye Yong’an of the Liver Disease Research Institute at Beijing University of Chinese Medicine, and Professor Han Ying of Xijing Hospital, as well as Deputy Director Li Lei, Deputy Secretaries-General Sun Yuanyuan and Zou Ting of the China Association of Traditional Chinese Medicine, along with Xiong Yigang, Chairman of Guizhou Ruihe Pharmaceutical Co., Ltd., and He Feng, Director of Research and Development.

At the meeting, Mr. Xie first outlined the background and core objectives of the session, emphasizing that the purpose of this symposium is to refine the post‑marketing evaluation clinical trial protocol for Shuganning Injection in accordance with scientific, standardized, and rigorous principles. General Manager Xiong delivered a welcoming address, while General Manager He provided an overview of the basic information on Shuganning Injection and the status of its post‑marketing studies. The Shuganning Injection project team from the Institute of Clinical Basic Medicine at the China Academy of Traditional Chinese Medicine then presented a detailed exposition of the clinical trial protocol.

The experts in attendance unanimously affirmed the product’s remarkable clinical efficacy in promoting bile flow and reducing jaundice, as well as protecting the liver and lowering enzyme levels. In conjunction with… Announcement on Further Promoting the Marketing Authorization Holder to Accelerate Post-Marketing Research and Evaluation of Traditional Chinese Medicine Injection Products (Draft for Public Comment) In accordance with the “Basic Technical Requirements for Post-Marketing Research and Evaluation of Traditional Chinese Medicine Injections (Draft for Comments)” and other relevant guidelines, the expert panel conducted thorough discussions and in-depth deliberations on key aspects—including RCT trial design, precise indication targeting, and the development of efficacy‑evaluation metrics—focusing on areas such as unlocking the product’s clinical value and leveraging its advantages in the diagnosis and treatment of acute and critical conditions. The panel put forward a series of professional, rigorous, and practically feasible optimization recommendations, providing crucial guidance for the scientific refinement and high‑quality implementation of the trial protocol.

The successful convening of this expert meeting has laid a solid foundation for the subsequent optimization of clinical trial protocols and the rigorous implementation of research standards. We will comprehensively draw on the expertise of our panel, continuously refine the trial design, and advance post‑marketing evaluation studies with high standards and superior quality, thereby providing robust, evidence‑based support for the rational clinical use of traditional Chinese medicines and fostering the inheritance, innovation, and high‑quality development of the TCM industry.