Qing-Shen Tongluo Granule, the First Class 1.1 TCM Innovative Drug Driven by Network Target Theory, Receives NMPA Approval for Phase III Clinical Trial

On April 14, 2026, Jiangsu Kanion Pharmaceutical Co., Ltd. submitted an application for1.1 Class 1 Innovative Traditional Chinese Medicine: Qingshen Tongluo Granules, received the Notice of Approval for Drug Clinical Trials from the National Medical Products Administration (No.: 2026LP01179), approving the conduct of confirmatory clinical trials of this product for rheumatoid arthritis with dampness-heat and bi-obstruction syndrome. Qingshen Tongluo Granules became the first to achieve exemption from clinical trials by applying network target technology combined with human use experience,Directly Enter Phase IIIof Category 1 innovative traditional Chinese medicine.

Against the backdrop of the implementation of new regulations on the registration and administration of traditional Chinese medicines, this product relies onIntelligent Technologies in Network Pharmacology and High-Quality Human EvidenceIt has established a comprehensive evaluation system and is currently a benchmark product with demonstrative value in the innovative research and development of traditional Chinese medicine.

Qingshen Tongluo Granules (formerly known as Jiawei Qingluo Granules) formula isTsinghua University Li Shao TeamAdoptCyber Range TechnologyOptimized patented prescription for the treatment of rheumatoid arthritis, “Jiawei Qingluo Yin” (Patent No.: ZL 201810806193.8; Inventors: Li Shao, Li Yan). In May 2022, Tsinghua University and Yijishan Hospital of Wannan Medical College granted Kanion Pharmaceutical an exclusive license for its industrial development. In accordance with the National Naming Conventions for Generic Chinese Proprietary Medicines, the product has been officially named “Qingshen Tongluo Granules.”

Qingshen Tongluo Granules are the first Class 1.1 new drug developed driven by network target theory and technologyA Class 1.1 innovative traditional Chinese medicine (TCM) drug, and the first such drug derived from Xin’an Medicine, its R&D paradigm holds significant demonstrative and guiding implications for the inheritance, innovation, and development of Traditional Chinese Medicine in the AI era.

To systematically inherit and transform the academic experience of National Masters of Traditional Chinese Medicine in treating bi-syndrome, the team led by Li Shao, Director of the Institute for Interdisciplinary Research on Traditional Chinese Medicine at Tsinghua University and Academician of the European Academy of Sciences and Arts,Network Target Theoryas a guide, relying on independently developedUNIQ Intelligent Navigation System, deeply mined 871 clinical case records of treating bi-syndrome by Li Jiren, the first National Master of Traditional Chinese Medicine, and distilled core empirical formulas; subsequently constructed key molecular networks for rheumatoid arthritis with dampness-heat obstruction syndrome, targeting the core modules of the network to elucidate the mechanisms of action of the core empirical formulas on one hand, and to conduct global search, high-precision prediction, quantitative analysis, and experimental validation of all Chinese herbal medicines targeting the core network modules on the other hand; based on the principles of network regulation, and integrating Professor Li Yan’s academic philosophy of “differentiating bi-syndrome by cold and heat” from Yijishan Hospital of Wannan Medical College, completedPrecision Prescription Optimization, resulting in innovative patented formulations with clearly defined mechanisms of action, precise targeting, and outstanding therapeutic efficacy.

This product is supported by robust and extensive human use experience and clinical evidence. Real-world studies have demonstrated that the optimized formulation achieves a higher ACR50 response rate (a core efficacy endpoint in rheumatoid arthritis) compared to the original formula.21% Increase; subsequently led by Yijishan Hospital of Wannan Medical College, in collaboration with 14 Grade A tertiary hospitals across ChinaMulticenter, Randomized, Double-Blind Clinical Trial, the system validated its definitive clinical value: the Qingshen Tongluo Granule treatment group demonstrated increases of 41.8% and 41.4% in ACR20 and ACR50 response rates, respectively, compared with the standard therapy group, with statistically significant differences (P<0.0001), thereby laying a solid evidence-based foundation for the efficient advancement of clinical trials.

1. Clear core efficacy and well-defined mechanism of action

This formula inherits the core therapeutic principles of clearing heat and unblocking collaterals, as well as dispelling dampness and alleviating pain. It integrates wind-dispelling and collateral-unblocking actions with qi-tonifying and tendon-relaxing effects, addressing both pathogenic factors and vital qi. It precisely targets key pathological processes in rheumatoid arthritis, including joint swelling and pain, synovial hyperplasia, and pannus formation. The formula exhibits multiple pharmacological effects, such as anti-inflammatory and analgesic activities, immunomodulation, and inhibition of angiogenesis, aligning with the holistic regulatory characteristics of Traditional Chinese Medicine.

2. Outstanding Clinical Advantages and Robust Evidence-Based Support

This product effectively addresses the limitations of existing treatments for rheumatoid arthritis, demonstrating significant therapeutic advantages in multicenter, randomized, double-blind clinical trials. Its “High-Quality Human Use Experience + Intelligent Technology Analysis + Clinical Evidence-Based Validation” complete chain of evidence, highly aligned with the “three-in-one” review requirements for new traditional Chinese medicine drugs.

1. Breaking Through the Bottleneck of Inheriting Renowned Physicians’ Expertise: Building a Digital, Living Transformation System

Leveraging network target technology, this achievement transforms the clinical experience and compatibility rules of National Medical Masters intoQuantifiable, Analyzable, Replicablean intelligent R&D system that breaks through the limitations of traditional empirical inheritance, constructs a full-chain technical framework of “human use experience–intelligent computing–clinical evaluation,” and achieves standardized, scientific, and innovative development of renowned physicians’ expertise, thereby providing a replicable demonstration pathway for the living inheritance of academic schools such as Xin’an Medicine.

2. Revolutionize the R&D Model of Traditional Chinese Medicine and Pioneer a New Path for “Intelligent Drug Discovery”

Distinct from the traditional experience-based formulation model, Qingshen Tongluo Granules are centered on network target technology to construct “Precision Prediction—Quantitative Analysis—Experimental Validation—Clinical Corroboration” intelligent R&D closed loop, aligning with the essential characteristics of traditional Chinese medicine (TCM), including multi-component, multi-target, and holistic regulation, thereby providing a paradigm for AI-enabled TCM innovation.

Of particular importance, this product isUNIQ Intelligent System Empowers Prescription Optimization by Integrating High-Quality Real-World Human Experience with Multi-Center Clinical Evidence, deeply implementing the "three-in-one" evaluation system for new traditional Chinese medicine (TCM) drug registration, achieving a major breakthrough in the efficient integration of human use experience with clinical trials and the conversion of evidence into regulatory submissions, significantly shortening the R&D cycle, and markedly improving the efficiency of TCM innovation.

The approval of Qingshen Tongluo Granules for clinical trials not only marks the entry of a high-end innovative traditional Chinese medicine (TCM) drug in the field of rheumatoid arthritis into a critical clinical stage, but alsoEmpirically Demonstrates the Core Value of Network Pharmacology in Transitioning from “Elucidating Traditional Chinese Medicine” to “Innovating New Pharmaceuticals”, thereby establishing a new system of precision R&D and scientific evaluation that is AI-enabled, aligned with the characteristics of traditional Chinese medicine (TCM), and compliant with regulatory review requirements, setting a new benchmark for high-quality innovation and scientific development of new TCM drugs in China.

References:

[1] Li Shao, Li Yan. A Traditional Chinese Medicine Formula Jiawei Qingluo Yin for Treating Rheumatic Diseases: ZL 201810806193.8 [P]. Beijing: China National Intellectual Property Administration. 2022-02-01.

[2] Li Yan, Wang Xin, Yang Zhe, Liao Nanxi, Wang Yiwei, Ji Chaofan, Li Shao*. A New Method for Optimizing Renowned Physicians’ Empirical Formulas Based on Network Targets: A Case Study of the Optimization and Development of “Qingluo Yin” [J]. China Journal of Chinese Materia Medica. 2022,47(19):5264-5273.

[3] Xu Jing. Efficacy of Jiawei Qingluo Granules in the Treatment of Rheumatoid Arthritis Verified[N]. China News of Traditional Chinese Medicine. 2025-05-26.