Traditional Chinese Medicine (TCM) has long been built on the accumulated wisdom of generations of physicians. However, when measured against the rigorous standards of modern medicine, the industry faces an unavoidable challenge: how to use repeatable, quantifiable data to prove its safety and efficacy. Recently, a review of corporate announcements by listed companies reveals that the term "evidence-based medicine" is being mentioned with increasing frequency by Chinese pharmaceutical firms. This approach, originating in the West, relies on large-scale randomized controlled trials (RCTs) and real-world studies to generate clinical data supporting a drug’s safety and effectiveness. The pressing question is how TCM’s therapeutic effects can be validated through clinical data, and what profound impact this shift will have on the industry. This investigation seeks to uncover the answers.

From Food-Medicine Homology to Evidence-Based Data

In recent years, a growing number of consumers have embraced wellness trends, unlocking new opportunities for TCM at the consumer level. At the recent 19th Health Industry Ecosystem Conference (2026 Xipu Summit), companies showcased innovative ideas: adding Astragalus oral liquid to regular coffee for an energy boost with restorative benefits, or pairing turmeric with potatoes for anti-inflammatory carbohydrates. Meanwhile, products like "Seven-White Drink," "Five-Red Soup," and "Sleep Calming Paste" are bringing TCM closer to everyday life. Yet, the industry is now pushing beyond product innovation to tackle a deeper question: why is TCM effective in the first place?

Suxiao Jiuxin Pills, a flagship product of Tianjin Darentang Group Co., Ltd. (referred to as "Darentang"), exemplifies this pursuit. Wang Lei, the company’s Party Secretary and Chairman, stated that to further substantiate the pills' efficacy, Darentang has collaborated with 12 top-tier hospitals to conduct observational studies involving over 2,800 cases. Through this evidence-based research, the company aims to validate the drug’s real-world clinical value. Similarly, Compound Kushen Injection, a signature product of Shanxi Zhendong Pharmaceutical Co., Ltd. (referred to as "Zhendong Pharmaceutical"), is undergoing clinical research with multiple scientific and medical institutions. Wang Rui, President of Zhendong Pharmaceutical, noted that despite being an established product with years of market presence, the company is adopting modern innovative drug development models to systematically conduct evidence-based research and academic promotion, thereby uncovering its full clinical potential. Meanwhile, Qiu Huawei, Chairman of China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (referred to as "CR Sanjiu"), highlighted that the company will focus on clinical needs and market demand, scouring medical institutions and research institutes for prescriptions with long-term clinical application potential. These will be developed using modern drug technology and evidence-based methodologies to ensure rigorous scientific validation. "Through evidence-based research, we aim to clearly articulate drug safety and efficacy using robust data, ensuring clinical medication quality and maximizing patient benefits," he explained.

Shifting From Visual Upgrades to Stronger Evidence

This transition from "fresh product appearances" to "harder evidence" reflects a fundamental change in how TCM companies define innovation.

"Previously, we discussed 'upholding tradition and innovating,' with many companies focusing heavily on preservation while limiting innovation to dosage form improvements, packaging upgrades, or consumption scenario optimization," said Wang Rui. "Now, innovation demands a deeper commitment to clinical value, evidence-based validation, and original research, ultimately culminating in clearer clinical benefits. To truly gain recognition from doctors and patients, a product’s clinical value must be supported by systematic data evidence."

Evidence-Based Medicine Is Not One-Size-Fits-All

Most existing TCM products derive from multi-herb compound formulas with decades of clinical practice. How can they be validated through data like modern innovative drugs? Jin Chunlin, Director of the Shanghai Health and Development Research Center, cites Shexiang Baoxin Pills an example. Its formula dates back to the Song Dynasty, but it was modernized in the 1970s when experts from Huashan Hospital affiliated with Fudan University used pharmacological research to refine the composition, resulting in the current seven-herb formula. From 2011 to 2021, Shanghai Hehe Pharmaceutical Co., Ltd., under Shanghai Pharmaceuticals Holding Co., Ltd., conducted a comprehensive evidence-based study covering 97 tertiary hospitals and involving over 2,600 patients with stable coronary artery disease. This large-scale trial ultimately confirmed the drug’s safety and efficacy. Another innovative TCM drug, Danning Tablets, has even gained approval for export to Canada. This demonstrates that TCM can be systematically transformed into data evidence that is understandable within modern medicine and various regulatory frameworks.

"Evidence-based medicine is an indispensable path for TCM modernization," Jin asserted. "It’s not about forcing TCM into the exact same evaluation logic as Western medicine, but rather helping it develop a language that the modern medical system can comprehend and accept. While chemical drugs often emphasize single targets and high selectivity, TCM compounds are characterized by multiple components and holistic regulation. Both can use standardized research to address efficacy and safety, but that doesn’t mean they must adopt identical mechanisms or development paradigms. TCM can maintain its theoretical foundation and intervention logic while meeting equally rigorous evidence standards for efficacy."

China is indeed gradually forming an evaluation system tailored to TCM research and development. Industry sources indicate that national policies are refining the "three-in-one" review evidence framework, which combines TCM theory, human experience, and clinical trials. Concurrently, there are efforts to phase out existing products lacking sufficient supporting evidence. For instance, proprietary Chinese medicines with labels still stating "not yet clear" for contraindications, adverse reactions, or precautions, and which fail to update this information within a specified timeframe, risk being removed from the national medical insurance drug catalog.

Unlocking New Development Space for the Industry

With these dual pressures—tightening entry standards and clearing out outdated stock—the competitive landscape for TCM enterprises is being reshaped. Jin believes that evidence-based medicine can help TCM overcome the "language barrier" within the modern healthcare system. Previously, some TCM products struggled to enter hospitals, insurance catalogs, or overseas markets due to a lack of high-quality clinical evidence. Now, generating higher-level evidence through large-scale RCTs and real-world studies will support clinical access, value assessments, insurance negotiations, and even internationalization.

However, this comes with higher hurdles. "High-quality evidence-based research can cost tens of millions of yuan or even over a hundred million, with study cycles spanning five to ten years. This demands immense financial resources, clinical access, and research management capabilities," Jin noted. He predicts this trend will objectively drive industry resources toward companies with strong research and integration capabilities.

"The continuously improving review and approval system for innovative TCM drugs is opening up new avenues for companies with genuine innovation capacity," Wang Rui stated. While older products and less innovative firms may face mounting pressure, those with substantial scale, R&D strength, and innovation will likely accelerate their development of new drugs. Qiu Huawei echoed this, noting that while evidence-based research poses significant technical barriers, it is a threshold the industry must cross. "By generating sufficient clinical evidence through rigorous research, companies can support TCM’s leading role in disease prevention, its synergistic role in treating major diseases, and its important function in rehabilitation," he added.

Some leading companies are already ahead of the curve. Innovative TCM drugs are classified into categories like 1.1, 1.2, and 1.3, with the 1.1 class demanding the highest level of R&D, clinical, and financial capability. According to data from the National Medical Products Administration (NMPA), three 1.1-class innovative TCM drugs—Zaoren Ningxin Dripping Pills, Jiaoqi Zhitong Gel Plaster, and Xiao'er Tongbian Granules—have been approved for market launch so far this year. The latter notably fills a gap in the domestic market for specialized pediatric constipation treatments.

A pipeline of innovative TCM drugs is also under development. Public filings show that Hubei Jumpcan Pharmaceutical Co., Ltd. has its 1.1-class new drug, Chaige Tuire Oral Liquid, with its marketing application accepted by the NMPA, while its Hanyan Granules are progressing through Phase II clinical trials. Shanghai Pharmaceuticals has completed Phase III clinical data collection for Shenqi Sheirong Pills, a potential treatment for mild-to-moderate cervical spondylotic myelopathy, and is now compiling the summary report; this drug could fill a clinical void in that therapeutic area. Additionally, the company is advancing Phase III trials for Huoling Shengji Granules, aimed at treating amyotrophic lateral sclerosis (ALS).

The Center for Drug Evaluation's "2025 Annual Drug Evaluation Report" reveals that in 2025, China received 103 clinical trial applications for innovative TCM drugs, spanning 89 varieties, and accepted 14 New Drug Applications (NDAs) for innovative TCM drugs, covering 13 varieties. Looking ahead, Li Hongjian, General Manager of the Big Data and Intelligence Center at Sinohealth Technology, told reporters that driven by policy support, an aging population, and growing health consciousness among younger generations, the concept of preventive treatment will further integrate TCM with consumer scenarios, opening up new growth prospects for the industry.