When traditional Chinese medicine is elevated to a national strategic level, innovation in Chinese medicine is gradually moving away from reliance on accumulated experience towards a more...Clinical Evidence and Standardized R&DThe foundational stage of development.
This change is first reflected in the adjustment of the regulatory system. Since 2020, policies such as the "Opinions on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine" and the "Special Provisions for the Registration and Management of Traditional Chinese Medicine" have been successively introduced, clearly establishing a review pathway that combines "Traditional Chinese Medicine theory, human experience, and clinical trials," which will...Clinical Human ExperienceIncorporating new drug registration evidence systems allows empirical formulas沉淀于临床一线的经验方 that have long been used in clinical settings to potentially enter standardized research and development processes.
"The 15th Five-Year Plan" has been fully launched, and the inheritance and innovation of traditional Chinese medicine have been included in the national key deployment. Policy support continues to deepen around the research and development of innovative Chinese medicines, the transformation of classic formulas, and the improvement of Chinese medicine quality and industry growth.
Against this backdrop, the application for new traditional Chinese medicine (TCM) drugs is showing a warming trend: In 2025, the number of registration applications for TCM Class 1 new drugs reached 117, including 89 clinical trial applications and 16 approved for production, with 73 approvals for clinical trials of Class 1.1 innovative drugs.
Although the improvement in the policy environment has provided fertile ground for the development of innovative traditional Chinese medicine (TCM), it has not directly addressed the core issues of TCM innovation. Unlike chemical drugs and biologics, which rely on established research and development paradigms, TCM research and development has long faced a more fundamental challenge:How to transform effective experiences scattered in clinical practice into verifiable, registrable drug products with industrialization potential.
It is against this backdrop that a category of platform enterprises centered on transformation capabilities has begun to emerge. Shengqu Jisheng Pharmaceutical Technology Co., Ltd. ("Shengqu Jisheng" for short), based in Chengdu, has chosen to enter from the clinical end, starting with "searching for clinically effective empirical formulas across China," exploring a model of TCM innovation that differs from traditional R&D pathways.
"The 'Clinical First, Then R&D' Model Breaks the Dilemma of High Costs and Low Success Rates in Traditional R&D"
In the field of TCM innovation,Uncertainty in Clinical Efficacy and Inefficiency in the R&D Pathway, which have long constituted the two core issues constraining the development of the industry.
On the one hand, the resources of Chinese patent medicines are extremely abundant. Monitoring data from the China Association of Traditional Chinese Medicine shows,As of the end of 2025, there are approximately 57,000 valid approval numbers for traditional Chinese medicine products in China, involving about 9,000 varieties.. However, in real clinical scenarios, the proportion of products that can form a stable consensus on efficacy and have further development value is not high.
On the other hand, the R&D paradigm inherited from chemical drugs and biologics — which starts from target screening, followed by compound optimization, pharmacological and toxicological studies, and then enters clinical trials — often faces the practical challenges of long cycles, high investment, and limited success rates. The industry commonly summarizes this model as "ten years, one billion US dollars, and less than 10% success rate," whose underlying logic does not fully align with the characteristics of Traditional Chinese Medicine (TCM), which is based on holistic regulation and the accumulation of clinical experience.
"Traditional R&D has already consumed a lot of time and cost before entering the clinical stage," said Mi Jun, founder of Shengqu Jisheng, in an interview.
Based on this judgment, Shenqu Jisheng prioritized clinical efficacy and proposed"First Clinical, Then R&D"The transformation path: prioritizing the selection of empirical formulas with an existing usage foundation from real clinical settings, conducting preliminary verification through investigator-initiated clinical studies (IIT), and then advancing to subsequent development stages such as new drug clinical trial applications (IND) after obtaining quantifiable data. The company disclosed that under this screening mechanism, some projects...The cycle from project initiation to IND application can be compressed to about one year, with relatively controllable early-stage investment.。
The premise of this model is the strict screening of clinical experience formulas. In an interview, Mi Jun mentioned that the screening intensity is about "one in ten," prioritizing complex diseases and areas where existing treatments are insufficient, with "whether it is superior to existing solutions" as the core criterion.
But moving from clinical experience formulas to new drugs is not just a matter of shifting the pathway forward. Before entering the standardized research and development system, two fundamental obstacles still need to be addressed: one is the intellectual property issue caused by unclear ownership, and the other is the standardization problem due to the difficulty in quantifying efficacy.
Centered around this key breakpoint, Shenqu Jisheng has gradually built up a set of transformation capabilities: on one hand, by jointly confirming rights with clinical experts and partners to clarify project ownership; on the other hand, through the collaboration of pharmaceutical science and clinical practice to complete formulation production, combined with Investigator-Initiated Trials (IIT) to refine indications, transforming the originally broad medication experience into quantifiable and reproducible clinical data.
Full-chain transformation, creating a one-stop innovative TCM transformation platform from clinical to market
Rooted in Pengzhou Traditional Chinese Medicine (TCM) Innovation City, Chengdu, the name "Shenqu Jisheng" is deeply meaningful: "Shenqu" is derived from fermented TCM herbs, symbolizing the transformation of clinical experience into new drugs; "Jisheng" reflects the original mission of "protecting public health and alleviating pain with TCM," aligning seamlessly with the company’s slogan, "Shenqu for the World, Caring for All Beings."
Relying on the endowment of regional traditional Chinese medicine resources and industrial supporting advantages, the company did not follow the traditional path of Chinese medicine enterprises focusing on production and sales or CROs concentrating on a single link. Instead, it positioned itself as a connecting node between clinical practice and the industry. Centering on the transformation process of traditional Chinese medicine from empirical formulas to new drugs, the company has built...An integrated platform covering key R&D and commercialization processes。
"TCM innovation transformation involves many links, from prescription screening and preparation technology, to clinical positioning and clinical research, and then to funding and industrialization connection. These aspects are often fragmented in the industry. We hope to connect these links," said Mi Jun in an interview.
In terms of specific pathways, the company starts with clinically experienced formulas, screens potential projects through literature and innovative assessments, and collaborates with clinical experts to complete formulation production, laying an industrial foundation. Subsequently, it uses IIT to identify indications and validate efficacy, progressively advancing subsequent development processes such as pharmaceutical science, pharmacology/toxicology, and IND.
The establishment of this full-process capability depends onDeeply integrate the core resources of the clinical, R&D, and industrial sectors, starting from clinical practice and returning to clinical practice.。
The company has built a three-dimensional core team of "clinical experts + drug R&D personnel + industry and capital professionals." Clinical experts ensure efficacy orientation, R&D personnel overcome technical challenges, and industry and capital professionals facilitate commercialization. The three groups complement and synergize with each other. Externally, the company continuously connects with high-quality clinical institutions, policy consulting organizations, and professional R&D service resources, establishing a stable collaborative system with internal and external linkages.
Multiple R&D pipelines are advancing simultaneously, covering indications such as kidney disease, autoimmune diseases, and gout.
Whether this transformation system is valid or not will ultimately be verified in specific projects.
In the project layout,Shenqu Jisheng has developed a pipeline covering multiple disease areas within half a year. Currently, there are 12 ongoing projects, spanning unmet clinical needs in chronic kidney disease, acute gout, chronic pain, thyroid hyperplasia, hepatobiliary duct stones, autoimmune diseases, and more.。
Taking an empirical formula in the field of nephrology as an example, this prescription is derived from a clinically long-used treatment plan with over 10 years of application experience. It also has the potential for further development into an innovative drug. After Shengqu Jisheng collaborated with relevant clinical experts, an IIT study was subsequently initiated. According to the company’s disclosed interim progress, the project has completed data collection for approximately 60 enrolled patients. Based on existing results, this solution demonstrates significant efficacy advantages over current treatments in some key indicators.
Based on the above clinical observation results, the project officially entered the initiation phase in September 2025, and work such as safety evaluation and pilot production will be progressively advanced, with plans to complete the IND application by the end of 2026.
In terms of project sources, the company mainly focuses on two types of resources: one is clinical experts with clear intentions for transformation and their empirical formulas, and the other is hospital preparations that meet innovation and indication requirements. In terms of cooperation models, the company does not simply adopt outright prescription buyouts but instead collaborates with prescription providers in research and development while sharing rights and interests. "We prefer to form long-term, deeply integrated relationships with clinical experts, working together to push projects forward," said Mi Jun.
Currently, the company has established cooperation with several top clinical experts in China, such as Professor Fan Junming, Professor Zeng Shengping, and Dr. Xia Longjiang. Apart from the Shenwei Formula, multiple projects including Xuanbai Pain Relief Gel and Qinggan Stone Expulsion Pills have entered the IIT or pre-trial stage, and the overall pipeline is still continuously expanding and advancing.
Starting with light assets, build productization and internationalization capabilities
Against the backdrop of a long innovation transformation cycle and substantial financial investment in traditional Chinese medicine, Shengqu Jisheng has chosen to start with an "incubation + transfer" model, building a relatively asset-light advancement path.
Specifically, on the one hand, the company systematically incubates clinical experience formulas to push them into standardized R&D pathways; on the other hand, it achieves capital reflux through phased project transfers to maintain the continuous operation of the pipeline.
On this basis, gradually form"Stage-based Transfer + Long-term Productization"The dual-track path - using transfers to support early cash flow and the listing of proprietary products to build long-term profitability. "Transfers are just a phased means; in the long run, we still aim to become an innovative traditional Chinese medicine enterprise with product capabilities," said Mi Jun.
If this model answers the question of "how stable it can go," then its further extended question would be: how far can this capability go.
At the international level, the core challenge faced by traditional Chinese medicine (TCM) over the long term lies in its complex material foundation and mechanisms of action, which create a high cognitive barrier within mainstream medical systems. In response, Shengqu Jisheng's approach is relatively clear: focusing on standardized clinical research as the core, validating efficacy through quantifiable data, and gradually building a system of medical evidence that can be accepted across regions.
In this direction, the company plans to continuously screen clinical projects and promote their transformation, gradually achieving the submission and market launch of innovative drugs. On this basis, the company will explore larger-scale clinical validation and market expansion pathways.
At the same time, the company is gradually building an open cooperation network, forming closer synergies with clinical experts, industry players, and capital to support the entire process of projects from early transformation to later implementation. Innovation in traditional Chinese medicine cannot be accomplished by a single entity alone; it requires the collaborative efforts of clinical, research and development, and industry stakeholders.
What needs to be seen is that the current innovation in traditional Chinese medicine (TCM) is still in the transition phase from empirical medicine to evidence-based medicine. The clinical resources, R&D systems, and industrial capabilities have not yet been fully integrated. Against this backdrop, what Shengqu Jisheng is attempting is to connect key links in a platform-oriented manner to improve conversion efficiency.
During this transitional phase, the investment logic for innovative traditional Chinese medicine (TCM) is also changing. As the evaluation system gradually improves and real-world evidence (RWE) is incorporated into the assessment framework, the path for TCM to move from "empirically effective" to "evidence-verifiable" is becoming increasingly clear, reducing some of the uncertainties in research and development.
At the same time,There are multiple Chinese medicine varieties that have achieved large-scale growth in areas such as respiratory, cardiovascular, and cerebrovascular fields.For example, products such as Su Huang Zhi Ke Capsules and Compound Danshen Dripping Pills have maintained sales of billions of yuan over the long term, to a certain extent verifying the commercial potential of traditional Chinese medicine products.
Against this backdrop, the path of exiting through front-end project selection based on clinical value and back-end phased transformation has gradually made innovation in traditional Chinese medicine exhibit “Selectable, Verifiable, Tradable"The asset attributes. From an investment perspective, as policies, market, and industry mechanisms gradually mature, the investment value of the innovative traditional Chinese medicine track is gradually emerging."
From "Empirical Formula" to "New Drug": This is not only an extension of the technical pathway but also a reconstruction of industrial logic. With policy support and industrial exploration proceeding in parallel, how to transform clinical value into verifiable and scalable product capabilities remains a question the entire industry needs to address. Practices like those of Shenqu Jisheng are providing a practical path to solving this problem.