Yusen Pharma Files for IPO with 21 TCM New Drug Candidates in Pipeline, 12 in Phase II Trials

Traditional Chinese Medicine (TCM) is a treasure of the Chinese nation, with a development history spanning thousands of years. However, in recent years, the research and development of new TCM drugs in China has not proceeded smoothly.

“Prior to 2002, traditional Chinese medicine (TCM) products were approved by individual provinces and municipalities, resulting in varying local standards, uneven quality of TCM products in circulation, and very low levels of innovation,” Xuan Zhenyu, founder of Suzhou Yusen New Drug Development Co., Ltd., told VCBeat.

A turning point emerged in 2002. That year, the Provisions for Drug Registration (Trial) were promulgated,Incorporated the registration of traditional Chinese medicine into unified national management,Registration of new traditional Chinese medicine drugs enters a stage with legal basis,This opened a window for researchers developing new traditional Chinese medicine (TCM) drugs. At that time, Xuan Zhenyu was also gradually influenced by the vibrant entrepreneurial atmosphere in Zhangjiang, Shanghai. In 2003, while pursuing his doctoral degree at Shanghai University of Traditional Chinese Medicine, Xuan Zhenyu founded Yusen New Drug, focusing on the research and development of new TCM drugs.

After more than a decade of development, Suzhou Yusen New Drug Development Co., Ltd. has established a comprehensive technological innovation platform covering the entire industry chain, including early discovery, research and development, and pilot-scale production of new traditional Chinese medicine (TCM) drugs, targetingIn-Depth Exploration and Innovation in the Advantaged Areas of Traditional Chinese Medicine Treatment for Infectious Diseases, Complex and Chronic Diseases, and Functional Disorders, currently the company is developing proprietary intellectual property rights21 Class 1 new traditional Chinese medicine (TCM) drugs, of which 12 have entered Phase II clinical trials,is currentlyOne of the institutions with the largest pipeline of new traditional Chinese medicine (TCM) drug candidates in China.

Although the Measures for the Administration of Drug Registration, introduced in 2002, incorporated traditional Chinese medicine (TCM) registration into unified national management, TCM has adhered to the quality and clinical evaluation standards applicable to chemical drugs for over a decade. This approach emphasizes material knowability and mechanisms of action derived from animal studies, failing to reflect the unique characteristics and developmental patterns of TCM research. Consequently, it has increased the difficulty of obtaining marketing approval for new TCM drugs, severely constraining the innovative development of TCM.

It is reported that the number of traditional Chinese medicine (TCM) preparations approved for clinical trials in China each year ranges from 10 to 20, while the number of innovative TCM drugs successfully launched on the market is even scarcer. Data show that only 10 new TCM drugs were approved in China between 2015 and 2020.

For years, constrained by the approval mechanisms for traditional Chinese medicine (TCM), TCM pharmaceutical companies have shown limited enthusiasm for R&D. Many enterprises have pivoted toward contract research organization (CRO) services or the development of chemical and biological drugs. To date, China has yet to produce any influential innovative TCM enterprises, with academic laboratories remaining the primary force in the long-term development of new TCM drugs.

Despite the unfavorable environment for the research and development (R&D) of new traditional Chinese medicine (TCM) drugs, Yusen New Drug has always been guided by the goal of developing innovative TCM drugs. Since its establishment, Xuan Zhenyu has simultaneously strengthened internal capabilities and led his team in the R&D of new TCM drugs, whileActively promote the establishment of evaluation standards for traditional Chinese medicine,Seeking an evaluation system for traditional Chinese medicine that aligns with its own unique characteristics, successivelyParticipated in the discussion and finalization of multiple related work guidelines.

For many years, Suzhou Yusen New Drug Development Co., Ltd. has been deeply engaged in the research and development of new traditional Chinese medicines, adhering toGuiding the R&D of New Traditional Chinese Medicine Drugs with TCM Theories, Emphasizing the Clinical Attributes of Traditional Chinese Medicine.The team has extensive experience in the screening and project initiation of new traditional Chinese medicine (TCM) drugs.Established a set of screening criteria for traditional Chinese medicine, ensuring the efficiency and accuracy of the screening process., enabling the company to continuously launch traditional Chinese medicines that meet market demands and possess clinical value.

It is understood that among the independent intellectual property rights under development by Yusen New Drug,21 Class I new drug candidates, including 12 in Phase II clinical trials, making it one of the institutions with the largest pipeline of new traditional Chinese medicine (TCM) drug candidates in China.

In terms of disease areas,Yusen New Drugs mainly focuses on infectious diseases, complex and chronic diseases, functional disorders, endocrine diseases, etc.“There are numerous diseases in these fields that remain unresolved by chemical and biological drugs, yet they represent areas of strength for traditional Chinese medicine (TCM), where TCM can play a significant role.”

Among gynecological inflammations, the incidence rate of candidal vaginitis ranges from 30% to 40%. Western medicine treatments for candidal vaginitis are associated with high recurrence rates and are difficult to achieve a radical cure. The new drug developed by YusenQinlingzi Vaginal Irrigation Solution is used for the treatment of candidal vaginitis, achieving a one-week cure rate of 67% and a three-month recurrence rate of less than 3%., far superior to chemical drugs. “Qinlingzi Vaginal Irrigation Solution officially went on sale in 2021 and is expected to be available in 500 hospitals by the end of the year.”

Leveraging its unique advantages in the research and development of new traditional Chinese medicine drugs, Suzhou Yusen New Drug Development Co., Ltd. has received multiple investments from Longmen Capital.

Wang Haining, Founding Partner of Longmen Capital, stated, “Compared with chemical drugs and biologics, traditional Chinese medicine (TCM) has long been a relatively niche area in the primary market. On one hand, the previous review and approval mechanisms for TCM were unreasonable; on the other, most investors lacked an understanding of the traditional TCM system. Over the past two years, regulatory and review frameworks for TCM have gradually evolved, creating significant opportunities for TCM innovation. TCM products with demonstrated clinical value and supported by evidence-based medicine are poised for a renaissance. Suzhou Yusen New Drug Development Co., Ltd. has faced considerable challenges over the past decade, but Dr. Xuan has remained steadfast in his research philosophy, making the company one of the few in the industry to pursue TCM innovation with scientific rigor. Years of accumulation have positioned Suzhou Yusen as one of the institutions with the largest pipeline of new TCM drug candidates in China.”

“Longmen Capital has made multiple rounds of investment in Yusen, driven by our steadfast belief that innovation in traditional Chinese medicine (TCM) is worth safeguarding. Although TCM investment has not been a hot spot, and Yusen’s valuation growth over the past few years has not been as rapid as that of our other biologic drug projects, the clinical value of high-quality TCM products is irreplaceable. It merits renewed scrutiny by healthcare professionals, which also serves as the foundational rationale for our pharmaceutical investments.”

After years of exploration, on September 28, 2020, the supporting documents for the classification of traditional Chinese medicine registration"Classification and Submission Requirements for Traditional Chinese Medicine Registration"Officially released. The document fully takes into account the product characteristics, degree of innovation, and review and management requirements for traditional Chinese medicine (TCM) registration applications.De-emphasize the content requirements for “active ingredients” and “active fractions” under the original registration classification management,Registration categories are no longer determined solely by material basis; instead, the evaluation of the efficacy of traditional Chinese medicine (TCM) is supported by TCM theories and clinical practice experience.

Xuan Zhenyu commented, “The revised ‘Classification of Traditional Chinese Medicine (TCM) Registrations and Requirements for Submission Materials’ has eliminated unreasonable evaluation methods that previously constrained TCM research and development, paving a brand-new path for the development of new TCM drugs. Driven by favorable policies, the new TCM drug industry has been revitalized, reigniting interest in TCM R&D.”

Xuan Zhenyu believes that, with the significant improvement in the R&D environment for traditional Chinese medicine,A Surge in Clinical Trial Approvals for Traditional Chinese Medicine Is Expected Within the Next 3–5 YearsIt is estimated that in 2023, the number of traditional Chinese medicine (TCM) products approved for clinical trials may reach 50–100, representing a three- to five-fold increase compared to previous years. By 2026, the number of TCM products approved for market launch may range from 30 to 50, marking an nearly ten-fold increase compared to earlier periods.

It is noteworthy that following the issuance of the “Classification and Submission Requirements for Traditional Chinese Medicine (TCM) Registration,” numerous enterprises have begun to strategically position themselves in the R&D of innovative TCMs, with many pharmaceutical companies extending cooperation offers to Suzhou Yusen New Drug Development Co., Ltd. Moving forward, Yusen will resume its Contract Research Organization (CRO) services, adopting a strategy centered on independent innovation supplemented by CRO activities. By collaborating with industry partners, Yusen aims to jointly promote the healthy development of new TCM drug R&D and continue to supply the market with valuable innovative TCM products.

Regarding the future of the industry, Xuan Zhenyu stated, “A favorable policy environment is a prerequisite for promoting innovative development in traditional Chinese medicine (TCM). We hope that more supporting guidelines will be implemented as soon as possible to accelerate the linked approval mechanism for new TCM drugs and their inclusion in the National Reimbursement Drug List. Furthermore, we recommend appropriately deferring centralized procurement of TCM products to avoid dampening innovation incentives due to cost compression.”