Hidden Champion in TCM CRO: Boji Medicine Files IPO Prospectus with Over 50 Investigational Drugs and 20+ Self-Developed Patents

Recently, stocks of listed traditional Chinese medicine (TCM) companies have experienced rare consecutive daily surges. The “Guiding Opinions on Medical Insurance Support for the Inheritance, Innovation, and Development of Traditional Chinese Medicine,” jointly issued by the National Healthcare Security Administration and the National Administration of Traditional Chinese Medicine on the last day of the year, has further boosted capital market confidence in the TCM industry.

As a well-established CRO, Boji Medicine boasts formidable strength in the field of innovative traditional Chinese medicine (TCM) drugs. Relevant data show that among the 17 approval documents for innovative TCM drugs granted by the National Medical Products Administration (NMPA) from 2017 to 2021, four were supported by Boji Medicine’s CRO services, accounting for over 20% of the total.

Wang Tingchun, Chairman of Boji Medicine, stated that R&D services for innovative traditional Chinese medicine (TCM) drugs are a traditional strength of the company. Although Boji Medicine has achieved remarkable results in recent years in the fields of innovative chemical drugs and biological products, it has never ceased its exploration and development of R&D services for innovative TCM drugs.

According to the company’s introduction, Boji Medicine currently has over 50 ongoing R&D service projects for new traditional Chinese medicine (TCM) drugs (covering both preclinical and clinical stages). It has helped clients secure production approvals for more than 20 new TCM drug projects and obtain clinical trial approvals for nearly 15 new TCM drug projects. The company is also conducting nearly 10 independent R&D projects and has obtained more than 20 patents through its independent R&D efforts (some of which have been licensed out). Notably, these initiatives include key clinical research projects for new TCM drugs led by distinguished experts such as Academician Yao Xinsheng, Academician Zhu Zhaoyun, and Academician Tian Jinzhou.

In the preclinical sector, Boji Medicine leverages the prestigious “Guangdong Provincial Engineering Technology Research Center for Active Components of Traditional Chinese Medicine,” accredited by the Guangdong Provincial Department of Science and Technology, to vigorously advance R&D services for innovative TCM drugs. Last year, it even set a new record by securing clinical trial approvals for four innovative TCM drugs in a single month.

Ma Renqiang, Deputy General Manager of Boji Medicine, stated that the company’s traditional Chinese medicine (TCM) R&D platform has evolved into a high-end platform for innovative TCM drug development, featuring specialized capabilities in TCM formula screening, topical TCM formulation development, and research on active TCM components. “We are at the forefront in China in specialized areas of TCM R&D, including druggability assessment in formula screening, separation and purification of active TCM components, and development of topical TCM formulations.”

It is well known that the selection of Chinese herbal medicine prescriptions for drug development is a key focus and challenge in the innovation of traditional Chinese medicine (TCM) drugs, but it also represents a critical breakthrough point in TCM drug research and development.

A relevant official from Boji Medicine introduced that the research and development of Class 1.1 new traditional Chinese medicines (TCM compound formulations) is a primary focus in prescription screening for drug commercialization. Preclinical studies in this area face multiple challenges, including clinical value assessment, formulation development, quality control, design of efficacy models and detection indicators, and non-clinical safety evaluation. Addressing these challenges requires in-depth collaboration among professionals from various disciplines, such as pharmaceutics, pharmacology, toxicology, and clinical medicine, as well as adopting a case-by-case analysis approach tailored to specific products to achieve breakthroughs.

“The Xiaoshi Gandan Granules project is a typical case of breaking conventions, conducting in-depth analysis, and engaging in multi-disciplinary collaboration,” said a relevant person in charge of the project team. Xiaoshi Gandan Granules are derived from a clinical experiential formula used by folk practitioners, primarily for the treatment of chronic cholecystitis. Early toxicological studies revealed that the high dosage of Natrii Sulfas (Mangxiao) in the formulation posed significant challenges to the conduct of non-clinical safety trials.

To ensure clinical safety, the Boji Medicine team collaborated with folk practitioners to develop a two-step strategy. In the first step, the Boji Medicine team adjusted the dosage of ingredients in the prescription and confirmed its development potential through preliminary animal efficacy and toxicology studies. In the second step, the folk practitioners applied the modified prescription in clinical practice to evaluate therapeutic efficacy and collected relevant case records as supporting evidence.

Through this dual approach, the project’s pharmaceutical and pharmacological/toxicological studies proceeded smoothly, ultimately passing all regulatory reviews by the National Medical Products Administration (NMPA) and securing approval for clinical trials.

“Evaluating efficacy and safety is a critical step in determining the druggability of a prescription. This requires that, during the screening process, we not only respect existing empirical evidence but also have the courage to make bold breakthroughs. Every step involves meticulous and prudent choices, as well as rigorous scientific judgment,” said Ma Renqiang.

In addition to new drug development through prescription screening, the exploration of R&D technologies for Class 1.2 new traditional Chinese medicine (TCM) drugs represents a significant breakthrough for Boji Medicine in the field of innovative TCM drug services.

“Class 1.2 new traditional Chinese medicine (TCM) drugs have been a key focus for Boji Medicine in recent years. The development of Class 1.2 new TCM drugs involves high costs, and the pharmaceutical research and development challenges are generally greater than those for Class 1.1 new TCM drugs.”

A representative from Boji Medicine stated that for Class 1.2 new traditional Chinese medicine (TCM) drugs, which involve isolating monomers from medicinal herbs or extracts, the process development of active pharmaceutical ingredients (APIs) requires not only modern TCM purification technologies but also refining techniques used in chemical drug APIs, thereby imposing new requirements on both the software and hardware for purification and refinement.

Relevant officials stated that whether the process involves purification and refinement starting from extracts, or extraction, purification, and refinement beginning with raw medicinal materials, the content of the target components remains extremely low. Furthermore, impurities are highly diverse, and the chemical and physical properties of related substances at the refinement stage remain poorly characterized, necessitating further exploration and discovery.

Quality by Design: The process development of active pharmaceutical ingredients (APIs) should draw on the extraction and purification strategies used in traditional Chinese medicine. Once a certain level of purification is achieved, reference should also be made to the refining approaches employed for chemical drugs. The process route should first be established, followed by parameter optimization, and multiple internal quality control standards should be implemented.

“Research on the manufacturing process for Class 1.2 new traditional Chinese medicine (TCM) drugs should not be confined to laboratory conditions; it must take into account production streamlining, post-commercialization cost feasibility, and quality controllability. Therefore, a comprehensive evaluation must be conducted during the process design phase to develop a marketable drug,” stated a representative from Boji Medicine. To achieve breakthroughs in project development, Boji Medicine has assembled a stable technical team with extensive experience in the preparation of single TCM compounds and has established modern TCM purification workshops of varying scales. These facilities enable pilot-scale and small-scale scale-up production, including extraction and concentration of medicinal materials (crude extracts), resin separation, membrane separation, dextran gel separation, and C18 separation.

With dual guarantees of human and material resources, pharmaceutical research on Class 1.2 new drugs has also entered a harvest season of flourishing achievements.

Currently, Boji Medicine’s independently developed Class 1.2 new traditional Chinese medicine (TCM) drug, Ginkgolide B Injection, has entered the clinical trial stage, while multiple promising candidates—including Hydroxysafflor Yellow A, Dipsacoside VI, and Crocetin—are in the preclinical research phase.

To date, Boji Medicine has conducted preclinical research on more than 10 projects involving single-component traditional Chinese medicines (TCMs) and active fractions. These projects cover multiple segments, including single TCM components, active TCM fractions, TCM compound formulas, and improved novel TCM drugs (e.g., reformulating oral medications for topical use). The dosage forms involved include oral solid preparations and topical preparations (such as creams and liniments).

“Over the next three years, Boji Medicine’s Drug Research Center will continue to increase its investments in talent acquisition, R&D, and equipment. We will further strengthen research in traditional Chinese medicine (TCM) purification technologies and placebo formulation technologies, enhance evaluation methodologies and infrastructure for geriatric medications (including cardiovascular drugs, diabetes and its complications, and antineoplastic agents) as well as topical formulations (such as nebulized and dermatological preparations), and establish a distinctive, practical, and highly efficient technical service platform to provide better support for TCM R&D,” said Ma Renqiang.

The professional strength in preclinical research services is merely the tip of the iceberg of Boji Medicine’s advantages in the R&D of innovative traditional Chinese medicine (TCM) drugs. In its clinical operations and CDMO segments, the company has also demonstrated remarkable capabilities in innovative TCM drug development. To date, Boji Medicine has undertaken more than 30 clinical projects for innovative TCM drugs, and has assisted clients in obtaining production approvals for over 20 new TCM drug products.

In the CDMO sector, Boji Technology Park, a subsidiary of Boji Medicine, has completed the construction of an extraction workshop with an area of 2,560 square meters. The facility meets GMP production requirements and is equipped with pre-processing equipment for Chinese herbal medicines, dynamic extraction tanks for traditional Chinese medicine (TCM), single- and double-effect concentrators, spray drying towers, tubular centrifuges, and large-diameter macroporous resin chromatography columns.

Tian Haigen, Deputy General Manager of Boji Science and Technology Park, stated that the park currently offers capabilities for aqueous extraction, alcoholic extraction, and volatile oil extraction, as well as high-vacuum, low-temperature condensation and concentration. Equipped with macroporous resin chromatography columns in various specifications, the facility can accommodate the purification of diverse product varieties and has an annual production capacity to process 500 tons of traditional Chinese medicinal materials.

To date, Boji Science and Technology Park has completed the extraction, purification, and preparation of active pharmaceutical ingredients (APIs) for multiple new traditional Chinese medicine (TCM) drug projects, as well as the production of clinical trial supplies.

If clinical operations, preclinical services, and CDMO activities are viewed as manifestations of Boji Medicine’s achievements in the field of traditional Chinese medicine (TCM) innovation, then its strategic layout in the incubator sector represents the future direction of Boji Medicine’s TCM innovative drug segment.

In April last year, Boji Medicine established a subsidiary, Jiangxi Bokang Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Jiangxi Bokang”), in the China Traditional Chinese Medicine Science and Technology Innovation City within the Ganjiang New Area, a national-level economic and technological development zone in Jiangxi Province.

According to the project leader, Jiangxi Bokang operates two bases—an incubator and a CDMO facility—covering a total area of 42 mu. It is a public platform dedicated to scientific innovation and industrialization, specializing in professional services for innovative traditional Chinese medicine (TCM) drugs.

The company boasts an R&D and testing center, along with production workshops for pilot-scale trials, traditional Chinese medicine (TCM) extraction, TCM decoction pieces, and oral solid and liquid dosage forms. It offers comprehensive R&D services covering all stages of product development, including project initiation and activity screening, pharmaceutical research (active pharmaceutical ingredients and formulations), drug evaluation (pharmacodynamics and toxicology), clinical trials, regulatory registration, CDMO manufacturing (MAH implementation), and technology transfer. Additionally, by leveraging the policies of the Traditional Chinese Medicine Science and Technology Innovation City and the Boqu Fund, the company provides financial support and assistance to incubated projects.

Within less than a year of its establishment, Jiangxi Bokang Incubator successfully attracted multiple projects and enterprises, including Qingzhikang Pharmaceutical Technology Co., Ltd.’s new Mongolian medicine project “Qingyan Lihou Capsules” from Inner Mongolia Medical University, Aize Biopharmaceutical Technology Co., Ltd.’s Class 1 new traditional Chinese medicine (TCM) project “Zhangfukang” from Harbin Medical University, and Jiangxi Lewei TCM Co., Ltd.’s “in-hospital preparation” project from the Fourth Military Medical University. Notably, the new Mongolian medicine “Qingyan Lihou Capsules” has completed Phase II clinical trials and received RMB 2.66 million in policy incentive funds from the TCM Science and Technology Innovation City. It is expected to complete Phase III clinical trials in 2021 and be launched for production and marketing in 2022.

Regarding the future development of Jiangxi Bokang, the project leader stated that, leveraging Boji Medicine’s high-quality R&D service capabilities for innovative traditional Chinese medicine (TCM) drugs, technical platform support, government policy incentives, and TCM industry investment funds, Jiangxi Bokang plans to facilitate the local government in attracting 10 high-quality new TCM drug projects over the next five years, file 10 invention patent applications, and provide comprehensive R&D and CDMO services to settled enterprises.

In Henan, Boji Medicine has similarly extended the strategic layout adopted in Jiangxi. Last year, the Henan Boji Institute of Traditional Chinese Medicine Co., Ltd. (hereinafter referred to as “Henan Boji”), a subsidiary of Boji Medicine and a modern TCM R&D public service platform based in Nanyang City, Henan Province, was officially established.

A relevant official from the company stated that Henan Boji will provide “one-stop” outsourced services (CRO + CDMO) covering the entire process of drug formulation quality research, pilot-scale amplification, and production for traditional Chinese medicine (TCM) enterprises and Marketing Authorization Holders (MAHs) settling in Nanyang. The platform is currently under construction, with multiple projects—including TCM extraction workshops, sterile preparation workshops, granule workshops, cream workshops, soft capsule workshops, and TCM decoction piece workshops—expected to commence construction within the year.

From multiple technological breakthroughs in preclinical research services—including pharmacology, efficacy, toxicology, and safety evaluation—to comprehensive capabilities spanning Phase I to Phase III clinical trials and post-marketing re-evaluation, and further to the expanded layout of CDMO manufacturing services and incubator development, a grand vision has now taken shape, showcasing Boji Medicine’s full-process R&D service capabilities in the field of innovative traditional Chinese medicine (TCM) drugs.

In Wang Tingchun’s view, traditional Chinese medicine (TCM) is a precious legacy handed down by our ancestors. Leveraging modern technological processes to drive the innovative development of TCM is the mission and responsibility of every Chinese pharmaceutical R&D professional. “To advance its TCM business, Boji Medicine has established Xinglin Traditional Chinese Medicine Technology (Guangzhou) Co., Ltd. This subsidiary will fully undertake preclinical R&D services and clinical research services for innovative TCM drugs. Xinglin Company will comprehensively inherit Boji Medicine’s historical strengths in TCM and spare no effort in supporting the innovative development of China’s TCM industry.”