Ruijing Biotech Secures Nearly RMB 100 Million in New Financing to Advance Molecular Diagnostics and Comprehensive Management for Thyroid Cancer

Shanghai Rigen Biotechnology Co., Ltd. (hereinafter referred to as “RIGEN-BIO”) has recently completed a new round of financing amounting to nearly RMB 100 million. This round was led by Boyuan Capital, with participation from Guotai Junan Innovation Investment and Yinshengtai Capital, while Qushi Capital served as the financial advisor. Previously, RIGEN-BIO secured its Series A financing led by Yuanhe Yuandian, with participation from ZhenFund and Jingxu Venture Capital. It is reported that this investment will support RIGEN-BIO in advancing its clinical pipeline, conducting scientific discovery and proof-of-concept for innovative products, and facilitating commercialization, thereby maintaining its leading position in the rapidly growing sector of thyroid cancer clinical diagnostics.

The population of patients with thyroid nodules is large and growing rapidly. The prevalence of thyroid nodules in China is approximately 19–49%, among which 7–15% are diagnosed as thyroid cancer. China has a substantial base of thyroid cancer patients, with the compound annual growth rate of new cases reaching as high as 22.86%. In recent years, the mortality rate among female thyroid cancer patients has also risen, and the disease is showing a trend toward affecting younger individuals, presenting a severe situation. RIGEN-BIO, grounded in clinical needs, is committed to reshaping the diagnosis and treatment pathway for thyroid cancer, providing more precise and comprehensive solutions for patients.

Currently, the differentiation between benign and malignant thyroid nodules primarily relies on conventional ultrasonography and cytopathological diagnosis. In clinical test results, there areNearly 30% of nodules yield indeterminate results on cytological examination.For patients with thyroid nodules of indeterminate benign or malignant nature, there is a significant risk of either missing malignant tumors or unnecessarily resecting benign nodules. The former can be life-threatening, while the latter necessitates lifelong exogenous thyroid hormone replacement therapy and regular monitoring of thyroid hormone levels. Thyroid hormone supplementation requires dynamic adjustment of oral hormone dosage based on individualized therapeutic targets. Both excessive and insufficient dosing pose potential health risks, such as cardiovascular disease, thereby increasing the burden on patients and the healthcare system.

Although the overall prognosis of thyroid cancer in China is relatively favorable, there remains a significant gap compared with Western developed countries. Literature indicates that a subset of cases with extremely high malignancy is strongly correlated with specific molecular events.Risk Stratification of Thyroid Cancer via Genetic Testing to Guide Surgical Approach and Optimize Patient Prognosis

Furthermore, thyroid nodules impose a significant psychological burden on patients prior to the definitive determination of their benign or malignant nature. Therefore, to achieve more precise diagnosis and treatment for patients with thyroid nodules, further improve the prognosis of patients with thyroid cancer, alleviate patients’ psychological burden, and avoid the trauma associated with overtreatment as well as the waste of medical resources,There is an urgent clinical need for accurate molecular-level characterization of thyroid nodules.

The WHO Classification and Grading Criteria for Endocrine and Neuroendocrine Tumors, 5th Edition, recently promulgated in 2022, explicitly states that driver genes are the fundamental factors in the initiation and progression of papillary thyroid carcinoma. It emphasizes that the identification of gene mutations such as BRAF, TERT, and RET fusions provides a basis for the auxiliary diagnosis, assessment of tumor biological behavior, prognostic evaluation, and guidance for highly effective and precise treatment of patients with advanced papillary thyroid carcinoma, high-grade carcinomas of follicular epithelial origin, and anaplastic thyroid carcinoma.

Currently, many hospitals can only perform molecular biomarker testing for thyroid cancer using Laboratory Developed Tests (LDTs). There is an urgent clinical need for commercial test kits specifically designed for preoperative fine-needle aspiration samples. In 2020, there were 220,000 new cases of thyroid cancer in China, with a rapid annual compound growth rate of 22.86%. Additionally, postoperative recurrence monitoring and health management for thyroid cancer patients hold significant market potential. In the futureThe market size of the molecular testing sector for thyroid cancer in China is projected to reach nearly RMB 10 billion.

Covering the entire continuum of thyroid cancer care—from preoperative sampling and diagnosis to postoperative monitoring—RIGEN-BIO has launched a comprehensive suite of products, including thyroid biopsy needles, multi-gene qPCR and NGS assays, the Thyroscan® thyroid nodule benign-malignant classifier, and solutions for postoperative recurrence monitoring, forProviding an integrated solution for the entire thyroid cancer diagnosis and treatment cycle.

After more than four years of R&D and accumulation, the companyPreoperative multi-gene qPCR and NGS products have entered the clinical registration phase,It has been validated by over 10,000 clinical samples, demonstrating a clear leading advantage in its niche sector.

Meanwhile, the company’s flagship exclusive product, Thyroscan®, a benign and malignant classifier for thyroid nodules, benchmarks against the U.S. Thyroseq® and is committed to replacing cytopathological diagnosis. Unlike the auxiliary diagnostics of registered PCR or NGS reagents,Thyroscan® employs a multi-gene, multi-module combinatorial approach and machine learning algorithms to achieve precise preoperative diagnosis of thyroid nodule nature, as well as postoperative risk stratification, prognostic assessment, and guidance for medication in thyroid cancer.thereby enabling precision diagnosis and treatment, and becoming the ultimate solution for molecular testing of thyroid nodules in China.

Thyroscan®, a classifier for differentiating benign from malignant thyroid nodules, is currently undergoing China’s only prospective clinical trial. Meanwhile, it is progressively building a genetic database of thyroid cancer specific to the Chinese population, leveraging the first-mover advantage of its core technology to establish formidable product barriers that are difficult to replicate. This positions Thyroscan® as a standard-setter among domestic enterprises and the owner of an integrated, end-to-end platform for the precise diagnosis and treatment of thyroid cancer.

In addition, the company hasProducts for postoperative recurrence monitoring have also entered the clinical validation phase.The company is dedicated to building an integrated, end-to-end platform for thyroid cancer, covering the entire continuum from detection to prognostic monitoring, with the aim of maximizing patient survival rates and quality of life, reducing healthcare costs, and alleviating the burden on socioeconomic and medical resources.

Meanwhile, RIGEN-BIO is activelyStrategic Layout for Chronic Disease Management After Thyroid Cancer Surgery, assisting postoperative patients with health monitoring. Although the prognosis for most thyroid cancer patients is favorable, they still require long-term health monitoring and medication adherence after surgery. Multiple follow-up visits per year involve repeated queuing for registration, payment, consultation, testing, and prescription collection, while the actual consultation time is extremely brief. This pattern of "long waits, short consultations" not only wastes hospital resources but also consumes a significant amount of valuable time for thyroid cancer patients, resulting in a very poor experience. Meanwhile, the limited outpatient hours available to surgical specialists are insufficient to meet the substantial demand from postoperative patients.

To change this situation, RIGEN-BIO will explore a new model,Fundamentally Addressing Follow-up and Health Monitoring for Patients with Thyroid DiseasesThis model will leverage RIGEN-BIO’s products to connect patients, physicians, hospitals, and payers, not only bringing significant convenience to patients but also substantially improving the efficiency of social medical resource utilization. In the future, the company will continue to expand this model to other types of cancer, gradually establishing a management database for cancer patients in China to provide more precise services to physicians and the broader patient population.

The company’s business currently covers more than ten provinces and nearly 100 Grade-A tertiary hospitals, cultivating hundreds of key clients. Following this round of financing, the company will further strengthen its sales team and expand its business footprint, providing Chinese patients with thyroid diseases with first-class diagnosis and treatment solutions that meet international standards. With product registrations, expansion of the product pipeline, and the establishment of a new model for chronic disease management, the company’s sales revenue is expected to grow exponentially.

Hong Gendong, CEO of RIGEN-BIO, stated: “Rooted in clinical needs, RIGEN-BIO is committed to becoming a precision diagnostics and therapeutics company that provides comprehensive coverage across the entire care continuum for thyroid cancer—including preoperative auxiliary diagnosis, postoperative recurrence monitoring, and routine management. We aim to be the leader in molecular testing for thyroid cancer, optimize medical resources, and benefit more patients. While we are currently focused on building an ecosystem for the diagnosis and treatment of thyroid diseases, our journey is not limited to this field; we are dedicated to providing patients with powerful tools to combat a wide range of diseases.”

Founder Hong Gendong joined Boehringer Ingelheim Pharmaceuticals in Germany early in his career, rising from sales representative to supervisor and then to regional sales manager, repeatedly achieving the number one market share in his region. Since launching his own venture in 2004, Mr. Hong has maintained close exchanges with advanced healthcare markets in the United States and Europe. He possesses a profound understanding of cutting-edge medical technologies and the differences among healthcare systems in China, the United States, and Europe. He has continuously built platforms for multidisciplinary expert communication and scientific research collaboration, demonstrating unique insights and macro-level strategic vision for corporate development.

Dr. Yang Feng, the Company’s Chief Scientific Officer (CSO), earned his Ph.D. in Molecular Medicine from Peking University and subsequently served as a Project Scientist at the School of Medicine, University of California, San Diego. Dr. Yang has profound expertise in molecular biology and extensive experience in basic research and technological translation. He has led multiple NIH-funded projects and published numerous high-impact articles in prestigious journals such as Nature and Cell.

Dr. Shi Han, the company’s CTO, earned his bachelor’s degree in Chemical Biology from Tsinghua University and later obtained his Ph.D. in Life Sciences from Northwestern University in the United States. He has published multiple academic papers in top-tier journals and possesses extensive experience in R&D management at leading U.S. IVD companies. Proficient in the development, design, and data analysis of molecular diagnostic assays across various platforms, he has previously led the development of multiple NGS panels for tumor testing and PCR-based diagnostic products.

Tao Feng, Founding Partner of Boyuan CapitalStatement: We are delighted that Boyuan Capital has led the investment in RIGEN-BIO. The in vitro diagnostics (IVD) sub-sector is experiencing rapid growth, with substantial unmet clinical needs remaining. By focusing on the thyroid-specific vertical and offering a product pipeline that covers the entire diagnostic workflow, RIGEN-BIO will further strengthen its leading position in the field of thyroid cancer management with this round of capital injection.

Jiang Wei, Chairman of Guotai Junan Innovation InvestmentRIGEN-BIO has assembled a team of top-tier talents in R&D, medical affairs, regulatory affairs, and commercial operations. With a profound understanding of how to integrate frontline clinical needs with technical product development, the company is poised to rapidly become a leading IVD enterprise in China.

Yang Tao, Managing Director of Healthcare Investment at Yinshengtai CapitalRIGEN-BIO focuses on the vertical niche of thyroid nodules and thyroid cancer, providing customers with comprehensive solutions that include molecular diagnostic products for differentiating benign from malignant thyroid cancer and monitoring recurrence, home-based full-course management products, and surgical consumables. We are highly optimistic about the company’s position as a leading enterprise in auxiliary diagnosis of thyroid cancer in China. Leveraging its dual advantages in R&D and marketing, RIGEN-BIO significantly outperforms competitors in product development, regulatory registration and certification, accumulation of thyroid cancer patient data, and channels with benchmark hospitals. It is poised to become the first company in China to obtain a Class III medical device certificate for thyroid cancer auxiliary diagnostic reagents, and has already entered a phase of rapid growth.

Boyuan Capital, established in 2017, is a professional investment firm dedicated to investing in and incubating outstanding healthcare startups in the Chinese market. Currently, Boyuan Capital manages two RMB funds and two USD funds, with total assets under management exceeding RMB 7 billion. More than just an investor, Boyuan Capital serves as a long-term partner to entrepreneurs. Since its inception, the firm has remained committed to an entrepreneur-centric approach, providing sustained support and active empowerment to exceptional founders in the healthcare sector, fostering an industry ecosystem, and cultivating the next generation of leading enterprises in China’s healthcare industry.

Guotai Junan Innovation Investment Co., Ltd. (hereinafter referred to as “Guotai Junan Innovation Investment”) is the sole wholly-owned private equity investment management subsidiary of Guotai Junan Securities Company. It is responsible for managing a diverse range of alternative assets, including private equity, new infrastructure, and special opportunities, with assets under management exceeding RMB 50 billion. The company focuses on empowering high-growth, high-quality enterprises with strong technological and innovative foundations. By leveraging capital, global perspective, and innovative investment solutions, it helps outstanding entrepreneurs maximize their potential, drives the overall development of the industries in which its portfolio companies operate, and strives to fulfill its mission of serving the nation through finance.

Yinshengtai Capital is a global investment institution with assets under management nearing RMB 10 billion. It currently maintains investment management offices in Beijing, Hong Kong, Qingdao, and Shanghai. Adhering to long-term structural value investing, Yinshengtai Capital seeks industry pioneers with sustainable competitive advantages. By leveraging in-depth insights into China’s macroeconomic and microeconomic trends and conducting comprehensive analyses of global market conditions, the firm focuses on leading enterprises with unique competitive edges in the healthcare and wellness, technological innovation, and consumer sectors. It provides financial support across all stages, from start-up to post-IPO, through investment vehicles including fund investments and direct equity investments.

Qushi Capital, a subsidiary of Qushi Holding Group, serves as the group’s boutique investment banking arm. It has provided services to dozens of top-tier enterprises and facilitated billions in financing from renowned domestic and international funds.