Rigen Biotech closes nearly RMB 100M Series B to expand integrated thyroid care platform

Recently, Rigen Biotech has successfully completed a nearly 100 million Series B financing round. This round was led by Efung Capital, with co-investment from Shanghai Fengxian Capital.

The funds will accelerate Rigen Biotech's commercialization progress, advance its clinical product pipeline, drive scientific discovery and proof-of-concept for novel products, enhance its integrated diagnosis and treatment layout for thyroid diseases, and solidify its leading position in the rapidly growing thyroid disease sector.

Rigen Biotech, founded in 2017 in Shanghai, boasts a core team with extensive experience in the oncology In Vitro Diagnostics (IVD) industries of both China and the United States. With deep insight into diagnostic and treatment disparities between these markets, the company precisely targets the real-world clinical needs in China, developing a comprehensive thyroid disease solution tailored to the local healthcare landscape. Focusing vertically on thyroid nodules and thyroid cancer, Rigen Biotech has established a full-process, comprehensive product matrix. This portfolio includes single-use thyroid biopsy needles, multi-gene qPCR detection kits, NGS detection kits, a thyroglobulin gene detection kit, and the Thyroscan® thyroid nodule benign/malignant classifier. The company is further enhancing its offerings with intraoperative treatment and post-operative chronic disease management products, dedicated to providing an integrated solution for the comprehensive, whole-course management of thyroid diseases.

In August 2023, Rigen Biotech pioneered the field by obtaining China's first Class III Medical Device Registration Certificate for a multi-gene detection product for thyroid nodules. This achievement successfully filled a critical gap in the thyroid nodule diagnostic market, establishing a first-mover compliance advantage and setting a new industry benchmark. In October 2025, its self-developed thyroglobulin gene detection kit entered the National Medical Products Administration (NMPA) Innovative Medical Device Special Review Process, underscoring the high recognition from Chinese regulatory authorities for its technological innovation capabilities. 

Moving forward, Rigen Biotech will continue to refine its molecular diagnostic solutions for thyroid cancer, guided by clinical guidelines and pressing market needs. Currently, Rigen Biotech's products have been adopted in over 30 Chinese provinces and municipalities, serving nearly 200 large, top-tier general hospitals and specialized cancer hospitals in China. The company has earned widespread trust from clinical institutions and industry peers through its reliable product quality and precise detection performance.

According to the latest 2024 data from the National Cancer Center of China, thyroid cancer has become the fastest-growing malignant tumor in the country, with annual new cases reaching 466,000. Its incidence rate has risen to third place among all cancer types. Although China's five-year survival rate for thyroid cancer has reached 92.6%, a significant gap remains compared to the 98.6% rate in developed countries in Europe and America, indicating clear room for improvement.

In clinical practice, the differentiation of benign and malignant thyroid nodules primarily relies on traditional ultrasound imaging and cytopathological diagnosis. However, approximately 30% of patients cannot obtain a definitive diagnosis of nodule nature through cytological examination. This not only imposes a heavy psychological burden on patients but also easily leads to overtreatment or delayed diagnosis, resulting in a waste of medical resources.

As a core technology for distinguishing benign from malignant thyroid nodules, prognostic assessment, and guiding personalized treatment, genetic testing has been strongly recommended by major domestic and international guidelines. These include the 2023 Bethesda Reporting System, the 2023 "Guidelines for the Diagnosis and Treatment of Thyroid Nodules and Differentiated Thyroid Cancer (Second edition)," and the 2025 ATA Management Guidelines. It has become a critical pathway for improving diagnostic and treatment outcomes.

Against this backdrop, the field of preoperative diagnosis and prognostic assessment for thyroid cancer holds immense market potential. The future market size for molecular testing in thyroid cancer in China is projected to approach 10 billion.

As a leader in this field, Rigen Biotech has consistently achieved breakthroughs in technology research and development and product innovation. Its "Human BRAF/TERT/CCDC6-RET Gene Mutation Detection Kit (Fluorescent PCR Method)," approved in 2023 (Registration Certificate No.: National Instrument Approval 20233401165), is the first and only multi-gene testing product in China approved for the preoperative diagnosis of benign and malignant thyroid nodules. Since its market approval, this kit has been successively selected for inclusion in the "Shanghai Innovative Medical Device Application Demonstration Project," the "Shanghai Innovative Product Recommendation Catalog," the "Shanghai High-Tech Achievement Transformation Project," and the "Shanghai Biopharmaceutical 'New and Excellent Drugs and Devices' Product Catalog." It benefits from policy support such as "DRG exemption" and exclusion from medical consumables spending controls, fully demonstrating its exceptional level of innovation, clinical value, and safety/quality control.

Another significant product from Rigen Biotech, the "Thyroglobulin (TG) Gene (mRNA) Detection Kit (Fluorescent PCR Method)," entered the NMPA's Innovative Medical Device Special Review Process in October 2025. This marks a high level of recognition from national authorities for the company's technological innovation capabilities.

Furthermore, Rigen Biotech's exclusive flagship product, the Thyroscan® Thyroid Nodule Benign/Malignant Classifier, benchmarks its technology against the prominent US product ThyroSeq® while being optimized for the characteristics of the Chinese population. This product integrates multiple genetic loci and modules to build a machine learning AI algorithm. It enables accurate preoperative diagnosis of thyroid nodule nature, as well as postoperative risk stratification, prognosis assessment, and medication guidance for thyroid cancer, truly achieving precision medicine. It can be considered the ultimate solution-type product for molecular testing of thyroid nodules in China. Currently, this product has completed China's only prospective clinical trial for thyroid nodules. Its detection performance matches or even surpasses that of similar international products. Simultaneously, Rigen Biotech has established a genetic database for thyroid cancer in the Chinese population, converting its first-mover technological advantage into a formidable product barrier. This solidifies Rigen Biotech's position as the standard-setter and owner of a comprehensive, integrated platform in this domain within China.

Rigen Biotech operates an international-standard GMP facility and R&D laboratory spanning over 2,500 square meters. The company holds ISO13485 quality management system certification and has earned numerous recognitions, including Shanghai High-Tech Enterprise, Shanghai Specialized, Refined, Unique, and New Enterprise, and Minhang District S&T Little Giant Enterprise. With a team of over 200 professionals, its core R&D group is led by five national-level senior experts. The company has filed more than 10 invention patents and over 20 software copyrights in molecular diagnostics, AI algorithms, and clinical medicine, demonstrating industry-leading technological capabilities.

Through a deeply integrated industry-university-research-hospital collaboration model, Rigen Biotech undertakes several national key projects. Its joint project with Zhejiang Provincial People's Hospital, "Establishment and Application of a Precision Diagnosis and Treatment System for Thyroid Cancer," received the Zhejiang Provincial Science and Technology Progress Award (First Class). Furthermore, a project led by The First Affiliated Hospital of Sun Yat-sen University, with Rigen Biotech as a partner—"Research on Precision Diagnostic Technologies for Thyroid Nodules and Stratified Therapy for Differentiated Thyroid Cancer (Project Number: 2024ZD0525600)"—was successfully approved as a major project in the "Prevention and Treatment Research of Cancer, Cardiovascular, Cerebrovascular, Respiratory, and Metabolic Diseases" program by the Development Center for Medical Science & Technology National Health Commission of the People's Republic of China.

On the commercial front, the company has built a nearly 100-person direct sales team covering the entire chain of academic promotion, clinical support, and channel management. Through highly efficient execution, it has achieved adoption in nearly 200 top-tier hospitals in China within two years, ranking among the industry leaders in market expansion efficiency. Following this financing round, Rigen Biotech will further expand its team size and business scope, accelerate product registration and pipeline extension, drive exponential revenue growth, and provide more patients with high-quality diagnostic and treatment solutions that meet international standards.