RIGEN-BIO Secures China's First Class III NMPA Certificate for Thyroid Nodule Molecular Diagnostic Kit

On August 16, 2023, the “Human BRAF/TERT/CCDC6-RET Gene Mutation Detection Kit (Fluorescent PCR Method),” independently developed by Shanghai Ruijing Biotechnology Co., Ltd. (hereinafter referred to as “Ruijing Biotech”), was approved by the National Medical Products Administration (NMPA) and obtained a Class III Medical Device Registration Certificate (Registration No.: Guo Xie Zhu Zhun 20233401165).

Approved and Published on the Official Website of the National Medical Products Administration

This kit is designed for the qualitative in vitro detection of mutations in the BRAF gene, TERT gene, and CCDC6-RET fusion gene in thyroid nodule samples where fine-needle aspiration biopsy has yielded indeterminate results regarding benign or malignant status, thereby aiding in the diagnosis of thyroid cancer. This product successfully fills a gap in the Chinese market for preoperative diagnostic products for thyroid cancer under the NMPA regulatory framework, establishing Ruijing Bio as a leader in providing compliant molecular diagnostic solutions within the specialized sector of thyroid cancer in China.

Ruijing Bio 3-Gene Detection Kit

According to the latest statistics, among the top ten most common newly diagnosed cancers in China in 2020, lung cancer, gastric cancer, and colorectal cancer ranked as the top three, followed by liver cancer, thyroid cancer, and breast cancer. In 2020, there were 395,800 new cases of thyroid cancer in China, ranking fifth among all cancer types. Meanwhile, the mortality rate from thyroid cancer among women has risen in recent years, and the overall patient population is trending toward a younger demographic, presenting a severe situation. (Data source: Frost & Sullivan, China Business Industry Research Institute)

In April 2020, the journal *Thyroid* published an epidemiological study on iodine and thyroid diseases by the team of Professor Teng Weiping and Professor Shan Zhongyan from China Medical University. The article reported a detection rate of thyroid nodules ranging from 19.0% to 46.6% [*Thyroid*. 2020;30(4):568-579]. Based on the lowest detection rate of 19%, the total number of individuals with thyroid nodules in the general population was estimated. Using China’s population of 1.41 billion, the number of people with thyroid nodules was calculated to be 268 million. In response to the current status of diagnosis and treatment of thyroid nodules, both the 2018 and 2022 editions of the *Guidelines for the Diagnosis and Treatment of Thyroid Cancer*, issued by the National Health Commission of China, explicitly recommend molecular testing for patients with indeterminate preoperative thyroid nodules. This approach further clarifies treatment pathways for patients with thyroid nodules, improves prognosis for thyroid cancer patients, alleviates psychological burden, and avoids trauma associated with overtreatment as well as the waste of medical resources.

Statistics on New Cancer Cases in China in 2020 Data Source: Frost & Sullivan, Compiled by AskCI Consulting

From the perspective of market competition in thyroid cancer genetic testing, prospective studies typically require extended periods for observation and data collection. Meanwhile, these studies face technical challenges in detecting extremely low nucleic acid quantities from thyroid cancer fine-needle aspiration samples. Only through rational study design, rigorous control, and thorough preparation can valuable results be achieved.

As a technology-driven company guided by clinical needs, Ruijing Biology has overcome numerous challenges through nearly six years of research and development and accumulation, launching the “Human BRAF/TERT/CCDC6-RET Gene Mutation Detection Kit (Fluorescent PCR Method)” as a flagship product. This kit has secured the first regulatory approval for preoperative thyroid cancer testing in China, meeting the urgent demands of both current and future markets. Ruijing Biology’s business now covers more than ten provinces and nearly 100 Grade A tertiary hospitals, establishing hundreds of key client relationships. With ongoing product registrations, expansion of the product pipeline, and the establishment of a new model for chronic disease management, the company is building a tiered, comprehensive product ecosystem targeting thyroid and other cancers. As a result, the company’s sales revenue is poised for exponential growth.

Ruijing Bio focuses on cancer genetic testing that is recognized by both Chinese and U.S. clinical guidelines. While mature products are available overseas, the company is strategically expanding into this previously untapped domestic market. In the field of thyroid cancer, Ruijing Bio has launched a comprehensive product portfolio covering the entire care continuum—from preoperative sampling and diagnosis to postoperative monitoring. This portfolio includes thyroid biopsy needles, the Thyroscan® benign/malignant classifier for thyroid nodules, multi-gene qPCR assays, next-generation sequencing (NGS) tests, and solutions for postoperative recurrence monitoring. By forming an integrated product matrix, the company provides one-stop solutions for the entire thyroid cancer diagnosis and treatment cycle. As a leader in molecular diagnostic solutions, Ruijing Bio has established itself as an industry benchmark, maintaining a leading position in the clinical testing sector for thyroid cancer while continuously expanding into new testing areas.

The Company's Flagship Exclusive Product: Thyroscan^®Thyroid Nodule Benign-Malignant Classifier, Benchmarking Against the U.S. Thyroseq^®, committed to exploring alternatives to cytopathology in the field of medical diagnosis. Currently, Thyroscan®, a classifier for benign and malignant thyroid nodules, is undergoing prospective clinical trials on thyroid nodules in the Chinese population, gradually accumulating a genetic database of thyroid cancer specific to this demographic. This effort aims to transform the first-mover advantage of its core technologies into formidable product barriers that are difficult to replicate. In the field of thyroid cancer, the company continues to expand its portfolio, which includes an approved three-gene PCR kit, NGS-registered products, and molecular diagnostics for postoperative monitoring of recurrence and metastasis.

Ruijing Biotechnology has launched a comprehensive suite of products covering the entire thyroid cancer care continuum—from preoperative sampling and diagnosis to postoperative monitoring—including thyroid biopsy needles, multi-gene qPCR assays, NGS testing, and solutions for postoperative recurrence monitoring. This provides an integrated, compliant solution for the entire thyroid cancer diagnosis and treatment cycle. Ruijing Biotechnology has emerged as a standard-setter among Chinese enterprises and the owner of an integrated, end-to-end platform for precision diagnosis and treatment of thyroid cancer. By building this all-in-one platform spanning from detection to prognostic monitoring, Ruijing Biotechnology aims to maximize patient survival rates and quality of life, reduce healthcare costs, and alleviate the burden on socioeconomic and medical resources.

Founder Mr. Hong Gendong joined Boehringer Ingelheim Pharmaceuticals GmbH 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. Mr. Hong Gendong stated, “Ruijing Bio focuses on tumor genetic testing recommended by both Chinese and U.S. clinical guidelines. While mature products exist abroad, this field remains largely untapped in China. We took the lead in establishing compliant domestic operations for thyroid cancer, becoming a precision diagnostics company that covers the entire care continuum—from preoperative diagnosis to postoperative recurrence monitoring and treatment. As a pioneer in molecular testing for thyroid cancer, we are continuously expanding into other cancer types, committed to providing Chinese patients with powerful tools to combat various diseases.”

Since founding his own venture in 2004, Mr. Hong Gendong has maintained close exchanges with advanced healthcare markets in the United States and Europe. He possesses a profound understanding of cutting-edge medical technologies, the differences among the Chinese, U.S., and European healthcare systems, and the real-world needs of clinical scenarios. He has continuously built platforms for multidisciplinary expert exchange and scientific research collaboration, demonstrating unique insights and macro-level strategic vision for the company’s development strategy.

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 possesses profound expertise in molecular biology and extensive experience in basic research and technology translation. He has principal-investigated multiple NIH-funded projects and authored numerous high-impact publications in prestigious journals such as Nature and Cell, covering diverse fields including medicine, biology, genetics, oncology, novel technology applications, and tumor marker discovery. With a deep understanding of interdisciplinary knowledge integration, he excels at efficiently leveraging multi-disciplinary resources. At Ruijing Biotechnology, Dr. Yang is primarily responsible for overall product strategy, encompassing clinical needs assessment, product pipeline selection, and concept and feasibility evaluation and validation.

Dr. Shi Han, the company’s Chief Technology Officer, 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 numerous 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 multiple platforms, he previously led the development of various tumor NGS panels and PCR-based diagnostic products. At Ruijing Biotechnology, Dr. Shi spearheaded the establishment of multiple technical platforms, including qPCR, NGS, ddPCR, and Sanger sequencing, as well as multi-omics testing platforms covering DNA variation, RNA expression, and epigenetics. He has secured over ten patents related to technological innovations and led the development of Ruijing’s Thyroscan® product line along with multiple PCR and NGS-based offerings.