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VCBeat (WeChat ID: vcbeat) has learned that Shanghai Ruijing Biotechnology Co., Ltd. (hereinafter referred to as “Ruijing Biotech”) recently announced the completion of its Series A financing round, raising nearly RMB 100 million. The round was led by Oriza Holdings, with participation from ZhenFund and Prosperico Ventures. The funds will be primarily used to advance clinical trials and regulatory registration for the company’s molecular diagnostic products for thyroid tumors, as well as to support new product development and channel expansion.
Ruijing Biotech is a high-tech enterprise dedicated to providing comprehensive molecular diagnostic solutions for oncology, with a particular focus on thyroid cancer. Established in August 2017, the company has developed a complete portfolio of PCR and NGS testing products in the field of thyroid cancer after three years of research and development, and is currently accelerating the regulatory registration and market launch of its products.
Ruijing Biotech boasts an exceptional team spanning R&D, medical affairs, commercialization, and management. Its R&D and medical teams are composed of four senior PhD holders who have returned to China from abroad. The founder, Mr. Hong Gendong, brings over two decades of experience in the commercial implementation of clinical products and team management. Mr. Hong stated, “China has a vast population of individuals with thyroid nodules, and in recent years, the incidence of thyroid cancer has surged dramatically. The clinical demand for molecular testing in thyroid cancer is clearly defined, yet there are no mature solutions available domestically. Ruijing has chosen to focus exclusively on thyroid cancer, providing comprehensive molecular diagnostic solutions for patients. We are delighted to have gained the favor and recognition of Oriza Holdings, ZhenFund, and Prosperico Ventures. Following this round of financing, we will actively advance the regulatory approval and market launch of our existing products, with the aim of better serving thyroid cancer patients in China.”
Ruijing Biotech has been recognized as a High-Tech Enterprise and certified under the ISO 13485 quality management system. To date, it has filed seven patent applications and registered 15 copyrights, and has successfully completed its first round of financing, raising nearly RMB 100 million.
Thyroid nodules are highly prevalent in the Chinese population, with approximately 10% progressing to thyroid cancer. Thyroid cancer is the most common endocrine malignancy, accounting for about 1% of all malignant tumors nationwide. Approximately 90% of thyroid cancers are well-differentiated papillary and follicular carcinomas, while the remaining 10% consist of high-risk, poorly differentiated types, including medullary carcinoma, anaplastic carcinoma, and poorly differentiated carcinoma. Although thyroid cancer is commonly regarded as an “indolent cancer” with a generally favorable prognosis, statistical data indicate that even among patients with well-differentiated thyroid cancer, 15% belong to a high-risk group with poorer outcomes. Consequently, the overall proportion of high-risk thyroid cancer patients exceeds 20%, necessitating risk-stratified management.
Diagnostic Workflow for Thyroid CancerThe diagnostic workflow for thyroid cancer typically begins with the detection of thyroid nodules via ultrasound. If high-risk features are indicated, patients should undergo fine-needle aspiration (FNA) for cytopathological examination to help determine whether the nodules are benign or malignant and to guide subsequent treatment plans. Cytopathological assessment is highly dependent on the pathologist’s experience, and a portion of FNA samples remain indeterminate for benignity or malignancy through cytology alone. For such cases, the international NCCN Guidelines clearly recommend molecular biomarker testing to aid in diagnosis. However, there is a lack of such molecular testing products in China.
In the United States, molecular testing has been widely adopted in clinical practice as an adjunctive tool for differentiating benign from malignant thyroid nodules and guiding postoperative targeted therapy for thyroid cancer. Currently, the two leading molecular testing products in the U.S. market are Afirma by Veracyte and Thyroseq developed by the University of Pittsburgh Medical Center (UPMC). By performing molecular analysis on fine-needle aspiration samples from thyroid nodules with indeterminate cytology, these tests significantly improve the preoperative accuracy of distinguishing benign from malignant thyroid cancers, thereby helping to avoid unnecessary surgeries and missed diagnoses of malignant cases. Furthermore, they provide valuable guidance for assessing poor clinical prognosis and selecting potential targeted therapies. As a publicly listed company, Veracyte has demonstrated remarkable market performance, with its stock price increasing more than 15-fold over the past three years and its market capitalization exceeding $4.5 billion.
China’s large population base is accompanied by higher incidence rates and faster growth of thyroid diseases compared to Europe and the United States. In recent years, the incidence of thyroid cancer in China has surged dramatically. From 2003 to 2012, the annual incidence rate increased by 20%, resulting in a 4.7-fold rise over the decade—the fastest growth among the top ten cancers. The number of new thyroid cancer cases in China was projected to exceed 400,000 in 2020.
Currently, the proportion of thyroid nodules undergoing preoperative fine-needle aspiration (FNA) has increased significantly year by year, and clinical experts have shown markedly higher acceptance of molecular testing on FNA samples. With growing emphasis among Chinese physicians and patients on precision diagnosis and treatment of thyroid cancer in recent years, demand for preoperative molecular testing has been rapidly unleashed. In the foreseeable future, the market size for molecular diagnostics in thyroid cancer is expected to expand rapidly.
The Ruijing team has deeply engaged with frontline clinical practice, gaining a profound understanding of clinical needs in China. Targeting the significant market opportunity in molecular testing for thyroid cancer, the company collaborates closely with Chinese clinical experts to develop molecular diagnostic products tailored for clinical use in China. Currently, it offers a variety of PCR and NGS testing solutions designed for different types of hospitals and application scenarios, comprehensively meeting the molecular testing needs of physicians across hospitals at all levels. By rapidly iterating and updating its products, including the development of assays for differentiating benign from malignant thyroid nodules, Ruijing is building a strong product portfolio barrier. Its products are currently in the stage of registration and certification.
Ruijing Bio is currently the only company in China dedicated to providing comprehensive, full-scenario molecular diagnostic solutions for thyroid cancer. By leveraging a multi-pronged strategy encompassing product R&D, regulatory registration and certification, and clinical collaborations, the company is accelerating the realization of precision diagnosis and treatment for thyroid cancer.
Dr. Hu Xiaofang, Partner at Oriza Holdings Healthcare, stated:“China has a high incidence of thyroid diseases, with a large patient population, creating significant market opportunities for the precise diagnosis and treatment of thyroid nodules/tumors. Ruijing Biotechnology has assembled an outstanding team spanning R&D, medicine, business, and management. With a deep understanding of clinical practice in China and strong organizational capabilities and execution power, we are confident that the Ruijing team can rapidly provide patients with thyroid diseases in China with world-class diagnostic and therapeutic solutions benchmarked against international standards.”
Dr. Chen Gaopeng, Vice President of Investment at ZhenFund, commented:“Identifying the key pain points in the clinical diagnosis and treatment of thyroid tumors was crucial for Ruijing during its early startup phase. Meanwhile, the company has assembled a team of industry elites from both domestic and international markets. With precise professional positioning and efficient teamwork, we are confident that Ruijing has very promising development prospects.”
Mr. Qian Tingzhi, President and Founding Partner of Prosperico Ventures, stated:“We place great emphasis on the commercialization capabilities of innovative projects. Ruijing’s molecular diagnostic project for thyroid cancer addresses an urgent clinical need by targeting a track with significant market potential. Furthermore, the company’s commercial operations team, boasting years of market experience, provides strong assurance for the successful market launch of its products.”