Runan Medical Files IPO Prospectus: Focused on Thyroid Cancer Genomic Testing with a Full-Cycle Diagnostic Product Portfolio

Genetic testing has become an indispensable component of precision oncology. In recent years, the tumor genetic testing sector has seen intense activity, with an increasing number of companies entering the field. The market for genetic testing products and sub-segments focused on liver cancer, lung cancer, breast cancer, colorectal cancer, and other malignancies has already evolved into a highly competitive "red ocean."

In contrast, genetic testing for thyroid tumors remains a blue-ocean market yet to be fully explored.

With the continuous advancement of imaging technologies and the increased detection rate of nodules, the population with thyroid nodules in China has reached 200–300 million. The vast number of individuals affected by thyroid nodules, coupled with the rising incidence and mortality rates of thyroid cancer, make standardized diagnosis and treatment of thyroid cancer imperative.

The National Health Commission’s “Guidelines for the Diagnosis and Treatment of Thyroid Cancer” explicitly recommend molecular testing for patients with indeterminate benign or malignant thyroid nodules prior to surgery, thereby avoiding patient trauma and waste of medical resources caused by overtreatment through precise preoperative subtyping and patient triage. The “CSCO Guidelines for the Diagnosis and Treatment of Differentiated Thyroid Cancer (2021 Edition)” also point out that genetic testing aids in differentiating between benign and malignant thyroid nodules, stratifying the risk of tumor recurrence, and providing a molecular basis for targeted therapy in differentiated thyroid cancer (DTC).

Accurately diagnosing the benign or malignant nature of thyroid nodules and differentiating between low-risk and high-risk thyroid cancers are critical steps in establishing a definitive diagnosis, avoiding overtreatment, ensuring standardized and thorough treatment, and developing personalized prognosis management models. In recent years, domestic companies have also begun to focus on and invest in the field of genetic testing for thyroid tumors, with the potential of this sector increasingly coming to light.

Shanghai Run'an Medical Technology Co., Ltd. is a high-tech biotechnology enterprise specializing in genetic testing for thyroid tumors. Guided by technological advancement, the company is dedicated to the discovery, research, translation, and application of novel biomarkers. Leveraging its independently developed patented technologies, the company explores new biomarkers and develops innovative molecular diagnostic tools. By conducting in-depth research into the molecular mechanisms underlying disease pathogenesis, it provides a theoretical basis for the development of accessible small-molecule drugs, thereby offering clinicians precise solutions for tumor diagnosis and treatment.

Run’an Medical was established in 2019. At that time, China’s genetic testing industry had just undergone a phase of explosive growth and entered its mid-stage development. Companies such as Burning Rock Biotech, BGI Genomics, and Genetron Health emerged as prominent players, securing advantageous competitive positions in the market, particularly in the field of genetic testing for common malignant tumors, including lung cancer, breast cancer, colorectal cancer, and neuro-oncological tumors.

As a latecomer, Run’an Medical aims to identify niches in the genetic testing market that align with its competitive advantages. Through in-depth analysis, the team found that competition in the thyroid cancer testing segment is relatively limited, with many industry giants having devoted few resources to this area. Nevertheless, given the inherent characteristics of thyroid cancer, the potential of this sector is no less than that of other cancers.

In this regard,Dr. Zhang Yuqing, Co-founder and CEO of Run'an MedicalIt was stated that, compared with highly lethal tumors such as lung cancer, breast cancer, and colorectal cancer, thyroid cancer has a low mortality rate; consequently, industry participation in this field is relatively limited. Meanwhile, there are relatively few targeted therapies available for thyroid cancer, resulting in a weak driving effect of targeted drugs on genetic testing demand and fewer application scenarios for such testing. Therefore, competition in the field of genetic testing for thyroid tumors is not intense.

Although the current penetration rate of genetic testing for thyroid tumors is low, there is a significant unmet clinical need in this field. On one hand, the incidence of thyroid tumors and nodules is high, with approximately 400,000 new cases diagnosed annually, and the incidence rate continues to rise, particularly among the Chinese population. Among individuals undergoing health screenings, the detection rate of thyroid nodules is approximately one-third; while the majority are benign, there remains a potential for malignant transformation.

On the other hand, thyroid tumors affect a large population, yet the disease itself is generally not severe. The primary treatment modality is surgery, which yields favorable outcomes. In light of this, genetic testing will play a unique and valuable role in the auxiliary diagnosis and prognostic assessment of thyroid tumors.

Furthermore, given the 10% to 30% recurrence rate of thyroid tumors, early detection and prognostic risk assessment are particularly crucial for patients at risk of recurrence, where genetic testing technologies also play a significant role.

In summary, while the population with thyroid nodules is substantial, there remain significant unmet clinical needs in early benign-malignant screening, differentiation of nodule status, assessment of malignant transformation risk, and prevention of recurrence. This gap represents a key opportunity for Shanghai Run'an Medical Technology Co., Ltd.

In recent years, with growing recognition of the importance of thyroid genetic testing, non-invasive testing is poised to play an increasingly vital role in the diagnosis and treatment of thyroid cancer, owing to its favorable patient compliance.

The challenge of non-invasive testing in clinical applications lies in the screening of non-invasive biomarkers. It is crucial to identify potential biomarkers or combinations thereof with high sensitivity and specificity from numerous candidates, thereby assisting clinicians and patients in accurately determining the benign or malignant nature of thyroid nodules as well as their stage of progression. This involves biomarker selection, the sensitivity and specificity of detection technologies, and the effective integration of these technologies into clinical practice.

Shanghai Run'an Medical Technology Co., Ltd. has actively pursued technological innovation and breakthroughs in the field of non-invasive biomarkers. The company has not only secured patent protection for multiple potential biomarkers and biomarker combinations but also continues to advance R&D efforts to optimize and improve methods for the detection and differential diagnosis of thyroid nodules.

Currently, Run'an Medical has established a full-cycle portfolio of testing products, ranging from genetic screening to prognostic assessment. Leveraging technical platforms such as ARMS-PCR, digital PCR, and NGS, it provides precise diagnostic and therapeutic solutions for thyroid tumors.

Furthermore, Run'an Medical is actively exploring and developing novel molecular probe detection technologies to enhance the precision and efficiency of thyroid tumor detection. Through the research and application of these technologies, Run'an Medical aims to provide more personalized and precise diagnostic and therapeutic services for patients with thyroid tumors, thereby establishing a differentiated competitive advantage in the industry.

According to Dr. Zhang Yuqing, the current competitive landscape of the thyroid genetic testing sector in China is relatively simple, dominated primarily by single-gene testing products targeting BRAF. The BRAF gene is a commonly mutated gene in thyroid cancer and serves as a crucial tumor marker for papillary thyroid carcinoma (PTC). Thyroid nodules with BRAF mutations carry a 99.8% risk of malignancy.

More companies are positioning themselves in the multi-gene testing market. Leveraging its technical advantages in PCR and NGS, Shanghai Run'an Medical Technology Co., Ltd. has developed a portfolio of products with distinct features. Currently, the company is prioritizing the advancement of a 12-gene testing product. Given that the mutation spectrum of thyroid tumors is relatively narrow, with 90% of genetic mutations in thyroid tumor patients concentrated in a few specific genes, targeting these common genes for testing can effectively cover the genetic variations found in the majority of thyroid tumor patients. This 12-gene testing product broadly covers commonly mutated genes, thereby offering greater cost-effectiveness.

Dr. Zhang Yuqing stated that, when patients’ financial circumstances permit, more extensive genetic testing can be conducted to improve the accuracy of diagnosis and prognostic assessment. Shanghai Run'an Medical Technology Co., Ltd. is also carrying out expert education initiatives to enhance awareness of the clinical value of multi-gene testing.

For patients with specific types of thyroid tumors, the company has also developed corresponding products. For instance, medullary thyroid carcinoma (MTC) is a tumor closely associated with hereditary factors and is categorized into two major types: hereditary and sporadic. Nearly all cases of hereditary MTC are accompanied by germline mutations in the RET gene, while 50% of sporadic MTC cases involve somatic mutations in the RET gene. Therefore, RET gene testing is virtually essential for MTC patients. In light of this characteristic, Run’an Medical has developed targeted solutions specifically for patients with medullary thyroid carcinoma to meet diverse clinical needs.

Furthermore, for highly malignant thyroid tumors such as anaplastic thyroid carcinoma (ATC), the company has developed an 88-gene testing panel. By covering a larger number of genes, this product provides clinicians with more comprehensive reference information for diagnosis and treatment.

Currently, Run'an Medical is actively pursuing product registration filings with the aim of obtaining the registration certificate for its first product as soon as possible. Meanwhile, the company is seeking support from local governments to facilitate the establishment of GMP-compliant standardized production facilities. This initiative will enable the company to undertake additional product registration and manufacturing tasks, thereby reducing facility utilization costs on one hand, and accelerating product R&D and registration processes on the other.

According to Dr. Zhang Yuqing, the industry currently focuses more on the relatively niche field of computer-aided diagnosis. Shanghai Run'an Medical Technology Co., Ltd. aims to broaden its horizons by actively exploring wider application scenarios and target populations. Through technological innovation, the company seeks to deliver products with differentiated competitive advantages, thereby establishing a unique market position in the field of thyroid nodule detection.

To achieve this goal, the company is actively building its technological reserves and advancing research and development. It aims to establish differentiated competitive advantages through continuous innovation and effort in the field of genetic testing for thyroid tumors—a sector with distinct market characteristics—and to develop more high-value products that meet a broader range of clinical needs.

Currently, the company is seeking financing opportunities to accelerate product R&D and market promotion, with the aim of achieving product registration and launch at an early stage, thereby benefiting a broad population of patients with thyroid nodules.

Looking to the future, a key objective of Run'an Medical is to address the clinical needs of patients with early-stage thyroid nodules. Currently, Run'an Medical is developing multiple genetic testing products for thyroid nodules, has filed numerous patents in the field of non-invasive detection, and has built substantial technical reserves in needle biopsy techniques. The company is actively pursuing product registration.

“We have developed a portfolio of innovative technologies and methodologies. By leveraging the synergy between these biomarkers and technologies, we aim to deliver higher-quality, more appropriate products for clinical use. Looking ahead, we hope that Shanghai Run'an Medical Technology Co., Ltd. will become a representative enterprise in the niche field of thyroid tumor genetic testing, attracting greater investor attention to this sector and jointly developing better testing solutions for patients with thyroid nodules,” said Dr. Zhang Yuqing.