NIE 2025 | Hongyuan Bio Zhang Jiangli: Challenges and Opportunities for Early Cancer Screening Technology

The following are the key points from Mr. Zhang Jiangli's speech:

I. Current Situation of Cancer Prevention and Control in China

Cancer has become a major public health problem that seriously threatens the health of the Chinese population. Over the past decade, the incidence of malignant tumors in the country has maintained an annual increase of 1.7%. Malignant tumor deaths account for 25% of all causes of death among residents, with an average of about 9 people getting cancer and 6 dying from it per minute. The low rate of early detection is the main reason for this current situation.

From the data, it can be seen that the number of new cancer cases and deaths in China are climbing year by year. In 2022, there were 4.8247 million new cases and 2.5742 million deaths, both ranking first globally. There is a significant gap in 5-year survival rates between China and foreign countries. In 2022, the overall 5-year relative survival rate for cancer patients in China was 43.7%, while the overall 5-year relative survival rate for cancer patients in the United States from 2014 to 2020 reached 69.0%. This gap largely stems from the higher proportion of late-stage diagnoses for major cancers in China, for example, 89% of colorectal cancer patients in China are diagnosed at an advanced stage, compared to only 60% in the United States.

Therefore, the key to cancer prevention and control lies in early diagnosis. Taking colorectal cancer as an example, its development process can last up to 10 years. Intervening during the golden early diagnosis stage (such as large adenomas or severe atypical hyperplasia), the 5-year survival rate can reach 92%-100%, while the 5-year survival rate for advanced adenocarcinoma is only 11%. Currently, cancer screening has been elevated to a national policy, with continuous promotion of related work by various departments. The 'Healthy China Initiative & Cancer Prevention and Control Implementation Plan (2023-2030)' clearly states that by 2030, it aims to significantly improve cancer screening, early diagnosis, and treatment capabilities, achieving an overall five-year cancer survival rate of 46.6%.

II. Cancer Early Screening Market and Technological Development

The market for early tumor detection is burgeoning with tremendous growth potential. From a global perspective, the global early tumor detection market size increased from $1 billion to $3.6 billion from 2019 to 2024, with a compound annual growth rate of 28.7%. It is expected that from 2024 to 2033, the market will continue to grow at a compound annual growth rate of 21.5%, reaching a market size of $207 billion by 2033.

The Chinese market has grown even more rapidly, increasing from 300 million yuan to 1.7 billion yuan from 2019 to 2024, with a compound annual growth rate of 42.1%. It is expected that from 2024 to 2033, the market will grow at a compound annual growth rate of 28.2%, reaching 164 billion yuan in 2033.

Mr. Zhang Jiangli proposed that in terms of technical routes, DNA methylation technology is the mainstream direction for early cancer detection. DNA methylation is a key epigenetic indicator for the early occurrence and development of tumors, and can participate in various biological processes by regulating genes. It has currently become the mainstream technical route for early cancer detection internationally. As a pioneer and leader in this field, Kunyuan Biotechnology has achieved fruitful results in technology research and development. In 2007, Professor Zhang Kun and Professor Gao Yuan completed the world's first whole-genome methylation targeted sequencing. In 2013, Professor Zhang Kun first discovered that trace methylation signals in the blood of cancer patients were abnormal and could be traced back. Subsequently, Kunyuan Biotechnology has successively published important research results in the fields of early detection for high-incidence cancers such as colorectal cancer, liver cancer, lung cancer, and pancreatic cancer, as well as multiple cancer types. Its subsidiary Chang'aike^®Gan'aike^®, GutSeer^®Technologies such as these have performed excellently in clinical validation.

Taking early colorectal cancer detection as an example, Kunyuan Biotechnology's technology development has covered fecal and blood samples. It has also tried both NGS and PCR testing platforms, expanding application scenarios from early detection to recurrence prediction and monitoring. The research type has progressed from retrospective studies to real-world prospective cohort studies, with the technology continuously iterating and upgrading.

III. Future Trends and Long-term Layout of Early Cancer Screening

Mr. Zhang Jiangli believes that the cancer early screening industry will exhibit five major trends in the future. The first is the combination of single-cancer screening and pan-cancer screening. Single-cancer products are aimed at the general population and clinically high-risk individuals, suitable for routine health check-ups and priced lower; pan-cancer products are targeted at high-net-worth individuals for high-end health management and are more expensive. The second is the combination of community screening, physical examination screening, and home self-screening. With the increasing awareness of public health management, home self-testing products, with their convenience and flexibility, will complement community screening and physical examination screening. The third is the deep integration of insurance with cancer screening, achieving full-process linkage through the 'cancer early detection + insurance coverage' model. The fourth is the full-process management of screening, diagnosis, and continuous monitoring, constructing a complete service chain from early examination, early diagnosis to early treatment. The fifth is the provision of new composite health management solutions using AI + big data, achieving dynamic, precise, and personalized health management and cancer risk prediction through artificial intelligence multi-omics modeling and big data analysis.

Kunyuan Biotechnology is actively deploying under industry trends, continuously enriching its product matrix. In the field of single cancer types, Chang'aike^®(Crohn's Disease and Colorectal Cancer) has obtained a Class III medical device registration certificate from the National Medical Products Administration (NMPA), Gan'aike^®(hepatocellular carcinoma), PDACatch™ (pancreatic cancer), etc., have excellent technical performance. PDACatch™ has also received Breakthrough Device Designation from the US FDA. In the field of multiple cancers, GutSeer^®Can detect five types of digestive tract cancers with a single blood test, PanSeer^®The system can detect cancer four years earlier than traditional diagnostic methods and has been validated through large-scale cohort studies. Meanwhile, Kunyuan Biotech is actively promoting commercialization, participating in the Yangzhou Hanjiang colorectal cancer screening project for the people's livelihood, having detected nearly 200,000 person-times in total, saving a large amount of medical funds for society; it has also jointly carried out early colorectal cancer detection with insurance institutions, covering more than 300,000 person-times, promoting the popularization of early cancer screening. In terms of global layout, the company is advancing service projects based on LDT with partners in the United States and promoting the registration of FDA in vitro diagnostic products. It has exported kits with CE certification to various European and Asia-Pacific countries, dedicated to contributing to global early cancer screening efforts.