China's First Cancer Early Screening Stock Marks the Dawn of a Multi-Billion-Dollar Industry

On February 18, 2021, China’s first publicly listed company specializing in early cancer screening was established. New Horizon Health officially listed on the Hong Kong Stock Exchange. On its listing day, the stock price surged to a high of HK$85.9, representing a 222.2% increase over the issue price. As of February 22, 2021, New Horizon Health’s market capitalization exceeded HK$30 billion.

Capital market recognition of New Horizon Health reflects the vast potential of the cancer early screening market. Currently, dozens of in vitro diagnostic (IVD) companies in China have clearly established layouts in the cancer early screening sector, with numerous products under development. Which cancer early screening companies, products, and technological approaches deserve our attention? This article provides an analysis from the perspectives of cancer early screening biomarkers, sample types, and cancer indications.

Detection accuracy is the primary requirement for cancer early screening products. At present, the biomarkers commonly used in cancer early screening fall into three categories: gene mutations, gene methylation, and protein markers. Among these, gene methylation has become a research hotspot for companies in the cancer early screening industry; Grail, an industry leader, focuses its cancer early screening efforts solely on methylation-based biomarkers.

However, due to the complex mechanisms of carcinogenesis, existing studies have demonstrated significant limitations in using single-omics approaches for early cancer screening. For instance, a foreign research team discovered that gene mutations are also present in healthy tissues, indicating substantial constraints on their utility for early detection. Additionally, as an early screening biomarker, gene methylation is susceptible to interference from various factors such as age and physiological stage, resulting in low specificity.

Sensitivity and specificity are the primary evaluation criteria for assessing the value of early cancer screening products. Sensitivity represents the ability to detect cancer patients, while specificity indicates the capacity to exclude healthy individuals. To achieve improved sensitivity and specificity, a multi-omics approach combining methylation, gene mutation information, and protein biomarkers is an effective strategy.

The value of multi-omics testing in the cancer early screening industry has been recognized by numerous enterprises and regulatory authorities both domestically and internationally.

Abroad, Cologuard, a product under Exact Sciences, is the only FDA-approved stool DNA-based test for early screening of colorectal cancer. The test detects seven KRAS gene mutations, methylation of the NDRG4 and BMP3 genes, and a beta-actin-related biomarker. It demonstrates a sensitivity of 92% and specificity of 87% for detecting colorectal cancer, with a sensitivity of 42% for detecting precancerous lesions in the colon and rectum.

Notably, several months ago, Exact Sciences acquired Thrive and Base Genomics precisely due to the recognized importance of multi-omics testing in early cancer screening.

In China, the colorectal cancer early screening product “Changweiqing,” approved by the NMPA, employs dual DNA and FIT testing, targeting four markers and 31 loci, encompassing gene mutations, gene methylation, and protein biomarkers.

Meanwhile, Genetron Health utilizes cfDNA extracted from blood to simultaneously detect gene mutations and gene methylation, addressing the challenge of requiring large blood volumes and multiple tests for concurrent detection of these markers, with a sensitivity of 92% and a specificity of 93%.

Sample type is also a key determinant of the value of cancer early screening products. Common samples for cancer early screening include blood, stool, urine, and sputum; domestic and international companies primarily focus their research on blood and stool samples.

Stool samples offer high accuracy and convenient collection, enabling at-home sampling. Since most early-stage cancers can be detected through blood tests, blood-based cancer screening technologies are applicable to a broader range of cancer types.

In summary, blood and stool samples each have their own advantages, and benchmark companies have already emerged in both niche sectors.

Regarding stool-based testing, New Horizon Health’s colorectal cancer early screening product “Changweiqing,” which is based on stool detection, has received approval from the National Medical Products Administration (NMPA), while its gastric cancer screening test product “Youyouguan” is currently under development.

Another industry benchmark, Genetron Health, is conducting research on early cancer screening based on blood samples. Genetron Health places significant emphasis on the suitability of blood samples for multi-cancer screening. Its short-term strategy focuses on high-incidence cancers (such as liver cancer, lung cancer, and gastrointestinal cancers), tackling them one cancer type at a time. Its early liver cancer screening product, HCCscreen, received the U.S. FDA’s “Breakthrough Device” designation last September.

HCCscreen is the first early screening product developed based on Genetron Health’s proprietary Mutation Capsule technology platform. This platform enables the simultaneous detection of methylation and various genetic mutations—including SNVs, Indels, and CNVs—from a small blood sample, allowing multiple tests to be performed on a single sample without compromising sensitivity. Leveraging the Mutation Capsule technology platform, Genetron Health has simultaneously deployed multiple single-cancer screening products.

Furthermore, Genetron Health is fully capable of integrating multiple single-cancer early screening products to develop a multi-cancer early screening product in the future. This approach not only ensures detection performance for each individual cancer type but also enables more efficient development of multi-cancer products, while offering a portfolio of options spanning both single-cancer and multi-cancer tests. This represents a typical strategy of leveraging robust underlying technology to expand into broader markets.

Of course, the choice between blood or stool samples merely reflects differing strategies; the ultimate goal for companies is to launch truly valuable cancer early screening products. Rather than being confined to a single sample type, companies flexibly develop products by leveraging the advantages of various samples in light of practical considerations.

For example, following its fecal DNA testing product Cologuard, Exact Sciences has also entered the field of blood-based early cancer screening, launching multi-cancer early detection (MCED) and liver cancer early screening products. Studies have shown that its MCED product demonstrated an overall sensitivity of 86% and specificity of 95% in testing 437 samples (180 cancer cases and 257 controls); its liver cancer early screening product achieved sensitivity and specificity of 80% and 90%, respectively, among 433 participants (135 liver cancer patients and 308 controls).

With a number of high-quality products entering the market and cancer early-screening companies such as Genetron Health, New Horizon Health, and Burning Rock Biotech going public one after another, cancer early screening has undoubtedly become a highly sought-after sector in China.

Cancer prevention and control in China remain a formidable challenge. According to the latest 2020 global cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 19.29 million new cancer cases worldwide in 2020, including 4.57 million in China, accounting for 23.7% of the global total. In 2020, there were 9.96 million cancer deaths globally, with 3 million in China, representing 30% of the total number of cancer deaths worldwide.

The high incidence and mortality rates of cancer have made cancer prevention and control a key focus of China’s policy agenda. In March 2019, the Government Work Report stated, “We must implement cancer prevention and control initiatives, advance preventive screening, early diagnosis and treatment, and breakthroughs in scientific research, with a focus on addressing critical issues affecting people’s livelihoods.”

Driven by factors such as policy, market dynamics, and technological advancements, China’s cancer early screening industry is in a phase of rapid growth. According to an industry report released by Frost & Sullivan (CIC), the total market potential for cancer early detection in China will exceed RMB 200 billion by 2030, with the most rapidly advancing clinical development focused on colorectal cancer and liver cancer screening products.

It is impossible to ignore that the cancer early screening market holds significant potential, yet faces considerable commercialization challenges. Companies are actively expanding their marketing teams and exploring commercialization pathways. For instance, Genetron Health’s liver cancer early screening product, HCCscreen, has achieved commercialization through three channels: hospitals, government programs, and health checkup institutions. It is believed that with deeper market education, technology-driven price reductions, and favorable policy support, the cancer early screening market will continue to mature.

Finally, returning to the question raised at the beginning: which early cancer screening companies and products are worth watching? VCBeat believes that three criteria must be met. First, they should target high-incidence cancers that lack effective screening technologies; for example, colorectal cancer and liver cancer are both high-incidence cancers in China, and traditional screening techniques have limitations. Second, the products should adopt a multi-omics screening strategy with high accuracy. Third, there should be more extensive commercial pathway layouts to ensure the large-scale adoption and efficiency of the products.

It is reasonable to expect that the cancer early screening market will continue to attract significant attention. As commercial pathways gradually expand and mature, China will undoubtedly see the emergence of more high-quality cancer early screening products, thereby increasing screening coverage and reducing the burden of cancer.