From Product Distribution to Independent R&D: Z-Biotech Develops the World’s Fastest HIV Infection Detection Method
Wei Zhanxing first came into contact with genetic testing in 2013, when he became the general product distributor for BGI Genomics in North China. At that time, the concept of genetic testing was not as widely recognized as it is today. Having spent many years navigating traditional industries, Wei possessed a keen market sense and clearly recognized the application prospects of genetic testing.
In January 2014, Wei Zhanxing established ZHANHANG BIOTECH in Shenzhen, Guangdong. As a national high-tech enterprise specializing in molecular diagnostics, ZHANHANG BIOTECH initially leveraged its accumulated channel resources for product distribution. Within two years, the company had assembled its own R&D team to develop globally leading, proprietary diagnostic products, thereby building a robust product pipeline.
Notably, the pivotal breakthrough achieved in 2017 in microRNA-based early cancer screening technology enabled ZHANHANG BIOTECH to be recognized as a National High-Tech Enterprise. Meanwhile, its HIV window-period detection product can highly specifically compress the viral latent window period to one-third of its original duration, positioning ZHANHANG BIOTECH’s product portfolio among the world’s unique and advanced offerings in the industry.
Studies have shown that microRNAs in peripheral blood are highly correlated with various diseases and undergo dynamic changes as the diseases progress. When tumors develop, changes in microRNA levels occur earlier than those in currently used tumor markers; therefore, microRNAs can be used to monitor disease progression and serve as biomarkers for diagnosis and prognosis.
The SOL technology employed in ZHANHANG BIOTECH’s microRNA-based early cancer screening product divides the long and short nucleic acid probes, which are complementary to the target miRNA, into two segments. Each segment is designed to hybridize with half of the target miRNA sequence. Given that a typical miRNA is 22 nucleotides in length, hybridization between one half of its sequence (i.e., 11 nucleotides) and the corresponding nucleic acid probe results in only weak binding. In cases of mismatch or partial complementarity, the binding affinity between the target miRNA and the probe is further reduced.
At this stage, repeated washing is performed to remove mismatched and partially complementary bindings between the nucleic acid probes and the target miRNA, thereby enhancing the specificity of the detection system.
Wei Zhanxing told VCBeat that, unlike most microRNA tests on the market that target only a single locus, ZHANHANG BIOTECH’s early cancer screening product integrates biological information from multiple loci for comprehensive assessment. In addition, ZHANHANG BIOTECH is collaborating with multiple oncology experts to conduct clinical studies and has already accumulated real-world samples from more than 1,000 cases using its lung cancer early screening product across various hospitals.
“We expect our lung cancer early screening product to enter the regulatory approval process by early next year, and anticipate obtaining medical device certification within two years,” said Wei Zhanxing. He noted that the company’s lung cancer early screening product has demonstrated strong accuracy during its preliminary application phase at third-party clinical laboratories, and will be promoted on a larger scale once regulatory approval is secured.
ZHANHANG BIOTECH’s other flagship product is an HIV window period detection kit.
Currently, the global situation regarding HIV infection (i.e., AIDS) is extremely severe, with the epidemic in China being particularly grave. According to statistics, there are approximately 800,000 people living with HIV in China, among whom 30% (nearly 250,000 individuals) are unaware of their infection status. In 2018, approximately 250,000 people died from AIDS-related causes.
In July 2018, the Joint United Nations Programme on HIV/AIDS (UNAIDS) proposed achieving the target that 90% of people living with HIV would know their status through testing by 2020. According to survey data from New Thinking Industry Research Center, China’s HIV testing volume increased to 315 million tests in 2018. However, there remains substantial room for growth in annual HIV testing volumes to meet UNAIDS’ 90% target, with the market expected to reach a scale of billions or even tens of billions.
HIV testing is a critical approach for preventing and controlling the spread of HIV, yet existing detection technologies suffer from a prolonged window period. After infecting the human body, the virus requires time to accumulate before sufficient levels of biomarkers are produced in the blood to be detected by diagnostic tools; this interval is known as the window period. According to the World Health Organization, the window period is defined as 2–3 weeks; however, its specific duration is closely related to the detection method employed. Traditional HIV diagnostic methods primarily include antibody testing, nucleic acid testing, and p24 antigen testing.
Antibody Diagnosis. It generally takes 3 weeks to 2 months from HIV entry into the body to antibody production, with HIV antibody concentrations reaching their peak at approximately 42 days. Virtually all infections can be detected through antibody testing.
Nucleic Acid Diagnosis. A sufficient viral load is required; it can generally be detected in the blood 10 days after infection, although sensitivity varies among individuals.
P24 Antigen Testing. This test also requires a sufficient viral load, which is typically reached approximately 10 days post-exposure. However, as the P24 antigen may disappear during the late asymptomatic stage, the test has limited accuracy. Therefore, to definitively rule out infection, a follow-up test should be conducted after three months to confirm a negative result.
Shortening the window period allows for earlier confirmation of infection status, enabling the use of integrase inhibitors to block viral replication within the body. This facilitates early intervention therapy, thereby controlling viral spread and achieving therapeutic goals. In August 2016, researchers at Aarhus University in Denmark announced the detection of an enzyme in HIV-infected cells, allowing for simple and rapid detection of HIV presence in the human body. Like other retroviruses, HIV contains integrase, an enzyme that enables the virus to anchor itself and integrate its DNA with human DNA, which is also the reason for the long-term persistence of the disease.
ZHANHANG BIOTECH’s research team has translated the findings of this study into practical applications. Unlike traditional HIV markers, ZHANHANG BIOTECH has independently designed a DNA sensor that detects viral integrase activity. Integrase is the core enzyme in the viral replication process; it exhibits high activity, with each viral particle containing 40–100 copies of integrase. This characteristic lowers the required threshold for viral load detection. Furthermore, our DNA sensor technology, combined with microfluidics and nanoprobes for result analysis, achieves ultra-high sensitivity.
According to market research statistics, ELISA kits currently hold the largest market share, accounting for more than half of all HIV testing kits; rapid test kits also capture approximately 20% of the market due to their speed and convenience. However, all currently available testing kits suffer from a prolonged window period. ZHANHANG BIOTECH plans to launch its initial product for HIV window-period detection in early 2020 and initiate the regulatory approval process.
In China, there are hundreds of companies operating in the field of early cancer screening. Unlike scientist-led startups that focus on top-tier tertiary hospitals in first-tier cities, ZHANHANG BIOTECH has a relatively mature business model. Adhering to its principle of rigorously selecting the best products for distribution, the company has established a stable market presence and consistent sales revenue, thereby gaining a unique competitive advantage.
Meanwhile, ZHANHANG BIOTECH is also striving to further revitalize its channel resources. On one hand, after years of collaboration with BGI and HuaDa, the company is exploring strategic partnerships leveraging its extensive network of distributors and sales channels. On the other hand, the company plans to establish a dedicated Key Account Department to engage with large enterprises, insurance institutions, and health management centers. This initiative aims to create a distributor platform and implement a city-level sales model, gradually extending product penetration down to the village and township levels.
In April 2019, ZHANHANG BIOTECH completed a RMB 20 million angel financing round, expanded its team, and further optimized its products. In July of the same year, at the Shenzhen Yantian Health Intelligence Valley held
Currently, ZHANHANG BIOTECH has launched its Series A financing round. The funds will be primarily allocated to the company’s newly initiated cell therapy and health management businesses. Wei Zhanxing told VCBeat that the company has already established a robust R&D team for this purpose.