LightBio Files IPO Prospectus: Pioneering Single-Molecule Detection for Next-Generation Precision Medicine

Genes are like a blueprint, one that primarily depicts the likelihood of future events. In most cases, genes themselves do not exert function; they must be transcribed and translated into functional molecules such as proteins to ultimately perform their biological roles.Proteins are not only the most fundamental building blocks of biological systems but also the ultimate effector molecules responsible for the division of labor, integration, and coordination in all life processes.

The primary reason for the slower development of proteomics compared to genomics: In sequencing, nucleic acids can be amplified, enabling the detection of originally low-copy sequences; in proteomics, since proteins cannot be amplified, limited sample amounts are insufficient to support proteomic-level detection and analysis.

The extent of disease progression ultimately requires analysis at the protein level. In recent years, with the rapid development and application of advanced technologies such as mass spectrometry and sample pretreatment, an increasing number of proteins have been identified and sequenced, facilitating their translation into clinical practice.

From an economic perspective, the most typical application is early disease screening; the economic burden associated with early testing, early detection, and early treatment is significantly lower than that of late-stage treatment.From the perspective of strategic sector allocationCurrently, cancer screening is gaining significant traction. Compared with other diseases, cancer has a higher mortality rate and imposes a heavier economic and social burden.From the perspective of market awareness, public awareness of early screening health checkups is gradually increasing. Due to the outbreak of the COVID-19 pandemic, the healthcare industry has received greater attention and accelerated its development.From a policy perspective, the promotion of universal screening programs under medical insurance and the centralized procurement of IVD products have both comprehensively boosted this sector.

How Should Companies Strategize to Address This Vast Unmet Market Need?Dr. He Hao, CEO and Founder of Light and Lifestated, “On one hand, proteomics places high demands on instrumentation and equipment, soMass Spectrometry Detection Technologyis a valuable and promising field awaiting breakthroughs and innovation. On the other hand,POCTIt is also a highly competitive sector. The COVID-19 pandemic enabled many POCT companies to reap substantial profits, and we have come to recognize that technology is not judged by its sophistication alone; as long as it meets market demand and delivers value, it is considered good technology. However, while capitalizing on this booming sector, it is essential to maintain cost control and pursue differentiated market competition.

“Ultra-sensitive protein detection based on big data of proteins is an emerging field in recent years."In contrast to the fierce competition in the IVD sector, the development and application of proteomics have only begun in recent years. Blood tests for conditions such as Alzheimer’s disease have also been explored only recently. Therefore, these new biomarkers and emerging application scenarios represent a valuable and promising blue-ocean market."

Capitalizing on the emerging blue-ocean market, Dr. He Hao founded Light and Life in 2019, focusing on the industrial translation of early screening for critical diseases. Regarding his original motivation, Dr. He Hao told VCBeat, “Born into a family of medical professionals, I developed a strong interest in the medical field from an early age due to my upbringing. My initial aspiration was to become a clinical physician; however, as the University of Science and Technology of China does not offer a clinical medicine program, I chose biology, a closely related discipline.”“If I can’t become a doctor, then I’ll be the scalpel in the doctor’s hand.”

To date, Light and Life has successfully assembled a highly advanced research team with extensive industry experience. Its core members each boast over ten years of expertise in areas such as corporate operations management, IVD device development, inorganic material R&D, organic material R&D, and clinical project management. Leveraging the deep complementarity between its disciplinary strengths and industrial advantages, Light and Life can rapidly translate cutting-edge technologies into clinical applications, thereby accelerating the development of the early screening industry for critical diseases.

In the early stages of disease, detection is challenging due to the low total expression levels of the target protein. Furthermore, since most assays rely on peripheral blood samples, in which the concentration of the target protein is even lower, an ultra-high-sensitivity protein detection method is required to enable the identification of proteins at ultra-low abundance.

Based on this, single-molecule detection technology has emerged.

On the industry front, although the single-molecule detection sector is still relatively early-stage, it has already moved beyond the initial R&D phase. Quanterix, a foreign company, has successfully launched single-molecule detection products and achieved profitability in 2021, with revenues reaching $110 million. In China, single-molecule detection companies such as Light and Life, Yuce Bio, and Caike Bio are gradually advancing their clinical trials and regulatory registration processes, facilitating industrial commercialization.Technical translation of single-molecule detection no longer requires extensive validation; the current focus of validation lies in the market value during the clinical application phase.

So, does the detection of low-abundance proteins hold clinical value? Take asymptomatic COVID-19 carriers as an example: although their viral load is low, this does not mean that there is no virus in their bodies; rather, the virus needs to replicate to a sufficient level to be detected. Achieving ultra-low-abundance detection at an early stage can significantly shorten the window for prevention, control, and treatment of infectious diseases, thereby reducing economic losses. Consider Alzheimer’s disease as another example: with the global trend of population aging, the number of Alzheimer’s patients is increasing year by year. While genetic testing may predict the probability of developing Alzheimer’s disease, it cannot determine the progression of the disease. Early single-molecule detection, however, can enable disease screening and facilitate timely prevention and intervention.

On the other hand, since single-molecule detection methods require lower protein abundance for analysis, the sample volume needed can be significantly reduced. For instance, while conventional methods may require 2 mL of blood, single-molecule detection only requires 0.2 mL of blood supplemented with 1.8 mL of diluent to complete the assay. Therefore, high-sensitivity detection holds greater significance for special populations such as children. Meanwhile, the reduction in sample consumption also leads to cost savings, which is one of the advantages promoting the adoption of this new technology.

Leveraging these advantages, Light and Life has independently developed its core fluorescent material for single-molecule detection—LightDot. LightDot is a rare-earth-doped upconversion luminescent material that enables zero background noise and ultra-long-term fluorescence stability. With a strictly controlled and reproducible manufacturing process, this fluorescent material allows for consistent mass production, with batch-to-batch variation in the emission intensity of individual fluorescent particles kept below 5%. By overcoming specialized know-how in the doping process, LightDot achieves visible-to-the-naked-eye luminescence from individual nanoscale particles.

What is the significance of this breakthrough? Dr. He Hao offered a vivid analogy: “Detecting an ultra-low-abundance protein is akin to spotting a single ant in a massive swimming pool. If we aim to detect this ant from the shore, it is impossible with the naked eye alone. Therefore, we typically label it with an optical molecule and capture its optical signal. However, traditional fluorescent materials are comparable to tiny LED bulbs; the brightness emitted by a single LED bulb may still be too faint to detect easily from the shore. In such cases, we might need 100 ants (i.e., 100 LED bulbs), meaning that a higher protein concentration is required for the signal to be captured.”

“Thus, when there is only one ant (one LED bead), its ‘brightness’ must be sufficiently high for the signal to be captured.”“Based on this logic, Light and Life has independently developed a new material called ‘Guangdian,’ which is two to three orders of magnitude brighter than traditional fluorescent materials, enabling the limit of detection for proteins to leap from ng/mL to fg/mL. This advancement facilitates the detection of trace amounts of proteins without requiring upgrades to more sensitive sensors or optoelectronic components. This represents the value and significance of Guangdian materials for the IVD industry.”

To continuously address critical industry challenges, Light and Life has established six core platforms: a proteomics platform, an antibody screening platform, an omics data platform, a single-molecule detection platform, an IVD product platform, and a specialized scientific literature database. The team has filed 14 intellectual property applications to date, including one granted invention patent, two design patents, and two exclusively licensed PCT international patents.

By leveraging multi-model integration of upstream and downstream resources through the capital market, Light and Life currently integrates new biomarker discovery, raw material preparation, product commercialization, and international sales. The company has established a presence in early screening, research services, and raw materials, with target customers including medical institutions, insurance providers, health checkup centers, individual home users, research institutes, pharmaceutical companies, and IVD enterprises.

In the future, we look forward to single-molecule detection companies such as Light and Life developing more comprehensive and precise market products, solving problems that genomics currently cannot address, and ushering in the third medical revolution characterized by the integration of precision diagnosis and targeted therapy.