Puguang Bio's Fifth-Generation CRET Luminescence Technology and Global Expansion: Filing for IPO

“Traditional chemiluminescence technology has seen no major technological upgrades domestically or internationally over the past two decades. Constrained by issues such as bulky instrumentation, complex solid-liquid separation and washing procedures, and the necessity for cold-chain transportation, this technology remains inaccessible to primary healthcare institutions. Through subtraction-based innovation, we have industrialized the latest scientific research advancements from the past decade, achieving iterative upgrades in product technology and performance. This has resulted in lower product costs, more compact instruments, easier reagent storage, and more convenient operation, enabling even the most grassroots medical institutions to access state-of-the-art immunodiagnostic tools.”

“The IVD industry has begun to experience all-around hyper-competition, which indicates that everyone remains bullish on this sector... The industry has officially entered a new phase of reshuffling. If there is a product with clear competitive advantages, I believe there will still be significant opportunities in the future.”

……

Throughout the hour-long interview, Dr. Cao Dan, speaking from the other end of the phone, maintained a rapid pace, yet every word was delivered with crisp precision and force. Even when confronted with challenging questions, he would pause briefly for reflection before responding with clear, well-structured, and swift articulation.

This marks Dr. Cao Dan’s 10th year in the IVD industry and the fourth year since he founded Poclight Biotechnology. Had fate taken a different turn, his counterpart in a parallel universe might currently be hurrying down a hallway in a university building in Nanjing to deliver a lecture. However, Dr. Cao is well content with his present situation, believing that this valuable experience has equipped him with “expertise from both the academic and industrial sectors, laying a solid foundation for the establishment of Poclight Biotechnology.”

Dr. Cao Dan, Founder of Poclight Biotechnology

Poclight Biotechnology, established in July 2019 and located in the Nanjing Jiangbei New Area Bio-medicine Valley, is dedicated to the field of rapid testing using “minimalist, ultra-fast homogeneous chemiluminescence.” Based on the underlying principle of “graphene-proximal touch chemiluminescence resonance energy transfer (CRET),” the company has developed fifth-generation chemiluminescence technology and products, holding full independent intellectual property rights.

Poclight Biotechnology has 5,000 m² of R&D and office space.², with a production workshop of 3,700 m²², featuring GMP workshops with Class 10,000 and Class 100,000 cleanroom standards.

After years of development, Poclight Biotechnology has cumulatively obtained 63 NMPA product registration certificates and 119 CE certificates. The company’s chemiluminescence assay reagents cover multiple fields, including infectious diseases, tumor markers, thyroid function testing, reproductive endocrine hormones, cardiac markers, inflammation detection, and veterinary diagnostics, encompassing high-volume clinical assays based on chemiluminescence methodologies both domestically and internationally.

Poclight Biotechnology Financing History, Data Source: Qichacha

Compared with traditional chemiluminescence technology, the fifth-generation chemiluminescence (dry, homogeneous) CRET technology platform pioneered by Poclight Biotechnology not only retains the advantages of traditional chemiluminescence, such as high precision, high sensitivity, and a wide signal range, but also leverages the properties of graphene oxide to eliminate the need for magnetic beads and the associated separation and washing steps. This enables homogeneous luminescence without complex fluidic pathways, significantly enhancing the convenience, accessibility, and timeliness of chemiluminescence-based diagnostics.

“The CRET detection process is similar to biochemical testing, involving only incubation and detection steps, which makes the workflow simple and efficient.” According to Dr. Cao Dan, CRET technology holds promise for replacing traditional POCT applications while enabling the integrated consolidation of various methodologies, thereby achieving comprehensive coverage across diverse application scenarios.

CRET vs. Traditional Chemiluminescence

Considering long-distance transportation and overseas application scenarios, Poclight Biotechnology has creatively launchedLyophilized bead immunoassay reagents address the pain points of traditional chemiluminescence assay reagents, which require cold-chain transportation, refrigerated storage, and have a short shelf life.The lyophilized beads dissolve instantly upon sample addition, enabling a homogeneous reaction with the first result available in just 3 minutes. This technology offers high accuracy, excellent reproducibility, low cost, rapid processing, and easy storage.

Lyophilized Bead Immunoassay Reagent

Based on the fifth-generation chemiluminescence CRET technology, the company has established multiple product platforms, each offering specialized reagent kits tailored to the unique characteristics of the respective platform.

Semi-automated Dry Chemiluminescence Immunoassay Analyzer(Su Xie Zhu Zhun 20222220007) is the company’s first-to-market desktop multi-channel chemiluminescence immunoassay analyzer. With a footprint no larger than an A4 sheet of paper and a height only slightly greater than that of a 6.5-inch smartphone, it is among the smallest chemiluminescence immunoassay analyzers globally. The analyzer features seven test channels and offers short turnaround times, with the first result available in just 3 minutes, enabling on-demand testing for convenient and rapid operation. It is the first device to apply chemiluminescence immunoassay technology to a POCT platform, achieving effective integration of chemiluminescence immunoassay with point-of-care testing. This combination provides physicians with rapid and convenient diagnostic references while maintaining high sensitivity and accuracy, allowing immediate testing at the patient’s side to quickly obtain accurate diagnostic results, significantly improving diagnostic efficiency and expanding the application scenarios of laboratory testing.

Particularly in clinical settings with stringent requirements for accuracy and turnaround time, such as hospital ICUs, emergency departments, cardiology units, and chest pain centers, it also enables smaller hospitals, community health centers, and clinics to provide convenient and accurate diagnostic services to general patients. Furthermore, it can be applied to pet disease testing in overseas veterinary hospitals, pet diagnostic facilities, and third-party pet testing laboratories.

Semi-Automated Dry Chemiluminescence Immunoassay Analyzer

Dry Automatic Chemiluminescence Immunoassay Analyzer(Su Xie Zhu Zhun 20232220795) is a tabletop, rapid, compact, fully automated chemiluminescence immunoassay analyzer that supports both lyophilized and liquid reagent formats, allowing customers to choose freely. It features 13 reagent positions and 24 sample positions, with the ability to insert emergency samples at any time during operation for immediate testing (“test-on-arrival”). At equivalent throughput speeds, the instrument occupies only one-third the footprint of competing products. Compared with traditional magnetic particle-based compact chemiluminescence immunoassay analyzers, this analyzer offers a shorter time-to-first-result and eliminates the need for wash solutions. It is widely applicable in clinical laboratories, emergency departments, ambulance centers, clinical wards, intensive care units (ICUs), primary healthcare facilities, third-party laboratories, and health examination centers.

Dry Fully Automated Chemiluminescence Immunoassay Analyzer

Ultra-high-speed Chemiluminescence Immunoassay Analyzer is the flagship product of Poclight Biotechnology, this device employs biochemical methods to achieve chemiluminescence, with a single-unit throughput of 1,000 tests per hour. It not only reduces the technical complexity associated with chemiluminescence products but also integrates both biochemical and immunoassay capabilities, achieving true bio-immuno integration. This eliminates the need for assembly lines and rapidly enhances immunoassay efficiency. Furthermore, it addresses the challenges encountered by traditional chemiluminescence systems when exceeding ultra-high throughput of 1,000 tests/hour, such as large equipment footprint, complex structure, multiple control systems, and high failure rates. The device is currently in the registration phase.

Ultra-High-Speed Chemiluminescence Immunoassay Analyzer

“The primary prerequisite for innovative technology is cost reduction and efficiency enhancement. We have adopted ‘subtraction innovation’ as our entry point, simplifying previously complex, multi-step testing procedures into a three-step process. Our competitive advantage lies in delivering a minimalist testing solution that is simple, rapid, and highly cost-effective, while achieving high efficiency and eliminating the constraints of cold-chain transportation and low-temperature storage,” summarized Dr. Cao Dan. He noted that the IVD industry is currently characterized by intense “red ocean” competition, and only fundamental innovation can enable companies to break through.

“Many of our peers, whether proactively or reactively, have shifted their focus overseas to expand their IVD businesses internationally. We established our global expansion strategy from the very beginning of our startup phase. From start to finish, international markets have been a major business direction for us, accounting for nearly 50% of our total business volume.”

Dr. Cao Dan told VCBeat that Poclight Biotechnology’s overseas expansion efforts are more advanced than its domestic promotion initiatives. The company has targeted developing countries as its initial entry point for global expansion and is building momentum for market access by participating in exhibitions worldwide. In 2023, the company secured market access in countries across the Middle East, Southeast Asia, North Africa, and South America. With distributors consistently placing repeat orders, Poclight Biotechnology has now signed agreements with distributors in nearly 30 countries.

Furthermore, the company has recently entered into collaborations with overseas government agencies, research institutions, universities, and enterprises, including the Ministry of Agriculture of Myanmar, Chulalongkorn University in Thailand, and entities in Singapore, actively expanding international cooperation and market promotion.

Poclight Biotechnology Engages in Discussions with International Partners

When discussing the global expansion of IVD companies, Dr. Cao Dan stated that domestic IVD enterprises need to develop market promotion plans based on a "one-country, one-policy" approach, tailored to the specific ethnic demographics, national conditions, and policies of each country. This is particularly relevant for chemiluminescence companies, as many distributors require localized R&D, production, and after-sales services. However, Poclight Biotechnology’s fifth-generation chemiluminescence products are not subject to these special requirements. Since these products do not require cold-chain logistics, they are convenient to transport and store, and after-sales support can be completed entirely online. Thanks to these product features, the impact of inadequate local power supply on testing is also effectively mitigated.

The current Chinese chemiluminescence market is at a critical juncture, marked by the most intense competition ever seen in this sector, yet also representing the initial formation of the industry’s strategic landscape. Only IVD companies that can withstand pressure, achieve self-breakthroughs, and secure market breakthroughs will avoid elimination, truly establish themselves as key players, step onto the global stage, and compete alongside industry giants. VCBeat sincerely hopes that Poclight Biotechnology will not only become the “Light of Pukou” in Jiangsu Province but also evolve into a synonym for world-class quality and brand excellence, shining as a “Universal Light.”