ACCB Biotech Files IPO Prospectus: Pioneering Integrated Multi-Platform Solutions for Comprehensive Cancer Precision Diagnostics

In 2004, Xu Junpu was the first to recognize the vast potential of the untapped market for tumor companion diagnostics and founded Beijing ACCB Biotech Ltd. (hereinafter referred to as “ACCB”), becoming one of the earliest entrepreneurs in China to enter the field of tumor companion diagnostics.

Xu Junpu graduated from the Department of Biological Sciences and Biotechnology at Tsinghua University. With over a decade of extensive experience in the biopharmaceutical industry, he possesses profound insights into precision oncology diagnostics. “Around the year 2000, molecular diagnostics had limited applications in oncology, primarily focusing on diagnosing cancers caused by viral infections, such as Epstein-Barr virus (EBV) associated with nasopharyngeal carcinoma and human papillomavirus (HPV) linked to cervical cancer. However, we believed thatTargeted therapies will gradually become mainstream, and tumor companion diagnostics will be a key direction for future molecular oncology diagnostics., thus founding ACCB.”

Consistent with Xu Junpu’s assessment, as China’s R&D of novel oncology drugs rapidly flourishes, companion diagnostics have become an essential pathway for new anti-tumor agents and are garnering increasing attention. This trend is driven by technological advancements, the continuous discovery of new targets and targeted therapies, and the inclusion of more targeted drugs and companion diagnostic products in the national medical insurance coverage.

Beijing ACCB Biotech Ltd., which has proactively positioned itself in the field of tumor companion diagnostics, has experienced rapid growth since its establishment and has become one of the leading enterprises in the industry. At the end of 2021, its self-developed Human KRAS Gene Mutation Detection Kit (Fluorescent PCR Method) passed the review by the National Medical Products Administration (NMPA) and obtained a Class III medical device registration certificate, marking it asChina’s First PCR-Based KRAS Gene Mutation Detection Kit with Companion Diagnostic Approval

From a blank slate to a flourishing landscape, tumor companion diagnostics have developed in China for over a decade, with industry competition becoming increasingly intense.

“It is evident that the trend in oncology drug development has shifted from targeted therapies to immunotherapies. Mature PCR technology is not well-suited for companion diagnostics in cancer immunotherapy, creating opportunities for next-generation sequencing (NGS) technologies. However, China’s NGS sector is highly fragmented, with numerous companies vying for market share; no single player has yet emerged as a dominant market leader, and industry compliance and regulatory frameworks remain relatively underdeveloped.”

Xu Junpu believes: “Future opportunities lie more in industry consolidation. In a complex and fragmented market, complementary advantages can be achieved through industry consolidation.”

“Integration” is one of the key words for ACCB’s technological innovation and business development in recent years.In 2020, Beijing ACCB Biotech Ltd. announced the completion of its strategic merger with Lianhe Medical.ACCB has accumulated profound expertise in PCR technology platforms, while Lianhe Medical is a leading enterprise in tumor NGS genetic testing, specializing in the urogenital field. Following the merger,Beijing ACCB Biotech Ltd. has established a comprehensive technical platform for tumor companion diagnostics, encompassing PCR, NGS, IHC, FISH, and other technologies.

“From a clinical perspective, the companion diagnostic needs of doctors and patients are undoubtedly diverse. In the market, various treatment modalities such as chemotherapy, targeted therapy, and immunotherapy coexist, each with its own advantages; there is no scenario where a single technology platform dominates,” said Xu Junpu. “Cancer therapies are also continuously being updated and iterated. Only by possessing multiple technology platforms can one remain invincible in long-term future development. Therefore,”Technical platform integration and multi-platform deployment represent a long-term industry trend.”

In terms of solution layout, ACCB Biotech is also undergoing integration. Currently, ACCB Biotech has gradually expanded from tumor companion diagnostics to niche markets such as early cancer screening, auxiliary diagnosis, treatment efficacy monitoring, and prognosis assessment, offeringDiagnostic products and testing services covering the entire cancer care continuum.

Xu Junpu stated, “We believeOnly truly disruptive innovation can genuinely lead the development of the molecular diagnostics industry in oncology.“In terms of product layout for technological R&D, ACCB has invested substantial effort and resources to achieve technological leadership. For instance, it offers the NGS capture panel with the highest number of genes on the market, employs tiling density enrichment for probes in key regions, and has independently developed molecular barcode-associated algorithms, enabling coverage of a broader range of potentially valuable genes and hotspot regions.”

Based on the fluorescent PCR platform, ACCB Biotech has independently developed genetic mutation detection products (including gene point mutations, insertions/deletions, fusions, and amplifications) by integrating ARMS primers and hydrolysis probe technologies, and has obtained multiple Class III medical device registration certificates.

These genetic testing kits are specifically designed for nucleic acid samples extracted from patients' paraffin-embedded tissue specimens, which are characterized by low yield and poor integrity, featuringRapid, Sensitive, Accurate, Simple, and Stablesuch features,It can detect gene mutations as low as 1% from nanogram-level DNA extracted from paraffin-embedded tissues, and enable simultaneous detection of more than 40 types of point mutations, insertions, and deletions in a single gene.Certain technical specifications exceed industry standards, enabling full replacement of comparable imported products.

The BioPCR® series, built on a PCR platform, encompasses multiple technologies including BIOMARK® (Baikangan) for single-gene detection, IntMark® for multi-gene analysis, LiqMark® for liquid biopsy, and ExoMark® for early screening. The ARMS-PCR product portfolio, primarily consisting of the Baikangan series, comprises 34 products. Among these, five products targeting EGFR, ALK, BRAF, NRAS, and PIK3CA have obtained Class III registration certificates from China’s National Medical Products Administration (NMPA), and six products have received CE certification.

In late December 2021, ACCB’s independently developedHuman KRAS Gene Mutation Detection Kit (Fluorescent PCR Method) Approved for Class III Medical Device Registration Certificate, this is the company’s first in vitro diagnostic kit with companion diagnostic qualification, and alsoChina's First PCR-Based KRAS Gene Mutation Detection Kit with Companion Diagnostic Approval, filling a gap in the industry.

Leveraging NGS platforms, ACCB Biotech pioneered the UniMark® product series in China, which includes UniEX™ extraction technology, UniTag® library preparation technology, UniDis® bioinformatics technology, and UniHRD® technology.

Xu Junpu candidly stated, “Strictly speaking, even now,”No truly disruptive innovations have yet emerged in the field of tumor companion diagnostics.“For instance, no large-panel companion diagnostic products have been approved yet, and the current limited number of genetic loci is insufficient to meet clinical needs. Beijing ACCB Biotech Ltd. has several disruptive innovative technologies under development, which are expected to be launched soon.”

Currently, the molecular oncology diagnostics industry has undoubtedly become one of the most promising sectors in the biopharmaceutical field, garnering favor from the industrial sector, clinical community, and investment circles. Reports indicate that molecular diagnostics is the fastest-growing segment within the in vitro diagnostics (IVD) field, with the domestic market size in China reaching RMB 13.21 billion in 2019 and achieving a compound annual growth rate (CAGR) of 31.63%.

Xu Junpu stated that in the future,The healthy development of companies in the field of molecular diagnostics for oncology requires support from effective business models and profitability, rather than relying solely on capital.Companies should not blindly pursue valuation and financing scale, but should focus on building a genuine profit model. Relying on leading technological strength, comprehensive product layout, and refined management, Beijing ACCB Biotech Ltd. has already achieved economies of scale, atAchieved profitability for the first time in 2020, with an average annual revenue growth of over 70% from 2019 to 2021.

Currently, ACCB Biotech covers more than 1,300 large hospitals in China and has an ecosystem of over 50 industry clients, supporting more than 50 major medical research projects in China and publishing over 40 academic papers.

In the future, ACCB Biotech will continue to deepen its engagement in the field of tumor companion diagnostics, consolidate its technological platform advantages, continuously expand its business scale, and further enhance profitability. Leveraging its leading position in China’s tumor companion diagnostics sector, the company aims to establish itself as a pioneer in providing full-cycle solutions for precision oncology.