Xieguang Bio Advances as a Leader in Autoimmune Quantitative Diagnostics with 22 Approved Assays and Files IPO Prospectus
More than 100 diseases are considered autoimmune disorders, and this number continues to grow. In China, approximately 20 million people suffer from autoimmune diseases, including about 3 million with severe cases. According to the "Research Report on the Domestic and International Medical Device and In Vitro Diagnostics Industry," the market size for autoantibody testing in China was estimated at RMB 1.2–1.5 billion in 2018. Driven by factors such as population aging, advances in disease research, changes in lifestyle habits, and DRG payment reform, the market size is projected to reach approximately RMB 2.228 billion by 2023, with a compound annual growth rate of around 14%.
Although the domestic market for autoantibody testing holds immense potential, European and American brands, having entered the Chinese market early, command an 80% share of the industry. Fortunately, in recent years, a cohort of domestic autoimmune testing companies has emerged, accelerating the process of import substitution; Sichuan Light Carrying Biotechnology Co., Ltd. is one such enterprise.
Sichuan Light Carrying Biotechnology, established in Chengdu, Sichuan in 2018, boasts a founding team with extensive R&D, manufacturing, and registration expertise in the field of chemiluminescence. The fully automated chemiluminescence systems (alkaline phosphatase and acridinium ester-based) and related products developed by the team have been validated by the market and received positive feedback. In January 2019, the company completed construction of a 3,000-square-meter facility integrating R&D, production, and administrative offices, marking its transition from an R&D-focused service-oriented enterprise to an integrated R&D and manufacturing enterprise.
Qin Feng, Chairman of Sichuan Light Carrying Biotechnology Co., Ltd., introduced that the company’s business lines are divided into two parts. First, it serves as an “R&D center” for in vitro diagnostic (IVD) manufacturers and medical device companies intending to enter the IVD field, providing outsourced services covering the entire product lifecycle, including chemiluminescence raw materials and technical R&D solutions. Second, it is building its own brand, focusing on the research and development of a quantitative detection platform for autoimmune antibodies.
By providing technical outsourcing services to enterprises, Light Carrying Biotechnology has achieved self-sustaining revenue generation, with sales surpassing RMB 10 million in 2019. In the field of quantitative detection of autoantibodies, the company has grown into a leading domestic player in automated quantitative testing. It has obtained 22 registration certificates for autoimmune antibody detection reagents in China and 59 CE marks for autoimmune products in the European Union.
In September 2020, Sichuan Light Carrying Biotechnology Co., Ltd. received strategic investment from Thalys Medical. Subsequently, with the support of Thalys Medical, the company will continue to increase its investments in the production and research and development of chemiluminescence immunoassays, further strengthening its advantageous position within the industry.
Autoimmune detection technologies are categorized into conventional methods (radioimmunoassay), qualitative assays (enzyme-linked immunosorbent assay, ELISA), semi-quantitative assays (batch quantitative detection technology), and magnetic particle chemiluminescence technology (fully automated chemiluminescence immunoassay).
Magnetic microparticle chemiluminescence technology enables fully automated operation, precise quantification, and random access sample loading, representing the most advanced technology currently available for autoimmune testing. The “Expert Recommendations and Consensus on the Clinical Application of Autoantibody Testing in Autoimmune Diseases” explicitly states that “autoantibody test results should be reported in a quantitative or semi-quantitative manner.”
However, at present, the autoimmune testing technologies applied in China remain relatively backward. Most domestic companies are still confined to qualitative and semi-quantitative assays, relying heavily on extensive and cumbersome manual operations. As one of the few enterprises in China dedicated to the research and development of magnetic particle chemiluminescence technology, Sichuan Light Carrying Biotechnology Co., Ltd. has secured a first-mover advantage and has grown into a leading provider of quantitative autoimmune diagnostics in the country.
Autoimmune diagnostic reagents encompass diverse structural molecules and mechanisms, requiring R&D personnel to possess extensive expertise in nucleic acids, proteins, and enzymes. This indicates that developing autoimmune diagnostic reagents is no easy task. Qin Feng stated that in the chemiluminescence industry, few companies are capable of developing more than 60 types of autoimmune diagnostic reagents. Light Carrying Biotechnology has completed its layout in this niche segment in the shortest time and stands as the autoimmune diagnostics company offering the most comprehensive product portfolio.
Light Carrying Biotechnology’s autoimmune testing portfolio primarily serves as a supplement to imported brands, enabling effective cost control through the use of in-house raw materials and reagents. The company’s R&D pipeline for raw materials includes 14 autoimmune testing items, 7 autoimmune antigens, and 3 antibodies. Its reagent portfolio comprises more than 50 autoimmune testing reagents across multiple series, including allergy, antinuclear antibody (ANA), autoimmune liver disease, and rheumatoid arthritis. Furthermore, Light Carrying Biotechnology’s autoimmune testing reagents are compatible with chemiluminescence immunoassay analyzers of various brands and models.
According to reports, Sichuan Light Carrying Biotechnology Co., Ltd. has obtained 22 registration certificates for autoimmune diagnostic reagents in China, with nearly 80 additional items currently under registration. The company expects to hold more than 50 reagent registration certificates by the end of this year. Additionally, the company has already secured 59 autoimmune diagnostic registrations in the European Union.
The era of quantitative autoantibody testing has arrived. The vast majority of autoantibody assays will gradually adopt the most advanced magnetic particle chemiluminescence technology to achieve accurate quantitative detection. Moving forward, Sichuan Light Carrying Biotechnology Co., Ltd. will continue to focus on quantitative autoimmune testing, consistently launching new products, improving reagent quality, and providing customers with high-quality reagents. In the future, the company also plans to extend its reach into the mid- and downstream sectors by developing therapeutic solutions, such as antibody drugs, thereby establishing its own brand in the diagnosis and treatment of autoimmune diseases.
The R&D Director at Light Carrying Biotechnology has over 10 years of experience in the development of diagnostic reagents, and the company boasts a strong R&D team. Meanwhile, the company has established a large-scale production workshop for diagnostic raw materials that meets GMP requirements, with single-batch labeling of key raw materials exceeding 1 million test kits. This achieves full-chain coverage from custom antigen and antibody development to project debugging and optimization, and finally to large-scale production of core materials. In other words, in addition to its R&D capabilities for automated quantitative testing projects, Light Carrying Biotechnology also possesses the capacity to provide technical outsourcing services.
Light Carrying Biotechnology R&D Center and R&D Team
The company’s other core business is chemiluminescence R&D outsourcing services, providing chemiluminescence reagents and systemic solutions to domestic in vitro diagnostic (IVD) enterprises. By building a comprehensive technical service platform, it assists partners in product development, technology transfer, regulatory registration, and market launch, thereby saving time and R&D costs while ensuring product quality.
Qin Feng stated, “Seeking external innovation and R&D collaborations has become a strategic priority for healthcare companies. In the field of in vitro diagnostics (IVD), Roche, Abbott, and Beckman are all seeking partners, with most of their newly launched products developed through collaborative models. These companies have also transitioned from traditional outsourcing arrangements to strategic partnership models, which better stimulate diverse innovative capabilities, enhance R&D efficiency, and achieve win-win outcomes.”
Sichuan Light Carrying Biotechnology excels in the integrated development of instruments and reagent systems, aiming to build a comprehensive chemiluminescence service platform. It provides partners with over 80 technical services, including assay optimization, customized solutions, bulk reagent OEM, and technical consulting.
Compared with other R&D outsourcing service providers, the company excels in the integrated development of reagents and instruments, offering a comprehensive product portfolio. In addition to routine outsourced services, it provides specialized testing panels covering oncology, thyroid function, hormones, infectious diseases, cardiac markers, infections, and bone metabolism.
Currently, Sichuan Light Carrying Biotechnology Co., Ltd. has served a total of 25 industrial clients and assisted three enterprises in obtaining more than 50 registration certificates. Qin Feng stated that the company will collaborate with more clients in the future, adding, “We aim to help our clients secure over 300 additional registration certificates, and we expect to serve more than 50 enterprises by 2023.”