EVLiXiR Biotech Files IPO Prospectus: A Mass Spectrometry-Driven Innovator in Exosome-Based Diagnostics and Therapeutics with 50+ Products and 100+ Clients Within Two Years
Exosomes have emerged as a standout sensation in the medical industry in recent years, with research interest continuing to surge. From basic research to technological development, exosomes have become a focal point across multiple high-profile fields, yielding widespread breakthroughs and attracting significant attention and favor from both the industry and investment communities.
Due to their unique biological properties and functions, exosomes have demonstrated significant potential in three key areas: disease treatment, disease diagnosis, and drug delivery. This has attracted a large number of elites from both the scientific research and industrial sectors to enter this field and explore the clinical application value of exosomes.
According to incomplete statistics from VCBeat, there are currently nearly 50 companies worldwide conducting exosome-related research. Among them,Nearly one-third of exosome companies focus on exosome diagnostics, with several having already launched commercial products; Nanjing EVLIXIR Biotechnology Co., Ltd. (hereinafter referred to as “EVLIXIR”) is one such example.。
EVLIXIR, established in September 2021, is an innovative biotechnology company dedicated to the development of exosome-based precision diagnostic and therapeutic products.. To date,The company has successfully developed a mass spectrometry-based exosomal protein biomarker discovery and diagnostic technology platform, as well as a scaffold-based targeted delivery technology platform for active therapeutic molecules, enabling the provision of a comprehensive range of high-quality exosome products, raw materials, and specialized technical services.. Furthermore, building upon its existing technology platform, the company has developed a series of products for proteomics research, further accelerating exosome research.
The entrepreneurial story of EVLIXIR begins with its four core founders.
In 2010,Dr. Zhang Hao, CEO of EVLIXIRAt that time, he earned a master’s degree from Nanjing University, with his primary research focusing on the development of diabetes medications and the use of plasma cell-free miRNAs for cancer diagnosis. Driven by an aspiration to engage in new drug development, Zhang Hao joined companies such as GenScript Biotech and Jirui Bio after graduation, where he was involved in R&D, translation, and management in fields including antibodies and gene editing.
In 2016, leveraging previously accumulated expertise and market insights,Zhang Hao co-founded an IVD company with Dr. Liu Jilai from the Academy of Military Medical Sciences in Beijing., by establishing a recombinant monoclonal antibody expression technology platform, to achieve the application of antibody recombinant technology in the field of diagnostics. During this period,Zhang Hao led the development of China’s first chemiluminescence-based clinical diagnostic kit for cell-free VEGF (Vascular Endothelial Growth Factor) in blood.。
Notably, Dr. Liu Jilai is Professor Zhang Hao’s first professor-partner. Dr. Liu is a senior expert with multidisciplinary backgrounds in clinical medicine, biochemistry, antibody engineering, and artificial intelligence. He previously served as an Associate Researcher at the Academy of Military Medical Sciences in Beijing and possesses extensive experience in AI-driven antigen design and antibody development, having led the development and optimization of more than 10 clinical diagnostic kits.
In 2018, Zhang Hao attended a lecture on exosome research delivered by Dr. Tao Weiguo at Purdue University, which opened the door for him to enter the field of exosomes. Subsequently, Zhang Hao joined Dr. Tao’s research group in China to learn mass spectrometry techniques and conduct exosome-related research, becoming his first doctoral student in China dedicated to industrial translation. After more than two years of research and development, Zhang Hao and Dr. Tao’s team completed the establishment and optimization of the exosome platform technology in the laboratory.
At this juncture, interest in exosome research continues to intensify, with broad prospects for future development.Dr. Tao is an expert in the fields of proteomics, exosome-modified proteome research, and translational science.He earned his Ph.D. at Purdue University’s Aston Lab under the supervision of Professor R. Graham Cooks, a pioneer in mass spectrometry and a member of four U.S. national academies. He has also served as President of the Chinese American Society for Mass Spectrometry (CASMS) and as a Board Member of the U.S. Human Proteome Organization (USHUPO).
In addition, Dr. Tao has developed multiple technologies that are now widely used in many research laboratories around the world, such as KALIP (Kinase Activity Linked Phosphoproteomics) for large-scale mapping of kinase-substrate networks and post-translationally modified proteins in extracellular vesicles (EVs) from biofluids (such as plasma and urine), making pioneering contributions to the field of biomarker discovery.
Translating exosome research from laboratory studies into industrialized products has become the shared vision of Zhang Hao and Dr. Tao. It was precisely at this time,Zhang Hao met the fourth key figure instrumental in the founding of EVLIXIR—Dr. Xia Jiang, a leader in site-specific antibody conjugation technology.。
Dr. Xia and Zhang Hao are both alumni of Nanjing University. Dr. Xia earned his Ph.D. from Stanford University in the United States in 2006 and completed his postdoctoral research at the California Institute of Technology/Howard Hughes Medical Institute. He has extensive research experience in site-specific antibody conjugation technology, exosome engineering, and synthetic biology, and has published more than 150 papers in journals such as Advanced Science, Angewandte Chemie International Edition, Molecular Therapy, Journal of the American Chemical Society, Nature Communications, Biomaterials, and ACS Nano.
Thus, in 2021, with the support of Dr. Tao, Zhang Hao joined forces with Dr. Xia and Dr. Liu to co-found EVLIXIR, assembling a multidisciplinary cross-functional team that accelerated the translation of exosome research from the laboratory into industrialized products.
Exosomes are extracellular vesicles with a diameter of 30–150 nm, composed of various natural components including proteins, lipids, nucleic acids, and small molecules. All cultured cell types can secrete exosomes, which are naturally present in body fluids such as blood, saliva, urine, and cerebrospinal fluid.
Although exosomes are widely present in biological fluids, the efficient extraction, isolation, and intact preservation of exosomes remain significant research challenges and key factors influencing the development of exosome-based clinical diagnostics and therapeutic carrier technologies.
To address these challenges, EVLIXIR has provided solutions. Leveraging mass spectrometry technology, the company’s team has built two major technical platforms focused on exosome delivery, detection, and preservation, filed related patents, and established technological barriers.
In terms of protein detection,The company has developed a mass spectrometry-based proteomics and targeted quantification platform for the detection of plasma cell-free proteins.This platform is suitable for the detection of various sample types, including different biological fluids, animal tissues, plant samples, protein gels, and pathological sections, and it features sample pre-processing capabilities. Notably, company data indicate that the platform’s analytical performance surpasses that of certain overseas competitors.
In the field of exosomal protein detection, the company has developed a high-throughput exosome extraction platform for biomarker discovery and quantification.Compared with current large-sample-volume detection technologies, this platform requires only a trace amount of sample to rapidly enrich exosomes, and by employing the latest Astral mass spectrometer, it can identify more than 5,000 exosomal proteins.
Building on its two major testing platforms, EVLIXIR has also timely launched a dual-technology platform based on chemiluminescence and immuno-mass spectrometry to drive the quantitative detection and clinical translation of circulating blood proteins.
Notably, through its core technology platform,EVLIXIR has identified a group of scaffold proteins, with research indicating that these proteins hold promise for achieving efficient and targeted drug delivery.. Currently, the company has applied for relevant patents, laying the foundation for research on exosome-based drug delivery.
Currently, leveraging its core technologies and team strengths, EVLIXIRWe have developed three core product series, including exosome products, exosome raw materials, and proteomics products. Our current off-the-shelf portfolio comprises over 50 products, covering all aspects of exosome detection, preservation, and delivery.。
In addition, EVLIXIR has 1600m2technical and product R&D center, as well as 2,000 m2A production center compliant with GMP manufacturing and registration filing requirements. On this basis,The company provides CDMO services, such as scientific translation and clinical diagnosis and treatment, to research institutes and biotechnology companies.Accelerate its clinical research and product development in the field of exosomes. Since launching this service in September 2023, the company has served nearly one hundred client enterprises across China and established a stable customer base.
In July 2023, Eisai/Biogen announced thatAlzheimer's disease (AD) The therapeutic drug Leqembi has received FDA approval for market launch. Shortly thereafter, the National Medical Products Administration also announced that Leqembi has been approved in China for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease caused by AD.
The approval of new drugs for Alzheimer’s disease (AD) has spurred growth in the early AD diagnosis market. According to a report by Huafu Securities, the prevalence of AD among adults aged 60 years and older in China is 3.9%, corresponding to 9.83 million individuals affected by the disease. The domestic market size for AD diagnostics is projected to exceed RMB 24 billion by 2030, with the blood testing segment accounting for approximately RMB 17.193 billion.
Previously, the Alzheimer’s Association (AA) and the National Institute on Aging (NIA) released the latest diagnostic criteria guidelines for Alzheimer’s disease (AD), explicitly incorporating plasma protein biomarkers into the updated standards for biomarker classification, disease diagnosis, and staging. The Chinese Expert Consensus on Simple Screening for Prodromal Alzheimer’s Disease (2023 Edition) also recommends decreased blood Aβ42 or Aβ42/40 ratio, along with elevated plasma p-tau, as preferred detection methods for AD.
Based on this, EVLIXIR has strategically entered the field of blood-based testing for Alzheimer's disease at an opportune time,Developed the EVDi-103 mass spectrometry assay kit for blood-based free Aβ42/40, clinical mass spectrometry methodologies for Aβ42/Aβ40, p-tau217, and p-tau181 have been preliminarily established.
Among them, EVDi-103 is a diagnostic product specifically developed for the Chinese population, and may outperform the testing methods of companies such as Quanterix, C2N, and Roche in terms of result accuracy and product accessibility. Currently,EVDi-103 is currently undergoing clinical trials to evaluate its efficacy and is expected to receive marketing approval by the end of next year.。
Over the past two years, EVLIXIR has achieved a breakthrough from 0 to 1, successfully translating exosome research into practical applications. The company has developed multiple series of commercial products, ultimately establishing a closed-loop commercialization model, with its products exported to overseas markets including Singapore and the United States.
In addition, EVLIXIR has received numerous honors, including the “Third Prize in the Life Sciences Entrepreneurship Category of the 2022 ‘Sci-Tech Innovation Jiangsu’ Innovation and Entrepreneurship Competition” and recognition as an “Outstanding Enterprise in the Jiangsu Division of the 10th ‘Entrepreneurship Jiangsu’ Sci-Tech Entrepreneurship Competition and the 11th China Innovation and Entrepreneurship Competition.” Furthermore, multiple research findings from the company have been published in renowned journals such as Molecular Therapy, Journal of Controlled Release, Advanced Healthcare Materials, Analytical Chemistry, Mol Cell Proteomics, Biomaterials Science, Cells, and Molecules.
However, the development path of EVLIXIR has not been smooth. In March 2023, Codiak BioSciences, a biopharmaceutical R&D company that pioneered exosome-based innovative therapies and was known as the “first exosome stock,” filed for bankruptcy. This event served as a severe blow to the exosome industry, and the development confidence of EVLIXIR was also affected.
However, EVLIXIR did not “collapse” as a result. Instead, through team restructuring and technological innovation, the company has regained its momentum for growth and achieved self-sustaining operational viability. In this regard, Zhang Hao stated, “From another perspective, the bankruptcy event has made EVLIXIR more astute in selecting its development direction to cope with the rapidly changing market.”This year, EVLIXIR will continue to expand its scope on the existing foundation, achieving the goal of “single-product sales revenue exceeding the RMB 2 million mark.”。
Looking ahead, Zhang Hao stated that EVLIXIR will seize opportunities to advance exosome-related research, while continuously updating and iterating its technologies to facilitate their translational application. This aims to make exosome research more efficient and straightforward, thereby enabling the production of more products that meet clinical needs.
We thank Haikuo Tiancheng Club for its support of this article.
References:
Huafu Securities. "AD Diagnostic Industry Research Report (I): New Alzheimer’s Disease Drugs Poised for Approval and Launch in China—How to Assess the Market Potential of the AD Diagnostic Industry?"