Hangzhou Ascel Biopharma Files for IPO: Pioneering Next-Gen Imaging Contrast Agents with Core Product On Track for 2027 Launch

In January this year, the field of contrast media witnessed a major development. On January 31, GE HealthCare announced an investment of €132 million (approximately RMB 1 billion) to expand its contrast media filling and manufacturing facility in Carrigtwohill, Cork, Ireland. The GE HealthCare Carrigtwohill plant is one of the key global production bases for contrast media. The expanded facility is expected to add annual production capacity equivalent to 25 million patient doses by the end of 2027. Irish Prime Minister Micheál Martin officiated at the groundbreaking ceremony for the new facility.

Contrast agents, also known as contrast media (hereinafter collectively referred to as contrast agents), are chemical substances injected into or ingested by the human body to enhance imaging visualization, playing a significant role in the detection and diagnosis of pathological conditions. Contrast agents are primarily used for visualizing blood vessels and body cavities, as well as for observing organ excretion rates. Based on the imaging modality employed, they can be categorized into X-ray, CT, MR, and ultrasound contrast agents. Driven by the accelerating global aging trend, rising incidence of chronic and degenerative diseases, widespread adoption of medical imaging technologies, and growing patient demand for high-quality medical imaging, the contrast agent market is experiencing unprecedented upward growth.

According to QYR data, the global contrast agent market reached sales of $6.116 billion in 2024 and is projected to grow to $9.507 billion by 2031, with a compound annual growth rate (CAGR) of 6.6%. Despite strong market demand, China’s contrast agent market remains dominated by imported or joint-venture products, leaving substantial room for domestic substitution. Recognizing this market gap, Hangzhou Ultra-Theranostics Biopharmaceuticals (hereinafter referred to as “Ultra-Theranostics”) focuses on novel imaging contrast agents and integrated tumor diagnosis and therapy. The company has developed several products, with its core product expected to launch as early as 2027. This positions Ultra-Theranostics to achieve rapid advancement in the novel contrast agent sector, introducing several cost-effective and efficiency-enhancing products to the industry.

Currently, the contrast media sector is characterized by a high degree of industry concentration, where the production status of a few large enterprises has a decisive impact on overall market supply. This is because the manufacturing process for contrast agents is complex, and any issues within the supply chain can lead to disruptions. New entrants must possess both strong technical capabilities and stable industrialization capacities. Globally, the market is currently dominated by major manufacturers such as GE Healthcare, Bayer, Bracco, and Guerbet Group, which collectively hold over 75% of the market share. In China, the market size reached RMB 29.5 billion in 2023, primarily divided among six companies: Hengrui, Yangtze River Pharmaceutical, GE, Bayer, Bracco, and Beilu Pharmaceutical. These six companies together account for 90% of the contrast agent market.

However, imported contrast agents suffer from high prices and supply shortages. Domestically produced contrast agents are mostly generic copies, lacking innovation, with some costing nearly RMB 1,000 per patient. Furthermore, current traditional contrast agents face multiple challenges, including short imaging windows, lack of tumor targeting, limited variety, and significant side effects. In response to these pain points, Ultra-Theranostics may offer valuable insights.

Ultra-Theranostics is a company dedicated to the research and development of novel imaging contrast agents and high-end theranostic drugs, as well as the production, customization, and sales of cutting-edge high-value compounds such as poly(sarcosine). Sun Qiuye, General Manager of Ultra-Theranostics, stated, “Although Ultra-Theranostics was established in 2023, its core project, ASR001, dates back to 2016. It originated from a collaboration between Professor Sun and Professor Ling at Zhejiang University, who discovered a novel polyamino acid nanomaterial (the precursor to ASR001) capable of loading ferric ions and exhibiting excellent magnetic resonance imaging (MRI) performance. The project won first place in the pharmaceutical category at the 2022 China-Europe Entrepreneurship Competition. Consequently, numerous pharmaceutical companies approached us with offers to purchase the intellectual property rights for commercialization. However, after extensive communication and evaluation, the team concluded that the maximum value of ASR001 could only be realized through the direct involvement of scientists. With financial support from Zheshang Venture Capital, along with policy support for scientist entrepreneurship and talent development from Zhejiang University and Xiaoshan District, Ultra-Theranostics was founded.”

Professor Sun, Founder and Chief Scientist of Ultra-Theranostics, is primarily engaged in research on polymeric nano-MRI contrast agents, integrated nanotheranostic probes, and nano-oncology drugs.

In the field of scientific research, Professor Sun has developed five novel imaging contrast agents in recent years and established more than ten new technologies for targeted diagnosis and treatment, as well as integrated theranostics, of various malignant tumors. As the principal investigator, he was awarded the Second Prize of the Provincial Science and Technology Progress Award. He has published over 80 SCI-indexed papers in journals including Science and Nature subsidiaries, and holds six authorized Chinese invention patents and one Japanese patent. He has presided over three General Programs of the National Natural Science Foundation of China, participated as a key member in three National Key and Major Projects, and led three provincial-level initiatives, including Provincial Key R&D Programs, the “Lingyan” Project, and Major Projects of the Provincial Health Commission.

In terms of industrial translation, Professor Sun, who serves as the Chief Physician in the Department of Radiology at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, has deeply specialized in molecular imaging and AI-based radiomics. This enables Professor Sun’s team to maintain long-term, close communication with clinical practitioners. Adopting an end-goal-oriented approach, the team is dedicated to developing breakthrough innovative contrast agents that address urgent clinical needs based on the actual demands for contrast media in diverse clinical scenarios across China and globally, thereby benefiting a larger patient population. Furthermore, Ultra-Theranostics has established collaborative partnerships with multiple experts from Zhejiang University, its affiliated hospitals, and Sun Yat-sen University. Notably, Professor Ling from the Department of Polymer Science and Engineering at Zhejiang University, and Mr. You Xiangdong, former Vice President of the Second Affiliated Hospital of Zhejiang University School of Medicine and current Managing Partner of Zheshang Venture Capital, are both co-founders of Ultra-Theranostics. Dr. Cao Yangyang, the R&D Director of Ultra-Theranostics, joined the company full-time after completing his postdoctoral fellowship at Zhejiang University. He currently oversees product research and development, as well as talent cultivation and management.

In addition to the core team’s expertise in related interdisciplinary fields, Ultra-Theranostics operates as a research-driven, multidisciplinary team, with R&D personnel accounting for over 80% of its workforce and covering the entire industry chain from laboratory research to large-scale product manufacturing. By leveraging the interdisciplinary integration and technological innovation across medical imaging, pharmaceutical formulations, new material synthesis, and life sciences, Ultra-Theranostics achieves the R&D and industrialization of core technologies and processes for novel imaging contrast agents and high-end theranostic drugs.

Ultra-Theranostics has developed ASR001, an iron-loaded magnetic resonance imaging (MRI) nano-contrast agent, based on its independently developed poly(amino acid) materials. Currently, the ASR001 project has been outsourced to a contract research organization (CRO) for preclinical trials. The company expects to complete the Investigational New Drug (IND) application in the second half of 2025 and submit the New Drug Application (NDA) by 2027. Professor Sun stated that once this novel contrast agent is approved for market launch, Ultra-Theranostics could engage in joint production and sales with pharmaceutical companies or generate revenue through licensing agreements. This product is poised to break the monopoly held by traditional gadolinium-based agents in the MRI contrast media market.

Overall, ASR001 addresses the key limitations of gadolinium-based contrast agents widely used in hospital radiology departments, including short imaging windows, lack of tumor targeting, limited product diversity, significant side effects, and high costs.

First, ASR001 enables high-quality whole-body cardiovascular imaging—including arteries and veins, as well as large and small vessels—with a single injection and an imaging window exceeding 5 hours. Moreover, ASR001 is eliminated via hepatobiliary metabolism, making it particularly suitable for patients with impaired renal function. Second, ASR001 achieves a relative uptake value (re) of >3 at tumor target sites, enabling targeted imaging for certain types of tumors. In addition, compared to novel contrast agents from foreign pharmaceutical companies priced at nearly RMB 1,000, and domestic generic contrast agents such as Xian’ai priced at over RMB 700, ASR001 costs only approximately RMB 32.2 per patient, positioning it to hold a significant advantage in commercial pricing.

Furthermore, ASR001 exhibits favorable extensibility, enabling further loading of antitumor drugs to achieve MRI-guided integrated tumor diagnosis and therapy. Leveraging the high extensibility of ASR001, Ultra-Theranostics has developed a series of nanocarrier formulations for common chemotherapeutic agents, including the lymphatic contrast agent ASR001-L, as well as nano-formulations of doxorubicin, temozolomide, and paclitaxel.

During the advancement of ASR001 and its derivative pipeline, an unexpected development occurred that surpassed Ultra-Theranostics’ expectations. Sun Qiuye told VCBeat, “At the Annual Conference of the Chinese Society of Radiology, leading experts showed even greater interest in ASR001-L than in the flagship candidate ASR001. This is because there is currently no dedicated lymphatic contrast agent available on the market. For lymphatic imaging examinations, clinicians have had to rely on traditional contrast agents administered via in situ injection into lymph nodes—a technique that is technically challenging, time-consuming, provides only a short detection window, and is invasive. In contrast, ASR001-L, modified with hyaluronic acid, can be administered via intramuscular or subcutaneous injection. Animal studies have demonstrated that a single subcutaneous or intramuscular injection enables high-quality lymphatic imaging for an extended duration (>24 hours), thereby addressing the aforementioned pain points and attracting significant industry attention.”

In addition to the aforementioned products, Ultra-Theranostics currently offers a diverse portfolio including the polyamino acid excipient ASR002, the synthetic collagen peptide aesthetic medicine pipeline ASR003, and various polypeptide or peptide-cluster research reagents such as synthetic custom polysarcosine. The company has already generated revenue through contract research services and customized polymer synthesis services. With aesthetic medicine products expected to launch rapidly, these offerings are anticipated to contribute to the company’s financial recovery.

At the beginning of this year, Ultra-Theranostics achieved a series of major breakthroughs.First, the joint project application by Ultra-Theranostics and Zhejiang University, titled “Research on New Technologies and Strategies for Precision Diagnosis and Treatment of Malignant Tumors: Novel Image-Guided Integrated Precision Targeted Theranostic Technologies for Glioma,” was selected for inclusion in Zhejiang Province’s 2025 “Vanguard and Leading Goose + X” R&D Key Project Plan. Second, Professor Sun, founder of Ultra-Theranostics, received funding from the National Natural Science Foundation of China (General Program) for his project entitled “Molecular Imaging Study on Immune Therapy Biomarkers and Their Evolution in Advanced Colorectal Cancer.”

According to public information, in the “Vanguard and Leading Goose + X” project applied for by Ultra-Theranostics, the team addresses the clinical issue of gadolinium-based magnetic resonance (MR) contrast agents lacking tumor targeting and specificity. The team will employ an iron-loaded polydopamine amino acid nanomicelle system developed by Ultra-Theranostics. These iron-loaded polydopamine amino acid nano-contrast agents can passively target tumor lesions via the enhanced permeability and retention (EPR) effect, thereby improving the precise visualization of glioma infiltration zones, particularly with clear delineation of tumor margins, and prolonging the MR enhancement phase. This approach yields high-quality MR images of gliomas as well as intraoperative fluorescence localization and navigation, facilitating precise tumor resection, while demonstrating favorable biosafety.

Regarding future development, Sun Qiuye stated, “In terms of pipeline development, Ultra-Theranostics will accelerate the advancement of its core candidate, ASR001, in the short term, with plans to submit Investigational New Drug (IND) applications in both China and the United States by the end of this year. In terms of corporate growth, the company aims to obtain recognition as a National High-Tech Enterprise within the next one to two years, while also establishing relevant R&D centers to achieve dual progress in corporate qualifications and scale. Regarding global expansion, Ultra-Theranostics is considering setting up overseas offices to accelerate its globalization strategy.”

To accelerate corporate growth, Ultra-Theranostics is actively pursuing a new round of financing, which is expected to close in mid-2026. Furthermore, the company seeks to foster active collaboration and exchange with industry chain partners to jointly accelerate global access to innovative contrast agents. As its products and services advance smoothly, Ultra-Theranostics aims to transition from an early-stage biopharmaceutical startup reliant solely on venture capital funding into a resilient, comprehensively developed, and self-sustaining high-end polyamino acid nanotheranostic platform. This transformation will position the company to gradually become a niche leader in the fields of novel contrast agents and tumor-targeted theranostics.

References:

Device Home, “$1 Billion: GE Healthcare Expands Again”