Recently, IxCell has obtained implied approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) for the clinical trial application of its independently developed IxCell PB-ZRAK Injection. The novel cell therapy product is indicated for the treatment of unresectable or metastatic advanced hepatocellular carcinoma (HCC) in patients with disease progression following standard-of-care therapies.
As a long-term strategic collaborator of IxCell, Medicilon provided comprehensive pharmacodynamic research services for IxCell PB-ZRAK Injection relying on its professional Cell and Gene Therapy (CGT) service platform. Through rigorous technical collaboration and joint efforts, the two parties have overcome multiple key technical challenges, facilitating a significant clinical advancement of cell therapy interventions for advanced liver cancer.
Unmet Clinical Needs in Liver Cancer Treatment and Breakthrough Potential of Cellular Immunotherapy
Liver cancer poses a severe global public health burden, with China accounting for nearly 50% of newly diagnosed cases worldwide. According to the 2024 National Cancer Report, the country records 367,700 new liver cancer cases and 316,500 cancer related deaths annually, ranking the disease the fourth highest in incidence and the second highest in mortality across all malignancies. In terms of market prospects, the global liver cancer therapeutic market is projected to expand steadily from USD 4.6 billion in 2026 to USD 16.7 billion by 2035.
Conventional therapeutic regimens, including surgical resection, radiotherapy, chemotherapy and targeted therapy, have encountered inherent efficacy limitations in the treatment of advanced liver cancer. Cellular immunotherapy has emerged as a state-of-the-art therapeutic modality for advanced HCC, characterized by precise anti-tumor specificity, reliable safety profiles and broad patient applicability. The research innovation and clinical translation of novel immune cell therapeutics are of profound clinical significance for addressing unmet medical needs, while possessing considerable industrial and market value.
Dual-Mechanism Synergy: A Novel Therapeutic Solution for Advanced Liver Cancer
IxCell PB-ZRAK Injection is an innovative mixed immune cell formulation independently developed by IxCell based on its proprietary immune cell technology platform. The product exerts dual anti-tumor mechanisms: T cells achieve precise recognition and elimination of tumor cells, while NK cells deliver broad-spectrum cytotoxic effects, yielding superior therapeutic efficacy against liver cancer. PB‑ZRAK complements the company’s iPSC‑NK and other immune‑cell pipelines from both technical and product perspectives, further refining IxCell’s product portfolio in the field of tumor immunotherapy. Meanwhile, leveraging its iPSC‑based technology platforms, IxCell continues to expand into indications such as immune‑mediated diseases.
To date, IxCell has built three core R&D and technical systems for cell‑based therapeutics: mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and immune cells. These are backed by a compliant cGMP‑compliant manufacturing infrastructure. The company’s core pipelines are among China’s first‑tier cell‑therapy programs. Multiple cell‑therapy candidates have entered clinical development, with its lead MSC product advancing into late‑stage clinical trials.
The implied approval of IxCell PB-ZRAK Injection fully validates IxCell’s profound technical reserves and independent innovation capabilities in the cell therapy sector. Furthermore, this milestone marks the company’s strategic advancement from regenerative medicine to tumor immunotherapy, offering a promising novel therapeutic option for patients suffering from advanced liver cancer.
Medicilon’s Professional CGT Platform Accelerates Preclinical R&D of Innovative Cell Therapies
During the preclinical research phase of IxCell PB-ZRAK Injection, Medicilon’s pharmacodynamic R&D team systematically addressed core technical difficulties, including the biological heterogeneity of living cell therapeutics, immunosuppressive microenvironment characteristics of solid tumors, and insufficient clinical correlation of traditional animal models. The team successfully constructed an orthotopic Hep G2 liver cancer animal model and completed standardized, systematic pharmacodynamic evaluation studies, establishing a solid preclinical theoretical and experimental foundation for the product’s clinical approval.As a pioneering CRO specializing in cell and gene therapy, Medicilon has built a mature and comprehensive CGT R&D service platform covering mainstream immune cell therapy technologies, including CAR-T, TCR-T, CAR-NK and TIL. The company provides one-stop integrated preclinical research services encompassing pharmacological and pharmacodynamic assessment, pharmacokinetic analysis, bioanalysis and drug safety evaluation. As of the end of June 2026, Medicilon has supported a total of 9 cell therapy drug candidates to obtain clinical trial approvals.
Medicilon extends its sincere congratulations to IxCell on the successful clinical approval of IxCell PB-ZRAK Injection. In the future, Medicilon will continue to iterate and upgrade its one-stop CGT preclinical R&D service system, accelerate the industrial translation of innovative cell therapy achievements, and facilitate the high-quality innovative development of global cell therapy pharmaceuticals.
