近期，上海爱萨尔生物医药股份有限公司自主研发的IxCell PB-ZRAK注射液临床试验申请，获国家药品监督管理局药品审评中心（CDE）默示许可，拟用于治疗经标准治疗失败的不可切除或转移性晚期肝细胞癌。
美迪西助力
作为爱萨尔生物的合作伙伴，美迪西依托CGT服务平台，为IxCell PB-ZRAK注射液提供了药效学服务。双方以专业协同攻克技术难关，共同推动细胞疗法在晚期肝癌领域取得关键临床进展。
肝癌挑战·免疫破局
肝癌临床缺口巨大，细胞免疫疗法成破局关键
据《2024年全国癌症报告》显示，全球近50%的新发肝癌都在中国，年新发36.77万例、年死亡31.65万例，肝癌发病人数居全癌种第4位，死亡人数高居第2位。与此同时，全球肝癌药物市场规模预计将从2026年的46亿美元增长至2035年的167亿美元。
在手术、放化疗、靶向治疗等传统手段逐渐面临疗效瓶颈的当下，细胞免疫治疗凭借精准杀伤肿瘤、安全性良好、适用人群广等独特优势，正成为晚期肝癌治疗的重要前沿方向。新型免疫细胞药物的成功研发与落地，不仅承载着巨大的临床价值，也蕴藏着广阔的市场机遇。
双效协同·肝癌新解
混合免疫细胞制剂，打造晚期肝癌治疗全新解决方案
IxCell PB-ZRAK注射液爱萨尔生物基于免疫细胞平台自主研发的混合免疫细胞制剂，通过T细胞精准识别并清除肿瘤细胞，同时利用NK细胞发挥广谱杀伤作用在肝癌治疗上取得良好治疗效果。PB-ZRAK与公司iPSC-NK等免疫细胞管线形成技术与产品层面的互补，进一步完善了爱萨尔生物在肿瘤免疫治疗领域的产品布局；同时，公司基于iPSC等技术平台持续拓展免疫性疾病等适应症方向。
目前，爱萨尔生物已建成间充质干细胞（MSCs）、诱导多能干细胞（iPSCs）、免疫细胞三大细胞药物研发与技术体系，配套合规cGMP产业化体系，核心管线位居国内第一梯队，多项细胞治疗产品已进入临床开发阶段，其中核心MSC产品已进入临床后期。本次IxCell PB-ZRAK注射液临床获批，不仅彰显了爱萨尔生物在细胞治疗领域深厚的技术积淀与创新潜能，也标志着其从再生医学稳健迈向肿瘤免疫治疗的战略性跨越，有望为晚期肝癌患者开辟新的治疗路径。
平台赋能·技术助力
美迪西CGT服务平台，助力细胞疗法临床前研发
在爱萨尔生物IxCell PB-ZRAK注射液临床前研究中，美迪西药效团队针对活细胞药物的生物学异质性、实体瘤免疫抑制微环境干扰以及动物模型临床相关性不足等挑战，开发了Hep G2肝癌原位模型，系统完成药效学评价工作，为该药临床获批奠定了坚实基础。
作为国内率先深耕细胞与基因治疗领域的CRO，美迪西已建立了完善的CGT研发服务平台，涵盖CAR-T、TCR-T、CAR-NK、TIL 等主流免疫细胞治疗技术，可提供药理药效研究、药代动力学研究、生物分析、药物安全性评价等一站式临床前研究服务，已助力9件细胞治疗药物获批临床（数据截至2026年6月底）。
MEDICILON
美迪西祝贺爱萨尔生物IxCell PB-ZRAK注射液获批临床，期待该产品在临床阶段进展顺利，早日为晚期肝癌患者带来福祉。未来，美迪西将持续迭代CGT一站式临床前研发服务能力，赋能更多细胞治疗创新成果加速从实验室走向临床，聚力推动国产先进细胞疗法创新发展。
关于爱萨尔生物
上海爱萨尔生物医药股份有限公司是以细胞制药为主要产品方向的生物制药公司，拥有领先的细胞制药工业化生产制造能力。公司以“专注细胞制药，铸就卓越品质”为己任，核心产品管线覆盖间充质干细胞药品、诱导多能干细胞药品和免疫细胞药品三大领域，建立健全了与之匹配的细胞生产制造平台。公司立足自主研发、不断创新，积累了四十多项细胞治疗相关产品的发明专利，建立了行业领先的生产制造标准。公司用于治疗膝关节骨关节炎的间充质干细胞产品已进入Ⅲ期临床研究，研发进度处于国内同类产品第一梯队，有望成为国内首批商品化的间充质干细胞药品。公司拥有集研发和生产为一体的4000㎡的细胞药品产业化基地，坐落于上海浦东张江核心园区，获得了高新技术企业、上海市专精特新中小企业、上海市重点企业等荣誉资质和称号。
关于美迪西
美迪西（股票代码：688202.SH）成立于2004年，专注于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研发服务。公司构建了覆盖药物发现、药学研究至临床前研究的一站式综合研发平台，并在ADC、核酸、多肽、CGT、PROTAC、抗体等前沿领域搭建了服务平台。公司建立了符合国际规范的质量体系，已获得中国NMPA、美国FDA、欧盟OECD等GLP认证以及AAALAC国际认证。目前，公司在国内外拥有约9.2万平方米研发实验室。至2026年6月底，公司已为全球超2000家客户提供药物研发服务，参与研发完成的新药项目已有691件IND获批临床，携手国内外合作伙伴共同推动药物创新突破。美迪西将继续立足全球，聚力创新，为人类健康贡献力量！欢迎访问公司官网 www.medicilon.com.cn 了解更多详情。
Medicilon Empowers IxCell’s IxCell PB-ZRAK Injection to Secure Clinical Trial Approval for Advanced Hepatocellular Carcinoma
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
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.
About Medicilon
From its inception in 2004, Shanghai Medicilon Inc.(SHA: 688202)has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. Medicilon has built an integrated one-stop R&D platform covering drug discovery, CMC and preclinical studies, and has established service platforms in cutting-edge fields such as ADC, nucleic acids, peptides, CGT, PROTAC, and antibodies. Medicilon has established a quality system in compliance with international standards and has obtained GLP certifications from China''s NMPA, the US FDA, the EU OECD,as well as AAALAC accreditation. Currently, Medicilon has nearly 92,000 square meters of R&D laboratories. By the end of June 2026, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 651 new drugs projects that have been approved for clinical trials with IND applications. For more information, please visit the company''s official website at www.medicilon.com.