Sinogene Kangyuan Biotech Receives Approval for Clinical Translation of AI-Powered Personalized Neoantigen Vaccine Targeting Glioblastoma and Other Solid Tumors

March 5, 2026National LevelLife and Health Industry Demonstration Zone — The New Technology Management Committee for Cells and Related Derivative Products in Beidaihe District has officially approved the translational application of the neoantigen tumor vaccine project developed by Zhongsheng Kangyuan Biotechnology (Beijing) Co., Ltd. This initiative aims to provide safe and effective next-generation personalized precision immunotherapy solutions for patients with malignant tumors worldwide. The project marks a significant milestone following the promulgation of the "Several Policy Measures of Hebei Province to Support the Development of the Life and Health Industry Innovation Demonstration Zone in Beidaihe,"The First Approved in the Demonstration Zone"Featuring internationally advanced technological capabilities."AI-Powered Personalized Cancer Vaccines: Translational Applicationsproject, marking China's in oncologyPrecisionImmunotherapy FieldAnother step forward.

Figure 1. High Incidence of Malignant Tumors and Urgent Clinical Needs

Neoantigen tumor vaccine technology has been the most active area in global oncology immunotherapy drug development in recent years. As an AI-driven innovative medical technology, it is regarded asThe Hope for Curing Malignant Solid Tumors. This technology leverages AI algorithms and big data analytics to enable precise and rapid screening of personalized anti-tumor targets. It simultaneously delivers more than ten targets into the human body via carriers such as dendritic cells (DCs), peptides, or mRNA, thereby potently activating the body’s anti-tumor immune response to precisely target and kill tumor cells.

The core competitiveness of neoantigen tumor vaccine technology lies in its AI algorithm model "Pan-cancer"Universality. Given that malignant solid tumors all exhibit heterogeneity driven by genetic mutations at the molecular pathological level, Zhongsheng Kangyuan’s AI algorithm platform can transcend tissue and organ limitations. By conducting in-depth analysis of individual patients’ tumor mutation profiles, it precisely identifies specific targets with strong immunogenicity. This "Universal Underlying Technical Logic, Customized Clinical Targetstechnical architecture, enabling this technology to achieve breakthroughs not only in the clinical treatment of glioblastoma (GBM) but also to provide comprehensive coverage for a variety of refractory solid tumors, including advanced-stage liver cancer, esophageal cancer, and cholangiocarcinoma.

Figure 2. Flowchart of neoantigen tumor vaccine preparation

In addition, Zhongsheng KangyuanOriginal and Globally PatentedThe "cellular immune editing technology" enhances the function of processed dendritic cells (DCs), significantly boosting overall therapeutic efficacy and enabling them to counteract the high heterogeneity, invasiveness, and immunosuppressive nature of malignant tumors. This breakthrough overcomes the clinical application bottlenecks of conventional neoantigen tumor vaccines, which are typically limited to preventing postoperative recurrence in early-stage cancer patients. Consequently, patients with previously untreatable, highly aggressive malignancies—such as progressive malignant brain tumors, unresectable advanced hepatocellular carcinoma, esophageal cancer, and cholangiocarcinoma—can now derive clinical benefit.

During the clinical research process, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) provided policy support characterized by "early intervention, customized strategies for each enterprise, comprehensive guidance throughout the entire process, and integrated research and review." The National Institutes for Food and Drug Control (NIFDC) also provided comprehensive guidance and confirmation regarding the manufacturing process and quality system. Thanks to these efforts, this therapy obtained approval in September 2025.Milestone Progress, obtainTwo Phase II Clinical Trials of Combination TherapyIND approval documents, respectively forGlioma and Liver Cancer, initiating nationwide, multicenter, large-cohort, randomized controlled trials to confirm efficacy, entering the final countdown to approval and market launch of the innovative drug.

Figure 3. Pharmacological efficacy of neoantigen tumor vaccines

Malignant tumors, such as glioblastoma (GBM, commonly known as"King of Brain Cancer"), the lesion exhibits invasive growth within the cranial cavity. Currently, there are no effective clinical treatments available; "surgery combined with radiotherapy and chemotherapy" remains the only standard treatment regimen. Most patients experience recurrence within 5–6 months post-surgery, after which no effective therapeutic options remain.Median overall survival is generally less than 16 months., there is an urgent clinical need for therapeutic agents. Prospective clinical study data show that Zhongsheng Kangyuan’s personalized dendritic cell injection, in combination with chemotherapy, for the treatment ofNewly Diagnosed GBMDemonstrates a significant survival benefit:

Figure 4. Historical Prospective Clinical Study Data of This Technology

Zhongsheng Kangyuan by Dr. Sidney Altman (1989 Nobel Prize in Chemistry Laureate) and co-founded by Dr. Cheng Xudong, it is a world-class institution dedicated to the research, development, and translation of personalized cancer vaccines. The company has established a R&D center and a GMP-compliant pilot production facility for cell-based therapeutics in the Zhongguancun Life Science Park in Beijing, and is currently preparing to build a large-scale manufacturing center for commercial production of cell-based drugs. The company is"National High-Tech Enterprise", Beijing Municipality"Specialized, Refined, Differential, and Innovative" Enterprises, a representative enterprise in Beijing's digital healthcare sector; its independently developed artificial neural network technology and dendritic cell immune editing technology have reachedWorld-Leading Level; it holds a leading position in the industry in areas such as tumor neoantigen identification technology, automated production processes for immune cells, quality management systems (CMC) for cell therapies, and clinical companion diagnostic technologies.

To facilitate project implementation and clinical translation, the company has assembled a top-tier team of experts in cell technology and clinical applications to provide comprehensive, high-quality clinical technical services for cancer patients receiving treatment in the Pilot Zone. The expert panel includes:

Dr. Xu Dong Cheng · Project Leader

Beijing Overseas High-Level Talent, Zhongguancun High-End Leading Talent; spearheaded the R&D of internationally leading and China-first personalized cancer vaccine technology based on CD40 pathway activation

Prof. Zhang Jing · Head of AI Technology

CAS "Outstanding Young Scientist," National Academic Leader in Bioinformatics and Intelligent Computing, with long-term engagement in cancer big data and AI algorithm research

Prof. Yonggao Mu · Clinical Expert

Director of the Department of Neurosurgery at Sun Yat-sen University Cancer Center, and Chairman of the Brain Glioma Professional Committee of the China Anti-Cancer Association, who spearheaded the development of national guidelines for the diagnosis and treatment of brain tumors.

The smooth approval and implementation of the Zhongsheng Kangyuan project also mark another substantive step forward in Beidaihe’s strategy to build itself into a “Famous Chinese City for Health and Elderly Care” and a highland for biotechnology R&D and translation.

As a national-level pilot zone for the health industry, the Beidaihe Life Health Industry Innovation Demonstration Zone has consistently focused on the introduction and translation of cutting-edge innovative medical technologies. By providing supporting green channels and accelerated approval mechanisms, it enables pilot implementation within the zone, accelerates technological maturation, and addresses critical clinical pain points. The recently approved Zhongsheng Kangyuan project features advanced technology, mature manufacturing processes and quality management systems, and meets urgent clinical needs that remain unaddressed, thereby demonstrating strong complementarity with the pilot policy framework.

In the subsequent process of project translation and application, Zhongsheng Kangyuan will continue to deepen its cooperation with the Pilot Zone, integrating the company's professional technical expertise with the clinical advantages of Beidaihe Hospital, so as to accelerate the clinical translation and promotion of this novel AI-enabled cancer vaccine technology, bringing more breakthrough advancements to China and even the world."Tailor-Made" Precision Immunotherapy Regimen, meeting the clinical needs of patients with malignant tumors.

Figure 5. Implementation Effect Diagram of the New Generation Personalized Precision Immunotherapy Regimen

Appendix: Project-Related Information

The full name of the project approved for clinical translational application is "Pilot Project on the Novel Technology of Personalized Dendritic Cell Injection for the Treatment of Malignant Solid Tumors."

Approving Authority:Beidaihe District Administrative Committee for New Technologies in Cells and Related Derivative Products, National Pilot Zone for the Health Industry

Technical Implementation Unit:Zhongsheng Kangyuan Biotechnology (Beijing) Co., Ltd.

Medical Institutions for Clinical Translation and Application:Qinhuangdao Beidaihe Hospital (Department of Medical Oncology)

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