China's DC Vaccine Landscape Achieves Multi-Front Breakthroughs with BLA Submissions Expected as Early as 2026
HRYZ
Immune Cell Therapy Developer
January 3, 2026
eMedClub News
In the field of tumor immunotherapy, based on dendritic cells（DC）The vaccine, with its innovative mechanism of "activating endogenous immunity," is driving treatment towards a more precise and long-lasting direction. This technology "trains" the patient's own DC cells in vitro to recognize tumor antigens, and after reinfusion, activates and guides T cells to launch targeted attacks, offering precise targeting and flexible loading.(Can carry multiple antigen forms such as polypeptides and mRNA), with three major advantages: long-lasting effects.
Currently, a complete DC vaccine category has been formed in China, covering multiple technical pathways and spanning from early exploration to Phase III clinical trials.(Including DC cell products)Echelon, demonstrating leading innovation efficiency and clinical transformation capabilities.
Haixin Biotechnology and Shanghai Second Military Medical University co-developed APDC(Antigen-sensitized human dendritic cells)YesThe First Therapeutic Vaccine in China Approved by CFDA for Phase III Clinical Trial to Treat Metastatic Colorectal CancerUnlike other DC vaccines, APDC first uses chemotherapy to remove some immunosuppressive factors, and then utilizes antigen-sensitized DCs to stimulate tumor-specific immunity, thereby killing tumor cells.
Previously disclosed Phase II clinical trial data show that the objective response rate of the APDC combined with chemotherapy group（ORR）Up to 45.07%, compared with the chemotherapy-alone group（25.35%）Significantly Improve（P=0.043）, and did not affect the patient's quality of life.(The improvement rates of the two groups were 40.85% and 39.44%, respectively, P=0.857)Currently, the company is exploring multiple dimensions to solve the issue of patient enrollment in this Phase III project.
Shanghai Dendreon Biomedical Technology Co., Ltd. introduced the American Dendreon Corporation（Dendreon）The World's First FDA-Approved Therapeutic Cancer Vaccine: Sipuleucel-T Injection (Provenge)(Main components are DC cells)Achieve a leading position in R&D progress. By the end of 2024, the Phase III pivotal registration clinical trial in China for this product has completed the apheresis and reinfusion of all 140 enrolled patients, entering the clinical observation phase. It is reported that its marketing authorization application...（BLA）Expected to be submitted in 2026。
Multi-Antigen Autologous Immune Cell Injection Developed by Hengrui Yuanzheng（MASCT）The series product MASCT-I for the treatment of urothelial carcinoma and soft tissue sarcoma has entered Phase II clinical trials, being the world's first multi-target T cell therapy product approved for clinical use against solid tumors. The active ingredients of MASCT includeLoaded with 15 tumor-associated antigensMature autologous DC cells and the aforementioned autologous effector T lymphocytes expanded by DC cell activation(T cells), to eliminate tumors through sequential treatment with the two.
Phase Ⅰ clinical data presented at the 2024 ASCO Annual Meeting showed that: in patients with advanced urothelial carcinoma who experienced progression after receiving first-line chemotherapy（n=19）In China, the overall survival time of MASCT-I monotherapy（OS）For41.2 months`, Duration of Relief` (DOR) For6.4 monthsAmong them, 9 patients who progressed switched to a combination therapy of MASCT-I and Camrelizumab, with a 24-month progression-free survival.（PFS）The rate was 55.6%, the 48-month DOR rate was 71.8%, with PFS exceeding43 months。
The core product of ZSNeo-DC1.1, developed by Zhongsheng Kangyuan, is a personalized neoantigen DC vaccine based on an AI platform, which throughPatient-specific tumor neoantigen peptide-loaded, achieving precise immunotherapy. In November 2025, the product's two Phase II clinical trials were approved by the CDE, respectively combining with temozolomide for the treatment of glioblastoma and combining with PD-1 monoclonal antibody for the treatment of hepatocellular carcinoma, marking the company's entry into the global AI+neoantigen immunotherapy first tier.
Notably, its Phase II clinical study on the combination with PD-1 monoclonal antibody for first-line treatment of hepatocellular carcinoma has made this vaccineThe only neoantigen cancer vaccine in China that has advanced to Phase II clinical trials for combination therapy。
In November 2025, Hengsai Bio KSD-301 DC Vaccine Combined with AG Regimen(Gemcitabine, Albumin-bound Paclitaxel)Treatment of Locally Advanced Unresectable Pancreatic Cancer Completes First Patient Dosing at Fudan University Shanghai Cancer Center.KSD-301 is developed by Hengsai Biotechnology based on its self-constructed Eco-DC Vax platform.Human Monocyte-Derived Autologous DC Vaccine Loaded with Broad-Spectrum Pancreatic Cancer Antigens Administered via Subcutaneous Injection。
The targeted Survivin DC cell injection independently developed by Qichen adopts the company's unique TriVac technology, through whichFunctional Modification of Tumor Antigen mRNA Sequences, significantly enhancing the expression and presentation efficiency of antigens in immune cells, breaking through the pharmaceutical barriers of traditional tumor-associated antigen vaccines. It is also one of the few mRNA-modified DC vaccines internationally to have entered the registrational clinical stage.
Publicly available data shows that the vaccine significantly prolongs patient OS. For patients with glioblastoma, the control group（n=28）OS is 11 months, treatment group（n=5）OS was 19 months; for patients with brain metastases from small cell lung cancer, the control group（n=13）OS is 7 months, treatment group（n=5）OS is 17 months. Among themOne patient's OS has exceeded 60 months.(5 years)。
Likang Life Technology "Personalized DC Vaccine Treatment Technology for Malignant Tumors"(150,000 RMB per session, 6-7 sessions per course)Has been selected for the second batch of cell and gene therapy technology project list in Boao Lecheng, Hainan, China.China's First Approved DC Vaccine Project for Paid TreatmentLK101 vaccine adopts the "AI + neoantigen" screening technology, enabling target prediction and rapid preparation within one day, and has initiated Phase II clinical trials for advanced lung cancer.
UNODC0407 by YouNuo Biotechnology is the DC anti-tumor cell injection LANEX-DC, approved for marketing after being introduced from Germany's LDG Medical Group. This drug utilizes proprietary autologous antigen-loading technology and induction differentiation technology, with no safety incidents reported in over 20 years of clinical application, and has demonstrated effectiveness against various solid tumors.
It has been approved for clinical treatment in China for locally advanced or metastatic pancreatic cancer that cannot be surgically removed. The project has been included in the "pilot" policy of Beidaihe New Area and is expected to carry out clinical transformation by the end of 2024.
In addition, the autologous DC vaccine Pulegendase from Huidun Bio and the personalized neoantigen mRNA-edited DC tumor vaccine from Kandese Medical have both entered Phase I clinical trials, targeting metastatic castration-resistant prostate cancer and refractory/drug-resistant recurrent ovarian cancer, respectively. More progress on DC vaccine types will not be listed one by one.
Conclusion
As引进products represented by Shanghai Dendreon Biomedical Technology Co., Ltd. are about to enter the application and listing stage in 2026, and key progress has been made by Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd., Haixin Biotechnology, and Sinobioway Yuanyuan, among other companies, in different technological routes, China's DC vaccine field has moved from technological followers to a new stage of independent innovation.
From traditional multi-target antigens to personalized neoantigens, from single-agent therapy to combination immunotherapy regimens, the industry is forming a dual-driven pattern of "introduction and validation" alongside "independent innovation." With the continuous accumulation of clinical data and the gradual clarification of regulatory pathways, China is expected to welcome its first commercial DC vaccine product within 2-3 years.`, providing more precise and accessible solutions for tumor immunotherapy.`
Editor-in-Chief: Ju
Proofread by Ju
References:
1.Official Websites of Various Enterprises
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