tricision's independently developed Survivin-Targeting Dendritic Cell (DC) Cell Injection has reached two major milestones in rapid succession: the Center for Drug Evaluation (CDE) has publicly listed the product for formal initiation of a Phase II Clinical Trial (CT) (Registration No. CTR20261465), and simultaneously, the personalized DC cell therapy has received approval for clinical application at Weiyuan Hospital in the Beidaihe Life and Health Industry Innovation Demonstration Zone. This dual-track advancement—clinical development and early patient access—marks a pivotal moment for the field.

Urgent Clinical Need: GBM Treatment Has Long Faced Bottlenecks

Glioblastoma Multiforme (GBM) is the most malignant primary tumor of the central nervous system, with an annual incidence of 5–8 per 100,000 in China. Even with the current standard-of-care STUPP regimen (surgery, radiotherapy, and temozolomide chemotherapy), nearly 100% of patients experience recurrence, and median Progression-Free Survival (PFS) after surgery is only 6.9 months. Globally, there has been a striking absence of breakthrough treatments for decades, leaving a profound unmet medical need.

Global First-in-Class Technology: mRNA-DC Cancer Vaccines Build Core Barriers

Survivin-Targeting DC Cell Injection holds two first-in-class advantages:

• World's first clinically approved Survivin-targeting Messenger RNA-Dendritic Cell (mRNA-DC) therapeutic cancer vaccine
• China's first innovative cancer vaccine using DCs as a delivery vehicle for Tumor-Associated Antigens (TAAs)

Powered by triVAC, tricision's proprietary antigen modification technology, the vaccine's immunogenicity is increased by an average of 20-fold—and up to 200-fold—compared to unmodified formulations. By loading modified Survivin antigen Messenger RNA (mRNA) into autologous DCs and reinfusing them, the vaccine activates specific immunity, clears residual tumor cells after surgery, and induces immune memory lasting over 1,600 days, fundamentally reducing the risk of recurrence.

Phase II Clinical Trial: First in China, Benchmarking International Standards

The Phase II CT is focused on newly diagnosed GBM (World Health Organization (WHO) Grade IV) and will comprehensively evaluate the vaccine's efficacy and safety. It is the first Survivin-targeting agent to enter Phase II in China. Survivin is internationally recognized as a core tumor antigen strongly correlated with proliferation, recurrence, and drug resistance. Globally, only the SurVaxM peptide vaccine (MimiVax, USA) targeting the same antigen has advanced to Phase 2b. tricision's mRNA-DC vaccine, with its distinct technological approach, directly demonstrates China's growing capability in cellular immunotherapy R&D.

Accelerated Clinical Translation: Personalized Therapy Reaches Patients First

Leveraging the "pioneering and pilot" policy of the Beidaihe Demonstration Zone, tricision's personalized DC cell therapy for glioma was formally launched at Weiyuan Hospital in March 2026. The program offers "one-patient, one-strategy" precision treatment for patients with post-surgical residual disease, chemoradiotherapy failure, intolerance, recurrence, or inoperable conditions—enabling earlier access to cutting-edge therapy.

Impressive Clinical Data: Long-Term Survival and Safety Dual Breakthroughs

Published clinical data show that the therapy has achieved significant outcomes:

• Median Progression-Free Survival (PFS) exceeding 26 months, with the longest Overall Survival (OS) exceeding 101 months
• Adverse events (AEs) limited to mild low-grade fever, with no Dose-Limiting Toxicity (DLT) or Serious Adverse Events (SAEs)
• Key results published in international journals including Cancer Immunology, Immunotherapy

Profound Industry Significance: A Chinese Solution Reshaping the GBM Treatment Landscape

From the successful progression of Phase I to the pivotal Phase II stage, and with simultaneous clinical application, China's mRNA-DC cancer vaccine R&D and translation capabilities have now entered the global first tier. This achievement provides an accessible, safe, and effective Chinese treatment option for a disease that has long defied standard therapy. As the clinical program advances and the scope of application expands, it is poised to reshape the global GBM treatment paradigm, offering patients new hope for long-term survival and even clinical cure.