The clinical trial of the world’s first oncolytic virus product based on the M1 skeleton of the hepatitis A virus, originally created by China, has completed its first administration at Zhongshan Third Hospital

March 24, 2025  Source: drugdu 56

China Launches First Clinical Trial of Intravenous Oncolytic Virus Therapy VRT106
By Thomas Yuan

GUANGZHOU — On March 19, 2025, researchers at the Third Affiliated Hospital of Sun Yat-sen University announced a key milestone in the development of VRT106, the world’s first oncolytic virus therapy based on the M1 skeleton of the hepatitis A virus. The Phase I clinical trial has officially begun, with the first patient enrolled and dosed via intravenous injection, showing no adverse reactions or infusion-related events.

Jointly led by Professor Peng Liang and Professor Xie Chan from the Department of Infectious Diseases, and Professor Dong Min from Oncology, the trial marks the initial human validation stage for this novel biopharmaceutical designed to treat a range of advanced solid tumors, including liver cancer, colon cancer, triple-negative breast cancer, and cervical cancer.

 

Precision-Targeted Therapy With Dual Anti-Cancer Action

Developed by Guangzhou Weilunte Pharmaceutical Technology Co., Ltd. (Weilunte), in partnership with Sun Yat-sen Medical College, VRT106 represents a major achievement under China's "13th Five-Year Plan" for new drug development. The drug leverages a unique mechanism: the oncolytic virus is engineered to recognize the MXRA8 receptor, which is overexpressed on tumor cells, allowing the therapy to selectively infect and destroy malignant tissue while sparing healthy cells.

Once inside the tumor, VRT106 not only induces direct viral oncolysis but also stimulates an immune response by activating T cells and dendritic cells (DCs), enhancing systemic anti-cancer effects. Delivered via freeze-dried intravenous formulation, the therapy is designed for stability and ease of clinical deployment.

 

Clinical Trial Framework and International Scope

The Phase I trial is being conducted at the hospital’s Phase I Clinical Research Center, a national-level facility with extensive experience in oncology, infectious disease, and imaging-based assessments. In addition to this China-based trial, VRT106 is undergoing parallel clinical evaluation in Japan, signaling the drug’s growing international significance in the global biotech and medical technology landscape.

Professor Yan Guangmei, Chief Scientist at Weilunte, confirmed that the company’s technical and clinical teams will strictly adhere to GCP (Good Clinical Practice) standards to ensure trial integrity and generate safety data for the upcoming Phase II clinical studies.

 

Innovation from Bench to Bedside

The launch of this clinical trial reinforces the role of China’s academic-medical ecosystem in advancing innovative cancer therapies and elevating biopharmaceutical R&D on a global scale. VRT106’s development—rooted in virology, oncology, and immunotherapy—also aligns with broader efforts to accelerate precision medicine and introduce high-value health products for previously untreatable solid tumors.

“As principal investigator, I’m hopeful that this study will lead to meaningful clinical outcomes,” said Professor Peng Liang. “Our aim is to provide better treatment options for solid tumor patients worldwide as soon as possible.”

The VRT106 trial showcases not only the technical maturity of China’s life sciences sector, but also its ambition to compete globally in next-generation cancer immunotherapies, contributing to a growing ecosystem of medical innovation, advanced therapeutic delivery, and targeted biologics.

 

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