Zhitong Finance App News, Shiyao Group (01093) announced that the Phase I clinical trial of SYS6077 injection (this product) developed by the Group to treat advanced malignant tumors (SYS6077-001) has been officially launched at the first research center in China.
This product is registered as a Class 1 therapeutic biological product. It is a generic off-the-shelf tumor therapeutic messenger ribonucleic acid (mRNA) vaccine developed based on a nano-delivery technology platform. By coding multiple neoantigens (neoantigens), it activates antigen-specific T-cell immune responses, thereby enhancing the body's ability to recognize and attack tumor cells. Preclinical studies have shown that the product can induce specific T-cell immune responses against multiple tumor antigens and shows anti-tumor activity in multiple animal tumor models; compared with other mRNA anti-tumor vaccines, the product has advantages such as wide coverage, low risk of immune escape, and short preparation cycle.
The Group received the “Drug Clinical Trial Approval Notice” issued by the State Drug Administration of the People's Republic of China in September 2026, and commenced clinical trials of SYS6077-001 after approval. The approved clinical trial is a multi-center phase I clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic characteristics, and initial antitumor activity of the product in patients with malignant tumors at different doses.
Currently, the recruitment and screening of participants for this clinical trial is being actively promoted.