Createmed IL-12 circular mRNA injection has been approved for clinical trials

On January 12, 2026, the IND application for cmRNA1210 injection from Suzhou Curemed Biopharmaceutical Technology Co., Ltd. 

(hereinafter referred to as "Curemed") was approved by the China Food and Drug Administration (CDE),

It is intended to develop treatments for advanced solid tumors (such as melanoma, colorectal cancer, etc.).

cmRNA1210 injection is a Class 1 therapeutic biological product independently developed by our company, 

based on the circular mRNA platform, 

specifically designed for the intratumoral injection of IL-12 circular mRNA to 

treat unresectable and advanced solid tumors.

It can encode single-chain human interleukin 12 (IL-12), 

and after local injection at the tumor site, 

it is taken up by cells and expresses high concentrations of IL-12.

IL-12 can promote the killing effect of CD8 T cells and NK cells in the tumor microenvironment, 

activating the body's anti-tumor immunity.

Compared to traditional linear mRNA, 

the preparation process of circular mRNA simplifies the capping and tailing steps,

The Clean-PIE system, a novel cyclization framework independently developed by Curemed ,

No need to introduce exogenous sequences, precise and efficient cyclization, 

lower immunogenicity, higher expression efficiency and duration.

Previously, CureVac had published an article titled 

"Intratumoral delivered novel circular mRNA encoding cytokines for immune modulation and cancer therapy",

This research represents an early attempt by CureVac to engineer circular mRNA.

Based on the IRES of EcoRV 29 and novel homologous arms and spacer sequences, 

a novel circular mRNA was created and named "cmRNA".

Compared to classical linear mRNA, cmRNA can mediate higher expression levels of 

various types of proteins both in vitro and in vivo.

This article demonstrates for the first time the feasibility of direct intratumoral injection of circular mRNA, 

and studies and optimizes the formulations suitable for intratumoral injection of circular mRNA.