RegeneBiologics' Lyophilized mRNA Vaccine for Herpes Zoster Receives CDE IND Acceptance

The clinical trial application for our company’s independently developed “Lyophilized Herpes Zoster mRNA Vaccine,” which possesses full independent intellectual property rights, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.

The “Lyophilized Zoster mRNA Vaccine” submitted for approval benefits from the company’s steadfast adherence to a philosophy guided by unmet clinical needs and drug developability. Focusing on the forefront of mRNA technology, the company has leveraged its independently developed proprietary foundational technologies to establish a comprehensive, fully autonomous intellectual property platform encompassing target design and screening, mRNA sequence optimization and synthesis, delivery and formulation, as well as CMC and industrialization.

As a representative product pipeline of RHGEN, the lyophilized mRNA vaccine for herpes zoster submitted for approval utilizes its proprietary immune-enhancing technologies—including antigen design, immune-enhancing cap analogs, and LNP delivery systems—as well as world-leading mRNA-LNP lyophilization technology. It not only demonstrated high-level immune responses in preclinical evaluations, indicating superior safety and a low incidence of adverse reactions, but also ensures the physicochemical properties and biological activity of mRNA-LNPs through lyophilization. This significantly enhances the long-term thermal stability of the vaccine product, enabling long-term storage under standard cold chain conditions at 2–8°C, thereby greatly improving the safety, convenience, and cost-effectiveness of clinical application.