ENO Bio has established foundational capabilities centered on the lipid components of mRNA drug delivery systems, enabling the synthesis and provision of various commercial-grade lipids to meet client drug development requirements. Building on this platform, the company has further advanced its capacity for lipid design and functional research. This allows for the custom design and synthesis of novel cationic lipids and novel helper lipids tailored to client needs, providing differentiated foundational elements for the development of new targeted delivery technologies.
Leveraging this expertise, ENO Bio has constructed a proprietary library of ionizable cationic lipids. These lipids demonstrate performance superior to conventional commercial ionizable cationic lipids. This platform offers clients new technological options and pathways for intellectual property breakthroughs, having already supported the successful advancement of multiple mRNA drug candidates with differentiated competitive advantages into clinical trials, where they have demonstrated promising druggability.
RHT19 is an ionizable lipid designed and developed by Eno Bio based on a mono-amino lipid structure. This lipid can form LNPs with varying delivery efficiencies by combining with common helper lipids—such as DSPC, DOPE, DMG-PEG2K, and cholesterol—in different ratios. Adjusting the types and proportions of these helper lipids enables the resulting LNP delivery system to achieve organ-specific targeting.
Compared to commercial lipids such as SM-102, RHT19 demonstrates superior expression efficiency at the same molar ratio, along with an excellent safety profile observed in safety evaluations. Eno Bio has completed the CMC process development for RHT19, effectively controlling impurities and achieving a purity of ≥98% as measured by HPLC-CAD. All quality metrics meet the standards for pharmaceutical excipients, enabling large-scale production.
Based on these developments, RHT19 has successfully obtained approval as a pharmaceutical excipient from the Center for Drug Evaluation (CDE) (Registration No.: F20240000674) and has a Drug Master File (DMF) filed (No. 31205). It has been applied in multiple pipeline candidates, including lyophilized mRNA vaccines for herpes zoster, bivalent RSV, and tuberculosis, mRNA-based therapeutics for oncology and hemophilia A, as well as mRNA-based gene editing drugs for ATTR and mRNA therapeutics for Alzheimer's disease-related epilepsy. Several of these candidates have already entered clinical trials, where RHT19's safety and efficacy have been successfully validated.