Lipid nanoparticle (LNP) technology has become a key platform in the field of nucleic acid drug delivery. From mRNA vaccines to in vivo CAR-T therapies, the supply of high-quality excipients directly impacts the performance of drug formulations and the progress of clinical translation. Sinopeg has been deeply engaged in the field of LNP delivery system excipients for many years, establishing a comprehensive product matrix covering cationic lipids, PEGylated lipids, helper phospholipids, and cholesterol. We have successfully completed the registration of multiple mainstream LNP lipids in both China and the US (CDE/DMF), hold several proprietary patented structures, and offer customized synthesis services.
01 Proprietary Lipids
Among the four major components of LNP delivery systems, ionizable lipids are responsible for nucleic acid drug encapsulation and endosomal escape, serving as the core element determining delivery efficiency.
Sinopeg's independently developed DHA-1 series cationic lipids have secured patent portfolios in three major core markets—China, Europe, and the United States—with the US patent granted in Markush generic form. Our patent applications cover a full-chain technical solution from "compound → composition → liposome or lipid nanoparticle → nucleic acid drug composition → formulation and application," establishing a comprehensive LNP delivery system patent framework.
If you use our cationic lipid products in your R&D or production, this layered and progressive protection—covering lipid raw materials, lipid compositions, and delivery systems—will provide intellectual property assurance for your project throughout its entire lifecycle, from R&D to commercialization, supporting your progress with greater confidence and stability.
Main Products in the DHA-1 Series Cationic Lipids
Among them, DHA-1 is one of the earlier ionizable lipid products to complete both CDE pharmaceutical excipient filing and FDA DMF submission. Clients can directly reference the filed dossiers in their drug registration applications in both China and the US (CDE Filing No.: F20230000445; DMF Filing No.: 039452).
In terms of PEG lipids, Sinopeg's independently developed mPEG-DTA-1 and HO-PEG-DTA-5 received Chinese patent authorization in 2023 (Patent No.: ZL202280003648.7) and further obtained European patent authorization in 2025 (Patent No.: EP4321504B1).
Additionally, mPEG-DTA-1 has also completed CDE filing (Filing No. F20230000444) and DMF submission (Filing No. 039451).
02 DSPE-PEG-X Series
The DSPE-PEG-X series is a class of key functionalized lipid materials used for targeted lipid nanoparticles (tLNPs), playing a central role in the technological innovation of transitioning CAR-T therapy from in vitro to in vivo.
Sinopeg's pharmaceutical excipient DSPE-PEG-MAL(NH₄⁺)-2K has successfully passed the pharmaceutical excipient registration with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (CDE Filing No.: F20260000073).
DSPE-PEG-X Series Products
03 Filed Lipids
Sinopeg actively advances the registration of core excipients with domestic and international regulatory authorities. Multiple products have completed CDE pharmaceutical excipient filing in China and FDA DMF submissions in the US, supporting simultaneous domestic and international filing of client projects.
04 Other Lipids
In addition to the above filed and proprietary products, Sinopeg also offers a variety of LNP components and novel lipid structures to meet the diverse R&D and production needs of different customers.
05 Customization Services
As a flexible and efficient nucleic acid delivery vehicle, LNP holds significant application value in mRNA vaccines and related therapeutic areas. Researchers worldwide are continuously conducting in-depth studies on the structural optimization and functional regulation of LNP components to further enhance delivery efficiency and safety, driving clinical translation and broader application of related technologies.
Sinopeg provides custom synthesis services for LNP lipids, committed to delivering lipid solutions tailored to different R&D needs. Leveraging our mature technology platforms and stable raw material supply systems, we support flexible customization from formulation design to performance modulation, helping clients advance their projects. For more information, please feel free to contact us—we will provide professional support and service solutions based on your specific requirements.
High-quality excipients are not merely products of chemical synthesis; they are the invisible cornerstone of successful drug delivery. With a product matrix covering all LNP components, compliance capabilities for dual filing in China and the US, and full-chain customization services, we provide clients with one-stop material and regulatory solutions from laboratory R&D to commercial production.
Choosing Sinopeg means choosing a long-term partner who deeply understands the fundamental logic of delivery. Together, let us safeguard the safety and efficacy of next-generation nucleic acid therapies.
Welcome to contact our technical team via the methods below for detailed product catalogs, filing dossiers, or customized solutions!
Email:sales@sinopeg.com
Website:www.sinopeg.com
