Recently, Sinopeg’s LNP lipid excipient product, DSPE-PEG-MAL(NH4+)-2K, has successfully completed pharmaceutical excipient filing with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (CDE Registration No.: F20260000073).

Product Name:α-Maleimidyl-ω-1,2-distearoyl-3-phosphatidylethanolamine polyethylene glycol (amide bond) ammonium salt

Product Abbreviation:DSPE-PEG-MAL(NH4+)
Molecular Weight:2,000

DSPE-PEG-MAL is a key functional excipient for lipid nanoparticle (LNP) carriers. This filed ammonium salt form can stably anchor into the lipid bilayer membrane during LNP self-assembly, providing reactive sites for targeted modification. Particularly amid the current wave of R&D inin vivoCAR-T and nucleic acid drugs (mRNA/siRNA), high-quality, high-activity MAL groups have become a core indicator for ensuring consistency in PEGylation reactions and the efficacy of final formulations.

Technical Breakthrough: Making "High Activity" the Standard
To meet clients’ upcoming clinical trial application timelines, Sinopeg’s R&D team successfully overcame the stability challenge of the MAL group in ammonium salt form and has now completed CDE filing. Compared with sodium or trifluoroacetate salts, the ammonium salt form more gently maintains microenvironmental pH during LNP self-assembly, preventing premature hydrolysis of the MAL group and thereby preserving higher targeting conjugation activity.

What does this mean?
✅Accelerated regulatory pathway:Under the associated review and approval system, clients can directly reference Sinopeg’s CDE registration number, significantly shortening IND submission timelines.
✅Process scale-up with confidence:We provide GMP-grade supply capabilities from gram to kilogram scale, overcoming the challenge of “lab-scale success but production-scale failure.”
✅True functionality:We focus not only on purity but also on the activity of “effective reactive groups.” Control over MAL group integrity is our core differentiator.

More Than a Product – Compliance Assurance
As a specialized drug delivery carrier supplier, Sinopeg has established a complete GMP quality management system. This successful filing represents official recognition of the manufacturing process, purity control, and batch-to-batch stability of DSPE-PEG-MAL(NH4+).
Dual-track filing:In addition to CDE filing in China, this product is actively progressing toward FDA DMF filing in the United States.
Customized characterization system:Leveraging Sinopeg’s years of experience in PEG derivative synthesis, we have developed specific characterization methods for MAL groups, ensuring that the “effective groups” in every batch are traceable and verifiable, providing comprehensive data support for downstream clients’ IND submissions.

Note:This product is intended for pharmaceutical excipient use only, for drug R&D or manufacturing. CDE filing status is subject to the official information published on the NMPA CDE website.

Sinopeg specializes in the R&D and production of polyethylene glycol derivatives, liposomes, and LNP delivery system excipients. Currently, the company has over 30 products that have completed CDE/DMF filings, with mature supply capabilities ranging from kilogram to hundred-kilogram scale. R&D institutions are warmly invited to contact us for more technical information~

Sinopeg CDE-Filed Excipient Product Matrix

Sinopeg DMF-Filed Excipient Product Matrix