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Guobang Pharma Unit's DMG-PEG2000 Excipient Clears CDE Review, Registration Status Becomes A

Published: Updated: By 24TopNews Editorial Desk

Guobang Pharma (605507) said its wholly owned subsidiary Zhejiang Guobang Pharmaceutical received an A result from the Center for Drug Evaluation for its DMG-PEG2000 excipient for injection under the joint review of excipients and formulations. The registration status has changed to A, meeting supply conditions for downstream customers' commercial formulation production. The PEGylated lipid is mainly used in mRNA vaccines, tumor therapeutic vaccines, protein replacement therapies and gene therapies.

On September 15, 2026, Guobang Pharma (605507) announced that the company recently learned from the Center for Drug Evaluation (CDE) of the National Medical Products Administration's "excipient and packaging material registration information" platform that the excipient "purified dimyristoyl glyceryl ester (for injection)" submitted by its wholly owned subsidiary Zhejiang Guobang Pharmaceutical Co. , Ltd. received an A result in the CDE joint review of excipients and formulations. The excipient's registration status has changed to A, meeting the supply conditions for downstream customers' commercial formulation production.

Purified dimyristoyl glyceryl ester (DMG-PEG2000) is a PEGylated lipid currently mainly used in the development and production of formulations in emerging fields such as mRNA vaccines, tumor therapeutic vaccines, protein replacement therapies and gene therapies, and is a key functional excipient for such formulations.

24TOPNEWS IMPACT INTELLIGENCE

Why this event matters

The event has a measured impact on 2 industrys. The strongest current signal is positive for Pharmaceuticals, with intensity 45/100 and 70% confidence over a medium term horizon.

Healthcare · 13.1

Pharmaceuticals

Direction
positive
Intensity
45
Confidence
70%
Horizon
Medium term
Effective impact +20
Healthcare · 13.3

Biotechnology

Direction
positive
Intensity
40
Confidence
65%
Horizon
Medium term
Effective impact +16

Impact figures are analytical estimates that combine direction, intensity, confidence and event importance. They are not investment advice.