Biopharma PEG Achieves FDA DMF Approval for HZ-PEG-HZ (1K), Bolstering Global Pharmaceutical Supply Chain

Watertown, MA - June 29, 2025 - Biopharma PEG, a leading innovator in high-quality polyethylene glycol (PEG) derivatives, today announced it has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for its self-developed HZ-PEG-HZ (1K) product. The assigned DMF number is 041864.

This significant achievement underscores Biopharma PEG's robust research and development capabilities and its unwavering commitment to providing pharmaceutical companies worldwide with reliable, compliant, and cutting-edge PEG products. The DMF approval for HZ-PEG-HZ (1K) streamlines the regulatory pathway for pharmaceutical manufacturers by offering a readily available and FDA-reviewed material, reducing the burden of independent documentation.

HZ-PEG-HZ (Hydrazide-PEG-Hydrazide) is a versatile bifunctional PEG derivative featuring hydrazide functional groups at both ends of the PEG chain. Its unique reactivity allows for the formation of stable yet pH-sensitive hydrazone bonds, making it an indispensable tool in various advanced biomedical applications.

"Obtaining FDA DMF approval for our HZ-PEG-HZ (1K) is a pivotal moment for Biopharma PEG and a testament to the dedication and expertise of our entire team," said Dr. Jack Deng, CEO of Biopharma PEG, "This milestone not only validates our rigorous quality control and manufacturing processes but also reinforces our position as a trusted partner in the global pharmaceutical industry. We are now even better equipped to support our clients in developing the next generation of innovative therapeutics and drug delivery systems."

The HZ-PEG-HZ (1K) product is critical for applications including:

l Controlled Drug Delivery Systems: Leveraging its pH-sensitive hydrazone bonds for targeted and controlled release of active pharmaceutical ingredients in specific physiological environments (e.g., tumor microenvironments, endosomes, lysosomes).

l Bioconjugation and Crosslinking: Facilitating the creation of stable linkages in antibody-drug conjugates (ADCs), protein modifications, and the construction of advanced hydrogels for tissue engineering and regenerative medicine.

l Surface Functionalization: Enhancing the biocompatibility and anti-fouling properties of medical devices and nanoparticles, and enabling the immobilization of biomolecules for diagnostics and biosensors.

Biopharma PEG remains committed to continuous innovation and the delivery of high-purity PEG derivatives that meet the stringent demands of pharmaceutical research and manufacturing. The FDA DMF approval for HZ-PEG-HZ (1K) exemplifies this commitment and opens new avenues for collaboration with pharmaceutical partners seeking to accelerate their drug development pipelines.

About Biopharma PEG:

Biopharma PEG is a global leader in the development and manufacturing of high-quality polyethylene glycol (PEG) derivatives and custom PEGylation services. With a focus on innovation, quality, and customer satisfaction, Biopharma PEG provides a comprehensive range of PEG products and solutions for drug delivery, medical devices, diagnostics, and various other biomedical applications. Our mission is to empower pharmaceutical and biotech companies with superior materials to advance healthcare.

Contact:

sales@biochempeg.com 

www.biochempeg.com