- CPC Scientific’s cGMP manufacturing facility in Hangzhou, China, has successfully completed a U.S. FDA Pre-License Inspection for commercial manufacturing of the Hepcludex® (bulevirtide-gmod) API.
- The inspection supports commercial production of the long-chain synthetic peptide API used in Hepcludex®, the first FDA-approved treatment for chronic hepatitis delta virus (HDV) infection in the United States.
CPC Scientific Inc., a peptide and oligonucleotide-focused contract research, development, and manufacturing organization (CRDMO), announced that its cGMP manufacturing facility, Chinese Peptide Company, in Hangzhou, China, has successfully completed a U.S. Food and Drug Administration (FDA) Pre-License Inspection (PLI). The inspection, conducted between January 26 and February 3, 2026, evaluated the facility’s commercial manufacturing operations for the active pharmaceutical ingredient (API) of Hepcludex® (bulevirtide-gmod) 8.5 mg for injection, which received accelerated FDA approval on May 22, 2026 as the first approved treatment for chronic hepatitis delta virus (HDV) infection in the United States.
According to the company, the commercial API is a fully synthetic long-chain peptide comprising more than 40 amino acids. CPC Scientific said peptides of this length are classified as biologics under current FDA regulatory frameworks, requiring more stringent manufacturing controls than traditional small-molecule peptide products. The company serves as the commercial API supplier for Hepcludex®.
“Following the landmark U.S. FDA accelerated approval of Hepcludex®, CPC Scientific extends our warmest and most sincere congratulations to our strategic partner, Gilead Sciences. As the commercial API supplier for this pioneering therapy, we are immensely proud to witness and support this historic medical advancement that may potentially alter the treatment landscape for patients with chronic HDV.”
Dr. Shawn Lee, Chairman of CPC Scientific and Chinese Peptide Company
The company stated that successful completion of the FDA inspection builds on more than 25 years of manufacturing experience and strengthens its position in supporting long-chain peptide development and commercial manufacturing. CPC Scientific also said it expects the validated capability to support future regulatory filings for next-generation long-chain peptide candidates, including those being explored for GLP-1 and obesity programs.
