Medtide Inc. (MEDTIDE) announced that its wholly owned subsidiary Chinese Peptide Company has passed a U.S. Food and Drug Administration Pre-License Inspection (PLI) for the commercial production of Hepcludex (bulevirtide-gmod) 8.5 mg injectable active pharmaceutical ingredient at its current Good Manufacturing Practice facility in Hangzhou, China.

The on-site inspection, conducted from 26 January to 3 February 2026, reviewed manufacturing operations for the complex, fully synthetic long-chain peptide. Successful completion of the PLI is a prerequisite for supplying the U.S. market following the FDA’s accelerated approval of Hepcludex on 22 May 2026 as the first and only treatment for chronic hepatitis delta virus (HDV) infection in the United States.

Chronic HDV affects an estimated 2%–4% of people with chronic hepatitis B, representing roughly 40,000–80,000 individuals in the U.S. The condition carries a significantly higher risk of severe liver fibrosis, cirrhosis, liver failure and cancer compared with HBV infection alone. Prior to Hepcludex, no FDA-approved therapies were available for HDV.

Founded in 2001 and headquartered in Hangzhou with an international base in California, Chinese Peptide Company operates metric-ton scale GMP capacity and has cleared inspections by multiple regulators, including the FDA, EMA, TGA and China’s NMPA. The contract research, development and manufacturing organization serves more than 1,000 pharmaceutical and biotech clients across 50-plus countries.

Medtide Inc., listed on the Hong Kong Main Board in 2025, leverages vertically integrated peptide and oligonucleotide platforms to support global therapeutic development and commercial supply.