Time：2026-07-31
[Hangzhou,China, July 31, 2026] — Chinese Peptide Company, a premier peptide andoligonucleotide-focused Contract Research, Development, and ManufacturingOrganization (CRDMO) and a wholly owned subsidiary of Medtide Inc. (HKEX:03880.HK), today announced that its current Good Manufacturing Practice (cGMP)manufacturing facility in Hangzhou, China, has successfully completed a Pre-LicenseInspection (PLI) conducted by the U.S. Food and Drug Administration (FDA).
Therigorous onsite audit, conducted from January 26 to February 3, 2026, comprehensivelyevaluated the facility's commercial manufacturing operations for the complex,fully synthetic long-chain peptide active pharmaceutical ingredient (API) ofHepcludex® (bulevirtide-gmod) 8.5 mg for injection, which received acceleratedapproval from the U.S. FDA on May 22, 2026, as the first and only approvedtreatment for chronic hepatitis delta virus (HDV) infection in the UnitedStates.
With a sequence exceeding 40 amino acids, thecommercial-scale manufacturing of the Hepcludex® API is long and complex. Undercurrent FDA regulatory frameworks, synthetic peptides of this length areclassified as biologics, mandating significantly more rigorous controlscompared to traditional small-molecule peptide NDAs.
About Chronic HDVand the Unmet Medical Need
Hepatitis delta virus (HDV) infection occursexclusively as a co-infection in individuals living with the hepatitis B virus(HBV). Chronic HDV is clinically recognized as the most severe andrapidly progressive form of viral hepatitis. Comparedwith HBV infection alone, HDV co-infection accelerates the disease progression,carrying a markedly higher risk of rapid progression toward severe liverfibrosis (scarring), cirrhosis, liver failure, liver cancer, and mortality.
Inthe United States, studies in general populations estimate that HDV affectsbetween 2% and 4% of individuals with chronic HBV, representing approximately40,000 to 80,000 people living with this devastating condition. Due tohistorically low screening rates and limited clinical pathways, patients facethe immense complexity of managing two distinct viral liver diseasessimultaneously. Prior to the accelerated approval of Hepcludex®(bulevirtide-gmod), there were no FDA-approved therapies available, leaving acritical gap in care. The landmark approval of Hepcludex® addresses thisprofound unmet medical need, marking a historic milestone that has thepotential to fundamentally alter the clinical course of HDV for patients in theUnited States.
ManagementCommentary
"Followingthe landmark U.S. FDA accelerated approval of Hepcludex®, Chinese PeptideCompany extends our warmest and most sincere congratulations to our strategicpartner, Gilead Sciences," said Dr. Shawn Lee, Chairman of Chinese PeptideCompany. "As the commercial API supplier for this pioneering therapy, weare immensely proud to witness and support this historic medical advancementthat may potentially alter the treatment landscape for patients with chronicHDV.”
“Thesuccessful completion of this rigorous FDA Pre-License Inspection stands as a proud milestone for our team,serving as a testament to our manufacturing capability and quality standardsforged over 25 years. ”
“Thismilestone, combined with our consistent track record of supportingmulti-regional filings for this program, further solidifies Chinese PeptideCompany’s position as an indispensable, strategic technical partner for theindustry’s most sophisticated long-chain peptide programs.”
“Lookingahead, this validation carries significant strategic weight beyond the programitself. Early-stage discovery pipelines in GLP-1 and obesity are increasinglyexploring next-generation candidates featuring longer-chain architectures, oftenaround or beyond 40 amino acids. We are uniquely positioned to leverage thisBLA-grade validated capability to support global partners pursuing commercialregulatory filings for this new class of molecules."
About ChinesePeptide Company
ChinesePeptide Company, a subsidiary of Medtide Inc. (HKEX:03880), is a peptide andoligonucleotide-focused Contract Research, Development, and ManufacturingOrganization (CRDMO), offering full-cycle services ranging from early-stagediscovery, pre-clinical research and clinical development to commercial-stageproduction. The company was founded in 2001 and is headquartered in Hangzhou,China, with its international headquarter located in California, USA. It hascommercial production sites and offices in both China and the United States.With over 25 years of experience in peptide API development and GMPmanufacturing, the company serves more than 1000 pharmaceutical andbiotechnology clients across 50+ countries and regions worldwide. The companyoperates metric-ton scale cGMP manufacturing capacity, and its manufacturingfacilities have successfully passed GMP inspections conducted by multipleregulatory authorities and quality organizations, including the U.S. FDA, NMPA,TGA and EMA, underscoring the company's consistent compliance withinternational quality and manufacturing standards.
Learnmore at: https://www.chinesepeptide.com/
About Medtide Inc.
TheCompany is a leading, publicly listed global Contract Research, Development,and Manufacturing Organization (CRDMO) that officially listed on the main boardof the Hong Kong Stock Exchange in 2025. Strategically leveraging itsvertically integrated platform, proprietary technology engines, and advancedmanufacturing infrastructure across the United States and China, the Company isdedicated to accelerating the development and sustainable commercial supply ofadvanced peptide and oligonucleotide therapeutics worldwide.
Learnmore at: www.medtideinc.com/
Source:
2.https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-hepatitis-delta-virus-hdv-infection
