CPC Scientific Announces U.S. FDA Pre-License Inspection (PLI) Successfully Completed at Its Hangzhou cGMP Manufacturing Facility for Hepcludex® API, Establishing a Proven Track Record Under the Stringent BLA Pathway

ROCKLIN, Calif. & HANGZHOU, China--(BUSINESS WIRE)--CPC Scientific Inc., a premier peptide and oligonucleotide-focused Contract Research, Development, and Manufacturing Organization (CRDMO) and a wholly owned subsidiary of Medtide Inc. (HKEX: 3880.HK), today announced that Chinese Peptide Company, its current Good Manufacturing Practice (cGMP) manufacturing facility, located in Hangzhou, China, has successfully completed a Pre-License Inspection (PLI) conducted by the U.S. Food and Drug Administration (FDA).

The rigorous onsite audit, conducted from January 26 to February 3, 2026, comprehensively evaluated the facility's commercial manufacturing operations for the complex, fully synthetic long-chain peptide active pharmaceutical ingredient (API) of Hepcludex® (bulevirtide-gmod) 8.5 mg for injection, which received accelerated approval from the U.S. FDA on May 22, 2026, as the first and only approved treatment for chronic hepatitis delta virus (HDV) infection in the United States.

With a sequence exceeding 40 amino acids, the commercial-scale manufacturing of the Hepcludex® API is long and complex. Under current FDA regulatory frameworks, synthetic peptides of this length are classified as biologics, mandating significantly more rigorous controls compared to traditional small-molecule peptide NDAs.

About Chronic HDV and the Unmet Medical Need

Hepatitis delta virus (HDV) infection occurs exclusively as a co-infection in individuals living with the hepatitis B virus (HBV). Chronic HDV is clinically recognized as the most severe and rapidly progressive form of viral hepatitis. Compared with HBV infection alone, HDV co-infection accelerates the disease progression, carrying a markedly higher risk of rapid progression toward severe liver fibrosis (scarring), cirrhosis, liver failure, liver cancer, and mortality.

In the United States, studies in general populations estimate that HDV affects between 2% and 4% of individuals with chronic HBV, representing approximately 40,000 to 80,000 people living with this devastating condition. Due to historically low screening rates and limited clinical pathways, patients face the immense complexity of managing two distinct viral liver diseases simultaneously. Prior to the accelerated approval of Hepcludex® (bulevirtide-gmod), there were no FDA-approved therapies available, leaving a critical gap in care. The landmark approval of Hepcludex® addresses this profound unmet medical need, marking a historic milestone that has the potential to fundamentally alter the clinical course of HDV for patients in the United States.

Management Commentary

“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,” said Dr. Shawn Lee, Chairman of both CPC Scientific and Chinese Peptide Company. “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.

“The successful 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 standards forged over 25 years.

“This milestone, combined with our consistent track record of supporting multi-regional filings for this program, further solidifies CPC Scientific’s position as an indispensable, strategic technical partner for the industry’s most sophisticated long-chain peptide programs.

“Looking ahead, this validation carries significant strategic weight beyond the program itself. Early-stage discovery pipelines in GLP-1 and obesity are increasingly exploring next-generation candidates featuring longer-chain architectures, often around or beyond 40 amino acids. We are uniquely positioned to leverage this BLA-grade validated capability to support global partners pursuing commercial regulatory filings for this new class of molecules.”

About CPC Scientific

CPC Scientific is a premier global Contract Research, Development, and Manufacturing Organization (CRDMO) specializing in synthetic peptides and oligonucleotides for the biopharmaceutical industry. Headquartered in Rocklin, California, CPC Scientific serves as the primary international corporate vehicle and strategic of Medtide Inc. (HKEX: 3880.HK), driving seamless global business operations and delivering access to an integrated infrastructure backed by nearly 25 years of technical excellence. The company supports pharmaceutical and biotechnology innovators through the most critical phases of drug development, with a particular focus on late-phase development, large-scale manufacturing, and commercial production.

Backed by metric-ton scale cGMP manufacturing, CPC Scientific operates world-class, cGMP-compliant commercial production facilities, including its core manufacturing asset in Hangzhou, China, which has successfully completed rigorous regulatory inspections conducted by multiple regulatory authorities and quality organizations, including the U.S. FDA, NMPA, TGA, and EMA, underscoring the company’s consistent compliance with international quality and manufacturing standards. To further strengthen global supply chain resilience and meet evolving market demands, CPC Scientific is actively expanding its global footprint with the development of a localized, state-of-the-art GMP manufacturing facility in the United States.

Learn more at: www.cpcscientific.com