[Rocklin, CA – May 29, 2026] — CPC Scientific, 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 its Hangzhou-based Good Manufacturing Practice (CGMP) manufacturing facility, Chinese Peptide Company (hereinafter referred to as “Chinese Peptide”), has successfully completed the Drug Master File (DMF) filing for its self-developed Tirzepatide active pharmaceutical ingredient (API) with the U.S. Food and Drug Administration (FDA) under DMF number 043979. The facility has recently received the official Acknowledgement Letter from the FDA.

This strategic milestone signifies that the organization’s formulation partners worldwide can now directly reference its DMF data upon authorization when submitting relevant drug application registrations to the U.S. FDA. This will significantly shorten the R&D and filing cycles for clients’ products, accelerating the commercialization and launch of premium therapeutics in this class.

Anchoring the Dual-Receptor Track to Capture the Multi-Billion Dollar Global Weight Loss Market

As an innovative dual GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) receptor agonist, Tirzepatide holds epoch-making medical significance in the treatment of metabolic diseases. Through a sophisticated dual-receptor synergistic mechanism, the product not only demonstrates outstanding performance in glycemic control for type 2 diabetes patients, but also unlocks revolutionary clinical potential for indications such as obesity and moderate-to-severe obstructive sleep apnea (OSA).

Currently, the global market for weight loss and metabolic diseases is experiencing explosive growth. As the absolute star molecule in this domain, the global market demand for high-quality, compliant Tirzepatide API remains robust. The official “listing” of the company’s Tirzepatide API not only further enriches the company’s pipeline of premium APIs in the metabolic disease sector, but also—leveraging its metric-ton-scale commercial CGMP manufacturing capacity—provides a robust, efficient, and compliant supply chain backbone for global formulation partners developing GLP-1/GIP dual-receptor agonist drugs.

Driven by Deep Technology Roots, Continuing to Lead the Global Peptide Compliance High Ground

The successful U.S. FDA DMF filing of Tirzepatide marks another heavyweight milestone in top-tier international regulatory compliance for CPC Scientific, following the successful Hong Kong IPO of its parent company, Medtide Inc.:

Direct Validation of R&D Depth: Tirzepatide features a complex structure and an exceptionally high barrier to synthesis. The smooth approval of this filing once again underscores CPC Scientific’s absolute leadership in the R&D and process scale-up of complex, long-chain, and large-scale intricate peptides.

Industry Benchmark for High Compliance: As one of the earliest established peptide enterprises in China to pass U.S. FDA on-site inspections, CPC Scientific consistently benchmarks against the highest international quality standards, ensuring every batch of API fully satisfies the highly stringent regulatory mandates of mainstream global markets.

Full-Lifecycle CRDMO Support: Harnessing its deep technical heritage, flexible scheduling advantages, and massive economies of scale, CPC Scientific continues to provide global pharmaceutical companies with a one-stop, full-lifecycle CRDMO service spanning early-stage discovery and CMC process optimization to multi-ton commercial production.

Since its inception in 2001, the company has dedicated 25 years of intensive cultivation to the peptide drug field. The successful U.S. FDA DMF registration of Tirzepatide API is not only a natural manifestation of the company’s accumulated technical and comprehensive strengths, but also delivers a powerful compliance endorsement for the company to penetrate premium international markets and catalyze global business collaborations. Moving forward, the company will continue to rely on its world-class manufacturing assets to offer more commercially competitive API solutions to global partners, contributing high-quality therapeutic support to the global metabolic disease landscape.

Read Chinese Peptide Press Release (中文)