Chinese Peptide Company, Subsidiary of Medtide Inc.: Tirzepatide API Successfully Secures US FDA DMF Filing, Fully Empowering the Global Weight Loss and Metabolism Arena

[Hangzhou, China – May 29, 2026] —— Today, Chinese Peptide Company (hereinafter referred to as "Chinese Peptide"), a wholly-owned subsidiary of Medtide Inc. (HKEX: 03880.HK), proudly announced that its self-developed Tirzepatide active pharmaceutical ingredient (API) has successfully completed the Drug Master File (DMF) filing with the U.S. Food and Drug Administration (FDA) under DMF number 043979. The company has recently received the official Acknowledgement Letter from the FDA.

This strategic milestone signifies that Chinese Peptide'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 Chinese Peptide'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 Chinese Peptide, following the successful Hong Kong IPO of its parent company, Medtide Inc.:

Direct Validation of R&D Depth: Tirzepatide features a complex structure and a high barrier to synthesis. The smooth approval of this filing once again underscores Chinese Peptide'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, Chinese Peptide consistently benchmarks against the highest international quality standards, ensuring every batch of API fully satisfies the stringent regulatory mandates of mainstream global markets.

Full-Lifecycle CRDMO Support: Harnessing its deep technical heritage, flexible scheduling advantages, and massive economies of scale, Chinese Peptide 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, Chinese Peptide 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, Chinese Peptide 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.

About Chinese Peptide

Chinese Peptide Company, a subsidiary of MEDTIDE Inc. (HKEX:03880), is a peptide and oligonucleotide-focused Contract Research, Development, and Manufacturing Organization (CRDMO), offering full-cycle services ranging from early-stage discovery, pre-clinical research and clinical development to commercial-stage production. The company was founded in 2001 and is headquartered in Hangzhou, China, with its international headquarter located in California, USA. It has commercial production sites and offices in both China and the United States.

We mainly provide (i) contract research organization (“CRO”) services, namely new chemical entity (“NCE”) discovery synthesis; (ii) contract development and manufacturing organization (“CDMO”) services, namely chemistry, manufacturing and controls (“CMC”) development, and commercial manufacturing. We have established global operations, with projects spanning across over 50 countries, including major markets such as China, the United States, Japan, Europe, South Korea, and Australia. We provide over 1,000 customers worldwide with peptide drug development, production, and CMC filing support services that meet regulatory requirements in major markets worldwide.

Leveraging our deep industry insights, established R&D and manufacturing capabilities, and premium reputation among customers, we have expanded our CDMO solutions to oligonucleotides since 2021. We have proactively adapted to meet the evolving needs of our customers, and expanded our production platform from peptides to oligonucleotides and introducing an advanced one-stop oligonucleotide platform.

We have a team of experts dedicated to the research and production of peptides and oligonucleotides, possessing extensive professional knowledge and project experience. We are capable of meeting production needs ranging from simple to complex and challenging molecules. Whether in technical capabilities or project management, we can meet customer requirements and provide high-quality, reliable services.

As a trusted and sustainable enterprise, Chinese Peptide Company has established long-term partnerships with many customers. Through close collaboration, we assist customers in bringing drugs that profoundly impact human health to the market, focusing on patients and committed to improving their lives, thus promoting the development of the human health industry.