Good News | Medtide Inc.’s Subsidiary Chinese Peptide Company Sees Triptorelin Pamoate API Accepted for CDE Registration, Adding a New Product to Its Peptide Hormone Regulatory Portfolio

In May 2026, Triptorelin Pamoate Active Pharmaceutical Ingredient (API) independently developed and manufactured by Chinese Peptide Company (hereinafter referred to as "Chinese Peptide Company"), a subsidiary of Medtide Inc., was officially accepted for registration by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA), with the registration number Y20260000253.

About Triptorelin Pamoate

Triptorelin Pamoate is a synthetic gonadotropin-releasing hormone (GnRH) analog that exerts pharmacological suppression of sex hormones by sustaining agonism of pituitary GnRH receptors and downregulating gonadotropin secretion. Its clinical applications cover multiple indications including endocrine therapy for prostate cancer, endometriosis, and central precocious puberty. It is one of the mature core varieties in the global peptide hormone drug market with stable and sustained demand.

Compared with other salt forms of triptorelin, the pamoate salt form demonstrates excellent salt formation stability and sustained-release compatibility in microsphere sustained-release formulations. It is the mainstream API form for long-acting injectable formulations (1-month and 3-month sustained release), which imposes stringent requirements on the inter-batch consistency, particle size distribution, and related substance control level of the API.

A Natural Extension of Technical Accumulation

Triptorelin has a decapeptide structure (pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH₂) and is a key competitive product of Chinese Peptide Company after years of in-depth cultivation in the field of GnRH analogs. The official acceptance of Triptorelin Pamoate by the CDE this time is a concentrated manifestation of the company’s profound technical accumulation in the field of complex peptide synthesis.

The domestically produced specifications declared this time achieve full coverage of nine packaging specifications ranging from 0.5g to 150g, fully demonstrating Chinese Peptide Company’s multi-dimensional capabilities to empower global clients: we can provide stable, high-standard API supply guarantees for both customized R&D needs and large-scale commercial batch production.

Accelerating Empowerment for Formulation Partners

Chinese Peptide Company always adheres to the concept of Quality by Design (QbD). The publication of this Triptorelin Pamoate API will bring significant advantages to downstream formulation partners:

Synchronized Associated Filing: The API has obtained a registration number and entered the public notice list (Status I). Formulation enterprises can immediately reference this registration number for associated applications, substantially reducing the time and cost of formulation R&D and registration.

Flexible Scale Matching: The declaration covers nine specifications ranging from 0.5g to 150g, which can precisely cover the needs across all stages from early-stage formulation R&D, pilot-scale amplification to commercial large-scale production.

We welcome partners interested in technical exchanges or business negotiations to contact us.

About Chinese Peptide Company

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.