Sermorelin

The clinical intervention for growth hormone deficiency has long been plagued by the pain points of high administration frequency and poor patient compliance. As a growth hormone-releasing hormone (GHRH) analog, sermorelin can specifically bind to GHRH receptors in the anterior pituitary gland to promote endogenous growth hormone secretion in a physiological pulsed mode, avoiding the risk of excessive secretion caused by direct supplementation of exogenous growth hormone. Clinically, it is mainly used for the diagnosis and adjuvant treatment of idiopathic growth hormone deficiency in children, and can also be applied to the adjustment of metabolic disorders related to insufficient growth hormone secretion in adults. It is suitable for people undergoing growth hormone stimulation test screening and patients who need mild regulation of growth hormone levels.

The current global sermorelin market size is approximately USD 120 million, with a compound annual growth rate maintained at around 6.8%. The growth drivers mainly come from the increasing demand for children's growth and development screening and the expansion of the diagnostic reagent market in the endocrinology field. As sermorelin is a polypeptide API, it has high barriers in synthesis process. At present, the global production capacity is mainly concentrated in a few specialized, refined, differential and innovative polypeptide pharmaceutical enterprises in Europe, the United States and China. There are a small number of related preparations approved for marketing in China, which have not been included in the national centralized volume-based procurement scope, and the market competition pattern is relatively moderate.

The original research enterprise of sermorelin is Ferring Pharmaceuticals from the United States, and the original research brand name is Geref. Its core compound patent in the United States expired in 2009, and the compound patent in China has also expired. The main dosage form approved for the original research product is injection, with specifications of 50μg/vial and 100μg/vial, which has been included in the FDA Reference Listed Drug Catalog. Up to now, there is no sermorelin preparation product approved for marketing in China, and no valid A-status registration number of sermorelin listed on the CDE API registration platform has been found. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for sermorelin. Most of the products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple national regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for the whole process of API R&D, quality research and registration.