Hexarelin

The clinical treatment of diseases such as growth hormone deficiency and muscular atrophy has long suffered from the pain points of high administration frequency and poor compliance. The emergence of tesamorelin has provided a new direction for the optimization of treatment regimens for these diseases. As a peptide drug of growth hormone secretagogue receptor (GHSR) agonist, it can endogenously stimulate the secretion of growth hormone by specifically activating the GHSR pathway, without affecting the normal secretion levels of other hormones such as thyroxine and cortisol. At present, it is clinically mainly used for replacement therapy in adult growth hormone deficiency and improvement of muscle mass in patients with cachexia, and can also be used as an adjuvant for the intervention of related diseases such as hypogonadism and osteoporosis. The applicable population covers patient groups in multiple departments including endocrinology, oncology, and geriatrics.

The global tesamorelin market is still in the early stage of development. The market size in 2023 was approximately USD 120 million. With the expansion of indications and the increase in demand for elderly chronic disease management, the compound annual growth rate is expected to reach 18.7% by 2028. In terms of the competitive landscape, overseas enterprises still occupy a dominant position. Only a small number of domestic enterprises have laid out the R&D of the API and preparations of this variety. The generic drug track has not yet entered a white-hot stage, and the variety has not been included in the national centralized procurement catalog.

The original research enterprise of tesamorelin is Theratechnologies, a US-based company, with the original brand name Egrifta SV. Its core compound patent in the US market expired in 2022. The main dosage form approved for the original product is lyophilized powder for injection, with specifications of 1 mg/vial and 2 mg/vial, which has been included in the FDA Reference Listed Drug Catalog. Up to now, there is no tesamorelin preparation product approved for marketing in China, and the CDE API registration platform has not yet publicized valid and active API registration numbers. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for tesamorelin API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of enterprises in the process of R&D, quality research and production.