特立帕肽

Osteoporosis is a high-incidence degenerative bone disease among the middle-aged and elderly population worldwide. Although existing anti-resorptive drugs can delay bone mass loss, they have limited repair effect on patients with severe bone damage that has already occurred. Teriparatide, as the first approved bone formation-promoting recombinant human parathyroid hormone analog, regulates the activity of osteoblasts and accelerates the synthesis of bone matrix and the repair of bone microstructure by selectively activating parathyroid hormone 1 receptor. It is mainly used for the treatment of primary osteoporosis, severe osteoporosis in postmenopausal women and glucocorticoid-induced osteoporosis, and can significantly reduce the risk of vertebral and non-vertebral fractures, especially suitable for elderly patients at high risk of fracture.

The global market size related to teriparatide had exceeded 2.8 billion US dollars in 2023. Driven by the rising global prevalence of osteoporosis and the growing base of the elderly population, it is expected to continue expanding at a compound annual growth rate of 6.2% by 2028. In terms of the domestic market, with the improvement of the diagnosis and treatment rate of osteoporosis patients and the expansion of medical insurance coverage, the compound annual growth rate in the past three years has reached 11.7%. At present, the original research product still accounts for more than 60% of the market share, and generic preparations from 3 domestic enterprises have passed the consistency evaluation. After centralized procurement, the clinical accessibility has been greatly improved, driving the continuous rise in the demand for upstream API.

The original research enterprise of teriparatide is Eli Lilly and Company, with the trade name "Forteo". Its core compound patent expired in the United States in 2019, and the core patent in China expired in 2020. The main dosage form of the original research product is injection, with specifications of 20μg per dose and 200μg per vial. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and also included in the FDA Reference Preparation Catalogue. In terms of domestic API registration, at present, 7 enterprises have obtained A status for their teriparatide APIs through CDE registration, and another 12 enterprises have obtained approval for the marketing of their preparation products, covering multiple dosage forms such as prefilled injection pens and freeze-dried powder for injection. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for teriparatide, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for API research and development, quality research and consistency evaluation work.