Pasireotide

As a rare endocrine malignant disease, Cushing's disease has long suffered from the pain points of limited clinical medication options and insufficient treatment response rate. Pasireotide is a new generation of somatostatin analog, which exerts its effect by binding to somatostatin receptors SSTR1, SSTR2, SSTR3 and SSTR5 with high affinity. Compared with traditional analogs, its binding affinity to SSTR5 is increased by nearly 40 times, and it can potently inhibit the excessive secretion of adrenocorticotropic hormone. It is currently the only targeted drug approved for the second-line treatment of Cushing's disease and for patients with surgical failure or inoperable conditions. Meanwhile, it is also applicable for the treatment of acromegaly and diarrhea syndrome associated with unresectable metastatic carcinoid, covering adult patients and some adolescent patient groups that meet the indications.

At present, the global market size related to pasireotide is approximately USD 1.1 billion, with a compound annual growth rate remaining at 6.8% in the recent three years. The growth momentum mainly comes from the improvement of rare disease medication security policies and the increased clinical awareness of targeted therapy for endocrine tumors. The current market is still dominated by the original research product, and generic drugs are still in the early layout stage. In China, only 3 enterprises have submitted registration applications for the active pharmaceutical ingredient (API), and it has not yet been included in the centralized procurement catalogue, featuring rigid clinical demand and loose competitive landscape in the market.

The original research enterprise of pasireotide is Novartis Pharma, with the trade name Signifor®. Its core compound patent expired in China in 2021, and the core formulation patent in the US market expired in 2022. The marketed formulations of the original research include two series: the small-volume injection with specifications of 1ml:0.3mg, 1ml:0.6mg and 1ml:0.9mg, and the sustained-release microspheres for injection with specifications of 20mg, 40mg and 60mg. All of them have been included in the FDA Reference Listed Drug Catalogue, among which the common injection has been included in China's *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)*. Up to now, the pasireotide APIs of 2 domestic enterprises have obtained the A status after registration with the Center for Drug Evaluation (CDE), and the common injections of the original research enterprise and 3 generic drug enterprises have been approved for marketing in China. (Data as of April 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for pasireotide, and most products are available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for API R&D, quality research and generic drug consistency evaluation.