Lanreotide

Somatostatin analogs are the core category of drugs in the field of neuroendocrine tumor treatment. As a representative long-acting variety among them, lanreotide specifically binds to somatostatin receptors, inhibits the excessive secretion of gastroenteropancreatic hormones, growth hormone, etc., and exerts the effect of anti-tumor proliferation at the same time. Clinically, it is mainly used for the long-term control of acromegaly, as well as the symptom relief and disease progression delay of gastroenteropancreatic neuroendocrine tumors (including carcinoid tumors). It is especially suitable for patients who require long-term administration and have low tolerance to injection frequency, and can significantly improve treatment compliance.

The global lanreotide market size has maintained steady growth in recent years. In 2023, the market size was approximately USD 1.12 billion, with a compound annual growth rate maintained at around 5.8%. The domestic market is still in a stage of rapid growth. In 2023, the terminal sales in public medical institutions exceeded RMB 870 million, with an annual growth rate of more than 22%. At present, the market is dominated by original research products, and 3 domestic enterprises have submitted marketing applications for generic drugs. With the expiration of relevant patents, the substitution space for generic drugs is gradually released, and the market competition will further intensify in the future.

The original research enterprise of lanreotide is Ipsen, with the trade name Somatuline®, and its compound patent in China expired in 2021. The main dosage form of the original research marketed product is lanreotide acetate sustained-release microspheres for injection, with specifications including 40mg, 60mg, 90mg and 120mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. Up to now, the lanreotide acetate APIs of a number of domestic enterprises have passed the registration of CDE and obtained A status. The original preparation and 2 domestic generic drugs have all been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for lanreotide API. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of the whole process of API R&D, quality research and production, helping enterprises efficiently promote project declaration and compliant production.