Tirzepatide

The continuous rise in the global prevalence of diabetes and obesity has driven R&D breakthroughs of multi-target anti-diabetic and weight-loss drugs, and tirzepatide is a representative product of such innovative therapies. As the first dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, it can synergistically enhance insulin secretion and inhibit glucagon release by activating the two receptors simultaneously, while delaying gastric emptying and reducing appetite. It has been approved not only for improving glycemic control in adult patients with type 2 diabetes mellitus, but also for chronic weight management in adults who are obese or overweight and have at least one weight-related complication, providing patients with metabolic diseases a treatment option superior to single-target GLP-1 receptor agonists.

Tirzepatide has maintained a rapid market growth momentum since its launch, with global sales exceeding USD 5.7 billion in 2023, and sales in the first half of 2024 reaching USD 5.18 billion, making it expected to exceed the USD 10 billion mark for the whole year. At present, the original research product still occupies a dominant position in major global markets, and generic drug companies in many countries including China are accelerating the R&D layout of APIs and preparations. As core patents expire successively, the launch of generic drugs in the future will further lower the access threshold for medication, and the market penetration rate still has room for an increase of at least 3 times.

The original research enterprise of tirzepatide is Eli Lilly and Company, with the trade names Mounjaro (for diabetes indication) and Zepbound (for weight loss indication). Its core compound patent will expire in 2030 in the United States, and the Chinese compound patent will expire in 2033. At present, the main dosage form of the original research product on the market is injection, with specifications covering 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg. The original research injection has been included in the *Catalogue of Chemical Medicines* of China, and is also a reference preparation recognized by the FDA. Up to now, no generic tirzepatide preparation has been approved for marketing in China. Dozens of enterprises have submitted DMF registrations on the CDE API registration platform, most of which are under review and approval, and no generic API has been registered with A status. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for impurity reference standards in the R&D and quality control process of tirzepatide, CATO can provide a full set of impurity reference standards for this API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the needs of various scenarios such as drug R&D, registration and declaration, and routine quality testing.