Lysipressin

In response to the clinical demand for long-term hormone replacement therapy for patients with central diabetes insipidus, lypressin, as a synthetic long-acting antidiuretic hormone analog, binds to the V2 receptors in the renal collecting ducts and promotes water reabsorption to reduce urine excretion. Its antidiuretic effect lasts 3-5 times longer than that of natural arginine vasopressin, which can significantly reduce the administration frequency for patients. In addition to the long-term control of central diabetes insipidus, this drug can also be used for the symptomatic treatment of postoperative abdominal distension and urinary incontinence. When bleeding occurs in some patients with hemophilia and von Willebrand disease, lypressin infusion can also promote the release of coagulation factor VIII to assist hemostasis. The applicable population covers patients with urinary system and hemorrhagic diseases of all age groups from children to the elderly.

The current global market size of lypressin is approximately USD 230 million, and the compound annual growth rate from 2023 to 2029 is expected to remain at 4.8%. The core growth drivers come from the improvement of the diagnosis and treatment coverage of rare diseases and the expansion of applications in postoperative hemostasis scenarios. The domestic market is still dominated by imported original research preparations at this stage, and the development of generic drugs is still in the clinical declaration stage. Since central diabetes insipidus is a disease included in the rare disease catalog, the corresponding preparation products can enjoy the priority review policy support for rare disease drugs, and have not yet been included in the scope of national centralized procurement, so the market return space for the development of APIs and generic drugs is considerable.

The original research enterprise of lypressin is Ferring Pharmaceuticals, and the original research trade name is Minirin®. The core compound patents of the original research drug expired in Europe and the United States in 2021 and 2022 respectively, and the compound patent in China expired in 2020. The currently marketed original research dosage forms include injection, nasal spray and oral tablet. The common specifications are injection 1ml:4μg, nasal spray 10ml:100μg, oral tablet 0.1mg/0.2mg. The original research dosage forms have been included in the China Listed Drug Catalog as reference preparations. Up to now, there is no domestic lypressin preparation approved in China, and there is no domestic lypressin registration number in A status on the CDE API registration platform for the time being, and only the registration number submitted by 1 enterprise is in the review and approval stage. (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 lypressin API, which can cover the qualitative and quantitative research needs of process impurities and degradation impurities. Most products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support the whole process of research and development and declaration of APIs and preparations.