Lusutrombopag

Chronic immune thrombocytopenia (ITP) is an acquired autoimmune hemorrhagic disease. Approximately 30% of patients still suffer from low platelet count and persistently high bleeding risk after first-line treatment, and there is a long-term unmet clinical need for long-acting therapies to increase platelet level. Lusutrombopag is a second-generation oral non-peptide thrombopoietin receptor (TPO-R) agonist. It binds to the TPO receptor on the surface of megakaryocytes, activates downstream signaling pathways such as STAT and PI3K, and promotes the proliferation and differentiation of megakaryocytes, thereby endogenously increasing platelet count. Currently, it is mainly indicated for the treatment of thrombocytopenia in patients with chronic liver disease-associated thrombocytopenia prior to elective invasive procedures, as well as for adult patients with chronic ITP who have an inadequate response to corticosteroids or immunoglobulin. Its characteristic of no need for frequent intravenous administration greatly improves patients' treatment adherence.

The global market size of lusutrombopag had exceeded USD 680 million in 2023, with a compound annual growth rate of around 21% in the recent three years. The core growth drivers come from the continuous expansion of the population with the indication of liver disease-associated thrombocytopenia, as well as the approval and launch of the ITP indication in more emerging markets. The current market is still dominated by the originator product, and no generic drug has been approved for marketing in China yet. As the core patents are approaching expiration, more than 10 domestic pharmaceutical companies have initiated the R&D and filing of generic drugs. The launch of generic drugs in the next 3 to 5 years is expected to rapidly promote the improvement of drug accessibility.

The originator of lusutrombopag is Shionogi Pharma Co., Ltd. of Japan, with the original brand name "Mulpleta", and its compound patent in China will expire in 2028. The marketed dosage form of the originator product is tablet, with a specification of 3 mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA, and is also a reference preparation recognized by the FDA. Up to now, one domestic enterprise has obtained the CDE registration number (status A) for lusutrombopag active pharmaceutical ingredient (API), and the originator and two domestic pharmaceutical companies have obtained marketing approval for lusutrombopag tablets. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for lusutrombopag, and the vast majority of the products are available from stock. Stock orders submitted before 16:00 can be dispatched on the same day. All products comply with the regulatory requirements of multiple countries such as the Chinese Pharmacopoeia and FDA, and can fully meet the research needs of the entire process including API R&D, quality research, registration and filing, etc.