Has Ropiprestim/Romigrastim been approved for marketing?

Romiplostim/Romiplostim (Romiplostim) its generic name is "romiplostim". Belongs to the thrombopoietin receptor agonist class (drugs that stimulate platelet production). Nplate is only available in branded form, in single-dose vials of varying concentrations. RoplastinProduced in E. coli by recombinant DNA technology, U.S. Food and Drug Administration (FDA) It was approved for sale on August 22, 2008. The State Food and Drug Administration approved the drug for sale in China in 2022 under the trade name Romiplate.

Roprostim is a new targeted drug that can be used in the clinical treatment of chronic immune thrombocytopenia (ITP). It increases megakaryocyte production by activating TPO receptors. Unlike previous generation TPO receptor agonists, it does not induce immunogenicity leading to thrombocytopenia. Early-stage Phase I/II clinical trials of loprostimshow promise across a broad dose range in patients with chronic ITP. The standard dosing regimen was further refined in several additional phase III randomized clinical trials. Furthermore, these trials showed that ropremilast was well tolerated and patients rarely experienced significant side effects.

Platelet responses are durable when treated with ropruprimostat, and most patients receive weekly injections of ropruprimostat, with some patients able to reduce their dose over time. Bleeding events were also reduced, and bleeding events were a more clinically meaningful endpoint in patients with chronicITP.

After the original drug for injection, Roprostim, is listed in the domestic market and included in the medical insurance, the price of the original version in Hong Kong may be more than 9,000 yuan, and the Hong Kong version will be around more than 8,000 yuan (the price may fluctuate due to exchange rate changes). In addition, there are European and German versions of the original drug Roplastin available overseas, each priced at approximately RMB 10,000 (affected by exchange rates), and the ingredients of these drugs are similar. However, there are currently no generic drugs of Ropremilast on the market overseas.