The relationship between loplastin/romilastin and Ruilisheng

Romiplostim/Romiplostim (Romiplostim), trade nameNplate, is a human thrombopoietin (TPO) mimetic peptide produced through DNA recombinant technology and belongs to the second generation long-acting TPO receptor agonist (TPO-RA). It is mainly used to treat chronic primary immune thrombocytopenia (ITP) in adults. By binding and activating TPO receptors, it promotes the maturation of megakaryocytes and platelet production, thereby effectively increasing the patient's platelet count. The original drug Roplastin is produced by the American company Amgen and has been approved for marketing in many countries and regions around the world. Its efficacy and safety have been widely recognized.

Ruilisheng (Roplastin for InjectionN01) is a domestically produced Roplastin for injection independently developed by Qilu Pharmaceutical. It received marketing approval from the State Food and Drug Administration in April 2024, becoming the first domestically produced Roplastin for injection approved for marketing. Ruilisheng is also a second-generation long-acting TPO-RA, and its pharmaceutical properties, efficacy, sustainability, and safety are basically the same as the original drug Roprostim. The launch of Ruilisheng has greatly improved the accessibility of the drug and provided a new treatment option for ITP patients.

The relationship between the two is mainly reflected in two aspects: composition and mechanism, market positioning and application. First of all, the ingredients of Ruilisheng and Ropremilast are basically the same, and they are both the active ingredients of Ropremilast. Ruilisheng is a trade name that presents the active ingredient Roprostim in a specific preparation form to facilitate patient identification and use. Therefore, the efficacy and side effects of Ruilisheng are consistent with those of Ropremilast, providing patients with similar medical effects.

Both drugs are currently on the market in China, and the imported original drug for injection, Roprostim, has also been reimbursed by the national medical insurance. However, due to the short time on the market, it may be difficult to purchase the drug.