How effective is Qilu Pharmaceutical’s Ropistim/Romigrastim?

Qilu Pharmaceutical's Romiplostim/Romiplostim (Romiplostim) is an injectable recombinant human thrombopoietin peptidomimetic-Fc fusion protein. It is a biosimilar of romiplostim (Nplate). After rigorous clinical trials and approved for marketing by the National Medical Products Administration, it became the first romiplostim biosimilar to be applied for marketing in China. This innovative drug is mainly used to treat idiopathic immune thrombocytopenia (ITP), providing a new treatment option for the majority of ITP patients.

Idiopathic immune thrombocytopenia is a disease in which the number of platelets is reduced due to abnormalities in the immune system. Patients are often at risk of severe bleeding and have a great impact on quality of life. Traditional treatments such as corticosteroids and immunosuppressive therapies have limited effectiveness in some patients, so there is an urgent need for novel therapies to improve the condition of these patients. Roprostim stimulates megakaryocytes in the bone marrow and promotes platelet production, thereby effectively increasing platelet count and reducing the occurrence of bleeding events.

The clinical effects of Roprostim have been widely recognized. In multiple clinical studies, platelet levels have increased in ITP patients treated with loplastin, and many patients may return to normal daily activities after receiving treatment. Clinical data showed that among patients without previous splenectomy, 61.8% of Qilu Pharmaceutical's ropruprimostat group achieved durable platelet response, which is similar to the report of the original drug ropruprimostat. The overall response rate in non-splenectomy patients (84%) was not strictly defined and was comparable to that of the original drug.

In addition, Qilu Pharmaceutical pays attention to the safety and effectiveness of the drug in the process of research and development of Roprostim. After rigorous clinical trials, relevant data show that the side effects of loplastin are relatively minor, mainly including mild headaches, infections and allergic reactions, and these adverse reactions are usually controllable.