Qilu Pharmaceutical Submits China's First Generic Romiplostim NDA for Immune Thrombocytopenia

On March 22, the CDE website showed that the marketing application of Qilu Pharmaceutical's Romiplostim Injection was accepted for the treatment of immune thrombocytopenia. This is the first generic Romiplostim submitted for marketing in China.

Originally developed by Amgen, Kyowa Hakko Kirin holds the development rights for this product in Greater China, South Korea, Singapore, Malaysia, and other regions. Romiplostim (trade name: Nplate) is a second-generation oral TPO-R agonist that stimulates intracellular transcription pathways by binding to the TPO receptor, thereby increasing platelet production.

In August 2008, the drug was first approved for marketing in the United States, followed by launches in dozens of countries and regions including the European Union and Japan. It entered the Chinese market in January 2022 for the treatment of immune thrombocytopenia. Currently, Romiplostim has been approved for multiple indications, including immune thrombocytopenia, acute radiation syndrome, and aplastic anemia.

Source: PharmaCube NextPharma

Since its launch, the sales of Romiplostim have continued to grow. According to Amgen's 2021 financial report, Nplate generated revenue of $1.027 billion, successfully entering the ranks of blockbuster drugs.

Amgen's Sales (Source: PharmaCube NextPharma)

Immune thrombocytopenia is an acquired autoimmune disease, with an incidence accounting for about 1/3 of hemorrhagic diseases, making it one of the most common hemorrhagic diseases in clinical practice. Clinical manifestations include reduced peripheral blood platelet count and/or bleeding. Adult ITP patients are prone to intracranial hemorrhage, while pediatric ITP patients are more likely to experience other severe bleeding symptoms.

The main treatment goal of ITP is to increase platelet levels to a safe range, prevent bleeding, and avoid treatment-related adverse reactions. Currently, the first-line clinical medications for ITP are mainly glucocorticoids and immunoglobulins, while second-line drugs primarily include thrombopoietin receptor (TPO-R) agonists, antibody-based therapies, and immunosuppressants.

In addition to Kyowa Hakko Kirin's Romiplostim, there are four other TPO-R agonists available in China: Novartis/GSK's Eltrombopag Ethanolamine, Hengrui's Hetrombopag Ethanolamine, Fosun Pharma's Avatrombopag, and 3SBio's Recombinant Human Thrombopoietin.