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TextPharmaceutical Guanlan
According to the latest announcement on the official website of the China National Medical Products Administration (NMPA), the roprostim for injection declared by Kyowa Kirin of Japan (formerly known as romiprostim for injection) has been approved
.
According to public information, roprostim is a thrombopoietin (TPO) receptor agonist developed by Amgen, and Kyowa Kirin owns the development rights of this product in Greater China, South Korea, Singapore, Malaysia and other regions.
Screenshot source: NMPA official website
ITP is a rare, serious autoimmune disease characterized by low platelet counts in the blood that can lead to serious bleeding events
.
In people with ITP, the immune system attacks and destroys the body's own platelets, which play an active role in blood clotting and wound healing
According to public information, romiplostim is a recombinant protein belonging to the TPO receptor agonist, which can stimulate the intracellular transcription pathway by binding to the TPO receptor, resulting in increased platelet production
.
Produced in Escherichia coli by recombinant DNA technology, the drug can mimic the body's natural thrombopoietin effect, thereby increasing platelet counts
According to an earlier Amgen press release, the mechanism of action of roprestim to stimulate platelet production by stimulating the thrombopoietin receptor is very different from commonly used drugs that increase platelet counts by inhibiting platelet destruction
.
In 2009, Ropstim was also selected as the "Best Biotechnology Product" by the Galen Award, known as the "Nobel Prize in Medicine"
Amgen once stated in a press release that roprostim has been approved for marketing in dozens of countries and regions around the world, including the United States, the European Union, Canada, and Australia.
The approved indications include ITP that is poorly treated by other drugs or surgery.
Adult patients, pediatric patients 1 year and older with ITP lasting at least 6 months and an inadequate response to corticosteroids, immunoglobulins, or splenectomy
.
In addition, the US FDA has successively granted orphan drug designation to roprostim for the treatment of aplastic anemia and chemotherapy-induced thrombocytopenia
In China, Kyowa Kirin submitted a new drug marketing application for roprostim in April 2020 and was accepted
.
According to the official website of Kyowa Fermentation Kirin, the company has the development rights of Ropstim in Greater China (including mainland China, Hong Kong, Macau and Taiwan), South Korea, Singapore, Malaysia and other regions
It is hoped that the approval of roprostim in China will also benefit more Chinese ITP patients
References:
[1] China State Food and Drug Administration's January 11 Drug Approval Document Pending Information.
[3] Kyowa Kirin official website, from https://
