Thrombopoietin (TPO)

Modality

Thrombopoietin (TPO) is an important element involved in platelet production pathway.

Recombinant human TPO or analogs as TPO receptor agonists (TPO-RAs), perform important roles in the treatment of immune thrombocytopenia (ITP) because they increase platelet production and reduce the requirement for other treatments.

The development of first-generation TPO-RAs such as human recombinant TPO, PEGylated megakaryocyte growth and development factor, was discontinued due to the reaction of neutralizing antibodies with endogenous TPO. Therefore, the second-generation TPO-RAs, like romiplostim, are being studied to avoid these cross-reacting immune responses.

Thrombopoietin (TPO) for Therapeutic Use

Romiplostim

A TPO-RA formulation, romiplostim (Nplate), has been approved for use in ITP patients in the United States, Europe, Australia, and certain countries in Africa and Asia, as well as to treat refractory aplastic anemia in Japan and Korea.

As a member of the TPO mimetic class, romiplostim is a Fc peptide fusion protein (also called peptibody) that increases platelet production by stimulating intracellular transcriptional pathways via the TPO receptor (also called cMpl). Romiplostim contains two identical single-stranded subunits, each of which contains human IgG1 Fc fragment covalently conjugated to a peptide and two thrombopoietin receptor-binding domains at a C-terminal. With low sequence similarity to endogenous TPO, romiplostim was developed by Amgen and generated by recombinant DNA technology using Escherichia coli (E. coli).

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Thrombopoietin (TPO) Pinelines

Generic Name	Brand Name/Altermative Name	Expression System	Indications	Manufacturer	R&D Stage
Romiplostim	AMG-531, AMP-2, Nplate	Escherichia coli	Thrombocytopenia in patients with chronic immune thrombocytopenia (ITP)	Amgen	Approval
Romiplostim biosimilar	惠尔凝	Escherichia coli	Thrombocytopenia in ITP patients	Kirin	Approval
Romiplostim biosimilar	QL-0911	Pending Update	Thrombocytopenia in ITP patients	Qilu Pharma	Submit for approval
Romiplostim biosimilar	267639-76-9	Pending Update	Thrombocytopenia in ITP patients	Enzene Biosciences	Phase III
Romiplostim biosimilar	Pending Update	Pending Update	Thrombocytopenia in ITP patients	Intas Biopharmaceuticals	Phase III
Romiplostim biosimilar	Pending Update	Pending Update	Thrombocytopenia in ITP patients	Eris Lifesciences	Phase III
Romiplostim biosimilar	GNR 069	Pending Update	Thrombocytopenia in ITP patients	Generium Pharmaceuticals	Phase III
Romiplostim biosimilar	TMP-Fc	Pending Update	Thrombocytopenia in ITP patients	Beijing Tide	Phase I
Romiplostim biosimilar	A-157	Pending Update	Thrombocytopenia in ITP patients	KLUS Pharma, Inc.	Pre-clinical

Reference:

[1] Kuter DJ. New thrombopoietic growth factors. Blood. 2007 Jun 1;109(11):4607-16. doi: 10.1182/blood-2006-10-019315.

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Thrombopoietin (TPO)

Modality