Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pegfilgrastim (Y shape) to reduce the incidence of preeclampsia. This marks a significant milestone in the development of innovative therapies for pregnancy-related complications.
Product Overview and Previous Approvals
Pegfilgrastim (Y shape) is a Category 1 biologic product and an in-house developed long-acting human granulocyte stimulating factor. It was approved in China in July 2023 for use in patients with non-myeloid malignant tumors to reduce the incidence of infection with febrile neutropenia when receiving bone marrow suppression anticancer drugs that are prone to cause febrile neutropenia.
Mechanism of Action and Potential Benefits
Preeclampsia (PE) is a pregnancy-specific disease. Pegfilgrastim can activate signaling pathways by binding to specific receptors (GCSFR) on placental trophoblast cells, promoting trophoblast cell migration, invasion, and vascular remodeling. This process may enhance placental implantation and development, potentially reducing the incidence of preeclampsia.
Licensing Agreement with Fosun Pharmaceutical
In June 2023, Amoytop struck a licensing deal with Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), granting Fosun exclusive promotion and marketing rights to pegfilgrastim (Y shape) in mainland China. This partnership is expected to further expand the reach and impact of this innovative therapy.-Fineline Info & Tech
