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特宝生物:珮金新增适应症获药物临床试验批准

Xiamen Amoytop Biotech: The new indication for Peiqin has received approval for clinical drug trials.

Breakings ·  Jan 6 18:57

Xiamen Amoytop Biotech announced that the company's product Peiqin (generic name: Tbo-filgrastim injection) has received approval from the National Medical Products Administration for a new indication "to reduce the incidence of preeclampsia" with the issuance of the "Notice of Approval for Clinical Drug Trials." Peiqin is a long-acting human granulocyte colony-stimulating factor independently developed by the company, which was approved for market on June 30, 2023, suitable for patients with non-myeloid malignancies undergoing treatment with myelosuppressive anticancer drugs that are likely to cause febrile neutropenia, aiming to reduce the incidence of infections manifested as febrile neutropenia. Peiqin is modified using 40kD Y-shaped branched polyethylene glycol (PEG) molecules on human granulocyte colony-stimulating factor, stimulating hematopoietic stem cells in the bone marrow to differentiate into granulocytes, promoting granulocyte proliferation, maturation, and release, restoring the number of neutrophils in peripheral blood, thereby reducing the incidence of infections after chemotherapy in cancer patients.

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