Pegfilgrastim-PEGylated Human Granulocyte Stimulating Factor Injection, A Long-acting White Blood Cell-raising Injection From Jiuyuan Gene, Has Been Approved For Marketing in China
January 20, 2025, Hangzhou Jiuyuan Genetic Biopharmaceutical Co., Ltd. (Stock Code:2566.HK) announced that its Pegylated Human Granulocyte Colony-Stimulating Factor Injection (Generic Name: Pegfilgrastim) has been approved for marketing by the National Medical Products Administration (NMPA) of China. The product is indicated for reducing the incidence of infections manifested as febrile neutropenia in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant risk of febrile neutropenia.
Pegfilgrastim is produced by conjugating human granulocyte colony-stimulating factor (hG-CSF) with 20KD polyethylene glycol (PEG) followed by purification. It features markedly prolonged half-life, enhanced biological stability, resistance to enzymatic degradation, reduced immunogenicity and antigenicity, and a lower tendency to induce neutralizing antibodies. As a pegylated human granulocyte colony-stimulating factor (PEG-hG-CSF) preparation, Pegfilgrastim requires only a single administration per chemotherapy cycle, which improves patient compliance, effectively ensures patient safety, and facilitates the implementation of full-dose and full-course chemotherapy regimens.
Pegylated human granulocyte colony-stimulating factor was included in the National Reimbursement Drug List (NRDL) as a Category B drug in 2017. Results from the Phase III clinical study of Pegfilgrastim-conducted with the innovator product (PEG-hG-CSF Injection, Neulastim®, Amgen Inc.) as the comparator-have confirmed that Pegfilgrastim is comparable to the innovator product in terms of efficacy and safety for preventing chemotherapy-induced neutropenia.
The acquisition of the drug registration certificate for Pegfilgrastim will enrich the Company's product pipeline in the field of hematotoxicity treatment induced by tumor radiotherapy and chemotherapy. It will complement the Company's existing daily-administered hG-CSF injection (Generic Name: Pegfilgrastim) and meet the diverse medication needs of patients undergoing cancer treatment.