Generic name: Telpegfilgrastim Injection

Brand name: Pegneugen®

Dosage form: Injectable solution

Strengths:

PFS:

2.0mg (8.0×107U)/ 1.0mL solution in a single-dose prefilled syringe

1.0mg (4.0×107U)/ 0.5mL solution in a single-dose prefilled syringe

Vials:

2.0mg (8.0×107U)/ 1.0mL solution in a single-dose vial

1.0mg (4.0×107U)/ 0.5mL solution in a single-dose vial

Indications: Telpegfilgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Telpegfilgrastim is not indicated for mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Advantages:

Pegneugen® is a long-acting human granulocyte colony-stimulating factor with independent intellectual property rights, using a more stable and brand new PEG (40kD, Y-shape) to modify. Compared with other PEG-rhG-CSF launched in China, Pegneugen® has following advantages:

• Longer half-life, reaching 56.9~90h;
• Lower administration dosage, only 1/3 of other launched PEG-rhG-CSF, i.e., at a fixed dose of 2mg or 33μg/kg;

Efficiently and steadily increase leukocyte while reducing the potential risk of bone marrow over mobilization.