Beijing Weiming Fuyuan Gene Drug Research Center Co Ltd

To evaluate the efficacy and safety of recombinant human serum albumin/granulocyte stimulating factor fusion protein for injection in preventing chemotherapy-induced neutropenia and to provide a basis for safe and effective dosing regimens in phase III clinical trials.

To evaluate the tolerability and safety of breast cancer patients after receiving single and multiple injections of different doses of recombinant human serum albumin/granulocyte stimulating factor fusion protein, and provide a basis for the dosing regimen of phase II clinical trials. To observe the pharmacokinetic characteristics of recombinant human serum albumin/granulocyte stimulating factor fusion protein after single and multiple administrations.

To preliminarily evaluate the effectiveness and safety of different doses of recombinant human serum albumin/granulocyte stimulating factor fusion protein for injection in preventing chemotherapy-induced neutropenia, explore its effective dose, and provide a basis for safe and effective dosing regimens in Phase III clinical trials. Comparative pharmacokinetic study of recombinant human serum albumin/granulocyte stimulating factor fusion protein was conducted with recombinant human granulocyte colony stimulating factor injection as control.