Pertuzumab Biosimilar (CSPC Pharma)

Primary study objectives: To compare the efficacy of SYSA1901/Pertuzumab (Perjeta®) combined with trastuzumab and docetaxel in the neoadjuvant treatment of patients with early or locally advanced HER2-positive breast cancer. Secondary study objectives: To compare the safety of SYSA1901/Pertuzumab (Perjeta®) combined with trastuzumab and docetaxel in the neoadjuvant treatment of patients with early or locally advanced HER2-positive breast cancer; To evaluate the pharmacokinetic (PK) characteristics of SYSA1901; To evaluate the immunogenicity of SYSA1901.

The main purpose of the study is to investigate the pharmacokinetic characteristics of the biosimilar (SYSA1901 injection), and to compare the main pharmacokinetic parameters of the two preparations by intravenous infusion in healthy male subjects with Pertuzumab Injection (trade name: Perjeta®/Perjeta®) as the reference drug, and to evaluate the pharmacokinetic similarity of the two preparations. Secondary purpose of the study is to compare the safety and immunogenicity of a single intravenous infusion of 420 mg (14 mL) of the biosimilar (SYSA1901 injection) and the reference drug Pertuzumab Injection (trade name: Perjeta®/Perjeta®) in healthy male subjects.