CSPC Baike (Yantai) Biopharmaceutical Co. Ltd.

Main study objectives: To verify the consistency of efficacy of SYN008 and Omalizumab for injection (Xolair) in the treatment of patients with refractory chronic spontaneous urticaria. Secondary study objectives: 1. To evaluate the safety of SYN008 and Omalizumab for injection (Xolair) in patients with refractory chronic spontaneous urticaria; 2. To evaluate the immunogenicity of SYN008 and Omalizumab for injection (Xolair) in patients with refractory chronic spontaneous urticaria; 3. Based on secondary efficacy endpoints, evaluate the efficacy of SYN008 and Omalizumab for injection (Xolair) in patients with refractory chronic spontaneous urticaria.

Primary objective: To compare the PK and PD characteristics of healthy subjects after subcutaneous injection of the new specification of 6.0mg (0.6ml)/vial (test preparation) and the original specification of 3.0mg (1.0ml)/vial (reference preparation) of PEGylated recombinant human granulocyte-stimulating factor injection produced by CSPC Biopharmaceuticals (Shandong) Co., Ltd. Secondary objective: To evaluate the immunogenicity and safety of the new specification and the original specification of PEGylated recombinant human granulocyte-stimulating factor injection produced by CSPC Biopharmaceuticals (Shandong) Co., Ltd. in healthy subjects after subcutaneous injection.