A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis

This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for fracture.

Inclusion Criteria: * Women who can walk freely (≥50 and ≤80 years); * As measured by DXA, the absolute value of BMD at lumbar spine, femoral neck or total hip was -4.0\2 years or \>2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or if the ovaries are preserved after hysterectomy, follicle stimulating hormone (FSH) levels \>40mIU/mL may be used to confirm the status of postoperative menopause. Exclusion Criteria: * Bone/metabolic disease * Hyperparathyroidism or hypoparathyroidism * Thyroid condition: Hyperthyroidism or hypothyroidism * Rheumatoid arthritis * Malignant tumors * Malabsorption syndrome * Liver cirrhosis, active hepatitis B or hepatitis C, and unstable liver disease; serum aspartate aminotransferase and alanine aminotransferase ≥ 2.0 times the upper limit of normal (ULN); alkaline phosphatase or total bilirubin ≥ 1.5 ULN; * Renal disease - severe impairment of kidney function * Clinically significant cardiovascular and cerebrovascular diseases (such as myocardial infarction, unstable angina or stroke, NYHA class III or IV heart failure in the 12 months prior to screening) and hematopoietic system disease judged by the investigator; * Hypercalcemia or hypocalcemia ; * vitamin D deficiency (25-hydroxyvitamin D, 25OHD \