The board of directors of Shandong Boan Biotechnology Co., Ltd. announced that it has initiated an international multi-center phase 3 clinical study in Europe, the United States, and Japan for the Company's in-house developed Denosumab Injection (BA6101 and BA1102), and recently the first patient in (FPI) has been enrolled. BA6101 and BA1102 are biosimilar products to Prolia and Xgeva, respectively. Prolia has been approved worldwide for the following indications: (1) Treatment of postmenopausal women with osteoporosis at high risk for fracture.

In postmenopausal women, Prolia significantly reduces the risk of vertebral, non-vertebral, and hip fractures; (2) Treatment to increase bone mass in men with osteoporosis at higher risk for fracture; (3) Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; (5) Treatment to increase bone mass In women at high risk for fracture receive adjuvant aromatase inhibitor therapy for breast cancer. Xgeva has been approved worldwide For the following indications: (1), Prevention of skeletal-related events in patients with bone metastases from solid tumors; (2) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; (3) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. This international multi-center Phase 3 study is a randomized, double-blind, parallel-group, reference-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of the Company's biosimilar product compared with the reference product.

According to the Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product issued by the United States Food and Drug Administration ("FDA"), the Guideline on similar biological medicinal products issued by European Medicines Agency ("EMA"), the Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics issued by Japanese Pharmaceuticals and Medical Devices Agency ("PMDA") and based on the discussions with FDA, EMA and PMDA, after completion of the Phase 3 clinical study, BA6101 and BA1102 can apply for approval for all same indications as Prolia and Xgeva in Europe, the United States, and Japan.