China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its subsidiary CP Pharmaceutical Qingdao has entered into a five-year cooperation agreement with compatriot firm Shandong Boan Biotechnology Co., Ltd. Under the agreement, CP Qingdao has obtained exclusive commercialization rights to LY06006/BA6101, a biosimilar version of US major Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), covering the territory of mainland China.
Agreement Details
As per the agreement, CP Qingdao will be responsible for the exclusive promotion of LY06006/BA6101 in mainland China. Following the signing of the agreement, CP Qingdao will pay a performance bond to Boan Bio in the agreed relevant year, and Boan Bio will pay the service fee to CP Qingdao within the term of the agreement.
Therapeutic Profile and Market Position
LY06006/BA6101 is approved to treat osteoporosis in postmenopausal women at high risk of fracture. Denosumab, a novel RANKL inhibitor originated by Amgen, is currently marketed in China by BeiGene. The monoclonal antibody has high affinity and specificity for the soluble and transmembrane form of human RANKL. The 120mg dosage form of the product, under the trade name Xgeva, was approved in China in May 2019 for use in adults and adolescents with mature skeletal development (defined as at least one mature long bone and weight of ≥45 kg) with inoperable giant cell tumor of bone or surgically removed giant cell tumors of bone that may cause severe dysfunction. It was commercially launched in December the same year. The 60mg dosage form, sold under the trade name Prolia and used to treat bone loss (osteoporosis) in at-risk patients, was approved in June 2020 in China. LY06006/BA6101, the world’s first Prolia biosimilar, is also being prepared for clinical and market filings in Europe and the United States.
Future Outlook
The cooperation agreement between CP Pharmaceutical Qingdao and Shandong Boan Biotechnology underscores Sino Biopharmaceutical’s commitment to expanding its portfolio of biosimilar products in China. With exclusive commercialization rights to LY06006/BA6101, the company is poised to address significant unmet needs in osteoporosis treatment. The ongoing efforts to secure clinical and market filings in Europe and the United States further highlight the global potential of this biosimilar therapy.-Fineline Info & Tech
