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Boan Biotech recently announced that subject enrollment for the international multicenter comparative clinical (Phase 3) study of the company's Denosumab Injections (BA6101 and BA11021) has been completed. This study is being conducted simultaneously in Europe, the United States and Japan. A meeting was also recently held in Germany to announce the results of the pharmacokinetic similarity clinical (Phase 1) study for BA6101.
Boan Biotech最近宣布,该公司Denosumab注射剂(BA6101和BA11021)的国际多中心比较临床(第3阶段)研究的受试者登记已经完成。这项研究正在欧洲、美国和日本同时进行。最近还在德国举行了一次会议,宣布BA6101药代动力学相似性临床(第一阶段)研究的结果。
Dr. Dou Changlin, President of R&D and Chief Operating Officer of Boan Biotech, and Dr. Zhou Ming, Chief Medical Officer of Boan Biotech, attended the meeting along with Dr. Rainard Fuhr from Parexel International GmbH, Principal Investigator of the Phase 1 clinical study of BA6101. Together with other clinical investigators, they discussed the results of this study and the application of Boan Biotech's Denosumab Injections in international markets.Dr.
博安生物科技研发总裁兼首席运营官窦长林博士和博安生物科技首席医疗官周明博士与BA6101第一阶段临床研究首席研究员、Parexel International GmbH的Rainard Fuhr博士一起出席了会议。他们与其他临床研究人员一起讨论了这项研究的结果以及Boan Biotech的Denosumab注射液在国际市场上的应用。博士。
Dou Changlin (5th from left in the front row), Dr. Zhou Ming (4th from left in the front row) and clinical investigators of the Phase 1 studyDr. Dou Changlin (5th from left in the front row), Dr. Zhou Ming (4th from left in the front row) and clinical investigators of the Phase 1 studyBA6101 and BA1102 are biosimilars to Denosumab Injection original drugs Prolia® and Xgeva® respectively.
Dou Changlin(前排左起第5位),Zhou Ming博士(前排左起第4位)和1期研究的临床研究人员Dr。Dou Changlin(前排左起第5位),Zhou Ming博士(前排左起第4位)和第一阶段研究的临床研究人员BA6101和BA1102分别是地诺单抗注射液原始药物Prolia®和Xgeva®的生物仿制药。
Prolia is widely used for treating osteoporosis around the world, whereas Xgeva is used globally for the treatment of diseases such as multiple myeloma and bone metastasis of solid tumors, giant cell tumors of bone, and hypercalcemia.In November 2022, BA6101 (trade name: Boyoubei® in Chinese) was launched in China firstly, to become China's first locally developed Denosumab Injection.
Prolia在世界各地广泛用于治疗骨质疏松症,而Xgeva在全球范围内用于治疗多发性骨髓瘤和实体瘤骨转移,骨巨细胞瘤和高钙血症等疾病。2022年11月,BA6101(中文商品名:Boyoubei®)首次在中国推出,成为中国首款本土开发的地诺单抗注射液。
The drug received positive feedback from doctors and patients on its clinical application. In March 2023, the biologics license applic.
该药的临床应用得到了医生和患者的积极反馈。2023年3月,生物制剂许可证申请。