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Hualan Genetic Recombinant Anti-RANKL Whole Human Monoclonal Antibody Injection (Dnosumab) Starting Clinical Trial

Hualan Genetic Recombinant Anti-RANKL Whole Human Monoclonal Antibody Injection (Dnosumab) Starting Clinical Trial

On October 11, 2018, Hualan Genetic Engineering Co., Ltd. received the clinical approval document of "Recombinant Anti-RANKL Whole Human Monoclonal Antibody Injection (Dnosumab)" issued by the State Drug Administration, with the approval number of 2018L03090. According to the drug registration procedure, Hualan Genetic Engineering Co., Ltd will organize and implement clinical trials as soon as possible in accordance with the requirements of the national drug clinical trials after obtaining the approval documents for the above drug clinical trials, and will apply the product production approval documents and GMP certificate after completing the clinical trials. Indication of Recombinant Anti-RANKL Whole Human Monoclonal Antibody Injection (Dnosumab): Osteoporosis, including the treatment of osteoporosis in postmenopausal women.

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TAG:  Bio-pharmaceuticals, Dnosumab, Hualan Bio, Anti-RANKL Monoclonal Antibody