Over 1 billion varieties! Consistency evaluation of zoledronic acid injection

On January 17, Kelun pharmaceutical announced that its zoledronic acid injection had been approved for listing by the State Food and Drug Administration and was deemed to have passed the consistency evaluation Zoledronic acid injection (100ml: 4mg) is a bisphosphonate drug developed by Novartis It was first approved in the European Union in 2001, and then approved in the United States, Japan, etc for the treatment of hypercalcemia caused by malignant tumors, and combined with standard anti-tumor drugs for the treatment of bone damage in solid tumor patients with bone metastasis and multiple myeloma patients Bone metastasis is a common complication of malignant tumor, which causes a series of bone related events such as bone pain, pathological fracture, hypercalcemia and so on, which seriously affects the quality of life of patients and significantly shortens the survival time of patients The clinical treatment is based on bone improvement drugs, combined with conventional anti-tumor treatment and symptomatic support treatment Bisphosphonates are commonly used in bone improvement Zoledronic acid is the third generation of bisphosphonate Compared with the first and second generation, zoledronic acid has a stronger anti bone absorption effect and a better clinical effect in reducing the incidence of bone related events It is the only bisphosphonate drug approved for different types of solid tumor bone metastasis and multiple myeloma bone damage in the world At present, zoledronic acid has been recommended by NCCN clinical practice guidelines for multiple myeloma (2020.v2), CSCO breast cancer diagnosis and treatment guidelines 2018v1 and other authoritative guidelines and experts at home and abroad Colen pharmaceutical zoledronic acid injection (100ml: 4mg) is the first approved infusion dosage form in China Compared with the existing powder injection and water injection type, colen pharmaceutical has the advantages of direct intravenous infusion, effective prevention of mismatching and preparation pollution, improvement of medication safety and medical efficiency In 2018, zoledronic acid powder and water injection sold 1.24 billion yuan in China Original title: