Qilu Pharmaceutical Submits China's First Denosumab Biosimilar NDA for Bone Metastasis Treatment

On August 30, Qilu Pharmaceutical received an acceptance notice from the National Medical Products Administration (NMPA) for the marketing authorization application of its denosumab injection, marking China's first denosumab biosimilar.

Bone is a common metastatic site for malignant tumors, particularly malignant solid tumors such as breast, prostate, and lung cancers. Bone metastases occur in 65%–80% of breast and prostate cancers and 30%–40% of lung cancers. Bone metastasis often portends a decline in quality of life and shortened survival. The resulting skeletal-related events (SREs), including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and the suffering associated with related treatments, severely compromise patients' quality of life. While controlling the primary disease, proactive prevention and treatment of SREs secondary to bone metastasis are of paramount importance.

Denosumab Injection is an antibody that specifically targets the receptor activator of nuclear factor kappa-B ligand (RANK-L); by specifically binding to RANK-L, it inhibits the maturation, differentiation, and function of osteoclasts, thereby reducing bone resorption and destruction, and is considered superior to conventional bisphosphonate therapy in delaying or preventing the occurrence of skeletal-related events (SREs) in patients with bone metastases from malignant tumors.

Responsible Editor: Liuli

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