December 22, 2021, Shanghai-Mabwell, an innovative biopharmaceutical company with the whole industrial chain, announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application of its wholly-owned subsidiary T-mab's development drug Denosumab injection biosimilars (R&D Code: 9MW0321).

9MW0321 is a recombinant human anti RANKL monoclonal antibody injection. It can inhibit the activation of OPG/RANKL/RANK signal transduction pathway by binding with RANKL, so as to inhibit tumor growth and reduce bone damage. It is used to prevent bone related events in patients with solid tumor bone metastasis. Bone is the third common metastatic site of malignant tumor, and the clinical demand is very broad. Since the primary drug Denosumab injection XGEVA® has been marketed in China, two indications have been obtained for the prevention of bone-related events in patients with bone metastases from solid tumors and patients with multiple myeloma, as well as for the treatment of giant cell tumor of bone that may result in severe dysfunction due to unresectable or surgical resection. Its efficacy and safety are widely recognized.

In the clinical development stage, Mabwell took the primary drug Denosumab injection as the control, and carried out the comparative study on the Pharmacokinetics of 9MW0321 and Denosumab injection in healthy subjects and the comparative study on the effectiveness and safety in patients with solid tumor bone metastasis. Both of the 2 main comparative studies reached the main research endpoint.

Professor Jiang Zefei, Vice President and Secretary of Breast Oncology Department, Fifth Medical Center, General Hospital of Chinese Society of Clinical Oncology (CSCO), said, "We conducted 2 clinical studies with the primary drug Denosumab injection as the control, and obtained positive clinical trial results. The results of the comparison study between 9MW0321 and primary drug Denosumab in the prevention of bone-related events in patients with bone metastasis from solid tumors showed that there was no significant difference in urinary type I collagen cross-linked N-telopeptide (uNTx/uCr) corrected by urinary creatinine between the two groups, it is confirmed that the clinical equivalence of 9MW0321 to the primary drug. We believe that the marketing of Mabwell's Denosumab biosimilars will further reduce patient burden. "

Dr. Liu Datao, Co-founder and CEO of Mabwell, said, "I am pleased that Mabwell has received NMPA acceptance for new drug application for two products at the same time. The market space of drugs for the prevention and treatment of tumor bone metastasis is very broad. There is a huge unmet clinical demand at home and even around the world. As a biopharmaceutical company in the whole industry chain, Mabwell will accelerate the clinical research of products under research, accelerate the implementation of innovative achievements by relying on the advantages of commercial production, and provide patients with more new drug products with better quality and accessibility. "

About bone related events in patients with solid tumor bone metastasis

Malignant bone metastasis or metastatic bone disease is a common disease of advanced cancer. It is common in breast cancer, lung cancer, prostate cancer, multiple myeloma, and so on. It refers to the metastasis of malignant tumor to the bone through blood circulation or lymphatic system. Bone is the third most common metastatic site of malignant tumors, second only to lung and liver. The incidence of bone metastasis in breast cancer and prostate cancer is as high as 65%-75%, and the incidence of bone metastasis in lung cancer is 30%-40%. Malignant tumor bone metastasis often leads to serious bone lesions, including bone pain, pathological fracture, spinal cord compression, hypercalcemia and other Skeleton Related Events (SREs), which will greatly reduce the quality of life of tumor patients, in severe cases, it will lead to rapid deterioration and even death.