The New Drug Application of Mabwell's Denosumab Injection Biosimilars 9MW0311 Was Accepted

Release time:Dec 22, 2021

December 22, 2021, Shanghai-Mabwell, an innovative biopharmaceutical company with the whole industrial chain, announced today that the National Medical Products Administration (NMPA) has accepted the New Drug Application of its Denosumab biosimilar (R&D code: 9MW0311), which is developed by its wholly-owned subsidiary T-mab.

9MW0311, a biosimilar of Prolia® (Denosumab), is a recombinant fully human anti-RANKL monoclonal antibody injection. The mechanism of action is that after the combination of RANKL, it can prevent the activation of RANK, inhibit the formation, activation and survival of osteoclasts, and reduce bone resorption, so as to eliminate the symptoms of systemic osteoporosis or local osteolysis.

Professor Xia Weibo, Director of Endocrinology Department, Peking Union Medical College Hospital, said: "Denosumab has been shown to significantly increase bone mineral density and improve the osteoporosis of patients in clinical practice. The clinical results showed that 9MW0311 is effective, safe and reliable in patients with osteoporosis. We believe that Denosumab biosimilars can help more patients improve their quality of life.”

Dr. Liu Datao, co-founder and CEO of Mabwell, said: "Another product received NMPA acceptance for new drug application, 9MW0311 will be able to meet global clinical therapeutic demands of osteoporosis. We provide high-quality biologics for patients with our unremitting efforts."

About osteoporosis in postmenopausal women

There are more than 200 million patients with osteoporosis worldwide. According to the results of the first epidemiological survey of osteoporosis in China published by the National Health Commission in 2018, osteoporosis has become a critical health problem for the middle-aged and elderly people in China. The prevalence of osteoporosis among women over 50 years old is 32.1%, and that of women over 65 years old is 51.6%. According to the 2012 statistical yearbook, China's current elderly population aged 50 and over has reached 338 million, which means that there are more than 50 million osteoporosis patients in China's elderly population aged 50 and over. It is estimated that by 2025, this number will exceed 150 million. Osteoporotic fracture (or fragility fracture) is a serious consequence of osteoporosis and does great harm. It is one of the main causes of disability and death in elderly patients. Within 1 year after hip fracture, 20% of patients will die of various complications, about 50% of patients will be disabled, and their quality of life will decline significantly. Moreover, the medical treatment and care of osteoporosis and fracture need to invest a lot of human, material and financial resources, resulting in a heavy burden on families and society.