China-based Mabwell Bioscience (SHA: 688062) has announced the establishment of a licensing agreement with the Russian pharmaceutical company Binnopharm Group, focused on 9MW0113, 9MW0321, and 9MW0311, Mabwell’s biosimilar versions of adalimumab and denosumab. Binnopharm will have exclusive rights to develop, register, manufacture, and market the drugs with a status of a local product in Russia and Eurasian Economic Union countries. Financial details of the agreement were not disclosed.
Biosimilar Products and Indications
Mabwell’s 9MW0113 (Junmaikang), a biosimilar of Humira, has been approved in China for eight indications: rheumatoid arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children, and Crohn’s disease in children.
9MW0321 is a proposed biosimilar of Xgeva (denosumab). Xgeva was approved for the indications of the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
9MW0311 is a proposed biosimilar of Prolia (denosumab). Prolia was approved for the indications of the treatment of osteoporosis in women who have undergone menopause who have an increased risk for fractures or who cannot take or did not respond to other medication treatments for osteoporosis; treatment of men who have an increased risk for fractures or who cannot take or did not respond to other medication treatments for osteoporosis; treatment of osteoporosis that is caused by corticosteroid medications in men and women who will be taking corticosteroid medications for at least six months and have an increased risk for fractures, or who cannot take or did not respond to other medication treatments for osteoporosis; treatment of bone loss in men who are being treated for prostate cancer with certain medications that cause bone loss; and treatment of bone loss in women with breast cancer who are receiving certain medications that increase their risk for fractures.
Binnopharm Group Profile
Binnopharm Group was founded through the consolidation of pharmaceutical assets of Sistema PJSFC (LSE: SSA, MOEX: AFKS) and is a top-five pharmaceutical company in Russia (according to AlphaRM) with a turnover of more than 25 billion Rubles. The firm is Russia’s largest producer of generic medicines and the leading manufacturer of products intended for the Commonwealth of Independent States (CIS) markets. In 2020, Binnopharm became the first company in the world to manufacture a Covid-19 vaccine.
Mabwell Bioscience Profile
Mabwell Bio is focused on the development of monoclonal antibodies, long-acting recombinant proteins, and other macromolecules, with a product pipeline consisting of upwards of 30 products and covering oncology, autoimmune disease, anti-infection, and eye diseases.-Fineline Info & Tech
