Amgen's US$4 billion monoclonal antibody is in crisis? This new domestic Class 2 drug is here

　　Pharmaceutical Network October 31, October 29, Kun Pharmaceutical Group announced that the company and Shanghai Kunheng application for a recombination of anti-RANKL all-human single-clone antibody injection of drugs clinical trial application has been accepted by the State Drug Administration It is reported that the new drug to the United States Amin company's monoclonal antibody drug tinno monoantigen as an imitation target, indications for high-risk fracture risk of menopausal female osteoporosis Table 1: The basic situation of the new drug accepted
(source: listed company announcement) announcement mentioned that the new drug to the United States Anjin company has been listed abroad monoclonal antibody drug tinno monoantigen as an imitation target, the development of amino acid sequence and tinnitus is completely consistent with biological products class 2 new drugs, indications for high risk of fracture stoidal osteoporosis Chart 1: Tino single anti-global sales (source: Minet multi-national listed company sales database) According to Minet data, in 2018, The global sales of Sino-Mono-Anti-2018 exceeded $4 billion, of which sales for the treatment of osteoporosis reached $2.291 billion, a growth rate of 16.4%; In May 2019, Amgen's Tinnomono-resistance (known as dishudan resistance) was approved by the State Drug Administration for treatment of non-surgically removed or surgically recitaled adults and adolescents with severe functional impairment that may lead to severe dysfunction, but the current tinnotatoum resistance to postmenopausal women with increased risk of fractures has not been listed in China the current clinical treatment program of osteoporosis in China mainly to bisphosphonates, estrogen, estrogen receptor regulators and calcite-reducing traditional small molecules, hormones and peptide drugs, tinnoprosy as the first single-clone antibody based on THE successful development of RANKL, innovative in clinical applications Based on the RANKL target development of tnobutiadin is the only successful market in the field of osteoporosis in recent years, the clinical scope of application is wide, because of its less , high safety, easy to use, better patient compliance and so on, Tinolmono resistance in foreign (UK and UK) the main guidelines have occupied an important therapeutic position in addition to the , Kun Pharmaceutical Group said that the development of the new drug coincides with the strategic layout currently under way by the Group in the field of biopharmaceuticals, while dinno monoresist as a potential heavyweight product for domestic osteoporosis treatment, and is highly consistent with the current major coverage areas of Baker Norton, a subsidiary of Kun Pharmaceutical Group, and is expected to strengthen Baker Norton's dominant position in the field of orthopaedics in the future sources: Internet database, announcement of listed companies