At a time when the dividend of generics has disappearedCSPC PharmaceuticalAlso began to embark on the road of innovation.
On February 3, according to the official website of CDE, the clinical application of Shanghai Xinshi Biomedical Co., Ltd. (hereinafter referred to as "Xinshi Biology") for NBL-012 injection has been accepted by the FDA, and the adaptation to the disease has not yet been announced.
Xinshi Biology is a subsidiary of CSPC Pharmaceutical. According to CSPC Pharmaceutical's announcement, NBL-012 is IL-23p19 antibody and is one of the IL-23 inhibitors.
IL-23 is a pro-inflammatory cytokine composed of p19 and p40 subunits. Subunits are the smallest covalent units that make up the fourth-order structure of proteins, and generally each subunit has a corresponding biochemical function.
Therefore, the inhibition of IL-23 subunit can inhibit the activity of IL-23 and achieve the purpose of treatment. NBL-012, which starts with p19 to inhibit the development of inflammatory factors, has previously applied for clinical application in the United States.
Clinically, the p19 subunit of IL-23 can target a variety of autoimmune diseases, including psoriasis, suppurative hidrosis and inflammatory bowel disease.
Whether it is psoriasis or enteritis, the global patient base is relatively large. In the case of psoriasis alone, about 23 per cent of the world's population suffers from psoriasis, and more than 6 million people suffer from psoriasis in China.
But at present, the therapeutic drugs for this kind of inflammation have not yet met the medical needs of the majority of patients. In recent years, IL-23 antibody has attracted more and more attention because of its good efficacy and safety.
Globally, there are many pharmaceutical companies involved in IL-23p19 antibody research and development, includingJohnson & Johnson，Abbvie，Eli Lilly and CoInternational giants such as Novartis have layout. Among them, Johnson & Johnson, Aberdeen, Novartis and other products have been approved to be listed on the market.
Domestic enterprises have also dabbled, but the progress has been slow. According to public information, among the fast-growing domestic pharmaceutical companiesKangzhe Pharmaceutical IndustryIL-23p19 antibody is in Ⅲ stage, and the indication is moderate to severe plaque psoriasis.INNOVENT BIOIL-23p19 antibody is in the first clinical stage.
Relatively speaking, in the domestic IL-23p19 antibody field, CSPC Pharmaceutical layout is not late. Of course, as for the success of research and development, it needs to be verified by follow-up clinical trials. From this point of view, the variables are still not small.
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