Senhwa Biosciences, Inc., a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with Biliary Tract Cancer.
Source:- Senhwa Biosciences, Inc.
In the US, approximately ~3,500 hospitalizations of Biliary tract cancer occur with an average incidence of ranges between 0.45 to 2 cases per 100,000 population per year. The incidence pool for Biliary tract cancer in the US is around 9.5K. Europe, it is estimated that every year, 12.5K new patients are diagnosed with Biliary tract cancer and incidence in Japan stands at around 4K patients. however, in China, the incidence number is quite high thus, poses significant public health questions.
Comprehensive insight on patient segmentation (Stage I, II, IIIA, IIIB & IVA, IVB ) has been provided into the epidemiology (Incidence and Prevalence) section of the Biliary tract cancer and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China. Drug utilization and analysis on the current clinical practice, KOL perspective on upcoming therapies, estimated TPP for pipeline assets, clinical characteristics upcoming therapies, and future treatment paradigm.
In terms of pharmacologic therapies, companies like AstraZeneca, Eli Lilly, Agios, Incyte, QED, Jiangsu HengRui, Bayer, Loxo Oncology, MEDIVIR, Bayer & Roche are in a race to build assets for BTC. companies have shifted their focus towards the development of targeted therapies. Expected launch of potential targeted therapies including potential FGFR gene fusions and somatic mutations in IDH 1/2 in Biliary tract cancer, PRKACA or PRKACB gene fusions in Biliary tract cancer, and ELF3 mutations in Biliary tract cancer/ampullary carcinoma. The market is expected to witness rapid growth with the launch of emerging targeted therapies, such as Ivosidenib (Agios), Pemigatinib (Incyte), Infigratinib (QED), Melphalan Hydrochloride (Delcath), Regorafenib (Bayer), Larotrectinib (Loxo), Entrectinib (Roche), Derazantinib (Basilea ), and Erdafitinib (J&J).
Thelansis is specialized in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area which includes both rare / ultra-rare and mainstream indication. Over the period of time, we have built a strong repository of 6,000+ Bio-pharma reports which essentially covers Epidemiology study and Market forecasting based on the KOL opinions. Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the major focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.
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