Biotech submits clinical applications for Skuchiu monobial-like drugs

On December 7th, the Drug Review Center (CDE) of the State Drug Administration of China announced that Baiotai Bio had submitted an application for clinical trial of Scucciyu single anti-injection fluid in category 3.3 according to the registration classification, and was accepted.
Skuchiyu monoantigen is a biologic agent targeting IL-17A, and the original product, secukinumab (English trade name: Cosentyx), has been approved in China for moderate to severe plaque psoriasis (PsO) and strong straight spina boutitis (AS).
screenshot source: CDE official website query Baiotai biological official website can be known, it has a target IL-17A in the field of autoimmune diseases products, research and development code-named BAT2306.
according to the company's earlier announcement, the preclinical antibody drug BAT2306 is its focus on promoting the next generation of biosypolytic drugs, the project will be declared in 2019 to 2021.
, it is assumed that the biosynthetic drug BAT2306 was submitted in category 3.3.
CDE website, no other companies have yet submitted applications in China for clinical trials of Skuchiyu mono-anti-biosynthic drugs, the first of which is bio-10otyme.
from the mechanism of action, IL-17A is the core pathogenic factor involved in inflammation and disease progression such as psoriasis, psoriasis arthritis, strong straight spina blanditis, nr-axSpA, etc.
highlight of Scuciu's monoantigen is that it specificly binds to IL-17A from any source without impeding the proper functioning of other cytokines.
precise targeting and the high safety of the entire human source, the drug demonstrates fast, long-lasting efficacy and safety in the treatment of a variety of autoimmune diseases.
From Novartis, Cosentyx is the first all-human biologic agent that directly inhibits IL-17A, according to public data released by the company.
Currently, the product has been marketed in many countries and regions, including the European Union countries and the United States, and has been approved for moderate to severe plaque psoriasis, psoriasis arthritis (PsA), strong straight spina blingitis, and radiologically negative spinal spinal arthritis (nr-axSpA), benefiting more than 300,000 patients worldwide.
, the autoimmune disease drug Cosentyx is the main engine of growth for its innovative drug business, according to Novartic's 2019 results.
the product's full-year 2019 revenue of more than $3.5 billion, the global clinical demand for the drug is great.
founded in 2003, 100 Otay Bio is dedicated to the development of a new generation of antibody drugs to treat major life-threatening diseases, focusing on cancer, autoimmune diseases, cardiovascular diseases, etc.
, the company has established more than 20 research and development pipelines in the research and development of products.
Among them, the first commercial product of BioPYOTA(Adamo monobial-like drugs) has been harvested 5 adaptations, covering strong spina bifida, rheumatoid arthritis, psoriasis, Crohn's disease and other autoimmune diseases.
plateboard glycoprotein II.b/III.a subject antagonist BAT2094 (Batefeiban) has submitted a new drug listing application in China.
application for the listing of BAT1706 (Beval Pearl Single Biosynthic Drug) has also been submitted in China, the United States, Europe and other countries and regions.
: s1. CDE.Retrieved Dec 7,2020, from s.2. Novartis Cosentyx® gains four points in with EU first-in-class approval in axial spondyloarthritis. Retrieved April 29, 2020, from the | can be ® strong straight spinalitis adaptation was approved. Retrieved April 28, 2020, from Novarma Group Official MicroSource:Pharmaceutical Mission Hills