Regdanvimab is under clinical development by Celltrion and currently in Phase II for Coronavirus Disease 2019 (COVID-19). According to GlobalData, Phase II drugs for Coronavirus Disease 2019 (COVID-19) have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Regdanvimab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Regdanvimab overview
Regdanvimab (Regkirona) is a human IgG1 monoclonal antibody. It is formulated as solution or concentrate for solution for intravenous route of administration. Regkirona is indicated for the treatment of adult patients aged 50 years and over, or with at least one underlying medical condition, with mild symptoms of coronavirus disease (COVID-19), and adult patients with moderate symptoms of coronavirus disease and who are at high risk of progressing to severe COVID-19..
Regdanvimab (CTP-59) is under development for the treatment of coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is administered through intravenous and inhalational route. It targets spike protein of SARS-CoV-2.
Celltrion overview
Celltrion is a biopharmaceutical company that focuses on the research, development, and manufacture of biosimilars and novel biopharmaceuticals. The company offers monoclonal antibodies for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn’s disease, psoriatic arthritis, and psoriasis. Its pipeline portfolio spans monoclonal antibody biosimilars for the treatment of rheumatoid arthritis; colorectal cancer; and respiratory disease; and antibody biologics and vaccines for infectious diseases such as hepatitis B, influenza, rabies, breast cancer, and seasonal influenza. Celltrion develops drugs by using its bioengineering and mammalian cell-culture technology. The company also carries out contract manufacturing of biosimilars. It has an operational presence in Korea, Russia, the UK, and the US. Celltrion is headquartered in Incheon, South Korea.
For a complete picture of Regdanvimab’s drug-specific PTSR and LoA scores, buy the report here.
Data Insights
From
The gold standard of business intelligence.
Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.
GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
