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6场半全场开奖历史:FB704A

6场半全场有多少奖金 www.dkpgas.com.cn

Indication
Rheumatoid arthritis (RA), cancer and cytokine storms, etc.
Product Advantages
1.Fully human antibody, low immunogenicity, and good safety.
2.Better anti-inflammation capability comparing with the marketed product Tocilizumab which targets IL-6R.
3.High specificity, the effect of causing infusion reactions, injection site reactions, severe infection rates, cancer exacerbations, and adverse effects on the hematopoietic system and vital organs (liver, lung, and kidney) and other side effects are low.
Status
Phase I clinical trial
Mechanism
Neutralizes IL-6 and then inhibits IL-6/IL-6R signaling
Potential Market
The drug market is expected to reach $15.2 billion in 2021.
  • FB704A is a fully human monoclonal antibody that inhibits IL-6/IL-6R signaling pathway by neutralizing IL-6. In many clinical trials, more than half of patients who have no response to anti-TNF-α have excellent response to anti IL-6/IL-6R related drugs, significantly increasing the market value of FB704A.
  • The biological function of FB704A has been verified in several vitro and in vivo studies, confirming its efficacy is no less than that of Tocilizumab. The current experimental results show that FB704A can effectively inhibit the secretion of pro-inflammatory cytokine, MCP and VEGF from synovial cells of rheumatoid arthritis patients, verifying that FB704A has the potential to treat rheumatoid arthritis. In addition, FB704A has undergone a series of cell-binding assay, cytokine release assay, hemolysis tests and other safety tests to confirm its safety. The 6-week repeated dose toxicology study conducted in rhesus monkeys indicates that FB704A has no drug-related adverse reactions.
  • In terms of indications, blocking IL-6/IL-6R response is associated with the treatment of many diseases, and clinical trials are also underway in cancer, dyscrasia, and blood diseases, so the potential market for FB704A is enormous. Overall, FB704A has core competitive advantages such as good safety, strong drug efficacy, and a wide range of therapeutic populations and indications.
  • Fountain Biopharma Inc. had completed the development of FB704A from screening to pre-clinical biological activity by using self-built key technologies and self-developed platforms, including: fully human derived phage library screening, affinity maturation, in vitro pharmacology activity confirmation, indication exploration, high-yield cell line screening, upstream 5L PD process optimization, downstream purification platform establishment, antibody physicochemical characterization analysis and functional analysis were established and verified.
  • FB704A also completed GMP scale production and pre-clinical toxicology study, and got the US FDA IND permission for Phase I study in February 2018. The Phase I study will be conducted in US.