FB704A
INDICATION
Severe neutrophilic asthma, autoimmune diseases, i.e. rheumatoid arthritis, systemic sclerosis.
MECHANISM OF ACTION
FB704A is a fully human monoclonal antibody that inhibits IL-6/IL-6R signaling pathway by neutralizing IL-6. IL-6 pathway has emerged as a pivotal pathway involved in immune regulation in many cancers and immune disorders.
CURRENT STATUS
1. Completion of phase 1 study in US.
2. US Phase 2 IND approval.
3. Phase 2 severe neutrophilic asthma recruiting in Taiwan.
EFFICACY
1. Fully human antibody, lower immunotoxicity and better safety.
2. It has good biological activity for inhibiting inflammation, and in vitro experiments show that it is superior to Tocilizumab, a marketed drug with a similar mechanism of action.
3. Antibody specificity is high, and side effects such as infusion reaction, injection site reaction, serious infection rate, cancer exacerbation rate, impact on hematopoietic system and vital organs (liver, lung, kidney) are very low.
MARKET POTENTIAL
  • FB704A may reduce Th1, Th2 and Th17 inflammation as well as airway hyper-responsiveness. The current recruiting severe asthma trial is for treatment in patients with severe asthma who have higher neutrophil counts in sputum. Such subtype of severe asthma can’t be well controlled by current treatments and FB704A will explore the possibility of improving symptoms on these severe asthma patients. The global population affected by neutrophilic asthma is about 110 million people1. Severe asthma accounts for 5% 2of total asthma patients, so it is estimated that there will be 5.5 million severe neutrophilic asthma patients. Sever neutrophilic asthma is a refractory disease that causes huge medical expenditure and cannot be effectively controlled by drugs currently on the market. There remains no effective biologics approved for treating severe neutrophilic asthma, either. The role for IL-6 in the pathology of this disease shows that FB704A has the potential to fulfil the unmet medical need in severe neutrophilic asthma. The global biologics market for treatment in severe neutrophilic asthma is estimated to reach US$90 billion by multiplying patient number and the average annual cost of biologics treatment at US$16,4253.
  • Over-activation of IL-6/IL-6R signaling pathway is related to many diseases. FB704A will continue to explore the application of systemic inflammation-related diseases to increase product value.

Ref.

1. Source: Literature Review, Frost & Sullivan Analysis

2. European Respiratory Journal 2018 52: PA3918

3. The Potential American Market for Generic Biological Treatments and the Associated Cost Savings
http://www.sonecon.com/docs/studies/0208_GenericBiologicsStudy.pdf