SCIENCE

Severe asthma (with high neutrophils), autoimmune diseases, i.e. rheumatoid arthritis, systemic sclerosis, and chronic kidney disease induced cardiovascular complications

FB704A can neutralize IL-6 specifically and inhibit IL-6/IL-6R classic- and trans-signaling at the same time, thereby inhibiting inflammatory responses.

1. Completed a phase 1 clinical trial in the US
2. Greenlighted to proceed with phase 2 clinical trials in severe asthma by the US FDA
3. A phase 2 clinical trial in severe asthma in Taiwan is ongoing

1. Fully human antibody, low immunotoxicity, and high safety
2. With high biological activity in inhibiting inflammation. In vitro studies showed superiority over commercially available drugs under a similar mechanism.
3. With high antibody specificity. The chances of inducing such side effects as an infusion reaction, an injection site reaction, severe infection, cancer progression, and an undesirable effect on the hematopoietic system or an important organ (e.g., liver, lungs, or kidney) are low.

• FB704A (anti-IL-6 Ab) can reduce bronchial hyperresponsiveness as well as the Th1, Th2, and Th17 inflammatory responses of the respiratory tract, inhibit IL-6 classic- and trans-signaling pathways, and therefore have a chance of improving the symptoms of severe asthma (with high neutrophils) and severe mixed-granulocytic asthma. Globally, about 110 million people suffer from asthma (with high neutrophils)¹, and about 5% of them are severe asthma cases², meaning there are about 5.5 million patients suffering from severe asthma(with high neutrophils). The patients with severe asthma(with high neutrophils) tend to have recurrent episodes, which result in huge medical expenses, and yet commercially available drugs are still unable to control the disease effectively. It is estimated that the global market of biologics for treating severe asthma, which is an unmet medical need, may reach tens of billions of US dollars³.
• Many diseases are related to over-activated IL-6/IL-6R signaling. We will continue exploring the application of FB704A to systemic inflammation-related diseases in order to maximize the value of the product.

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