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 simultaneously, thereby treating and preventing immune-related diseases.

1. Completed a phase I clinical trial in the US
2. Greenlighted to proceed with phase II clinical trials in severe asthma by the US FDA
3. A phase II clinical trial in severe asthma in Taiwan is ongoing
4. A phase II clinical trial for chronic kidney diseases with a high risk of cardiovascular diseases 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, FB704A is unlikely to cause infusion reactions, injection site reactions, rates of serious infections, or cancer progression. Besides, it has mild side effects on the hematopoietic system and vital organs (liver, lung, or kidney).

1. 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. Globally, about 110 million people suffer from asthma , and about 5% of them are severe asthma cases, meaning there are about 5.5 million patients who have severe asthma . Patients with severe asthma tend to have recurrent episodes, which result in substantial medical expenses. 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, an unmet medical need, may reach tens of billions of US dollars.
2. Over 800 million people worldwide suffer from chronic kidney disease (CKD), and this number continues to grow. Data Bridge Market Research analysis shows that the CKD market was valued at $13.22 billion in 2022 and is expected to grow to $18.8 billion by 2030, with a projected annual compound growth rate of 4.5% during the forecast period. Kidney damage is associated with chronic inflammation, a key driver of atherosclerotic cardiovascular disease. Despite following guideline-recommended management of cardiovascular risk factors, the high risk of cardiovascular events persists in CKD patients, affecting 50% of the CKD population. The small molecule drug Farxiga® (dapagliflozin), the first FDA-approved SGLT2 inhibitor for treating CKD in 2021, has no biologics approved to reduce cardiovascular risk. According to SVB Securities, Farxiga achieved quarterly sales of $1 billion for the first time in the first three months of 2022, a 67% year-on-year increase, far exceeding Wall Street's expectation of 20%, indicating that chronic kidney disease with a high risk of cardiovascular diseases is a potential medical market.
3. 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.