FB704A

Indications

Severe asthma (with high neutrophils), autoimmune diseases, i.e. rheumatoid arthritis, and systemic sclerosis

Mechanism of Action

FB704A can neutralize IL-6 specifically and inhibit IL-6/IL-6R classic- and trans-signaling simultaneously, thereby treating and preventing immune-related diseases.

Current Status

  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

Product Advantages

  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).

Market Potentials

  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. 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.

R&D Progress

FB704A-en

Ongoing
Completed
Research Code Therapeutic Area Indication Development Region Pre-Clinical Phase I Phase II Phase III NDA Market More
FB704A
Immunology Severe Asthma
Taiwan