Su-Jae Lee, CEO of FNCT BIOTECH
FB-101, which is developed by FNCT BIOTECH, can fundamentally inhibit the onset of the disease and enable reversible treatment
FB-101 also has a long half-life, which reduces the number of doses needed and improves patient convenience
“My desire to translate ideas from the lab into real-world therapeutics for patients led me to start a startup. As president and chief scientific officer (CSO), I am currently leading R&D and corporate operations simultaneously to grow FNCT BIOTECH into a global biopharmaceutical company.”
FNCT BIOTECH’s flagship product is ‘FB-101’, a new drug based on a human monoclonal antibody. The drug targets idiopathic pulmonary fibrosis (IPF), a deadly disease with a mortality rate of up to 50% within five years of diagnosis. However, no treatment has dramatically improved survival rates thus far.
Currently, there are only two FDA-approved drugs, Roche’s pirfenidone (Esbriet) and Boehringer Ingelheim’s nintedanib (Ofev), which only slow disease progression by delaying the decline in forced vital capacity (FVC). Furthermore, these drugs often have severe side effects, causing approximately half of patients to discontinue treatment. Thus, they are more effective at slowing disease progression than providing an ultimate cure.
“Existing treatments simply slow the progression of the disease. However, we aim to reverse the disease itself and provide patients with a new lease on life. What sets FB-101 apart is its ability to fundamentally inhibit the disease and offer reversible treatment. In particular, FB-101 has the advantage of reducing the number of doses due to its long half-life, which increases patient convenience.”
FB-101 is directed at a novel target: Granulocyte Colony-Stimulating Factor 3 (CSF3), which regulates the onset and progression of fibrosis. While CSF3 is primarily known as a factor involved in hematopoietic cell physiology and immune response regulation, our recent studies have indicated that it is a super-regulator of fibrosis development, including pulmonary fibrosis.
It acts as an upstream factor in the activation of the TGF-β pathway, a key driver of fibrosis. In other words, overactivation of CSF3 signaling leads to amplified activation of TGF-β. This, in turn, triggers collagen deposition, fibroblast activity, and tissue stiffening, accelerating IPF progression. While previously developed drugs have focused on TGF-β downstream pathways or collagen degradation, FB-101 has the potential to provide radical, reversible treatment by blocking CSF3 itself, thereby preventing TGF-β amplification.
Since its founding, FNCT BIOTECH has been targeting the global market. The company is currently discussing joint research with global pharmaceutical companies and pursuing a business strategy centered on out-licensing. FNCT BIOTECH is not limited to Korean research results but rather aims for partnerships and technology transfers that are common in the global market.
FNCT BIOTECH secured approximately 6.87 billion won in its Series A investment round, which concluded in June 2025. Based on this funding, the company is now actively advancing pharmacology testing of the antibody and the CMC (chemistry, manufacturing and controls) development process. The company is preparing for a Series B investment and accelerating efforts to raise funds for R&D and clinical trials.
Regarding future plans, Lee stated, “Our short-term goal is to attract additional investment, secure stable R&D funding, and enter clinical trials for FB-101. In the mid- to long-term, we aim to establish strategic partnerships with global pharmaceutical companies and grow into a global leader in fibrosis and cancer therapeutics.”
Founded: November 2021
Main business: antibody-based new drug development
Achievements: Selected as a KHIDI-AMGEN Golden Ticket 2024; Selected for the Startup Scale-up Package in May 2025; Selected as a candidate project for the National New Drug Development Project in October 2024; Selected as a global startup team for the Bio I-Core Project in January 2024; Selected for the public-private partnership to foster startup discovery in November 2022; Selected and graduated from the Tech Incubator Program for Startups (TIPS) of the Ministry of SMEs and Startups in July 2022; Selected as a leading project for the National New Drug Development Project in May 2022; Registered 6 patents; Filed 23 patent applications
reporter jinho lee
jinho2323@hankyung.com
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