Disease Research Areas

Interstitial lung disease (ILD) affects lung function by thickening the lung interstitium due to excessive production and accumulation of collagen, resulting in a wide variety of symptoms.

The interstitium is a lacy network of body tissue that supports the alveoli, which are like small grape-like sacs, and contains capillaries that facilitate gas exchange between blood and air. The potential causes of interstitial lung disease are inflammation, scarring, and edema.

There are many types of interstitial lung disease, the most common of which are:

• Infections caused by bacteria, viruses, and infectious bacteria
• Idiopathic pulmonary fibrosis (IPF) with an unknown cause
• Nonspecific interstitial pneumonia (NSIP) associated with autoimmune conditions such as rheumatoid arthritis (RA) and scleroderma (SD), and unspecified interstitial fibrosis pneumonia is also classified as interstitial pneumonia. In some cases, interstitial lung disease associated with connective tissue disease (CTD-ILD) is also classified as this.
The disease and progression process are related to the TGF-beta (fibroblast transformation and promoting factor), VEGF (vascular endothelial growth factor), PDGF (platelet-derived growth factor), and FGF (fibroblast growth factor) signaling pathways, but the intracellular mechanism of collagen overproduction and accumulation remains unclear.

Before pirfenidone was approved for idiopathic pulmonary fibrosis in China, the United States, Europe, and Japan, steroids were the only treatment, but their effectiveness was questionable, and they were accompanied by serious side effects.

Currently, the Company is continuing development for the expansion of indications for pirfenidone (Etuary®] [Chinese: 艾思瑞]) beyond idiopathic pulmonary fibrosis, particularly for interstitial lung disease associated with connective tissue diseases in China.

Human liver plays an important role in fat metabolism, carbohydrate metabolism, and blood purification. Liver disease is caused by various factors, including hepatitis B and C viruses, excessive alcohol intake, obesity, and autoimmune diseases. In developing countries, hepatitis B virus is the main cause, while other factors are the main causes in developed countries.

It is estimated that up to 10% of the population in China has been infected with hepatitis B virus. In addition, with the rapid economic development in recent years, there has been a significant increase in liver disease caused by obesity.

Many patients with liver fibrosis do not show specific symptoms, but liver function gradually declines over several years as fibrosis progresses. Even if symptoms improve with successful treatment with antiviral drugs, liver fibrosis may progress for several years.

The most common tests to examine liver function are liver enzyme tests such as ALT (GPT) and AST (GOT). Additionally, liver biopsy is the most accurate method to determine the extent of fibrosis.

Fibrosis may progress to cirrhosis without being detected by tests. During the cirrhosis stage, liver function declines rapidly and may lead to acute liver failure (ACLF), which increases the morbidity and mortality of patients. Currently, liver transplantation is the only treatment option, but it is expensive and has a shortage of donors. Furthermore, the risk of hepatitis B and C infection in transplanted livers needs to be considered.

Chronic kidney disease (CKD) is a condition without noticeable symptoms, where kidney function gradually deteriorates over many years. Patients with hypertension and diabetes are at higher risk of developing hypertensive nephrosclerosis (HN) and diabetic nephropathy (DN). Glomerulonephritis is also one of the causes of CKD.

CKD is diagnosed by an increase in blood creatinine levels when the condition has progressed. This indicates a decrease in the glomerular filtration rate (GFR) of the kidneys, meaning that the kidneys are no longer able to properly excrete waste products.

CKD is classified into 5 stages according to its severity.

Currently, the standard treatment for CKD patients is ACE inhibitors (Angiotensin-Converting Enzyme inhibitors) and ARBs (Angiotensin II Receptor Blockers), but the disease may still progress despite these treatments. Stage 5 is called end-stage renal failure, and expensive dialysis treatments or kidney transplantations are the best treatment options.

Regardless of the cause, CKD is characterized by the progression of renal fibrosis, which is the excessive accumulation of collagen. This manifests as glomerular sclerosis or tubulointerstitial fibrosis. Scientific research has revealed that the TGF-βsignaling pathway is involved in the renal fibrosis process.

Our group’s ETUARY® (Chinese: 艾思瑞) and F351 are both inhibitors of the TGF-β signaling pathway. Their effectiveness against pulmonary, hepatic, and renal fibrosis has been confirmed in various animal experiments, representing a new potential therapeutic approach for CKD treatment.

Cancer can be broadly categorized into two types: "solid tumors" and "hematologic malignancies." Solid tumors form masses in organs or tissues and include lung cancer, breast cancer, colorectal cancer, and prostate cancer. In contrast, hematologic malignancies arise in the bone marrow or lymphatic system, affecting blood or immune cells, with leukemia and multiple myeloma being representative examples.
Although recent advancements in treatments such as molecular targeted therapies have been made for solid tumors, many cases still face challenges such as specific protein abnormalities and drug resistance. As a result, there is a strong need for the development of therapies with novel mechanisms of action and greater selectivity.
Cullgen's drug discovery technology utilizes targeted protein degraders to suppress cancer cell proliferation signals and achieve antitumor effects. This degradation-based approach is gaining attention because, unlike conventional inhibitors, it directly degrades target proteins, potentially overcoming drug resistance and long-term side effects.
Cullgen is currently conducting a Phase 1 clinical trial in solid tumors using its orally administered TRK (tropomyosin receptor kinase) inhibitor candidate, CG001419, and is aiming to expand its application to a broader range of cancer types and conditions.
In hematologic malignancies, acute myeloid leukemia (AML) is one of the most common subtypes in adults. It is characterized by the abnormal proliferation of immature myeloid cells and impaired differentiation into normal blood cells.
Cullgen is developing CG009301, a novel drug candidate that selectively degrades GSPT1, a protein essential for protein translation in rapidly proliferating leukemia cells. Degradation of GSPT1 is expected to induce cell death in cancer cells.
The Phase 1 clinical trial for CG009301 began in China in April 2025.

Opioids, such as morphine, are known for their strong analgesic effects but also for their high risk of dependence. Current treatment guidelines recommend limiting the use of opioids and instead encourage the use of NSAIDs (nonsteroidal anti-inflammatory drugs), although these alternatives are often insufficient for adequate pain control.
In the past 20 years, only one non-NSAID, non-opioid drug has been approved by the U.S. FDA for acute pain treatment.
Cullgen is also expanding the use of CG001419 to the pain management field and initiated a Phase 1 trial in 2025 targeting acute and chronic postoperative pain with a non-opioid approach.
CG001419 possesses a novel mechanism of action and high selectivity, distinct from TRK inhibitors and anti-NGF antibodies. It may overcome the challenges related to side effects and limited efficacy that have been seen in pain treatments involving TRK inhibitors.