Pulmonary fibrosis
ETUARY®  (Pirfenidone)
国药准字H20133376
Pirfenidone is currently one of the two types of IPF drugs approved in China. ETUARY®, an IPF drug that we manufacture and sell in China, is the first National Class 1.1 Drug approved in China for mild to moderate IPF and is included in National Reimbursement Drug List for the treatment of IPF.

Indication: the treatment of mild to moderate IPF.
Disease Areas
Pulmonary fibrosis
Liver fibrosis
Renal fibrosis
Other Areas

IPF is a rare disease which is a specific form of life-threatening, chronic and progressive fibrosing interstitial pneumonia, occurring primarily in the elderly and limited to lungs. It is characterized by progressive worsening of dyspnea and lung function and is associated with a poor prognosis. IPF’s damages to lungs are irreversible.


According to Frost & Sullivan, the five-year survival rate is of patients diagnosed with IPF within one year is about 66%, while 18% for patients with a fibrosis incubation period of more than four years. However, in practice, it is often difficult for IPF patients to receive timely medical treatment since IPF at early stage is easily misdiagnosed as less severe diseases such as interstitial pneumonia. As a result, IPF patients have a medium survival period of only two to three years after diagnosis.


ETUARY®  |  Pirfenidone
国药准字H20133376
Indication: The treatment of mild to moderate IPF

Liver fibrosis is a reversible over-repair reaction of liver tissue injury and is a main pathological change in the progression from chronic liver disease to cirrhosis. Liver fibrosis is a pathological change in most chronic liver diseases, such as chronic hepatitis B (“CHB”), chronic hepatitis C (“CHC”), alcoholic liver disease (“ALD”), and nonalcoholic fatty liver disease (“NAFLD”) and others. Liver fibrosis can be caused by not only chronic liver diseases, but also etiologies such as genetic and metabolic diseases. In 2020, the population of liver fibrosis associated with CHB accounted for 46.7% of the total liver fibrosis patients in China.


F351 is in phase III clinical trial. To date, F351 is the most clinically advanced drug for the treatment of liver fibrosis in both China and globally to effectively reverse the fibrosis process. The phase II clinical result of F351 presents favorable safety and efficacy profile for liver fibrosis associated with CHB. It reverses liver fibrosis by inhibiting hepatic stellate cell proliferation while simultaneously blocking the TGF-signaling pathway, both of which play important roles in the liver fibrosis associated with CHB. Due to the severity of the disease and the clinical trial progress of F351 comparing with the currently available treatments, F351 was granted a Breakthrough Therapy designation by CDE in March 2021 and we commenced the patient enrollment for its phase III clinical trial in January 2022. 

Renal fibrosis is the most common tissue and pathological changes that accompany chronic kidney diseases such as diabetes, high blood pressure and bacterial infections, and it is an important pathological feature of renal damages. fibrosis is a direct consequence of the kidney’s limited capacity to regenerate after injury and is characterized by an excessive accumulation and deposition of extracellular matrix. Renal scarring results in a progressive loss of renal function, ultimately leading to end-stage renal failure. The current treatments for renal fibrosis include general treatment, etiological treatment, anti-fibrosis treatment and non-drug treatment.


Diabetic kidney disease (“DKD”) is a chronic kidney disease (“CKD”) caused by diabetes mellitus. Around 19% of CKD patients will develop fibrosis symptoms. As one of the serious complications of diabetes, DKD in China is characterized by high prevalence, great harm, low awareness rate, low treatment rate and low control rate. In 2020, there were 133.1 million patients with diabetes mellitus, and 22.3% of these patients are accompanied with DKD.

COPD


Chronic obstructive pulmonary disease (“COPD”) is a chronic inflammatory lung disease which causes obstructed air flow from the lungs. It consists of three separate illnesses: emphysema, chronic bronchitis, and chronic obstructive asthma. COPD causes the destruction of barriers between alveoli inside lungs, causing airways getting swollen and clogged with mucus. In most cases, COPD develops very slowly and symptoms may come over years before being diagnosed. COPD has become the third most common chronic disease in China after hypertension and diabetes.


PAH


Pulmonary arterial hypertension (“PAH”) is a rare disease and a progressive, lifethreatening disorder characterized by increased pressure in the pulmonary arteries that carry blood from the heart to the lungs. PAH occurs when the pulmonary arteries thicken or grow rigid. This restricts blood flow through the lungs, causing pulmonary hypertension, and making the heart work harder to pump blood to the lung circulation. The increased pressure strains the heart, which can limit physical activity, eventually resulting in right ventricular heart failure and reduced life expectancy. Severe shortness of breath is the most frequent initial symptom of PAH, followed by fatigue, weakness, chest pains, dizziness, and fainting. These can make it difficult for patients to undertake even mild exercise, especially at later stages of the disease. Patients can also experience peripheral edema, swelling of the ankles and legs. This may also include the face and abdomen in more extreme cases. PAH may also cause a cough, sometimes with hemoptysis. In its advanced stages, severe PAH patients develop symptom of heart failure and cyanosis, or a bluish tinge to the skin due to abnormally low levels of oxygen.


Acute/Acute-on-Chronic Liver Failure


Liver failure is severe liver damage caused by a variety of factors, resulting in severe impairment or loss of synthesis, detoxification, metabolism and biotransformation functions. Liver failure follows with syndromes of jaundice, coagulation dysfunction, hepatorenal syndrome, hepatic encephalopathy and ascites. The causes of liver failure are complex and include hepatitis viruses (especially hepatitis B virus) and other viruses, drugs, hepatotoxic substances (e.g., alcohol, chemical agents, etc.), bacteria, and parasites. In China, HBV, drugs and hepatotoxic substances are the most common causes of liver failure. Liver failure can be divided into acute liver failure, acute-on-chronic liver failure, sub-acute liver failure, sub-acute-on-chronic liver failure and chronic liver failure according to the severity, symptom, causation and frequency of the onset of a certain liver failure.

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