Etuary® (F647)

Etuary® (Pirfenidone) is an anti-inflammatory small-molecule compound designed to combat idiopathic pulmonary fibrosis (IPF), which is a lethal disease without therapy. There are nearly half a million IPF patients in China. The SARS virus and lung cancer radiation therapy are the two most common causes of ALI which may also lead to lung inflammation and fibrosis.

In May of 2005, Shanghai Genomics received a Clinical Trial Permit from the Chinese State Food and Drug Administration. Etuary® has completed two multi-center Phase II clinical studies for Idiopathic Pulmonary Fibrosis and Radiation Pnemonitis. During animal model studies, Etuary® effectively protected the animals against drug induced lung damage and greatly improved the animal’s nutritional status. By the end of December, 2013, our affiliated company, Beijing Continent, had received manufacture permit on Etuary® from CFDA for commercial launch.

F351 (NCE)

F351 is a non-steroid anti-fibrosis small-molecule drug that is being developed for kidney fibrosis and liver fibrosis. Liver disease is commonly regarded as China’s “National Disease”, with over 90 million people affected by HBV and nearly 6 million liver fibrosis patients. At the meantime, chronic kidney disease also affects nearly 20 million people in China, which often at the end stage, results in kidney fibrosis and kidney failure. Liver and kidney transplants are the only two expensive approaches today.

In more than 7 animal model studies, F351 significantly reduced the presence of liver fibrosis and kidney fibrosis and normalized major biochemical and pathological disturbances associated with the disease. With no toxicity observed in animal models at high dosages and good water solubility, F351 has entered into Phase Ib clinical trial. Being easy to synthesize and having superior potency, when compared to Chinese herbal medicines, F351 is the ideal drug to combat liver fibrosis.

F573 (NCE)

F573 is a dipeptide pan-caspase inhibitor developed by Shanghai Genomics for liver failure, which is an end stage of severe hepatitis caused by HBV infection. China, as the largest HBV pandemic country, has more than half a million cases of liver failure every year. Other than liver transplant, there is no effective therapy worldwide.

F573 strongly and irreversibly inhibit a broad spectrum of caspases, which are key executioners of cellular apoptosis. In 4 animal models tested, F573 significantly reduced animal mortality caused by liver damage. In addition, the drug showed excellent safety profile and PK profile. In July, 2011, Shanghai Genomics has filed IND with Shanghai FDA for the development of F573 for acute liver failure.

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