Ascletis' IND Filing for Its Non-alcoholic Steatohepatitis (NASH) Drug Accepted by NMPA

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Feb 17, 2020, 19:00 ET

HANGZHOU, China and SHAOXING, China, Feb. 17, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) announces today the application for in-house developed Category 1 Drug ASC41 for clinical trials of NASH indication has been accepted by China's National Medical Products Administration (NMPA).

ASC41 is expected to be used in combination with ASC40, another innovative drug of the Company, for treatment of NASH. ASC41 is an oral thyroid hormone receptor beta (THR-beta) agonist, while ASC40 is an oral fatty acid synthase (FASN) inhibitor.

"We are excited about the clinical trial application of ASC41, the 1st in-house developed candidate drug for NASH, is accepted by NMPA," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "Ascletis is an innovative R&D driven biotech company, we are rapidly moving from 'First-in-China' to 'First-in-Class'."

Ascletis also has diverse pipelines for series of antiviral drugs. In the field of HBV, ASC22 is a first-in-class PD-L1 antibody candidate drug for chronic hepatitis B on global basis, by blocking the PD-1/PD-L1 pathway to effectively improve the function of specific T-cell and have subcutaneous injection and room temperature stability characteristics. Recently, Ascletis had received the approval to conduct clinical trials in chronic hepatitis B patients by NMPA.

In the field of Novel Coronavirus Pneumonia (NCP), which is currently ravaging China, ASC09/Ritonavir fixed-dose combination (ASC09F) and Ritonavir gained attention of relevant institutions and first-line clinical experts in China. The clinical trials of NCP of above-mentioned drugs initiated by the researchers have been launched in Wuhan, Zhejiang, Chongqing and other serious areas of the epidemic. Ascletis provides trial materials and comprehensive technical support for the above-mentioned clinical trials, contributes to fight the epidemic and to cure the patients. (Registration number of clinical trials at Wuhan Tongji Hospital: NCT04261270; Registration number of clinical trials at The First Affiliated Hospital of Zhejiang University Medical College: NCT04261907; Registration number of clinical trials at The Second Affiliated Hospital of Chongqing Medical University: ChiCTR2000029759.)

About NASH

Non-alcoholic Steatohepatitis (NASH), also known as metabolic steatohepatitis, is mainly manifested in unexplained intrahepatic fat accumulation, which can lead to chronic liver inflammation and liver cell injury, and can lead to liver fibrosis, liver cirrhosis, and eventually lead to liver cancer or liver failure.

According to the Journal of Hepatology, there were 32.81 million people in China with NASH in 2016, and the number is expected to reach 48.26 million by 2030. Presently there are no drugs for NASH available.

About Ascletis

Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing antiviral, steatohepatitis, and tumor-related innovative drugs for unmet medical needs in China and Globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis' pipeline is focused primarily on three therapeutic areas: 1. HCV: one commercial stage product, one near commercial stage drug and two R&D stage drug candidates. Ganovo® (Danoprevir) is the first direct-acting anti-viral agent for hepatitis C, developed by a domestic firm in China. 2. HBV: one commercial stage product and three R&D stage drug candidates. Pegasys® (Peginterferon alfa-2a) is a leading marketed pegylated interferon for hepatitis B&C partnered with Roche. 3. NASH (Non-Alcoholic SteatoHepatitis): three R&D stage drug candidates against three different targets for combination treatments. For more information, please visit www.ascletis.com.

SOURCE Ascletis Pharma Inc.