Ascletis Receives IND Approval for its HIV Drug ASC09F

Ascletis Pharma Inc. (HKEX code: 1672) announces today that it received IND approval from National Medical Products Administration (NMPA) for its human immunodeficiency virus (HIV) protease inhibitor ASC09F (ASC09/Ritonavir Fixed-Dose Combination).

ASC09 has an unprecedented high genetic barrier to resistance and has completed Phase I and Phase IIa clinical trials, which have shown potent anti-viral activity. Previous clinical trials have also shown that ASC09 is safe and well-tolerated. After two weeks of treatment of mono-therapy, ASC09 demonstrated up to a 1.79 log viral load decrease (62-fold reduction of viral load in blood samples of patients). Our studies have shown that ASC09 requires seven mutations before HIV develops resistance to ASC09, indicating ASC09 to have high genetic barrier to resistance compared to other approved protease inhibitors. These characteristics make ASC09 a promising HIV drug therapy candidate for both treatment-naïve and treatment-experienced patients. ASC09 is a potential best-in-class protease inhibitor to treat HIV type-1 infections, licensed as TMC310911 from Janssen R&D Ireland in 2013 for development and commercialization in greater China.

In addition to being a HIV protease inhibitor, ritonavir is a potent CYP3A4 inhibitor. A low-dose of ritonavir can inhibit CYP3A4-mediated metabolism of other HIV protease inhibitors, increase their drug plasma concentration, and boost their overall exposure, thus increase their potency.

"We are excited by IND approval of ASC09F from NMPA,"said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, "adhering to the mission that innovative cures liberate life to the fullest, Ascletis will accelerate the development of innovative drugs to benefit more patients as soon as possible."

About Ascletis 

Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong, S.A.R., China 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.

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