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Ascletis Announces Inclusion in New Catalogue of China National Reimbursement Drug List (NRDL) of ASCLEVIR®/ GANOVO® Regimen, an All-oral Direct Anti-HCV Therapy

HANGZHOU, ChinaA and SHAOXING, China, Dec. 2, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces that its all-oral direct anti-hepatitis C virus (HCV) ASCLEVIR (Ravidasvir)/ GANOVO (Danoprevir) regimen has been included in theMedicine Catalog for National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2021) (a??a? 1/2 a®¶a??ae?¬a?»c??a??e?©a??a·?a 1/4 ¤a??e?©a??c??e??a??e?©e??a??c?®a 1/2 ?i 1/4 ?2021i 1/4 ?a??a??)A (the "National Reimbursement Drug List" or the "NRDL").A The results from the Phase II/III clinical trials in China with the all-oral direct anti-HCV ASCLEVIR / GANOVO regimen showed a 99% cure rate in genotype 1 non-cirrhosis HCV patients. ASCLEVIR is a pan-genotypic NS5AA inhibitor with high genetic barrier to resistance, with a cure rate of 100% in patients with baseline NS5AA resistance. Both ASCLEVIR and GANOVOhave been included in The Guideline of Prevention and Treatment for Chronic Hepatitis C (2019 version) (a??a,?a??e??c??e??ae?»ae??a??i 1/4 ?2019c??i 1/4 ?a??) and Management Process of Hospital Screening for Hepatitis C in China (Trial) in 2021 (a??a,­a? 1/2 a,?a??c??ae??ae?§e??c??e??a??c­?ae??c®?c??aeµ?c??i 1/4 ?e??e??i 1/4 ?a??). Ascletis was the leader for the Anti-HCV Program of National Science and Technology Major Project for "Innovative Drug Development" Programs, and both ASCLEVIR and GANOVOareA the important achievements of this Project during the 13th Five-year Plan Period."The assessment by National Healthcare Security Administration ("NHSA") is based on multi-factors including efficacy, safety, economy, novelty and fairness. We are glad that Ascletis' all-oral regimen has been recognized. There are approximately 10 million patients infected with HCV in China, inclusion in the NRDL will significantly improve the accessibility, release financial burdens of patients and their families, and bring positive impacts to them," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, "Cure of HCV is a solid step towards our mission 'Innovative cures liberate life to the fullest'. Ascletis will continue to support the country's healthcare system and contributes to the national 'Healthy China' strategy."Prof. Lai Wei, Vice President of Beijing Tsinghua Changgung Hospital said, "the clinical results of the all-oral direct anti-HCV ASCLEVIR (Ravidasvir)/ GANOVO (Danoprevir) regimen demonstrated a sustained virological response rate (SVR12) of 99% in genotype 1 non-cirrhosis HCV patients with good safety profiles. The inclusion in NRDL of the all-oral regimen developed by domestic company will further release financial burdens of HCV patients, improve the accessibility of the drugs, eliminate the threat of viral hepatitis to public health and achieve 'Healthy China 2030' objectives."
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