Hangzhou and Shaoxing, China, December 3, 2021-- 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 the Medicine Catalog for National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2021) (《国家基本医疗保险、工伤保险和生育保险药品目录（2021）年》) (the “National Reimbursement Drug List” or the “NRDL”).
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 NS5A inhibitor with high genetic barrier to resistance, with a cure rate of 100% in patients with baseline NS5A resistance. Both ASCLEVIR® and GANOVO® have been included in The Guideline of Prevention and Treatment for Chronic Hepatitis C (2019 version) (《丙型肝炎防治指南（2019版）》) and Management Process of Hospital Screening for Hepatitis C in China (Trial) in 2021 (《中国丙型病毒性肝炎院内筛查管理流程（试行）》). 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 GANOVO® are 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.”
About Hepatitis C
Hepatitis C is a chronic infection with high morbidity and mortality and is one of the main causes of cirrhosis and liver cancer. There are approximately 10 million people infected with HCV in China with approximately 220,000 new infections each year recently.
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), a global platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors) to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 18 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.
1. Viral Diseases: (1) Hepatitis B Virus (functional cure): focus on breakthrough therapies for CHB functional cure with a subcutaneously-injected PD-L1 antibody – ASC22 and Pegasys® as cornerstone drugs. (2) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients. (3) Hepatitis C: successfully launched an all-oral regimen of combining ASCLEVIR® and GANOVO® (RDV/DNV regimen).
2. Non-alcoholic Steatohepatitis/Primary Biliary Cholangitis: Gannex, a wholly-owned company of Ascletis, is dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THRβ and FXR, three fixed-dose combinations for NASH and one PBC program targeting FXR.
3. Cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors): a pipeline of oral inhibitors targeting FASN, which plays a key role in cancer lipid metabolism, and a pipeline of oral PD-L1 small molecule next generation immune checkpoint inhibitors.
4. Exploratory Indications: Acne: Following NASH and recurrent GBM, the third indication for ASC40 has been approved to enter Phase 2 clinical trial.
Ascletis Pharma Inc.