Ascletis announces the inclusion in the new catalog of the Chinese national list of reimbursed drugs (NRDL) of the ASCLEVIR® / GANOVO® regimen, an all-oral direct anti-HCV therapy


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HANGZHOU, China and SHAOXING, China, December 3, 2021 / PRNewswire / – Ascletis Pharma Inc. (HKEX: 1672) today announced that its all-oral direct anti-hepatitis C virus (HCV) ASCLEVIR® (Ravidasvir) / GANOVO® (Danoprevir) has been included in the Catalog of medicines for basic national health insurance, occupational accident insurance and maternity insurance (2021) (??2021??) (the “National List of Reimbursed Medicines” or the “NRDL”).

The results of phase II / III clinical trials in China with direct all oral anti-HCV ASCLEVIR® / GANOVO® The regimen showed a 99% cure rate in non-cirrhotic HCV genotype 1 patients. ASCLEVIR® is a pan-genotypic NS5A inhibitor with a high genetic barrier to resistance, with a 100% cure rate in patients with baseline NS5A resistance. The two ASCLEVIR® and GANOVO® have been included in Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2019 Version) (??2019??) and Process for managing hospital screening for hepatitis C in China (essay) in 2021 (??). Ascletis was the anti-HCV program leader of the major national science and technology project for “innovative drug development” programs, and both ASCLEVIR® and GANOVO® are the significant achievements of this project during the 13th period of the five-year plan.

“The National Healthcare Security Administration (‘NHSA’) assessment is based on several factors, including effectiveness, safety, economy, novelty and fairness. We are pleased that the all-oral Ascletis diet has been recognized. There are approximately 10 million HCV infected patients in China, inclusion in the NRDL will dramatically improve accessibility, ease the financial burden on patients and their families and bring positive impacts to them, ”said Dr. Jinzi J. Wu, Founder, CEO of Ascletis, “Cure of HCV is an important step towards our mission” Innovative remedies liberate life to the fullest. ” Ascletis will continue to support the country’s health system and contribute to the national “healthy China” strategy. “

Teacher. Lai wei, Vice President of Tsinghua Changgung Hospital in Beijing said: “Clinical results of all-oral direct anti-HCV ASCLEVIR® (Ravidasvir) / GANOVO® (Danoprevir) demonstrated a sustained virologic response rate (SVR12) of 99% in non-cirrhotic HCV genotype 1 patients with good safety profiles. The inclusion in the NRDL of the all-oral regimen developed by a national company will further reduce the financial burden of patients infected with HCV, improve the accessibility of drugs, eliminate the threat of viral hepatitis to public health and achieve the objectives “Healthy China 2030”.

About hepatitis C

Hepatitis C is a chronic infection with high morbidity and mortality and is a leading cause of cirrhosis and liver cancer. There are approximately 10 million people infected with HCV in China with around 220,000 new infections each year recently.

About Ascletis

Ascletis is an innovative R&D-driven biotechnology listed on the Hong Kong Stock Exchange (1672.HK), a global platform spanning 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 meet unmet medical needs both in China and globally. Led by a management team with deep expertise and proven track record, Ascletis targets therapeutic areas with unmet medical needs from a global perspective and effectively advances pipeline developments with the aim of dominating global competition. To date, Ascletis has three commercialized products and 18 strong R&D pipelines of globally competitive drug candidates, and is actively exploring new therapeutic areas.

1. Viral diseases: (1) Hepatitis B virus (functional cure): focus on breakthrough therapies for functional cure of CHB with PD-L1 antibody injected subcutaneously – ASC22 and Pegasys® as drugs basic. (2) HIV / AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to functional recovery in HIV-infected patients. (3) Hepatitis C: successful launch of an all-oral treatment regimen combining ASCLEVIR® and GANOVO® (RDV / DNV regimen).
2. Non-alcoholic steatohepatitis / primary biliary cholangitis: Gannex, a company 100% owned by Ascletis, is engaged in 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 a 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 dot inhibitors next-generation small molecule PD-L1 immune control agent.
4. Exploratory indications: Acne: Following NASH and recurrent GBM, the third indication for AUC40 has been approved for entry into the Phase 2 clinical trial.

SOURCE Ascletis Pharma Inc.

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