Suzhou Alphamab Co., Ltd.

Ascletis Pharma has submitted applications seeking marketing authorisation for ritonavir in eight European countries, namely the Netherlands, Portugal, Spain, Denmark, Belgium, Poland, Sweden and Italy. The company submitted the applications through its agent in the region. In January, Ascletis expanded the production of ritonavir tablets and oral direct-acting antiviral research and development (R&D) pipeline to treat SARS-CoV-2 infection. A 100mg film-coated oral tablet, ritonavir is a pharmacokinetic booster of various oral antiviral therapies that act on viral proteases. It is also a component of Pfizer’s oral antiviral Covid-19 drug, Paxlovid. Last month, the company sought marketing authorisation for ritonavir in the UK, France, Germany and Ireland. The company also anticipates submitting additional marketing authorization applications for the oral tablet in various other regions, including North and South America, Euro-Asia, Asian Pacific and Africa. Currently, Ascletis possesses the only authorised oral ritonavir tablet in China, which has also passed bioequivalence study. The China National Medical Products Administration granted approval to ritonavir in September last year. By leveraging complex formulation technology, the company substantially boosted ritonavir’s human bioavailability which otherwise has a reduced solubility. It thereby attained human bioequivalence with Norvir produced originally by AbbVie. Ascletis is presently holding talks with various multi-national pharmaceutical firms for commercially supplying ritonavir in China and across the globe. In January 2019, Ascletis entered an exclusive licensing agreement with Suzhou Alphamab for developing an investigational candidate, KN035, to treat viral diseases such as hepatitis B in Greater China. Under the deal, Ascletis obtained an exclusive licence for developing and commercialising ASC22 (KN035) to treat viral diseases in the region.

Ascletis Pharma Inc. (HKEX: 1672) announces today the Investigational New Drug (IND) application approval by U.S. Food and Drug Administration (FDA) and initiation of global development of ASC22 (Envafolimab), a first-in-class, subcutaneously administered PD-L1 antibody for functional cure of chronic hepatitis B (CHB). The recent research paper, titled "Prevalence of Chronic Hepatitis B Virus Infection in the United States" published in June 2020, showed an overall estimated prevalence for chronic hepatitis B virus (HBV) infection in the U.S. of 1.59 million patients (range 1.25–2.49 million). Both the World Health Organization (WHO) and U.S. Department of Health and Human Services (DHHS) have articulated formal hepatitis elimination plans. ASC22 Phase IIb study (ClinicalTrials.gov Identifier: NCT04465890) is a randomized, single-blind, placebo-controlled, multi-center clinical trial in China which evaluates the efficacy and safety of 149 CHB patients for 24-week treatment of 1 mg/kg or 2.5 mg/kg ASC22 or matching placebo given once every two weeks (Q2W) in combination with NAs. Interim results, which were accepted for oral presentation in Late Breaking Session at The Liver Meeting® 2021 by the American Association for the Study of Liver Diseases (AASLD) showed that in patients with the baseline hepatitis B surface antigen (HBsAg) level ≤ 500 IU/mL, approximately 19% (3/16) of patients in the treatment group obtained HBsAg loss versus no subject achieved HBsAg loss in the placebo group and no rebound after the last dosing of ASC22, indicating HBV functional cure. Phase IIa and IIb clinical studies of ASC22 for HBV functional cure were selected for inclusion in the "Best of The Liver Meeting's Summary" in 2021 by AASLD review committee. Such inclusion is a singular honor and indicates the high level with which the AASLD review committee regards Ascletis' research in CHB functional cure. Ascletis announced it had obtained a global and exclusive license as of 8 November, 2021 from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B. Ascletis books sales globally for ASC22 of all viral diseases. ASC22 is the most advanced clinical stage immunotherapy in the world for CHB functional cure, i.e. HBsAg loss, through blocking PD-1/PD-L1 pathway. "ASC22 (Envafolimab) U.S. IND approval enables us to initiate U.S. and global clinical trials for CHB functional cure. Meanwhile, we are looking forward to collaborating with the industrial leaders in the field of functional cure of CHB." said Jinzi J. Wu, PhD, Founder, Chairman and CEO of Ascletis. About Ascletis 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 20 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

HANGZHOU, China and SHAOXING, China and SUZHOU, China, Nov. 7, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (1672.HK) and Suzhou Alphamab Co., Ltd. (Suzhou Alphamab) jointly announce today that Ascletis' subsidiary and Suzhou Alphamab have entered into an exclusive and worldwide license agreement outside Greater China for ASC22 (Envafolimab) to treat all viral diseases including Hepatitis B. ASC22, also known as KN035, is a first-in-class subcutaneously injected PD-L1 antibody. Oncology indications are under development by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. and an oncology biologic license application ("BLA") of KN035 was submitted to China National Medicine Products Administration (NMPA) in December 2020. Under the terms of this agreement, Ascletis obtained an exclusive and worldwide license outside Greater China from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B. Ascletis will pay Suzhou Alphamab a cash upfront payment and Suzhou Alphamab will be eligible to receive payments from Ascletis on development, regulatory and commercial milestones as well as tiered royalties from the mid-teens to around twenty percent on future sales of ASC22. Suzhou Alphamab will manufacture ASC22 for clinical trials and commercialization of viral indications for Ascletis. Together with the exclusive license agreement in Greater China announced jointly by Ascletis and Suzhou Alphamab on January 14, 2019 (Details referring to press release: ), Ascletis has now obtained a global and exclusive license from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B. Ascletis books sales globally for ASC22 of all viral diseases. ASC22 is the most advanced clinical stage immunotherapy in the world for chronic hepatitis B (CHB) functional cure, i.e. hepatitis B surface antigen (HBsAg) loss, through blocking PD-1/PD-L1 pathway. A Phase IIa clinical trial of ASC22 in CHB patients was completed and the data indicated that there was a trend of dose dependent HBsAg reduction after single dose administration of 0.3, 1.0 or 2.5 mg/kg ASC22. Among three patients receiving 2.5 mg/kg dose, one patient achieved a maximum HBsAg reduction of 1.2 log10 IU/mL during the 12-week follow up. The Phase IIa results will be presented in oral parallel session at The Liver Meeting® 2021 by the American Association for the Study of Liver Diseases (AASLD), one of the world's premier meetings on liver disease and will be held during November 12 to November 15 this year. ASC22 is currently in a Phase IIb clinical trial in China with the entire enrollment of 149 CHB patients completed in July this year and preliminary Phase IIb data indicated that HBsAg reduction was observed in the 1 mg/kg ASC22 once every two weeks plus nucleos(t)ide analogs group with greater HBsAg reduction observed in patients with HBsAg ≤ 500 IU/mL at baseline while no HBsAg reduction was observed for the placebo plus nucleos(t)ide analogs group. Jinzi J. Wu, PhD, Founder, Chairman and CEO at Ascletis said, "Suzhou Alphamab is a leading biopharmaceutical company and we're thrilled to partner with it on a global basis. Ascletis is a global leader in antiviral drug development such as Hepatitis B which remains a highly unmet medical need globally. Through the strategic partnership with Alphamab, we are accelerating the global development of ASC22 as a first-in-class HBV immunotherapy with the encouraging Phase IIa and Phase IIb efficacy data as well as the advantage in safety and convenience, and hope to offer a functional cure for Hepatitis B patients soon." About Ascletis 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. View original content: SOURCE Ascletis Pharma Inc. Company Codes: HongKong:1672