Ascletis and Suzhou Alphamab Extend Partnership to Global License Agreement for ASC22 (Envafolimab) to Treat Hepatitis B and Other Viral Diseases

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HANGZHOU, China and SHAOXING, China and SUZHOU, China, November 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 global licensing agreement outside Greater China for ASC22 (Envafolimab) to treat all viral diseases, including hepatitis B. ASC22, also known as KN035, is a first PD-L1 antibody injected subcutaneously. The oncology indications are under development by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. and an application for a Biologic Oncology License (“BLA”) of KN035 has been submitted to the China National Medicine Products Administration. december 2020.

Under the terms of this agreement, Ascletis obtained an exclusive and worldwide license excluding Greater China of Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases, including hepatitis B. Ascletis will pay Suzhou Alphamab an upfront cash payment and Suzhou Alphamab will be eligible to receive payments from Ascletis on development, regulatory milestones and commercial as well as mid-teens tiered royalties of approximately twenty percent on future sales of ASC22. Suzhou Alphamab will manufacture ASC22 for clinical trials and the commercialization of viral indications for Ascletis.

With the exclusive license agreement in Greater China jointly announced by Ascletis and Suzhou Alphamab on January 14, 2019 (Details referring to the press release: https://www.ascletis.com/news_detail/171/id/290.html), Ascletis has now obtained a worldwide and exclusive license from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases, including hepatitis B. Ascletis has worldwide sales for ASC22 of all viral diseases.

ASC22 is the world’s most advanced clinical stage immunotherapy for the functional cure of chronic hepatitis B (CHB), i.e. loss of hepatitis B surface antigen (HBsAg) , by blocking the PD-1 / PD-L1 pathway. A phase IIa clinical trial of AUC22 in patients with HCB has been completed and data indicated that there was a trend for dose-dependent reduction of HBsAg after dosing. single 0.3, 1.0 or 2.5 mg / kg ASC22. Among three patients receiving a dose of 2.5 mg / kg, one patient achieved a maximal reduction in HBsAg of 1.2 logten IU / mL during the 12 week follow-up. The results of Phase IIa will be presented in parallel oral session at The Liver Meeting® 2021 by the American Association for the Study of Liver Diseases (AASLD), one of the world’s largest 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 full enrollment of 149 CHB patients completed in July of this year and preliminary phase IIb data indicated that a reduction in HBsAg was observed in the 1 mg / kg ASC22 group once every two weeks plus nucleos

Jinzi J. Wu, PhD, Founder, CEO of Ascletis said, “Suzhou Alphamab is a leading biopharmaceutical company and we are delighted to partner with them globally. Ascletis is a world leader in the development of antiviral drugs such as hepatitis B which remains a Thanks to the strategic partnership with Alphamab, we are accelerating the global development of ASC22 as a first class immunotherapy against HBV with data encouraging the efficacy of phases IIa and IIb as well as the benefit in terms of safety and convenience, and I hope to offer a functional remedy to patients with hepatitis B soon. “

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 point inhibitors next-generation small molecule PD-L1 immune control system. 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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