Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1715 |
| INN | Ebronucimab |
| Status | Approved |
| Drug code(s) | AK102 |
| Brand name | 伊喜宁 |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PCSK9 |
| Indications of clinical studies | Hyperlipidemia, Homozygous Familial Hypercholesterolemia |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 09, 2018 |
| Start of Phase 2 | May 13, 2019 |
| Start of Phase 3 | December 01, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Ebronucimab |
| US or EU approved indications | None |
| Company | Akesobio Australia Pty Ltd |
| Licensee/Partner | DAWNRAYS PHARMACEUTICAL (HOLDINGS) LIMITED |
| Comments about company or candidate | Sep 2024: Approved in China for treatment of primary hypercholesterolemia and mixed hyperlipidemia and heterozygous familial hypercholesterolemia https://www.akesobio.com/en/media/akeso-news/akeso-s-ebronucimab-pcsk9-approved-for-two-indications-for-the-treatment-of-hypercholesterolemia-in-china/ June 1, 2023: Akeso Inc. announced today that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for its fully human anti-PCSK9 monoclonal antibody ebronucimab (AK102) for 2 indications 1) primary hypercholesterolemia and mixed hyperlipidemia, and 2) heterozygous familial hypercholesterolemia (HeFH). Ebronucimab is jointly developed by Akeso and AD Pharmaceuticals (a joint venture with Akeso). Dec 2021: Ebronucimab (AK102) completed patient enrollment early in a pivotal registrational phase III clinical trial in the People’s Republic of China (‘‘China’’) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia. NCT03933293 Phase 2 study started recruiting on May 13, 2019. NCT04169386 Phase 1 started in May 2018. Agreement with Dawnrays confirms monoclonal antibody composition of matter (http://en.dawnrays.com/UploadFiles/AnnmentFile/a168305-e_announcementdiscloseabletransation161214.pdf); On 14 December 2016 (after trading hours), Dawnrays Biotech, a wholly-owned subsidiary of the Company, and Zhongshan KF entered into the JV Agreement, for the purpose of, amongst other things, establishing the JV Co and regulating the funding and management arrangements with respect to the JV Co and the respective rights and obligations of Dawnrays Biotech and Zhongshan KF. |
| Full address of company | Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia Australia Australia https://www.akesobio.com/en/about-us/contact-us/ |
IgG1 lambda2
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |