Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 64 |
| INN | Zuberitamab |
| Status | Approved |
| Drug code(s) | HS006, Zebetuzumab |
| Brand name | Enrexib, Anruixi |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD20 |
| Indications of clinical studies | Primary immune thrombocytopenia, B cell lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2015 |
| Start of Phase 2 | May 15, 2016 |
| Start of Phase 3 | October 15, 2018 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2023 |
| Date of first US approval | |
| INN, US product name | Zuberitamab |
| US or EU approved indications | None |
| Company | Zhejiang Hisun Pharmaceutical Company Ltd or Zhejiang Borui Biopharmaceutical Co. Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | Sept. 13, 2023: Recently, BioRay Pharmaceutical Co., Ltd. announced that its independently developed Class I innovative therapeutic biological product, Zuberitamab Injection (trade name: Anruixi®), indicated for the treatment of CD20-positive diffuse large B-cell lymphoma (DLBCL), was officially approved for marketing by the National Medical Products Administration (NMPA). https://www.prnewswire.com/news-releases/zuberitamab-anruixi-the-first-domestically-developed-anti-cd20-antibody-as-a-class-i-innovative-drug-from-bioray-pharmaceutical-has-been-approved-for-marketing-in-china-301925846.html May 17, 2023: Recently, the State Drug Administration approved the listing of Zebetumumab Injection (trade name: Enrexib) declared by Zhejiang Borui Biopharmaceutical Co., Ltd. The drug is suitable for adult patients with CD20-positive diffuse large B-cell lymphoma, not specified (DLBCL, NOS), and should be combined with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone). https://www.nmpa.gov.cn/yaowen/ypjgyw/20230517152922112.html CTR20211966 Phase 2 in Primary Immune Thrombocytopenia started in Dec 2021; hospital approvals granted from June 2021 to Feb 2022; record status is recruiting when accessed in Mar 2023 July 2021: Zebetuzumab is a new and differentiated human-mouse chimeric anti-CD20 monoclonal antibody independently developed by Borui Bio. Previously, this product has carried out Phase III clinical trials of non-Ho's lymphoma, primary immune thrombocytopenia (ITP) is the second indication for Zebetuzumab to enter the clinical stage. CTR20180855 Phase 3 study in DLBCL started in 2018 is completed. NCT03485118 Phase 2 study completed in 2016. Start of clinical studies estimated as mid-2010. |
| Full address of company | No. 46, Waisha Road, Jiaojiang District, Taizhou, Zhejiang, 318000 Asia China https://www.globaldata.com/company-profile/zhejiang-hisun-pharmaceutical-co-ltd/locations/ |
immunoglobulin G1-kappa, anti-[Homo sapiens MS4A1 (membrane spanning 4-domains subfamily A member 1, CD20)], chimeric monoclonal antibody
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |