Zuberitamab Approved Naked monospecific

Antibody Information

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

Therapeutic information

Target(s)	CD20
Indications of clinical studies	Primary immune thrombocytopenia, B cell lymphoma
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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 information

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/

Description/comment

immunoglobulin G1-kappa, anti-[Homo sapiens MS4A1 (membrane spanning 4-domains subfamily A member 1, CD20)], chimeric monoclonal antibody

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None