Tagitanlimab Approved Naked monospecific

Antibody Information

Entry ID	1713
INN	Tagitanlimab
Status	Approved
Drug code(s)	A167, KL-A167, KLA-167, HBM9167
Brand name	科泰萊®
mAb sequence source	mAb humanized
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)	PD-L1
Indications of clinical studies	Breast cancer, non-small cell lung cancer, nasopharyngeal cancer, Lymphoma, solid tumors
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)	September 01, 2017
Start of Phase 2	July 01, 2018
Start of Phase 3	June 01, 2022
Date BLA/NDA submitted to FDA
Year of first approval (global)	2024
Date of first US approval
INN, US product name	Tagitanlimab
US or EU approved indications	None

Company information

Company	Sichuan Kelun Pharmaceutical Research Institute Co. Ltd.
Licensee/Partner	Harbour BioMed
Comments about company or candidate	January 23, 2025 press release: National Medical Products Administration approved tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer. Dec. 31, 2024 Chengdu: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand1(PD-L1)-directed innovative humanized monoclonal antibody (“mAb”) tagitanlimab (formerly KL-A167) (科泰莱®) for the treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) who have failed after prior 2L+ chemotherapy. This is the world's first PD-L1 monoclonal antibody approved for the treatment of NPC. (https://en.kelun-biotech.com/newsCenter.aspx?mid=18) As of June 2024, the Sichuan Kelun-Biotech Biopharmaceutical expected to launch trastuzumab botidotin, as well as sacituzumab tirumotecan (SKB264/MK-2870, 佳泰萊®) and tagitanlimab (A167, 科泰萊®), in the China market in the second half of 2024 or the first half of 2025. https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0819/2024081901322.pdf As per company website accessed Aug 28, 2022, HBM9167 is not listed in Harbour Biomed's pipeline. Klus Pharma website pipeline, accessed Aug 10, 2022: Currently, the BLA has been filed to NMPA in China for two solid tumor indications. Sep 10, 2021 Klus Pharma press release: Listed as A167 (anti-PD-L1 mAb, BLA filing); NMPA Acceptance number: CXSS2101052 NCT05294172 is a Phase 3 of KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma; due to start in June 2022. NCT05351788 is a Phase 2 study of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. Feb 27, 2020: Harbour BioMed announced U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application for a Phase 2 clinical trial of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC). Separately, the Agency’s Office of Orphan Products Development granted HBM9167 Orphan Drug Designation (ODD) for the use in treating NPC. NCT03848286 Phase 2 study in Recurrent or Metastatic Nasopharyngeal Carcinoma patients Who Have Received Previous At Least Two Lines of Chemotherapy and NCT03580564 Phase 2 study in lymphoma not yet recruiting as of May 17, 2019. Aug 2018: KL A167 licensed to Harbour BioMed worldwide (excluding China, Hong Kong, Macau and Taiwan). A167 (formerly KL-A167) is an anti-programmed death-ligand 1 (PD-L1) antibody currently in multiple Phase I and Phase II trials in China targeting lymphoma and solid tumors, as of Aug 2018 (www.genengnews.com/topics/drug-discovery/harbour-biomed-to-develop-kelun-biotechs-cancer-immunotherapy-candidate-a167/). Founded in 2014, KLUS Pharma is a subsidiary of Kelun-Biotech, which is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd.
Full address of company	No.36 West Baihua Road, Qingyang District, Chengdu, Sichuan, P. R. China Asia China https://en.kelun.com/intro/6.html

Description/comment

Immune checkpoint target

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None