Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1713 |
| INN | Tagitanlimab |
| Status | Regulatory review |
| 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 |
| Target(s) | PD-L1 |
| Indications of clinical studies | Breast cancer, non-small cell lung cancer, nasopharyngeal cancer, Lymphoma, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review 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) | None |
| Date of first US approval | |
| INN, US product name | Tagitanlimab |
| US or EU approved indications | None |
| Company | Sichuan Kelun Pharmaceutical Research Institute Co. Ltd. |
| Licensee/Partner | Harbour BioMed |
| Comments about company or candidate | 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 |
Immune checkpoint target
| Anticipated events | Regulatory review China - anticipate approval second half of 2024 or the first half of 2025 - https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0819/2024081901322.pdf |
| Factor(s) contributing to discontinuation | None |