Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2059 |
| INN | Coprelotamab |
| Status | Terminated |
| Drug code(s) | GB221 |
| Brand name | None |
| 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) | HER2 |
| Indications of clinical studies | Breast cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | November 07, 2011 |
| Start of Phase 2 | |
| Start of Phase 3 | November 24, 2016 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Genor Biopharma Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | Genor Interim results 2024: Continued internal development of GB226 PD-1 and GB221, have been paused and pending further assessment of development strategy and resource allocation. (https://www.genorbio.com/media/1420/2024-interim-report-en.pdf) Jan 2023: The phase 3 study NCT04164615 for breast cancer has no updates since 2019. There is no mention of this molecule in Genor Biopharma in 2022 annual or interim results. March 2022: Listed as in pivotal study; March 2021 press release: Regarding key drug candidates in our portfolio treating breast cancer, we plan to file NDA to NMPA for Coprelotamab (GB221) in HER2+ breast cancer at Q4 of 2021. https://www.genorbio.com/en/media/corporate-news/genor-biopharma-releases-its-annual-results-for-2020/ CTR20190884 completed in Sep 2020 CTR20171510 Phase III clinical trial comparing the efficacy and safety of GB221 combined with docetaxel and trastuzumab combined with docetaxel in the first-line treatment of patients with HER2-positive metastatic breast cancer started in May 2018 NCT04164615 is A Randomized, Double-blind, Multi-center Phase 3 Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer |
| Full address of company | 1690 Zhangheng Road, Building 3, Pudong New District, Shanghai Asia China https://www.genorbio.com/en/contact/ |
Coprelotamab has a different allotype compared to trastuzumab.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |