Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 492 |
| INN | Geptanolimab |
| Status | No development reported |
| Drug code(s) | CBT-501, GB226, Genolimzumab (not WHO assigned INN), APT-501 |
| Brand name | Aibining 艾比寧® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Non-small cell lung cancer, Colorectal cancer, Hepatocellular and Renal Cell Carcinoma (Phase 1/2 study), Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review China |
| Status | No development reported |
| Start of clinical phase (IND filing or first Phase 1) | March 27, 2017 |
| Start of Phase 2 | July 02, 2018 |
| Start of Phase 3 | |
| 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 | CBT Pharmaceuticals Inc., Apollomics (Australia) Pty. Ltd. |
| 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) June 12, 2023: The board of directors of the Company (the “Board”) announces that the Company has been notified by the China National Medical Products Administration that the New Product Application approval of Geptanolimab (GB226) as a treatment for relapsed/refractory peripheral T-cell lymphoma (PTCL) was not granted. Mar 2022 update: The NDA for Geptanolimab (GB226) was officially accepted by the National Medical Products Administration (NMPA) and granted for priority review by the Center for Drug Evaluation (CDE), and successfully passed the NDA pre-approval inspection by the National Medical Products Administration. Mar 2021: GB226 (Geptanolimab) – NDA approval for r/r PTCL expected Q321. Genor Biopharma expects to launch Geptanolimab (GB226) at Q3 this year, it is the first PD-1 inhibitor worldwide for peripheral T-cell lymphoma (PTCL). August 5, 2020 -- Genor Biopharma Co. Inc announced that National Medical Products Administration (NMPA) has granted priority review status to its new drug application (NDA) for Geptanolimab, a PD-1 mAb, on July 28, 7 days after the NDA acceptance. Relapsed/refractory Peripheral T cell Lymphoma (PTCL) is the first indication that Genor targeted for its Geptanolimab. It is currently the first PD-1 mAb in China and globally being applied for this disease setting. NCT03976856 Phase 1 in NSCLC not yet recruiting as of June 6, 2019. NCT03977090 Phase 1 in colorectal cancer started in April 2019. Sep 2018: CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, today announced the initiation of the APOLLO Oncology Clinical Trials Program. The initial Phase 1/2 study, NCT03655613, is a two-arm clinical trial targeting locally advanced or metastatic disease: CBT-101 with CBT-501 (genolimzumab; anti-PD-1) in hepatocellular carcinoma (HCC), or CBT-101 and nivolumab in renal cell carcinoma (RCC). CBT-101 targets the epithelial to mesenchymal transition (EMT) pathway, and CBT-501 is CBT’s IgG4 humanized monoclonal antibody against the PD-1 membrane receptor on immune cells. Nivolumab (OPDIVO®; Bristol-Myers Squibb Company) is approved for advanced kidney cancer. April 2018: CBT Pharmaceuticals expects to initiate a Phase Ib/II study of CBT-501 in combination with CG200745 by the end of 2018. First clinical study NCT03053466 done in Australia. The antibody (CBT-501, GB226) was developed by Genor BioPharma Co. Ltd., a Walvax Company, who owns development and commercialization rights in China. CBT Pharmaceuticals, Inc. retains rest of the world (ROW) rights. An investigational new drug application has been approved by the China Food and Drug Administration (CFDA), and a Phase 1 trial will be initiated in China by Genor. |
| Full address of company | 1690 Zhangheng Road, Building 3, Pudong New District, Shanghai Asia China https://www.genorbio.com/en/contact/ |
Immune checkpoint inhibitor; S228P hinge stabilized. CBT-501 is a novel humanized IgG4 monoclonal antibody targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. CBT-501 has a comparable efficacy profile in in vitro and in vivo studies to marketed anti-PD-1 antibodies and has a favorable safety profile with very low undesirable antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activity.
| Anticipated events | Termination |
| Factor(s) contributing to discontinuation | None |