Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1719 |
| INN | Benmelstobart |
| Status | Approved |
| Drug code(s) | CBT-502, TQB2450, APL-502 |
| Brand name | Andewei |
| 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 | Nasopharyngeal Carcinoma, Endometrial Cancer, Triple-neg breast cancer, Ovarian cancer, Small Cell Lung Cancer, Hodgkin's lymphoma, Head and Neck Squamous Cell Carcinoma, non-small cell lung cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 01, 2018 |
| Start of Phase 2 | March 15, 2019 |
| Start of Phase 3 | June 11, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Benmelstobart |
| US or EU approved indications | None |
| Company | CBT Pharmaceuticals Inc |
| Licensee/Partner | Chia Tai Tianqing Pharmaceutical Group Co. Ltd. a member enterprise of Sino Biopharmaceutical, Apollomic Inc. |
| Comments about company or candidate | On April 29, 2024, benmelstobart was approved for marketing by NMPA in combination with anlotinib, carboplatin, and etoposide for the first-line treatment of extensive-stage small cell lung cancer. Feb 2024 press release notes the application has NMPA priority review and that, in January 2023, the new drug application for Benmelstobart was formally accepted by the CDE for first-line treatment of small cell lung cancer in combination with anlotinib. Jan 2023: The board of directors (the “Board”) of Sino Biopharmaceutical Limited announces that the Phase III clinical trial of the Group’s Category I antitumor innovative drug TQB2450 Injection in combination with Anlotinib Hydrochloride Capsules for the first-line treatment of small cell lung cancer (“SCLC”) has completed its interim analysis and reached the pre-defined end point of the protocol as reviewed by the Independent Data Monitoring Committee (IDMC). The Group has recently submitted a new drug marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People’s Republic of China and the application has been accepted. https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0113/2023011300357.pdf Phase 3 https://www.apollomicsinc.com/pipeline/ . The phase 3 study NCT05718167 for NSCLC that is not yet recruiting as of Feb 2023 on clinicaltrials.gov, is CTR20223447 and is recruiting. NCT04405505 is a Phase 3 study in triple-neg. breast cancer. NCT04964479 Phase 3 in NSCLC due to start in July 2021. NCT04325763 Phase 3 study in Non-Small Cell Lung Cancer That Have Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy started recruiting in May 2021. NCT03855384 Phase 3 in head and neck cancer recruiting as of June 2019. NCT03800706 Phase 2 in Hodgkin's lymphoma started in March 2019. Total of 11 studies, including NCT04002622 Phase 2 study in Primary Mediastinal B-cell Lymphoma, not yet recruiting as of June 28, 2019. NCT03996408 Phase 1/2 study in Cholangiocarcinoma not yet recruiting as of June 26, 2918; NCT03983928 Phase 1 in NSCLC not yet recruiting as of June 12, 2019; NCT03910127 Phase 1 study in NSCLC not yet recruiting as of May 6, 2019. NCT03897283 Phase 1 study in solid tumors not yet recruiting as of April 2. CBT-502 (TQB2450) is a novel humanized IgG1 antibody against programmed cell death-ligand 1(PD-L1) developed by CBT Pharmaceuticals, Inc. April 2018: The anti-PD-L1 humanized monoclonal antibody” (code: “TQB2450”) injection developed by Sino Pharmaceutical Limited has been approved by the China Food and Drug Administration of the People’s Republic of China earlier for pharmaceutical clinical trial and its Phase I clinical trial has formally commenced. The product is an innovative anti-PD-L1 humanized monoclonal antibody drug for which Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of the Company, has applied registration as a therapeutic biological product |
| Full address of company | Pleasanton, CA North America United States of America https://www.linkedin.com/company/cbt-pharmaceuticals-inc. |
Immune checkpoint modulator. Humanized IgG1 (http://mct.aacrjournals.org/content/17/1_Supplement/A200). No Fc receptor activity; Binding affinity to human PD-L1 (SPR) Kd ~ 250 pM (https://www.apollomicsinc.com/wp-content/uploads/2017/10/CBT-502-tQB2450-Poster.pdf)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |