Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 734 |
| INN | None |
| Status | Clinical |
| Drug code(s) | HS-20093, GSK5764227 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | TBD |
| Format details | TBD |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | Undisclosed |
| Ave. DAR | ___ |
| Conjugated/fused moiety | Topoisomerase I inhibitor |
| Discovery method/technology | None |
| Target(s) | B7-H3 |
| Indications of clinical studies | Bone and Soft Tissue Sarcoma, Esophageal Carcinoma, Small cell lung cancer, Head and Neck Squamous Cell Carcinoma, Prostate cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2021 |
| Start of Phase 2 | June 15, 2023 |
| Start of Phase 3 | July 15, 2024 |
| 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 | Shanghai Hansoh Biomedical Co. Ltd |
| Licensee/Partner | GSK |
| Comments about company or candidate | Nov 1, 2024: Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (“NMPA”) of China, with the proposed indication being extensive stage small cell lung cancer (“ES-SCLC”) developed after standard first-line treatment (platinum doublet chemotherapy combined with immuno-therapy). Aug 2024: The US Food and Drug Administration has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), the Company’s investigational B7-H3-targeted antibody-drug conjugate being evaluated for the treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy (relapsed or refractory). CTR20242440 / NCT06526624 Phase 3 study in small cell lung cancer due to start in Sep 2024. NCT06112704 Phase 2 in Esophageal Carcinoma due to start in Jan 2024. Dec 2023: GSK gains the ex-China rights to develop and commercialize B7-H3-targeted ADC HS-20093. NCT06007729 Phase 2 study in head & neck cancer due to start in Sep 2023. NCT06001255 Phase 2 study in prostate cancer due to start in Sep 2023 NCT05830123 / CTR20230946 Phase 2 study in Osteosarcoma and Other Sarcomas started in June 2023. NCT05276609 is a Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Intravenous Administration of HS-20093 in Patients With Locally Advanced or Metastatic Solid Tumors Who Have Progressed Following Prior Therapy started in Nov 2021 recruiting as of last update in Feb 2023. July 15, 2021: The investigational new drug （IND） application for HS-20089 （for injection） and HS-20093 （for injection）， two new Class 1 therapeutic biological products independently developed by Shanghai Hansoh BioMedical Co., Ltd. under Hansoh Pharma （3692.HK）， was accepted and publicized by the National Medical Products Administration |
| Full address of company | No.9 Dongjin Road, Huaguoshan Avenue, Lianyuangang, Jiangsu, China Asia China http://www.hansoh.cn/en/job/ren-cai-li-nian.htm |
HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. Topoisomerase inhibitor (TOPOi) payload
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |