Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 361 |
| INN | None |
| Status | Clinical |
| Drug code(s) | B007 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | TBD |
| Format, general category | TBD |
| Format details | TBD |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD20 |
| Indications of clinical studies | Pemphigus, Generalized Myasthenia Gravis, Primary membranous nephropathy, non-Hodgkin's lymphoma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 30, 2021 |
| Start of Phase 2 | |
| Start of Phase 3 | June 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 Jiaolian Drug Research and Development Co. Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06470191 Phase 2/3 in Primary Membranous Nephropathy start in July 2024. NCT06454357 / CTR20240985 Phase 2/3 in Pemphigus started in June 2024 NCT06447597 is A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis due to start in June 2024 NCT05668403 / CTR20223217 Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy started in Mar 2023 recruting as of last update in June 2023. On November 30, 2021 the phase Ia clinical trial of the recombinant anti-CD20 humanized monoclonal antibody subcutaneous injection developed by Shanghai Jiaolian Drug Research and Development Co., Ltd., a wholly-owned subsidiary of Shanghai Pharmaceuticals, successfully completed the first patient in the Affiliated Hospital of Xuzhou Medical University Enrolled in the group, and completed the enrollment of the second patient at Ruijin Hospital Affiliated to Shanghai Jiaotong University, the team leader unit, on the same day. The safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injection of recombinant anti-CD20 humanized monoclonal antibody being carried out by Shanghai Pharmaceuticals in patients with CD20-positive B-cell non-Hodgkin's lymphoma (CTR20211328) |
| Full address of company | Shanghai Shi, China Asia China https://synapse.patsnap.com/organization/7f1e5f4bd5f4bc2bcbb9eed0ad5657da |
B007 is a recombinant anti-CD20 humanized monoclonal antibody subcutaneous injection developed by Shanghai Jiaolian Pharmaceutical Co., Ltd. , which is a new type of human recombinant monoclonal antibody product. According to the public information of Shanghai Pharmaceuticals, the product has a high degree of humanization and is expected to have lower immunogenicity and longer half-life . The drug's in vitro activity, target selectivity, in vivo efficacy and therapeutic window are comparable to or have certain advantages with some similar products. In addition, compared with intravenous injection, subcutaneous injection can shorten the administration time from about 2 hours to 5 minutes, reduce the invasive operation of the patient's vein, and is expected to greatly improve the convenience of medication and patient satisfaction.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |