Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1721 |
| INN | Stapokibart |
| Status | Approved |
| Drug code(s) | CM310 |
| Brand name | Kangyueda, 康悦达 |
| 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) | IL-4R alpha |
| Indications of clinical studies | Chronic Pruritus of Unknown Origin, Chronic Rhinosinusitis With Nasal Polyps, Severe asthma, COPD, atopic dermatitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2019 |
| Start of Phase 2 | February 15, 2021 |
| Start of Phase 3 | April 15, 2022 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Stapokibart |
| US or EU approved indications | None |
| Company | Keymed Biosciences Co.Ltd |
| Licensee/Partner | CSPC ZhongQi Pharmaceutical Technology Co. Ltd. |
| Comments about company or candidate | Sept.12, 2024: Keymed Biosciences Inc. announced the National Medical Products Administration (the "NMPA") of China has recently approved the new drug application for Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), for the indication of moderate-to-severe atopic dermatitis in adults. https://finance.yahoo.com/news/stapokibart-granted-marketing-approval-national-160700388.html Dec 7, 2023: Keymed Biosciences Inc. announced that the new drug application of Stapokibart injection (an anti-IL-4Ra monoclonal antibody, R&D codename: CM310) was accepted by the National Medical Products Administration (" NMPA") and granted priority review on December 7, 2023. Drug name: Stapokibart injection. Dosage form: Injection. Proposed indication: For the treatment of moderate-to-severe atopic dermatitis in adults who are poorly controlled or unsuitable for topical therapy. The application is based on a multi-center, randomized, double-blind, placebo-controlled phase III study (CM310AD005). Phase 2/3 study for Moderate to Severe Asthma (NCT05761028) not yet recruiting (confirmed on chinadrugtrials as well) but sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Mar 2023: Initiated Phase III registrational clinical trial for adults with moderate to severe AD in 2022 Q1; Completed the patient enrollment in 2022 November; The Company plans to complete this trial and submit the NDA for this indication in 2023. CTR20221480 with status "In progress, recruiting"seems the same as NCT05436275 Phase 3 due to start in Aug 2022. Received Breakthrough therapy designation (BTD) from the Center for Drug Evaluation/NMPA for the treatment of moderate to severe AD in June 2022. NCT05265923 Phase 3 study in atopic dermatitis started in April 2022 recruting as of last update in Feb 2023. NCT04893941 Phase 1/2 study in atopic dermatitis started in July 2020. NCT06161090 Phase 1 started in Nov 2019. The Product applied for clinical trial as class 1 Biological Product in China and was approved for the indication of moderate to severe asthma in July 2019. CM310 is currently under Phase II clinical trial. |
| Full address of company | Building D2, No.18 Middle Road, Tianfu International Bio-Town, Chengdu, Sichuan Asia China https://en.keymedbio.com/list-147-1.html |
CM310 is a recombinant humanized monoclonal antibody injection developed by KEYMED BIOSCIENCES with proprietary intellectual property rights targeting human interleukin 4 receptor α subunit (IL-4Rα). The product inhibits inflammatory response through the specific binding, for the treatment of moderate to severe asthma, COPD and atopic dermatitis.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |