Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1740 |
| INN | Suciraslimab |
| Status | Regulatory review |
| Drug code(s) | SM03 |
| Brand name | (Pending) |
| mAb sequence source | mAb chimeric |
| 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) | CD22 |
| Indications of clinical studies | Systemic lupus erythematosus, rheumatoid arthritis, non-Hodgkin lymphoma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 15, 2007 |
| Start of Phase 2 | December 15, 2014 |
| 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 | Shenzhen Lonn Ryonn |
| Licensee/Partner | SinoMab BioScience Limited |
| Comments about company or candidate | Sep 5, 2023: The board of directors of the Company is pleased to announce that the National Medical Products Administration of the People’s Republic of China (‘‘PRC’’) has accepted the biologics license application for the Company’s flagship product, SM03 (Suciraslimab), in the treatment of rheumatoid arthritis (‘‘RA’’) (Acceptance No.: CXSS2300072). https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0905/2023090500382.pdf Press release (April 26, 2023) "SinoMab Announces that Phase III Clinical Trial of its Flagship Product SM03 (Suciraslimab) Achieved the Primary Endpoint for Rheumatoid Arthritis" and "The Group will accelerate the commercialization of Suciraslimab and strive to submit the Biologics License Application (BLA) to the National Medical Products Administration (NMPA) in the third quarter of 2023 at its earliest" https://www.sinomab.com/wp-content/uploads/2023/04/Press-Release-SinoMab-3681.HK-Announces-that-Phase-III-Clinical-Trial-of-its-Flagship-Product-SM03-Suciraslimab-Achieved-the-Primary-Endpoint-for-Rheumatoid-Arthritis.pdf YE 2021 report: The primary analysis readout of Phase 3 study is expected in the third quarter of 2022. The efficacy and safety of SM03 has been evaluated in a phase II clinical study in moderate-to-severely active RA patients and has achieved desirable results. Both high-dosage group and low-dosage group met the primary endpoint and showed significantly better performance than the placebo group. We plan to submit the New Drug Application (“NDA”) to the National Medical Products Administration (“NMPA”) in the first half of 2023 and expect to realise the commercialization of SM03 in the second half of 2023. Phase 2 results reported in 2020: https://ard.bmj.com/content/79/Suppl_1/131.1 July 2019: SinoMab Biosciences filed IPO in Hong Kong. With SM03, SinoMab is targeting some of the biggest indications in immunology: rheumatoid arthritis (PhIII), systemic lupus erythematosus (PhI) and Sjögren’s syndrome (IND), in addition to non-Hodgkin’s lymphoma (PhII) (https://pbs.twimg.com/media/D--FmREXoAATo12.jpg). NCT04192617 Phase 2 in RA started in Dec 2014. ChiCTR-OIN-15007541 clinical study in China from 2011-12-01 To 2014-03-31: A Phase 1 Open Label Study of the Safety and Pharmacokinetics of SM03, an anti-CD22 antibody, in Chinese Systemic Lupus Erythematosus Subjects With Active Disease. SinoMab Bioscience Limited (SinoMab) is a private company established in 2001 by a team of antibody and biotechnology professionals. It is a clinical stage biopharmaceutical company that creates and develops therapeutic antibodies. Phase 1 results published in Clin Drug Investig. 2016 Nov;36(11):889-902. CONCLUSION: Pharmacokinetic exposure increased in a lower-than-dose-proportional manner up to 900 mg. SM03 was well tolerated at doses ranging from 240 mg/m2 to 900 mg, with no new safety signals identified. SM03 has potential efficacy in Chinese patients with SLE. Phase 1 data also published in MAbs. 2012 Mar-Apr;4(2):256-66. doi: 10.4161/mabs.4.2.19136. |
| Full address of company | No.15 Science Park West Avenue,, Hong Kong Science Park, Pak Shek Kok,, New Territories, Hong Kong Asia China https://www.sinomab.com/contact/ |
SM03 is a novel recombinant, human/mouse chimeric immunoglobulin G1 monoclonal antibody directed against the CD22 antigen on human B lymphocytes
| Anticipated events | Regulatory review China - anticipate approval |
| Factor(s) contributing to discontinuation | None |