drugset
Drugs / SM03
last change Jul 2025 re-read 3 minutes ago

SM03

Monoclonal antibody targets CD22

Developed for
rheumatoid arthritis
Investigated by
SinoMab BioScience Ltd

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed China (NMPA) — rheumatoid arthritis 2023-09-05

“has accepted the biologics license application (‘‘BLA’’) for SM03, in the treatment of RA on 5 September 2023.” sinomab.com ↗

Trials 3

today NCT04312815 · Ph 3 NCT04192617 · Ph 2 NCT04704492 · Ph 1
201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04704492 Aug 2012 → Dec 2013 rheumatoid arthritis SinoMab BioScience Ltd Completed No outcome recorded
Phase 21 trial · 1 met primary
Phase 2 NCT04192617 Dec 2014 → Feb 2016 rheumatoid arthritis SinoMab BioScience Ltd Completed Met primary
Phase 31 trial · 1 met primary
Phase 3 NCT04312815 Dec 2017 → Dec 2021 rheumatoid arthritis SinoMab BioScience Ltd Unknown Met primary

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2025-07-10 SinoMab BioScience Ltd Results SinoMab (03681.HK) Globally First-in-Class SM03 (Suciraslimab) Achieves Breakthrough Preclinical Results in SLE, DemonstraƟng PosiƟve Immune ModulaƟon with PotenƟal MulƟ-Organ ProtecƟon and Superior Long-Term Safety sinomab.com ↗
2025-02-11 SinoMab BioScience Ltd Results Article Published on Journal of Neuroinflammation Revealing Suciraslimab’s Dual Mechanism of Action in Combating Alzheimer’s Disease: Anti-Inflammation and Promotion of Amyloid-Beta Clearance sinomab.com ↗
2023-11-15 SinoMab BioScience Ltd Regulatory SinoMab Submits Another IND Application for Flagship Product SM03 (Suciraslimab) for the Treatment of Alzheimer’s Disease, Which was Accepted by NMPA CDE sinomab.com ↗
an Investigational New Drug application (‘‘IND’’), for Mild Cognitive Impairment (‘‘MCI’’) or Mild Dementia due to Alzheimer’s Disease (‘‘AD’’) for Suciraslimab has been filed with and accepted by the Center for Drug Evaluation
2023-09-19 SinoMab BioScience Ltd Results Dr. Shui On LEUNG , Chairman of SinoMab, was Invited to Attend IFRA 2023 Showcases the Clinical Trial Results of SM03 (Suciraslimab) and Receives International Recognition sinomab.com ↗
2023-04-26 SinoMab BioScience Ltd Results SinoMab Announces that Phase III Clinical Trial of its Flagship Product SM03 (Suciraslimab) Achieved the Primary Endpoint for Rheumatoid Arthritis sinomab.com ↗
SinoMab Announces that Phase III Clinical Trial of its Flagship Product SM03 (Suciraslimab) Achieved the Primary Endpoint for Rheumatoid Arthritis
2020-06-10 SinoMab BioScience Ltd Results SinoMab Announces Clinical Results on its First-in-target SM03 at EULAR 2020 Congress sinomab.com ↗
Professor Zhang said that SM03 has shown significant efficacy for the treatment for RA without increase in adverse events.

All press releases naming this drug 8 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as SM03 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04192617 ↗
2

NCT04312815 ↗

NCT04704492 ↗
Modality Monoclonal antibody “SM03, an anti-human CD22 monoclonal antibody” PMID 34508557 ↗ May 2022
Route Intravenous “SM03: 600 mg intravenous (IV)” NCT04192617 ↗
Target CD22 “SM03, a novel chimaeric mAb specific to B cell-restricted antigen CD22” PMID 34508557 ↗ May 2022