UB652
ProductInfliximab injection
Strength100mg/vial
IndicationsRheumatoid arthritis; Ankylosing spondylitis; Psoriasis; Crohn's disease; Ulcerative colitis
TherapeuticsImmunology & Inflammation; Rheumatology; Gastroenterology & Hepatology; Dermatology
GMPCN - NMPA; PIC/S
RegistrationChina
ModalitiesAntibody
Exclusive Summary
- Proven Bioequivalence: Robust head-to-head clinical data (Ph1 & Ph3) demonstrating high similarity to the reference product (Remicade®) in pharmacokinetics, efficacy (PASI 75), and immunogenicity.
- Established Commercial Capability: NMPA-approved since Sep 2021 with a stable supply chain backed by a 200 million RMB production line investment.
- Broad Indication Coverage: Covers major autoimmune indications (RA, AS, CD, PsO), serving the high demand for cost-effective biologics in global markets.
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