Drug intelligence / Profile preview

SIM1907-05

Development stage
Unknown
Lead developer
Simcere Pharmaceutical Group
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Administration
Intradermal
01

Overview

SIM1907-05 is a recombinant Mycobacterium tuberculosis fusion protein consisting of the 6 kDa early secretory antigenic target (ESAT-6) and the 10 kDa culture filtrate protein (CFP-10). Developed by Simcere Pharmaceutical in collaboration with the Shanghai Public Health Clinical Center, it is designed as an immunotherapy or preventive vaccine for latent tuberculosis infection (LTBI). The fusion protein targets specific antigens that are present in virulent M. tuberculosis but absent in the Bacillus Calmette-Guérin (BCG) vaccine strain, allowing it to stimulate a targeted T-cell mediated immune response. SIM1907-05 is currently being evaluated in Phase 3 clinical trials in China as a short-course preventive treatment to reduce the risk of LTBI progressing to active tuberculosis, positioning it as a potential alternative or adjunct to traditional long-term antibiotic regimens like isoniazid and rifapentine. While the same fusion protein is used as a diagnostic skin test (brand name Ekear), SIM1907-05 refers specifically to the therapeutic development program.

Other names
Recombinant Mycobacterium tuberculosis fusion protein (EC)EC fusion proteinESAT6-CFP10 fusion proteinESAT-6-CFP10 fusion proteinESAT 6-CFP10 fusion protein
02

Targets

ESAT-6/CFP-10-specific T-cell receptor

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