On June 22, the NMPA official website showed that IntellimRNA Biotech’s “GR1801” has been approved for marketing in China for passive immunization of adult rabies virus-exposed individuals. Notably, according to Insight Database statistics, this is the first and currently only bispecific antibody drug in the field of rabies.
GR1801 Injection is a recombinant fully human anti-rabies virus (RABV) bispecific antibody independently developed by IntellimRNA Biotech, targeting the envelope glycoprotein (G protein) of RABV. By targeting and binding to epitope I and/or III of the G protein, GR1801 blocks its binding to receptors, thereby preventing viral neural invasion before the active immunity from rabies vaccine fully takes effect, thus preventing rabies. GR1801 is the world’s first bispecific antibody for rabies passive immunization. Its molecular design meets the WHO recommendation for anti-rabies virus antibody development—using a combination of multiple monoclonal antibodies targeting different antigenic sites as a “cocktail” formulation to ensure efficacy against different viral strains or genotypes.
The approval of GR1801 is based on positive results from a parallel-group, randomized, double-blind Phase III clinical study evaluating its use for passive immunization in adults with suspected WHO Category III rabies virus exposure (Registration No.: NCT05846568/CTR20222502), which enrolled as many as 1,200 participants. Previously, IntellimRNA Biotech announced that this Phase III trial had met its primary efficacy endpoint, though clinical data have not yet been disclosed.
According to publicly available information, in previously completed clinical trials of GR1801, the monotherapy at a dose of 0.05 mg/kg demonstrated comparable efficacy to the positive control drug HRIG in terms of onset time, antibody titer levels, positivity rate, and time to peak. At different doses (0.05 mg/kg, 0.1 mg/kg) in combination with vaccine, antibody titer levels within 7 days were significantly superior to the standard therapy of HRIG combined with vaccine. Results from the GR1801-002 clinical trial showed that in both the high- and low-dose GR1801 groups, the positivity rate reached 97.37% and 100% on Day 1, respectively, and maintained 100% positivity for the subsequent 7 days.
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