Drug intelligence / Profile preview

CS-2034

Development stage
Phase 2
Lead developer
CanSino Biologics
Modality
Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems, mRNA Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

**CS-2034** is an investigational mRNA COVID-19 vaccine developed by CanSino Biologics. It encodes a prefusion conformation-stabilized, full-length SARS-CoV-2 spike protein based on the original strain, incorporating four convergent mutations (K417N, E484K, N501Y, D614G) for enhanced immunogenicity. The vaccine is codon-optimized, nucleotide-modified, lipid nanoparticle-formulated (using four lipids), and supplied at 0.1 mg/mL in single-dose vials with excipients like tromethamine, sodium acetate, and sucrose. In phase II trials, low-dose (25 µg, 0.3 mL) and high-dose (50 µg, 0.5 mL) regimens showed favorable safety (mild-moderate reactogenicity) and strong humoral responses, including 100% seroconversion for neutralizing antibodies against the ancestral strain, with the low dose selected for further development due to comparable efficacy and lower reactogenicity. Phase IIb data as a heterologous booster post-inactivated vaccines demonstrated superior neutralizing titers (e.g., 29-fold higher vs. BA.5) and protection against Omicron subvariants.[1][2]

Other names
mrna vaccine-Yu Qin-COVID-19CanSino mRNA COVID-19 vaccine
02

Targets

SARS-CoV-2 spike

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