Qiming Venture Partners' portfolio company SinocellTech (SHSE: 688520) announced that its self-developed quadrivalent (based on Alpha/Beta/Delta/Omicron variants) recombinant S-Trimer protein vaccine against SARS-CoV-2 virus SCTV01E was included for emergency use in China.
SCTV01E is the world's first quadrivalent COVID-19 vaccine and SinocellTech's second COVID-19 vaccine product to be approved for emergency use in China after SCTV01C, the bivalent (Based on Alpha and Beta variants) recombinant trimeric S protein vaccine against the SARS-CoV-2 virus.
SCTV01E is a new-generation quadrivalent recombinant protein vaccine developed by SinocellTech for the prevention of disease caused by SARS-CoV-2 virus infection, in response to the rapid mutation of the SARS-CoV-2 virus and the decline in the neutralization antibody level and protection rate of the first-generation vaccines at home and abroad based on the original strains.
The active ingredients of SCTV01E contain the recombinant S trimer protein antigens of four major variants identified by WHO - Alpha, Beta, Delta, and Omicron, and adjuvanted with an oil-in-water emulsion that can significantly enhance Th1 cells than traditional aluminum adjuvants. As a new-generation quadrivalent recombinant protein vaccine, SCTV01E is an upgraded version based on SCTV01C.
SCTV01E received emergency approval from China's National Medical Products Administration in November 2022 for clinical trials. Many clinical trials are being conducted right now both domestically and internationally. The clinical data show that SCTV01E has demonstrated strengths of broad-spectrum cross-protection and the potential of effective control of infection against new mutant strains that may appear in the future.
Data from preclinical and clinical studies have shown that the safety of SCTV01E is highly similar to that of inactivated vaccines. In terms of immunogenicity, SCTV01E can induce uniform and ultra-high layers of true virus-neutralizing antibodies against Omicron BA.1 and BA.5 variants, achieving the preset superior efficacy endpoint index compared to the inactivated vaccine and Pfizer mRNA vaccine.