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SinocellTech's Recombinant Protein COVID-19 Vaccine SCTV01C Approved for Emergency Use in China

07/12/2022 | Qiming Venture Partners

Qiming Venture Partners' portfolio company SinocellTech (SHSE: 688520) announced that its self-developed bivalent (Based on Alpha and Beta Variants) recombinant trimeric S protein vaccine against SARS-CoV-2 variants SCTV01C has been included for emergency use in China.

SCTV01C is a new-generation bivalent 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 SCTV01C comprise of trimeric spike extracellular domain (S-ECD) of SARS-CoV-2 variants Alpha (B.1.1.7) and Beta (B.1.351), and adjuvanted with SCT-VA02B, an oil-in-water emulsion.

SCTV01C received emergency approval from the National Medical Products Administration of China in November 2021 to conduct clinical trials. So far, several clinical studies domestically and abroad have obtained results from interim analysis and immune persistence analysis.

Data from preclinical and clinical studies have shown that the safety of SCTV01C is highly similar to that of inactivated vaccines. In terms of immunogenicity, SCTV01C can induce uniform and ultra-high layers of true virus-neutralizing antibodies against current circulating Omicron BA.1 and BA.5 variants, respectively achieving the preset superior efficacy endpoint index of inactivated vaccine and the preset non-inferior endpoint index for the comparison to Pfizer mRNA vaccine. It showed outstanding advantages of broad-spectrum cross-protection and the potential of effective control of infection against new mutant strains that may appear in the future.

In addition, 12 months after booster immunization with SCTV01C, the neutralizing antibody layer still maintained in the high range of 170–678, demonstrating the outstanding immune persistence of SCTV01C.