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Source: Pharmaceutical Investment Tribe
, Ltd.
(hereinafter referred to as "China Cell Engineering"), received a letter from relevant national departments that its self-developed recombinant new coronavirus 2-valent (Alpha/Beta variant) S trimeric protein vaccine (project code: SCTV01C) was included in emergency use
after demonstration by relevant national departments.
SCTV01C is a new generation of recombinant protein vaccine independently developed by Shenzhou Cell for the above problems, which is clinically intended to prevent diseases
caused by new coronavirus infection.
The active ingredients of SCTV01C contain recombinant S trimeric protein antigens of two WHO-recognized major variants, alpha and beta, respectively, and adopt a new oil-in-water adjuvant
that significantly enhances Th1 cells more than traditional aluminum adjuvants.
SCTV01C received emergency approval from the National Medical Products Administration (hereinafter referred to as "NMPA") for clinical trials in November 2021, and has carried out a number of clinical studies at home and abroad so far, and obtained partial interim analysis and immunopersistence analysis results
.
On November 16, 2022, China Cell announced the results of the phase III sequential enhancement immunosafety and immunogenicity comparison clinical study of
SCTV01C in the UAE.
The data showed that 28 days after booster immunization, the geometric mean (GMT) of neutralizing antibodies induced by mRNA vaccine against the euvirus of Omicron BA.
1 was 1049, while the geometric mean (GMT) of neutralizing antibodies induced by SCTV01C in Shenzhou cells was 1189, and the LSGMR (minimum squares geometric mean ratio) of SCTV01C versus Pfizer mRNA seedlings was 1.
04 (95%) CI 0.
87, 1.
24), the preset non-inferior endpoint (the WHO lower non-inferior boundary criterion is 0.
67).
For the true virus against Omicron BA.
5, the geometric mean (GMT) of neutralizing antibodies induced by mRNA vaccine was 1687 28 days after booster immunization, while the geometric mean (GMT) of neutralizing antibodies induced by Shenzhou Cell SCTV01C was 1736, which was also better than that of mRNA vaccines
.
In addition to the bivalent SCTV01C, Shenzhou Cell also has a quadrivalent new crown vaccine SCTV01E synchronously released research data
.
.
For Omicron BA.
1 and Omicron BA.
5 euviruses, the LSGMRs of SCTV01E compared with Pfizer mRNA seedlings were 1.
55 and 1.
28, respectively, which reached the preset efficacy endpoint
.
In addition, the study data showed that neutralizing antibody titers remained in the higher range of 170-678 at 12 months after booster immunization with SCTV01C, demonstrating the outstanding immune persistence
of SCTV01C.
Shenzhou Cell said that the recombinant new coronavirus 2-valent (Alpha/Beta variant) S trimeric protein vaccine SCTV01C was included in emergency use this time and is not expected to have a significant impact on the company's performance this year; If it is used by relevant national departments for large-scale procurement, it will have a certain positive impact on the company's subsequent performance and help enhance the company's core competitiveness
.
Some market analysts believe that if the vaccine of Shenzhou Cell can be used in large-scale people, it will continue to show the effect of Pfizer's first-generation mRNA vaccine, which will greatly help
the epidemic prevention.
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