-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On December 4, China Cell Engineering Co.
, Ltd.
(hereinafter referred to as "China Cell Engineering"), a holding subsidiary of Beijing Shenzhou Cell Biotechnology Group Co.
, Ltd.
(hereinafter referred to as "the Company"), announced that the company's self-developed recombinant new coronavirus 2-valent (Alpha/Beta variant) S trimeric protein vaccine (SCTV01C) was included in emergency use
after the demonstration of relevant national departments.
, Ltd
SCTV01C is a new generation of 2-valent variant recombinant protein vaccine independently developed by China Cell Engineering for the problems of rapid mutation of new coronavirus and the decline of neutralizing antibody titer and protection rate of variant neutralizing antibodies based on the original strain, and is clinically intended to be used to prevent diseases caused by novel coronavirus infection (COVID-19).
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 was approved by the National Medical Products Administration for clinical trials in November 2021, and has carried out a number of clinical studies at home and abroad so far, and obtained some interim analysis and immunopersistence analysis results
。 Preclinical and clinical research data show that the safety profile of SCTV01C is highly similar to that of inactivated seedlings after inoculation.
In terms of immunogenicity, the currently circulating Omicron BA.
1 and BA.
5 variants can induce uniform and ultra-high euvirus neutralizing antibody titers, which meet the preset efficacy endpoint index of comparison with inactivated seedlings and the preset non-inferior endpoint indicators of Pfizer mRNA vaccine, respectively, demonstrating outstanding broad-spectrum cross-protection advantages and efficient anti-infection potential for new variants that may appear in the future.
In addition, neutralizing antibody titers remained in the high range of 170-678 at 12 months after booster immunization with SCTV01C, demonstrating outstanding immune persistence
of SCTV01C.
On December 5, Clover announced that its new coronavirus vaccine SCB-2019 (CpG1018/Aluminum Adjuvant) has been evaluated by Chinese authorities and included in emergency use
in China.
Clover has developed the SCB-2019 antigen, a stable trimeric structural fusion protein (S-trimer ™)
based on the original strain S protein of SARS-CoV-2 (novel coronavirus).
Its new crown vaccine SCB-2019 (CpG1018/aluminum adjuvant) is composed of SCB-2019 antigen combined with two adjuvants, namely CpG of Dynavax
1018 adjuvant and aluminum hydroxide (aluminum adjuvant) composition
.
According to "SPECTRA" PHASE II/III data from Clover enrolling more than 30,000 subjects in five countries around the world, SCB-2019 (CpG
1018/alum) is 100%
protective against severe COVID-19 disease caused by any strain in clinical trials.
Coronavirus vaccine SCB-2019 (CpG
1018/alum) is expected to allow it to be used
as a booster dose regardless of the technical route of the primary immunization vaccine and the history of previous COVID infection.
To date, these clinical trials have shown SCB-2019 (CpG
1018/alum) induced a robust immune response
against variants including Omicron.
Clover's recently released Phase III data show the neutralizing effect of SCB-2019 (CpG 1018/Alum) on a broad spectrum, highlighting SCB-2019 (CpG
1018/alum) as a universal booster in China and other countries, regardless of previous vaccination route or history of infection, and is suitable for different age groups
.
III Data from heterologous booster doses previously administered with inactivated vaccines in phase phase clinical trials
III Data from heterologous booster doses previously administered with inactivated vaccines in phase phase clinical trialsBased on data from Clover as a heterologous booster shot of a previously administered inactivated vaccine in a Phase III clinical trial released in the third quarter of this year, SCB-2019 showed a broad-spectrum neutralizing effect
.
For the globally dominant Omicron
In the BA.
5 variant subtype and other Omicron variant subtypes (BA.
1, BA.
2), SCB-2019 as a heterologous third dose induced 5-6 times higher neutralizing antibody levels compared with the third dose of inactivated vaccine, and the immune response against the original novel coronavirus strain was 12 times
higher in subjects who received two previous doses of inactivated vaccine.
Phase II/III clinical trials showed a robust neutralizing response against Omicron BA.
5
5
Among subjects who had previously received two doses of inactivated vaccine, data on SCB-2019 as a heterologous third booster were consistent with the results published in August, namely when SCB-2019 was used as a homologous third booster dose, or when people with a history of prior COVID infection were vaccinated against the dominant Omicron
The BA.
5 variant subtype produced a robust immune response
.
Significantly reduce household transmission of the new crown
Significantly reduce household transmission of the new crownOn November 30, Clover and the International Vaccine Institute jointly announced Clinical Infectious
Diseases publishes additional data from SPECTRA, a global phase II/III clinical trial.
Compared with placebo subjects, vaccination with SCB-2019 vaccine reduced the risk of transmission of
the new coronavirus in family members.
The study data showed that household contacts of household contacts who had been vaccinated with SCB-2019 were 84%
less likely to be infected than households with infected family members who were not vaccinated.
Clover production base in Changxing, Zhejiang
Clover is seeking regulatory approval for SCB-2019 from the European Medicines Agency and the World Health Organization, and is actively preparing for commercialization
in China and globally.
It is understood that Zhejiang Clover has obtained the "Drug Production License" issued by the Zhejiang Provincial Drug Administration, and its CDMO has successfully passed the European Union (EMA)
GMP verification and has obtained the EU GMP certificate
for SCB-2019 production.
On December 5, with the approval of relevant national departments, the recombinant novel coronavirus protein vaccine (Sf9 cell) developed by West China Hospital of Sichuan University and Chengdu Wesker Biotechnology Co.
, Ltd.
was included in emergency use (EUA), contributing to the prevention and control of the new crown epidemic in China and the world
.
This is China's first recombinant protein novel coronavirus protein vaccine produced by the insect cell technology platform approved for emergency use, and it is also the first new crown vaccine
approved for emergency use led by Chinese universities.
, Ltd.
Recombinant Novel Coronavirus Protein Vaccine (Sf9 Cells) Wickxin Included in Emergency Use (EUA)
In 2020, Wesker Biotech completed a financing of 300 million yuan, led by Shanghai Pharmaceutical, and subsequently completed multiple rounds of financing to introduce investors such as CDH Investment and CICC Capital
.
The scientific research team led by Professor Wei Yuquan, academician of the Chinese Academy of Sciences and director of the State Key Laboratory of Biotherapy at West China Hospital of Sichuan University, is the core team of Wesker Biologics, specializing in vaccine R&D and production and immunotherapy
.
In addition to using insect cells to develop new crown vaccines, Wesker is also using insect cell technology to develop and produce more than 20 immunotherapy innovative products such as rabies vaccines, influenza vaccines, herpesvirus vaccines, and a variety of tumor vaccines, and has obtained and applied for more than 30 patents for related products and technologies
.
After the outbreak of the new crown epidemic in early 2020, Sichuan University actively practiced the responsibility mission of a research university as a national strategic scientific and technological force, gave full play to its advantages in vaccine research and development, and actively invested in scientific and technological actions against the new crown
.
The team of scientists from the State Key Laboratory of Biotherapy of West China Hospital of Sichuan University has been approved and funded by the vaccine research and development special class of the scientific research group of the joint prevention and control mechanism of the State Council, which is one of the five new crown vaccine research and development technical routes funded by the state, and has received strong support
from relevant central ministries and commissions such as the Ministry of Education, as well as leaders of Sichuan Province and Chengdu City and relevant departments of high-tech zones.
The data show that Wickxin can significantly induce neutralizing antibodies against new coronavirus prototypes and variants, and sequential booster immunization on the basis of existing vaccine immunization can obtain a stronger immune response
.
In terms of preparation technology, Wickxin uses internationally advanced production technology to introduce the gene of the new coronavirus into insect cells, prepare the new coronavirus S protein, induce the human body to produce antibodies to block the virus infection, and has achieved large-scale production
.
The use of insect cells to produce recombinant new crown protein vaccine not only has good protein expression quality, but also has high
safety.
At present, this technical route has been applied to vaccine production internationally, and recombinant protein vaccines such as influenza vaccines and cervical cancer vaccines have been marketed
.
West China Hospital of Sichuan University actively supports the industrialization of the vaccine and established Chengdu Wesker Biotechnology Co.
, Ltd.
in Chengdu High-tech Zone to promote the industrialization
of the vaccine.
As an innovative biopharmaceutical enterprise integrating vaccine R&D, production and sales, it has been successfully selected as a unicorn enterprise
for two consecutive years in 2021-2022.
Wesker Biotech has a mature insect cell expression platform, new adjuvant platform, bacterial vaccine platform, tumor vaccine platform and immunotherapy platform, and has more than 20 product pipelines such as new crown vaccine, multivalent influenza vaccine, herpesvirus vaccine, tumor immune preparation, etc
.
In the future, Wesker Biotech will adhere to the corporate proposition of "life trust, science and technology", become an international advanced vaccine and immunotherapy platform, seek innovation for the prevention and defeat of human diseases, let innovative vaccines and immunotherapies from China to the world, and protect the brilliance of more lives!
