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Recent popular reports from Yimike ★Fosun Pharma announces the progress of domestic clinical trials of mRNA COVID-19 vaccine for the first time, and the safety and effectiveness data show that it is consistent with overseas ★Fosun Pharma announces 2020 annual results: a number of innovations have accelerated the transformation and implementation of global commercialization capabilities Significant improvementMedMed broke the news on April 24, 2021/eMedClub News/--Recently, Nature Medicine published the results of a phase 1 clinical trial in China of the mRNA new crown vaccine BNT162b1 jointly developed by Fosun Pharma/German BioNTech This is the first time that Fosun Pharma has disclosed the complete clinical data of BNT162b1 in China.
BNT162b1 is an mRNA vaccine developed based on BioNTech’s proprietary mRNA technology platform, which encodes the receptor binding domain (RBD) antigen of the new coronavirus spike protein and is delivered via lipid nanoparticles (LNP).
The Phase 1 clinical trial was conducted in Jiangsu Province, China, to evaluate the preliminary safety, tolerability and immunogenicity of BNT162b1 in the Chinese population.
The latest research data show that: BNT162b1 has acceptable safety and can produce high levels of humoral and cellular immune responses in Asian populations.
On March 16, 2020, BioNTech and Fosun Pharma announced a strategic cooperation agreement.
The two parties will jointly develop and commercialize vaccine products (including BNT162b1 and BNT162b2) against the new coronavirus in Greater China based on BioNTech's proprietary mRNA technology platform.
.
In July 2020, BNT162b1 officially launched Phase 1 clinical trial in China.
The Phase 1 clinical trial is in charge of the Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Public Health Research Institute).
The trial site is located in the Vaccine Engineering Center of China Medical City, Taizhou City.
Control Center, Taizhou People’s Hospital and other units jointly participated.The clinical data of BNT162b1 in China was first released from July 18, 2020 to August 14, 2020.
144 subjects were randomly assigned at a ratio of 1:1:1, and received BNT162b1 (dose 10μg) and BNT162b1 ( The dose is 30 µg) and placebo for the initial and booster immunizations.
The interval between the two vaccinations is 21 days.
The study subjects were mainly in two age groups, 18-55 years old (young group) and 65-85 years old (old group), and the two age groups were enrolled in the same group.
In terms of vaccine-induced antibody response, BNT162b1 vaccination can induce a significant neutralizing antibody response.
In the third week after the second dose of BNT162b1 inoculation, the geometric mean titers (GMT) of neutralizing antibodies in the young group at 10 µg and 30 µg in the young group were 232.
9 and 254; the GMT in the elderly group at 10 µg and 30 µg was 80 and 160.
Compared with convalescent controls, the average neutralizing potency of BNT162b1 reached 2.
1 times (young group) and 1.
3 times (old group) at a dose of 30ug.
In terms of vaccine-induced T cell response, Sp1-reactive T cells (Sp1-reactive T cells) increased significantly on the 7th day after the booster dose of BNT162b1, regardless of dose and age.
In terms of safety: The local and systemic reactions induced by BNT162b1 vaccination are usually dose-dependent, and are mainly transient and mild to moderate.
Grade 3 fever is the only serious adverse reaction related to the BNT162b1 vaccine.
The overall frequency of local adverse reactions after the initial and booster vaccination of the BNT162b1 vaccine was similar.
Overall, the BNT162b1 vaccine has acceptable safety.
It can induce strong humoral and cellular immune responses in healthy Asian adults of different ages (18-55 and 65-85 years), providing protection against the new crown The protection and immunity are consistent with overseas data.This study confirmed the safety and effectiveness of the mRNA-based new crown vaccine BNT162b1 in Asian populations, and provided more support for the development and popularization of mRNA vaccines in Asian populations.
Provide support for the second phase of b2 in China On November 24, 2020, Fosun Pharma started the Phase II clinical trial of BNT162b2 in mainland China.
Up to now, the enrollment of 960 subjects in the domestic phase II clinical trial of the BNT162b2 vaccine and the two-dose vaccination program with an interval of 21 days have been completed.
At present, no serious adverse reactions related to the vaccine have been found in the follow-up.
Recommended reading: Fosun Pharma announced for the first time the progress of the domestic clinical trial of mRNA COVID-19 vaccine.
The safety and efficacy data show that it is consistent with overseas.
According to the results of the global phase III clinical trial of BNT162b2, BNT162b2 has reached all the main efficacy endpoints and is in the prevention of COVID-19.
The effectiveness of infection is 95%, and the effectiveness of adults over 65 years old is more than 94%, showing consistent effectiveness across all ages, genders, races, and ethnic groups.
Compared with the placebo group, it showed obvious protective effect as early as 12 days after the first injection, and the protection rate reached 52% after only one injection.
At present, the BNT162b2 vaccine has been authorized for use by health regulatory authorities in more than 65 countries and regions including the United Kingdom, the United States, Canada, Israel, and the European Union.
Fosun Pharma is responsible for the R&D and commercialization of the BNT162b2 vaccine in the Greater China region.
It was approved for emergency use in Hong Kong, China on January 25, 2021, and was granted a special import permit in Macau, China on February 23, 2021.
As of April 23, 2021, since the launch of the vaccination plan, the Hong Kong Special Administrative Region government has vaccinated the citizens with a total of 559,000 doses of BNT162b2, of which about 409,400 citizens have received the first dose of the vaccine.
Approximately 149,600 citizens have received the second dose of vaccine.
There are currently 24 community vaccination centers in Hong Kong that provide appointments for vaccination of Fubitai vaccine. As of 4 pm on April 23, a total of 150,647 people in the Macao Special Administrative Region have scheduled appointments for vaccinations against the new crown vaccine (including the inactivated vaccine and Fubitai mRNA vaccine).
Among them, a total of 90,063 people have completed vaccination.
Summary my country's epidemic prevention and control has achieved major strategic results.
The epidemic has been effectively controlled on the whole, but the risk of rebound cannot be ignored in the slightest.
The global epidemic is still in a pandemic, and normalized epidemic prevention and control still cannot be relaxed.
Carrying out new crown pneumonia vaccination is the most powerful measure to prevent and control the epidemic, and it is also the most important strategy for my country's current prevention and control of the new crown pneumonia epidemic.
At present, no new coronavirus vaccine based on mRNA technology has been approved for use in mainland China.
Gao Fu, director of the Chinese Center for Disease Control and Prevention, called for “mRNA vaccines” at the 2021 National Vaccine and Health Conference.
He said that we cannot ignore mRNA vaccines just because there are already several new coronavirus vaccines in our country.
Innovative thinking is needed to create mRNA vaccines creatively.
In addition, Gao Fu said that mRNA technology will provide various opportunities for infectious diseases, AIDS, genetic diseases, rare diseases, and tumors.
He hopes that when developing classic traditional vaccines, it will take into account the benefits that mRNA vaccines may bring to humans.
At the same time, domestic vaccination hesitation is still common.
At the 2021 National Vaccine and Health Conference, experts have stated that the new crown virus is the common enemy of all mankind.
Before the world has reached herd immunity, the international community should not respond to the epidemic.
Take it lightly.
At present, the production capacity and accessibility of the new crown vaccine are improving, and the current citizens must accelerate the process of vaccination, so as to protect their health and return to normal life as soon as possible.
Reference materials: 1.
Yimike has always been committed to the cutting-edge technology, industry trends, industry insights and other original news reports of bio-innovative drugs, all-media high-end matrix There are 160,000+ users, of which industrial users account for more than 50%, scientific research and clinical users are about 30%, and investment institutions account for more than 5%. In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
BNT162b1 is an mRNA vaccine developed based on BioNTech’s proprietary mRNA technology platform, which encodes the receptor binding domain (RBD) antigen of the new coronavirus spike protein and is delivered via lipid nanoparticles (LNP).
The Phase 1 clinical trial was conducted in Jiangsu Province, China, to evaluate the preliminary safety, tolerability and immunogenicity of BNT162b1 in the Chinese population.
The latest research data show that: BNT162b1 has acceptable safety and can produce high levels of humoral and cellular immune responses in Asian populations.
On March 16, 2020, BioNTech and Fosun Pharma announced a strategic cooperation agreement.
The two parties will jointly develop and commercialize vaccine products (including BNT162b1 and BNT162b2) against the new coronavirus in Greater China based on BioNTech's proprietary mRNA technology platform.
.
In July 2020, BNT162b1 officially launched Phase 1 clinical trial in China.
The Phase 1 clinical trial is in charge of the Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Public Health Research Institute).
The trial site is located in the Vaccine Engineering Center of China Medical City, Taizhou City.
Control Center, Taizhou People’s Hospital and other units jointly participated.The clinical data of BNT162b1 in China was first released from July 18, 2020 to August 14, 2020.
144 subjects were randomly assigned at a ratio of 1:1:1, and received BNT162b1 (dose 10μg) and BNT162b1 ( The dose is 30 µg) and placebo for the initial and booster immunizations.
The interval between the two vaccinations is 21 days.
The study subjects were mainly in two age groups, 18-55 years old (young group) and 65-85 years old (old group), and the two age groups were enrolled in the same group.
In terms of vaccine-induced antibody response, BNT162b1 vaccination can induce a significant neutralizing antibody response.
In the third week after the second dose of BNT162b1 inoculation, the geometric mean titers (GMT) of neutralizing antibodies in the young group at 10 µg and 30 µg in the young group were 232.
9 and 254; the GMT in the elderly group at 10 µg and 30 µg was 80 and 160.
Compared with convalescent controls, the average neutralizing potency of BNT162b1 reached 2.
1 times (young group) and 1.
3 times (old group) at a dose of 30ug.
In terms of vaccine-induced T cell response, Sp1-reactive T cells (Sp1-reactive T cells) increased significantly on the 7th day after the booster dose of BNT162b1, regardless of dose and age.
In terms of safety: The local and systemic reactions induced by BNT162b1 vaccination are usually dose-dependent, and are mainly transient and mild to moderate.
Grade 3 fever is the only serious adverse reaction related to the BNT162b1 vaccine.
The overall frequency of local adverse reactions after the initial and booster vaccination of the BNT162b1 vaccine was similar.
Overall, the BNT162b1 vaccine has acceptable safety.
It can induce strong humoral and cellular immune responses in healthy Asian adults of different ages (18-55 and 65-85 years), providing protection against the new crown The protection and immunity are consistent with overseas data.This study confirmed the safety and effectiveness of the mRNA-based new crown vaccine BNT162b1 in Asian populations, and provided more support for the development and popularization of mRNA vaccines in Asian populations.
Provide support for the second phase of b2 in China On November 24, 2020, Fosun Pharma started the Phase II clinical trial of BNT162b2 in mainland China.
Up to now, the enrollment of 960 subjects in the domestic phase II clinical trial of the BNT162b2 vaccine and the two-dose vaccination program with an interval of 21 days have been completed.
At present, no serious adverse reactions related to the vaccine have been found in the follow-up.
Recommended reading: Fosun Pharma announced for the first time the progress of the domestic clinical trial of mRNA COVID-19 vaccine.
The safety and efficacy data show that it is consistent with overseas.
According to the results of the global phase III clinical trial of BNT162b2, BNT162b2 has reached all the main efficacy endpoints and is in the prevention of COVID-19.
The effectiveness of infection is 95%, and the effectiveness of adults over 65 years old is more than 94%, showing consistent effectiveness across all ages, genders, races, and ethnic groups.
Compared with the placebo group, it showed obvious protective effect as early as 12 days after the first injection, and the protection rate reached 52% after only one injection.
At present, the BNT162b2 vaccine has been authorized for use by health regulatory authorities in more than 65 countries and regions including the United Kingdom, the United States, Canada, Israel, and the European Union.
Fosun Pharma is responsible for the R&D and commercialization of the BNT162b2 vaccine in the Greater China region.
It was approved for emergency use in Hong Kong, China on January 25, 2021, and was granted a special import permit in Macau, China on February 23, 2021.
As of April 23, 2021, since the launch of the vaccination plan, the Hong Kong Special Administrative Region government has vaccinated the citizens with a total of 559,000 doses of BNT162b2, of which about 409,400 citizens have received the first dose of the vaccine.
Approximately 149,600 citizens have received the second dose of vaccine.
There are currently 24 community vaccination centers in Hong Kong that provide appointments for vaccination of Fubitai vaccine. As of 4 pm on April 23, a total of 150,647 people in the Macao Special Administrative Region have scheduled appointments for vaccinations against the new crown vaccine (including the inactivated vaccine and Fubitai mRNA vaccine).
Among them, a total of 90,063 people have completed vaccination.
Summary my country's epidemic prevention and control has achieved major strategic results.
The epidemic has been effectively controlled on the whole, but the risk of rebound cannot be ignored in the slightest.
The global epidemic is still in a pandemic, and normalized epidemic prevention and control still cannot be relaxed.
Carrying out new crown pneumonia vaccination is the most powerful measure to prevent and control the epidemic, and it is also the most important strategy for my country's current prevention and control of the new crown pneumonia epidemic.
At present, no new coronavirus vaccine based on mRNA technology has been approved for use in mainland China.
Gao Fu, director of the Chinese Center for Disease Control and Prevention, called for “mRNA vaccines” at the 2021 National Vaccine and Health Conference.
He said that we cannot ignore mRNA vaccines just because there are already several new coronavirus vaccines in our country.
Innovative thinking is needed to create mRNA vaccines creatively.
In addition, Gao Fu said that mRNA technology will provide various opportunities for infectious diseases, AIDS, genetic diseases, rare diseases, and tumors.
He hopes that when developing classic traditional vaccines, it will take into account the benefits that mRNA vaccines may bring to humans.
At the same time, domestic vaccination hesitation is still common.
At the 2021 National Vaccine and Health Conference, experts have stated that the new crown virus is the common enemy of all mankind.
Before the world has reached herd immunity, the international community should not respond to the epidemic.
Take it lightly.
At present, the production capacity and accessibility of the new crown vaccine are improving, and the current citizens must accelerate the process of vaccination, so as to protect their health and return to normal life as soon as possible.
Reference materials: 1.
Yimike has always been committed to the cutting-edge technology, industry trends, industry insights and other original news reports of bio-innovative drugs, all-media high-end matrix There are 160,000+ users, of which industrial users account for more than 50%, scientific research and clinical users are about 30%, and investment institutions account for more than 5%. In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
