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Cervical cancer is the second most common malignancy in women aged 15-44
.
It is estimated that there are about 109,000 new cases of cervical cancer in China each year, resulting in about 59,000 deaths
.
Persistent infection of high-risk human papillomavirus (HPV) is the main cause of cervical cancer in women, of which HPV types 16 and 18 are the most harmful, causing about 70% of cervical cancers
.
In 2020, the World Health Organization (WHO) released the "Global Strategy to Accelerate the Elimination of Cervical Cancer", which proposed to achieve the goal of "more than 90% coverage of HPV vaccine for girls under 15 years old" by 2030
.
For a long time in the past, only three preventive HPV vaccines have been approved for use in the world, and their high prices and insufficient production capacity have greatly hindered the promotion and application of HPV vaccines
.
Xin Ke Ning®, the first domestic bivalent HPV vaccine jointly developed by Xiamen University and Wantai Bio, was launched in China in December 2019, with two doses approved for 9-14 years old and three doses for 15-45-year-old women The program will pass the World Health Organization PQ certification in 2021 and be approved for marketing in Morocco and Nepal in 2022, contributing to the prevention and control of cervical cancer in China and the world
.
On August 26, 2022, 17 domestic research teams, including Xia Ningshao's team from Xiamen University, cooperated and published a paper entitled: Efficacy in The Lancet Infectious diseases, a sub-journal of The Lancet.
, safety, and immunogenicity of an Escherichia coliproduced Human Papillomavirus (16 and 18) L1 virus-like particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial clinical trial paper
.
This is the first terminal analysis study of a phase III clinical trial of a domestic bivalent HPV vaccine
.
The results showed that the HPV vaccine showed extremely high protective efficacy in preventing HPV 16/18-related lesions and persistent infection in women aged 18-45 during the 66-month follow-up period
.
The research team carried out a multi-center, randomized, double-blind, controlled (hepatitis E vaccine Yikening®) Phase III clinical trial of Xinkening® based on 5 sites across the country.
3683 people and the control group) were followed up for 66 months
.
In 2019, the results of the interim analysis of the 42-month follow-up of the study were published in JNCI: Journal of the National Cancer Institute, and the data showed that the vaccine was associated with HPV type 16 and/or 18 infection in the per-protocol set (PPS) population.
The protection rate for high-grade genital lesions endpoints (CIN2+ and/or VIN2+ and/or VaIN2+) was 100.
0%, and the protection rate against HPV type 16 and/or type 18 persistent infection (over 6 months) was 97.
8%.
The promotion and application of Xinke Ning ®, its long-term effectiveness and safety have attracted people's attention
.
The results of the final analysis of the 66-month follow-up of the Phase III clinical trial of CINCONYL® showed that in the per-protocol set (PPS) population, the vaccine was effective against HPV type 16 and/or 18 infection-related lesion endpoints (CIN2+ and/or or VIN2+ and/or VaIN2+) protection was 100.
0% (95% CI: 67.
2%-100.
0%), and the protective efficacy was 100.
0% (95% CI: 67.
2%-100.
0%) in the 18-26 and 27-45 age groups, respectively : 40.
6%-100.
0%) and 100.
0% (95% confidence interval: -7.
7%-100.
0%)
.
Protection against persistent HPV type 16 and/or 18 infection (over 6 months) was 97.
3% (95% confidence interval: 89.
9%-99.
7%), protection between the 18-26 and 27-45 age groups The powers were 93.
9% (95% CI: 76.
3%-99.
3%) and 100.
0% (95% CI: 90.
6%-100.
0%), respectively
.
Cumulative incidence of high-grade genital lesions and persistent infections associated with HPV 16/18 in the PPS population
The vaccine was safe, with no serious adverse events related to vaccination and no pregnancy outcomes related to vaccination throughout the study period and abnormalities in neonatal health
.
The vaccine is effective in inducing high levels of HPV type 16 and 18 neutralizing antibodies and IgG antibodies in subjects for at least 66 months
.
The results of this study confirm that Cincoline® has excellent efficacy and good safety in susceptible women aged 27-45 and 18-26 years old, and can effectively prevent HPV types 16 and/or 18-related Cervical high-grade precancerous lesions and persistent infection
.
Professor Zhao Fanghui of Cancer Hospital of Chinese Academy of Medical Sciences, Professor Wu Ting of School of Public Health of Xiamen University, Chief Physician Hu Yuemei of Jiangsu Provincial Center for Disease Control and Prevention, Professor Wei Lihui of Peking University People's Hospital, Chief Physician Liming Qiang of Liuzhou Center for Disease Control and Prevention, China Food and Drug Control Research Researcher Huang Weijin of the Academy of Sciences, Professor Chen Wen of Cancer Hospital of Chinese Academy of Medical Sciences, and Professor Huang Shoujie of Xiamen University School of Public Health are the co-first authors of the paper
.
Professor Xia Ningshao, School of Public Health, Xiamen University, Professor Qiao Youlin, School of Qun Medicine and Public Health, Chinese Academy of Medical Sciences, and Professor Zhang Jun, School of Public Health, Xiamen University are the co-corresponding authors of the paper
.
The research was supported by the National Natural Science Foundation of China, the National Key R&D Program, the Fujian Provincial Health Education Joint Research Program, the Fujian Provincial Natural Science Foundation, the Central University R&D Fund, the Innovation Unit of the Chinese Academy of Medical Sciences, and Xiamen Wantai Canghai Biotechnology Co.
,
Ltd.
Paper link:
.
It is estimated that there are about 109,000 new cases of cervical cancer in China each year, resulting in about 59,000 deaths
.
Persistent infection of high-risk human papillomavirus (HPV) is the main cause of cervical cancer in women, of which HPV types 16 and 18 are the most harmful, causing about 70% of cervical cancers
.
In 2020, the World Health Organization (WHO) released the "Global Strategy to Accelerate the Elimination of Cervical Cancer", which proposed to achieve the goal of "more than 90% coverage of HPV vaccine for girls under 15 years old" by 2030
.
For a long time in the past, only three preventive HPV vaccines have been approved for use in the world, and their high prices and insufficient production capacity have greatly hindered the promotion and application of HPV vaccines
.
Xin Ke Ning®, the first domestic bivalent HPV vaccine jointly developed by Xiamen University and Wantai Bio, was launched in China in December 2019, with two doses approved for 9-14 years old and three doses for 15-45-year-old women The program will pass the World Health Organization PQ certification in 2021 and be approved for marketing in Morocco and Nepal in 2022, contributing to the prevention and control of cervical cancer in China and the world
.
On August 26, 2022, 17 domestic research teams, including Xia Ningshao's team from Xiamen University, cooperated and published a paper entitled: Efficacy in The Lancet Infectious diseases, a sub-journal of The Lancet.
, safety, and immunogenicity of an Escherichia coliproduced Human Papillomavirus (16 and 18) L1 virus-like particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial clinical trial paper
.
This is the first terminal analysis study of a phase III clinical trial of a domestic bivalent HPV vaccine
.
The results showed that the HPV vaccine showed extremely high protective efficacy in preventing HPV 16/18-related lesions and persistent infection in women aged 18-45 during the 66-month follow-up period
.
The research team carried out a multi-center, randomized, double-blind, controlled (hepatitis E vaccine Yikening®) Phase III clinical trial of Xinkening® based on 5 sites across the country.
3683 people and the control group) were followed up for 66 months
.
In 2019, the results of the interim analysis of the 42-month follow-up of the study were published in JNCI: Journal of the National Cancer Institute, and the data showed that the vaccine was associated with HPV type 16 and/or 18 infection in the per-protocol set (PPS) population.
The protection rate for high-grade genital lesions endpoints (CIN2+ and/or VIN2+ and/or VaIN2+) was 100.
0%, and the protection rate against HPV type 16 and/or type 18 persistent infection (over 6 months) was 97.
8%.
The promotion and application of Xinke Ning ®, its long-term effectiveness and safety have attracted people's attention
.
The results of the final analysis of the 66-month follow-up of the Phase III clinical trial of CINCONYL® showed that in the per-protocol set (PPS) population, the vaccine was effective against HPV type 16 and/or 18 infection-related lesion endpoints (CIN2+ and/or or VIN2+ and/or VaIN2+) protection was 100.
0% (95% CI: 67.
2%-100.
0%), and the protective efficacy was 100.
0% (95% CI: 67.
2%-100.
0%) in the 18-26 and 27-45 age groups, respectively : 40.
6%-100.
0%) and 100.
0% (95% confidence interval: -7.
7%-100.
0%)
.
Protection against persistent HPV type 16 and/or 18 infection (over 6 months) was 97.
3% (95% confidence interval: 89.
9%-99.
7%), protection between the 18-26 and 27-45 age groups The powers were 93.
9% (95% CI: 76.
3%-99.
3%) and 100.
0% (95% CI: 90.
6%-100.
0%), respectively
.
Cumulative incidence of high-grade genital lesions and persistent infections associated with HPV 16/18 in the PPS population
The vaccine was safe, with no serious adverse events related to vaccination and no pregnancy outcomes related to vaccination throughout the study period and abnormalities in neonatal health
.
The vaccine is effective in inducing high levels of HPV type 16 and 18 neutralizing antibodies and IgG antibodies in subjects for at least 66 months
.
The results of this study confirm that Cincoline® has excellent efficacy and good safety in susceptible women aged 27-45 and 18-26 years old, and can effectively prevent HPV types 16 and/or 18-related Cervical high-grade precancerous lesions and persistent infection
.
Professor Zhao Fanghui of Cancer Hospital of Chinese Academy of Medical Sciences, Professor Wu Ting of School of Public Health of Xiamen University, Chief Physician Hu Yuemei of Jiangsu Provincial Center for Disease Control and Prevention, Professor Wei Lihui of Peking University People's Hospital, Chief Physician Liming Qiang of Liuzhou Center for Disease Control and Prevention, China Food and Drug Control Research Researcher Huang Weijin of the Academy of Sciences, Professor Chen Wen of Cancer Hospital of Chinese Academy of Medical Sciences, and Professor Huang Shoujie of Xiamen University School of Public Health are the co-first authors of the paper
.
Professor Xia Ningshao, School of Public Health, Xiamen University, Professor Qiao Youlin, School of Qun Medicine and Public Health, Chinese Academy of Medical Sciences, and Professor Zhang Jun, School of Public Health, Xiamen University are the co-corresponding authors of the paper
.
The research was supported by the National Natural Science Foundation of China, the National Key R&D Program, the Fujian Provincial Health Education Joint Research Program, the Fujian Provincial Natural Science Foundation, the Central University R&D Fund, the Innovation Unit of the Chinese Academy of Medical Sciences, and Xiamen Wantai Canghai Biotechnology Co.
,
Ltd.
Paper link:
reprint welcome to forward to Moments and WeChat groups
