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▎WuXi AppTec content team editor (the content of this article is from the press release of Tengsheng Boyao) On March 31, Tengsheng Boyao Biotechnology Co.
, Ltd.
(hereinafter referred to as "Tengsheng Boyao" or the "company"), at the 2022 Asia Pacific Liver Research Society At the 31st meeting (APASL), a phase 2 randomized, randomized trial of its clinical stage small interfering ribonucleic acid (siRNA) BRII-835 (VIR-2218) in Chinese patients with chronic hepatitis B virus (HBV) infection was announced.
The latest data from the double-blind, placebo-controlled trial, which was held online from March 30 to April 3 in Seoul, South Korea
.
Data showed a dose-dependent reduction in HBV surface antigen (HBsAg) levels in Chinese patients with chronic HBV infection following two doses of BRII-835 (VIR-2218), and a reduction in HBsAg levels in both HBeAg-negative and HBeAg-positive patients to a similar degree
.
In addition, BRII-835 (VIR-2218) was well tolerated, all treatment-emergent adverse events (TEAEs) were mild or moderate, and no clinically significant increases in alanine aminotransferase (ALT) were observed high
.
Professor Jia Jidong, Liver Disease Research Center, Beijing Friendship Hospital, Capital Medical University, said: "In this study, after two doses of BRII-835 (VIR-2218), serum HBsAg levels in HBeAg-negative and HBeAg-positive Chinese patients with chronic HBV infection were dose-dependent.
Dependence is reduced, which is consistent with previous findings in other races/ethnics
.
Supported by these data, we believe that BRII-835 (VIR-2218) class can reduce the high viral antigen load caused by chronic HBV infection It has the potential to become the cornerstone of a functional cure for chronic HBV, thereby helping to solve the major global public health problems caused by chronic HBV infection
.
” said Dr.
Yan Li, Chief Medical Officer of Tengsheng Biopharmaceuticals: “The development of chronic HBV infection A functional cure is one of the goals of Tengsheng Boyao
.
We are conducting multiple studies to evaluate different combination regimens, and we are pleased that the data from this study support the potential of siRNA as the backbone of combination regimens
.
We look forward to seeing more data from these studies on the use of BRII-835 (VIR-2218) in combination with other drugs by the end of the year
.
"Abstract ID: L-OP-1324 Report Title: Safety and Antiviral Activity of X-Gene-targeting RNAi Therapy BRII-835 (VIR-2218) in Chinese Chronic HBV Infected Patients with Two Dosages (One Month Interval) Lecturer: Prof.
Jia Jidong, MD, Ph.
D.
, Professor of Medicine, Capital Medical University, Director of Liver Disease Research Center, Beijing Friendship Hospital Among 16 Chinese non-cirrhotic chronic HBV infected patients who achieved virological suppression, received twice (interval one month) subcutaneous administration of BRII-835 (VIR-2218) showed good tolerability in patients receiving 50 mg and 100 mg doses of BRII-835 (VIR-2218) 12 weeks after the last dose The mean HBsAg reductions observed in HBeAg-negative patients were 1.
02 log10 IU/mL and 1.
22 log10 IU/mL, and HBeAg-positive patients were 0.
70 log10 IU/mL and 1.
15 log10 IU/mL, respectively Serum HBsAg levels consistently below baseline through Week 48 in all patients >1 log10 IU/mL About BRII-835 (VIR-2218) BRII-835 (VIR-2218) is a subcutaneously administered target An investigational siRNA drug for HBV, which mediates RNA interference (RNAi), has the potential to have direct antiviral activity against HBV and induce an effective immune response
.
It is the first siRNA to enter the clinic using Enhanced Stabilized Chemistry+ (ESC+) technology , enhances stability and minimizes off-target effects, resulting in improved therapeutic efficacy
.
Tengsheng Biopharma acquired the exclusive rights to develop and commercialize VIR-2218 in Greater China from Vir Biotech ("Vir") in 2020
.
At the same time, three Phase 2 studies sponsored by Tengsheng Biopharmaceutical and Vir are evaluating BRII-835 (VIR-2218) as a combination of functional cures for chronic HBV infection, including: BRII-835 (VIR-2218) combined with Combination of BRII-179 (a therapeutic recombinant protein vaccine), pegylated interferon-α (PEG-IFN-α), and/or VIR-3434 (a monoclonal antibody against HBV)
.
About Hepatitis B Hepatitis B is one of the most serious public health problems in the world, with more than 290 million people infected worldwide, and about 70 million people infected in China
.
Hepatitis B virus infection is a major cause of liver disease, and current treatments are difficult to cure, and many patients develop liver cancer
.
About 780,000 people die each year from complications of chronic HBV infection, such as liver decompensation and hepatocellular carcinoma
.
Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
, Ltd.
(hereinafter referred to as "Tengsheng Boyao" or the "company"), at the 2022 Asia Pacific Liver Research Society At the 31st meeting (APASL), a phase 2 randomized, randomized trial of its clinical stage small interfering ribonucleic acid (siRNA) BRII-835 (VIR-2218) in Chinese patients with chronic hepatitis B virus (HBV) infection was announced.
The latest data from the double-blind, placebo-controlled trial, which was held online from March 30 to April 3 in Seoul, South Korea
.
Data showed a dose-dependent reduction in HBV surface antigen (HBsAg) levels in Chinese patients with chronic HBV infection following two doses of BRII-835 (VIR-2218), and a reduction in HBsAg levels in both HBeAg-negative and HBeAg-positive patients to a similar degree
.
In addition, BRII-835 (VIR-2218) was well tolerated, all treatment-emergent adverse events (TEAEs) were mild or moderate, and no clinically significant increases in alanine aminotransferase (ALT) were observed high
.
Professor Jia Jidong, Liver Disease Research Center, Beijing Friendship Hospital, Capital Medical University, said: "In this study, after two doses of BRII-835 (VIR-2218), serum HBsAg levels in HBeAg-negative and HBeAg-positive Chinese patients with chronic HBV infection were dose-dependent.
Dependence is reduced, which is consistent with previous findings in other races/ethnics
.
Supported by these data, we believe that BRII-835 (VIR-2218) class can reduce the high viral antigen load caused by chronic HBV infection It has the potential to become the cornerstone of a functional cure for chronic HBV, thereby helping to solve the major global public health problems caused by chronic HBV infection
.
” said Dr.
Yan Li, Chief Medical Officer of Tengsheng Biopharmaceuticals: “The development of chronic HBV infection A functional cure is one of the goals of Tengsheng Boyao
.
We are conducting multiple studies to evaluate different combination regimens, and we are pleased that the data from this study support the potential of siRNA as the backbone of combination regimens
.
We look forward to seeing more data from these studies on the use of BRII-835 (VIR-2218) in combination with other drugs by the end of the year
.
"Abstract ID: L-OP-1324 Report Title: Safety and Antiviral Activity of X-Gene-targeting RNAi Therapy BRII-835 (VIR-2218) in Chinese Chronic HBV Infected Patients with Two Dosages (One Month Interval) Lecturer: Prof.
Jia Jidong, MD, Ph.
D.
, Professor of Medicine, Capital Medical University, Director of Liver Disease Research Center, Beijing Friendship Hospital Among 16 Chinese non-cirrhotic chronic HBV infected patients who achieved virological suppression, received twice (interval one month) subcutaneous administration of BRII-835 (VIR-2218) showed good tolerability in patients receiving 50 mg and 100 mg doses of BRII-835 (VIR-2218) 12 weeks after the last dose The mean HBsAg reductions observed in HBeAg-negative patients were 1.
02 log10 IU/mL and 1.
22 log10 IU/mL, and HBeAg-positive patients were 0.
70 log10 IU/mL and 1.
15 log10 IU/mL, respectively Serum HBsAg levels consistently below baseline through Week 48 in all patients >1 log10 IU/mL About BRII-835 (VIR-2218) BRII-835 (VIR-2218) is a subcutaneously administered target An investigational siRNA drug for HBV, which mediates RNA interference (RNAi), has the potential to have direct antiviral activity against HBV and induce an effective immune response
.
It is the first siRNA to enter the clinic using Enhanced Stabilized Chemistry+ (ESC+) technology , enhances stability and minimizes off-target effects, resulting in improved therapeutic efficacy
.
Tengsheng Biopharma acquired the exclusive rights to develop and commercialize VIR-2218 in Greater China from Vir Biotech ("Vir") in 2020
.
At the same time, three Phase 2 studies sponsored by Tengsheng Biopharmaceutical and Vir are evaluating BRII-835 (VIR-2218) as a combination of functional cures for chronic HBV infection, including: BRII-835 (VIR-2218) combined with Combination of BRII-179 (a therapeutic recombinant protein vaccine), pegylated interferon-α (PEG-IFN-α), and/or VIR-3434 (a monoclonal antibody against HBV)
.
About Hepatitis B Hepatitis B is one of the most serious public health problems in the world, with more than 290 million people infected worldwide, and about 70 million people infected in China
.
Hepatitis B virus infection is a major cause of liver disease, and current treatments are difficult to cure, and many patients develop liver cancer
.
About 780,000 people die each year from complications of chronic HBV infection, such as liver decompensation and hepatocellular carcinoma
.
Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.