The 48-week end-of-treatment data from the ongoing phase 2 ENSURE study clearly shows that elebsiran combined with PEG-IFNα can achieve more benefits, leading to higher functional cure rates

Data from multiple joint studies carried out by the company and its partners will continue to support the company's strategy to achieve functional cure for HBV in a wider range of patient groups through the right combination treatment options

BEIJING, China and Durham, North Carolina, November 19, 2024/PRNewswire/ -- Tengshengbo Pharmaceutical Biotechnology Co., Ltd. (“Tengshengbo Pharmaceutical” or “Company”, stock code: 2137.HK), a biotechnology company dedicated to developing treatment plans for diseases where patients' medical needs are not being met to improve patients' health conditions and treatment choices, made the latest breakthrough (late-breaking) at the American Society for Liver Disease Research (AASLD) annual meeting held in San Diego, California, USA from November 15 to 19 ) The latest data from its ongoing Phase 2 ENSURE study was published in the form of an oral report.

ENSURE is a positive controlled, randomized, phase 2 study to evaluate the effects of experimental small interfering ribonucleic acid (siRNA) elebsiran (BRII-835, VIR-2218) combined with polyethylene glycol interferon α (PEG-IFNα) on chronic HBV infected people with a hepatitis B surface antigen (HBsAg) baseline of 100—3,000 IU/ml. The study excluded HBV patients with low baseline levels of HBsAg (<100 IU/ml) to study potential efficacy in a wider patient population. ENSURE 48-week end-of-treatment (EOT) data showed that at the end of treatment, 26.3% (5/19) or 33.3% (6/18) of participants treated with 200 mg or 100 mg elebsiran combined with PEG-IFNα achieved HBsAg serum clearance, while only 5.6% (1/18) of participants receiving PEG-IFNα monotherapy achieved HBsAg serum clearance.

Professor Jia Jidong, director of the Liver Disease Center at Beijing Friendship Hospital affiliated to Capital Medical University, said, “The EOT data from the ENSURE study is very clear. Previous studies have shown that siRNA combined with PEG-IFNα is one of the most promising treatments for higher HBsAg serum clearance. For the first time, the ensure study provided evidence of the effect of siRNA on achieving functional healing based on existing PEG-IFNα therapy. We believe elebsiran is expected to have a significant impact on improving the functional cure rate of HBV.”

Dr. David Margolis, Chief Medical Officer of Tengsheng Pharmaceuticals, said, “We are very encouraged by the data from this trial, and it will continue to support our goal of developing functional treatments for chronic HBV in target populations. The results highlight elebsiran's potential as the core of a combination treatment protocol being evaluated in several ongoing clinical studies. We look forward to combining elebsiran with other treatments through the ongoing Phase 2 study to provide a higher functional cure rate for 0.254 billion people infected with chronic HBV globally.”

Abstract Number: 5008
Latest Breakthrough Oral Report Title: Preliminary Results of Elebsiran (BRII-835) Combined with Polyethylene Glycol Interferon α (PEG-IFNα) Comparing the Efficacy and Safety of PEG-IFNα in Virologically Inhibited Chronic Hepatitis B Virus (HBV) Infected with Virologically Inhibited Chronic Hepatitis B Virus (HBV)
Speaker: Professor Jia Jidong, Director of Liver Disease Center, Beijing Friendship Hospital Affiliated to Capital Medical University

• At the end of treatment, HBSAG serum clearance was 26.3% (5/19) and 33.3% (6/18) of the elebsiran 200 mg + PEG-IFNα cohort, respectively, which was significantly higher than that of the PEG-IFNα monotherapy cohort (5.6%).
• In the subgroup with an HBsAg baseline of 100-1,500 IU/ml, 31.3% (5/16) or 40.0% (6/15) of participants treated with elebsiran 200 mg or 100 mg with PEG-IFNα, respectively, achieved HBsAg serum clearance.
• The decrease in HBsAg in the Elebsiran + PEG-IFNα cohort at the end of treatment (mean [SE]: -2.47 [0.28] or -3.01 [0.28] log10 IU/mL of elebsiran 200 mg or 100 mg, respectively) was greater than the PEG-IFNα cohort (-1.02 [0.30] log10 IU/mL).
• In participants with baseline HBsAg levels of 100—3,000 IU/ml, elebsiran 200 mg and 100 mg doses combined with PEG-IFNα achieved similar HBsAg serum clearance and HBsAg reduction.
• Among virologically suppressed participants with chronic HBV infection, treatment with elebsiran in combination with PEG-IFNα was generally safe and well tolerated.
• Follow-up after treatment is ongoing and will continue for 24 weeks after completion of treatment.

As part of Tengsheng Pharma's development of a unique functional cure for HBV, the company and its partners are actively promoting a number of joint studies on our differentiated product portfolio, including elebsiran, TobeviBART, a broad-spectrum anti-HBV monoclonal antibody for HBV, and BRII-179, a recombinant protein HBV immunotherapeutic drug. We'll share key data at the 2025 scientific conference.

About Hepatitis B

Hepatitis B virus (HBV) infection is one of the most significant infectious disease threats in the world, with more than 0.254 billion infected people worldwide. [1] Chronic HBV infection is the leading cause of liver disease, and approximately 0.82 million people die each year from complications of chronic HBV infection. [1] The number of people infected with chronic HBV in China reached 87 million, which is very noteworthy. [2]

About Elebsiran (BRII-835, VIR-2218)

Elebsiran is a small interfering ribonucleic acid (siRNA) investigational drug targeting hepatitis B virus (HBV) administered subcutaneously. It aims to degrade HBV RNA transcripts and limit the production of hepatitis B surface antigen. It has direct antiviral activity against HBV and hepatitis D virus (HDV). It is the first siRNA to enter the clinic to use enhanced stabilization chemically enhancing technology to enhance stability and minimize off-target activity, thereby potentially improving the therapeutic index. Tengsheng Pharmaceuticals obtained exclusive rights to develop and commercialize elebsiran in Greater China from Vir Biotechnology, Inc. in 2020.

About Tengsheng Bo Pharmaceutical

Tengsheng Pharmaceuticals (stock code: 2137.HK) is a biotechnology company dedicated to developing innovative treatments for major public health challenges with huge unmet patient needs, limited treatment options, and serious social discrimination for patients. The company focuses on infectious diseases and central nervous system diseases, and is advancing a product pipeline covering a variety of unique drug candidates, with a focus on leading projects targeting hepatitis B virus (HBV) infection. Led by a visionary and experienced leadership team, the company operates in major biotechnology centers located in Raleigh-Durham, the San Francisco Bay Area, Beijing, and Shanghai. For more information, visit.

[1] World Health Organization. (April 2024). Global Climate Report 2024: Action for access in low- and middle-income countries. World Health Organization. Expected from

[2] World Health Organization. Strongly. World Health Organization. Expected from.