Hepatitis B Functional Cure Rate Reaches 26%! GSK Resubmits ASO Drug Bepirovirsen for Approval as Four Companies Disclose Pipeline Progress Within Two Days
GSK
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CHIATAI TIANQING
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May 30, 2026
eMedClub News
On May 25, its domestic marketing application was not approved; just two days later, GSK resubmitted the marketing application for bepruvelsen injection., the rapid reversal from “setback” to “restart” has heightened the suspense surrounding this candidate product.
Chronic hepatitis B affects over 250 million people worldwide, with chronic hepatitis B virus carriers in ChinaApproximately 75 million people, existing nucleosides(Acid)Analogues can only inhibit viral replication, require lifelong medication, and make it difficult to achieve functional cure. Bepruvirsen Injection is a triple-mechanism ASO therapy that inhibits the replication of viral DNA in the body and reduces hepatitis B surface antigen in the blood.（HBsAg）levels, and stimulate the immune system to enhance the likelihood of a durable response.
On May 28, GSK at the 2026 European Association for the Study of the Liver（EASL）The latest Phase III clinical trial results of Bepirovirsen Injection were announced at the annual conference. The participants in this B-Well series of trials were all receiving nucleos(t)ide(Acid)In patients with chronic hepatitis B receiving daily analog-based standard therapy, subjects received weekly injections of beprivepant or placebo for 24 weeks, followed by continued standard antiviral therapy for an additional 24 or 48 weeks, with functional cure assessed at Week 72. Two B-Well trialsA total of 1,838 patients were enrolled.。
The results showed that 19% of patients in the Bepirovirsen group achieved a functional cure after treatment with Bepirovirsen injection, compared to 0% in the placebo group; among them,Hepatitis B Surface Antigen（HBsAg）In the subgroup of patients with baseline levels below 1,000 IU/mL, the functional cure rate reached 26%.. This data further validates the potential of Bepirovirsen to achieve a functional cure for chronic hepatitis B.
Bepirovirsen injection was initially developed by Ionis, and GSK later acquired its global rights through an upfront payment of $262 million plus milestone payments. On May 11,CHIATAI TIANQING and GSK Reach Exclusive Strategic Partnership, CHIATAI TIANQING will be responsible for the importation, distribution, hospital access, and promotional and non-promotional activities of Bepruvir Injection in mainland China, and all sales revenue generated by this product will be recognized as CHIATAI TIANQING’s operating revenue.
The resubmission of the marketing application within a short timeframe has drawn widespread attention from the industry and patient communities. As one of the fastest-developing candidate drugs for the functional cure of hepatitis B globally, the outcome of the secondary review for Bepirovirsen Injection is highly anticipated. Its final approval status will directly impact the implementation of finite-duration “curative regimens” for chronic hepatitis B in China.
In Just Two Days, Frequent Advances in Innovative Hepatitis B Therapies in China
Chronic Hepatitis B Presents a Vast Unmet Clinical Need, Drawing Significant Industry Attention to Innovative Therapies. Multiple Domestic Biopharmaceutical Companies Have Been Continuously Deepening Their Efforts in the Field of Novel Hepatitis B Treatments and Have Recently Achieved New Progress.
Haobo Pharmaceutical
On May 27, Haobo Pharma presented the end-of-follow-up data from its Phase II clinical trial of AHB-137, an independently developed antisense oligonucleotide (ASO) therapy for treatment-naïve chronic hepatitis B, at the 2026 EASL Annual Meeting. The data showed that 16 weeks of monotherapy with AHB-137 rapidly and potently suppressed HBV DNA and achieved HBsAg clearance. Follow-up data 24 weeks after treatment cessation demonstrated that virologic response and antigen clearance were durably maintained post-treatment.The clinical cure rate reached 70% in patients with baseline HBsAg levels of 100–1000 IU/mL., while the overall safety profile was as expected.
Brii Biosciences
On May 27, Brii Biosciences presented data on elebsiran in combination with pegylated interferon alpha at the EASL Annual Meeting.（PEG-IFNα）Final Results from Cohorts 1–4 of the Phase II ENSURE Study for the Treatment of Chronic Hepatitis B. Among these, Cohorts 1–3 aimed to evaluate the efficacy contribution of elebsiran in participants with HBV infection when used in combination with PEG-IFNα, while Cohort 4 assessed a novel sequential combination therapy strategy for chronic hepatitis B—utilizing Brii Biosciences’ therapeutic vaccine BRII‑179 for immune activation and participant screening.
BRII-179 is a novel recombinant protein-based immunotherapeutic candidate for hepatitis B virus (HBV), capable of expressing the HBV Pre-S1, Pre-S2, and S surface antigens, designed to induce enhanced and broad B-cell and T-cell immune responses.Elebsiran is a subcutaneously administered siRNA targeting HBV., designed to degrade HBV RNA transcripts and limit the production of hepatitis B surface antigen, with activity against both HBV and hepatitis D virus（HDV）direct antiviral activity.
The final results showed that the benefit of HBsAg clearance observed in the elebsiran combined with PEG-IFNα treatment cohort,Conversion to a higher rate of functional cure than PEG-IFNα monotherapyParticipants who had previously received BRII-179 treatment, particularly anti-HBs responders, achieved higher rates of functional cure, suggesting that BRII-179 may play a crucial role in achieving durable immunological control of HBV.
Xingyao Kunze
On May 26, Fosun Pharma Industry, a subsidiary controlled by Fosun Pharma, proposed to invest approximately RMB 414 million to participate in the Series B financing of Xingyao Kunze alongside other new investors, and to acquire part of the equity held by its associates, Suzhou Fund and Tianjin Fund.
Starlight Biopharma’s HT-101+HT-102 is a combination therapy for the functional cure of hepatitis B,Among them, HT-101 is an independently developed GalNAc-conjugated siRNA candidate drug., aiming to silence HBV RNA and inhibit the continuous production of HBsAg,HT-102 is a neutralizing antibody targeting HBsAg, aiming to promote the clearance of circulating HBsAg.
In January this year, the Phase II clinical trial application for this combination therapy was approved by the U.S. FDA for the treatment of chronic hepatitis B. Previously, data disclosed by Xingyao Kunze at the 2025 American Association for the Study of Liver Diseases (AASLD) Annual Meeting showed that the combination therapy of HT-101 + HT-102 in patients with chronic hepatitis BAchieved rapid clearance with a clearance rate of up to 90%。
Hengrui Medicine
On May 26, Hengrui Medicine on the ClinicalTrials.gov websitePhase III Clinical Trial of Novel Hepatitis B siRNA Drug HRS-5635 for the Treatment of Chronic Hepatitis B Infection Registered。
HRS-5635 is a novel covalently conjugated triantennary N-acetylgalactosamine（GalNAc）of double-stranded siRNA, the results of its Phase II clinical study as monotherapy for chronic hepatitis B showed that HRS-5635 has the potential to improve functional cure rates in chronic hepatitis B and also demonstrates a favorable safety profile.
In addition, companies such as Bowang Pharmaceutical, Ribobio, and Yuanda Saichengweixin have also achieved numerous breakthroughs, which will not be enumerated here. Overall, the global treatment landscape for chronic hepatitis B has officially moved beyond the era of single-mode viral suppression. Multiple innovative technological pathways, including antisense oligonucleotides (ASOs) and siRNA-based therapeutic vaccines, are simultaneously accelerating. Several core pipeline candidates are concurrently entering pivotal Phase II and III clinical trials. The next five years are expected to witness a concentrated realization of outcomes in the quest for a hepatitis B cure, with hepatitis B therapy poised to transition from "passive long-term control" to "clinical cure."
Responsible Editor | Xun
Proofread by Xun
References:
1.https://www.fiercebiotech.com/biotech/gsks-hepatitis
-b-drug-cures-one-fifth-patients-major-step-pervasive-disease
2. Corporate Official Website
Shanghai Zhaowei Technology Development Co., Ltd., established in 1998, is a biotechnology company specializing in the supply of nucleic acid raw materials and CDMO services. With nearly three decades of deep industry expertise, the company continues to provide stable support for the research, development, and industrialization of nucleic acid therapeutics worldwide, having become a trusted partner in the global nucleic acid sector.
The company offers over 2,000 catalog products, covering the full spectrum of raw materials for the nucleic acid drug industry, including phosphoramidite monomers, modified nucleosides, triphosphates, cap analogs, GalNAc, liposomes, and enzymes. With an annual production capacity of 58 metric tons of phosphoramidite monomers and the ability to supply raw materials for more than 10.5 billion doses of mRNA vaccines, it serves as a core raw material supplier for numerous clinical-stage and marketed nucleic acid drug pipelines.
In the field of CDMO services, Shanghai Zhaowei Technology possesses mature end-to-end capabilities for small nucleic acid and mRNA drugs, providing seamless full-process services from laboratory-scale pilot studies to commercial launch. Leveraging a vertically integrated supply chain system, core technology platforms such as chemoenzymatic synthesis, and production capacity at the ton scale, the company has successfully delivered multiple nucleic acid drug CDMO projects, helping clients achieve rapid drug translation and commercialization.
For more information about Hongene Biotech and its products and services, please visit the official website at www.hongene.com and follow our WeChat Official Account “Shanghai Hongene Biotech.”」。
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