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I: Basic Product Information
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Category |
Details |
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Product Overview |
Clinical trial data indicate that Bepirovirsen demonstrates significant efficacy in patients with chronic hepatitis B (CHB). In an early Phase 2b trial, [nearly one-third of patients achieved the disappearance of key hepatitis B virus (HBV) markers, Hepatitis B surface antigen (HBsAg) and HBV DNA, after 24 weeks of treatment]{.mark}, suggesting a substantial reduction in virus-induced liver damage. Furthermore, [approximately 10% of patients maintained this clearance effect 24 weeks after stopping treatment, without significant side effects, indicating the potential for long-term, stable therapeutic effects rather than just transient viral suppression.]{.mark} |
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Generic Name |
Bepirovirsen |
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CAS Number |
1403787-62-1 |
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Dosage Form & Strength |
Injection, 150 mg/mL |
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Approval/Launch Timeline |
Global Phase III trials initiated simultaneously in the US, EU, Japan, China, etc., in October 2022. Global launch anticipated in 2026. |
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English Name |
Bepirovirsen (GSK3228836; GSK3228836A; GSK836) |
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Originator/Developer |
Ionis Pharmaceuticals Inc.; GlaxoSmithKline (GSK) |
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Key Excipients |
Not retrieved |
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Formulation Assessment |
Cannot be assessed at this time. (Common injection types include large/small volume injections, powder injections, microsphere/liposome/nanoparticle injections – potentially offering long-acting delivery to reduce frequency, improve bioavailability, and enhance compliance). Sterilization methods for sterile products include: moist heat, dry heat, radiation, ethylene oxide, and filtration. |
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Indications |
Hepatitis B virus infection; Viral hepatitis B; Chronic hepatitis B (CHB); HIV infection |
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Dosage & Administration |
Not publicly disclosed |
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Mechanism of Action / Target |
HBV; Chemical Drug; Oligonucleotide; Antisense; 2′-OMe modified |
II: Patent Status
No patents for this active pharmaceutical ingredient (API) or formulation have been identified in the Chinese market. Based on searches, the formulation patent expires in the US and WIPO in October 2043.
(Image: Patent expiration timeline chart - would be embedded here)
III: Competitive Landscape Analysis
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Drug Name (Generic) |
Drug Category |
Target |
Indications (Total) in Development |
Originator / Developer |
Highest Global Phase |
Global Phase Date |
Highest China Phase |
China Phase Date |
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Neracorvir |
Chemical Drug |
Capsid protein; Nucleocapsid; cccDNA |
Viral hepatitis B; Chronic hepatitis B |
Shanghai WuXi AppTec Co., Ltd.; Fujian Cosunter Pharmaceutical Co., Ltd. |
Phase III |
2025-06-15 |
Phase III |
2025-06-28 |
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AHB-137 |
Chemical Drug; Oligonucleotide; Antisense |
HBV |
Chronic hepatitis B |
Hangzhou HighBroad Medical Co., Ltd. |
Phase III |
2025-07-23 |
Phase III |
2025-07-23 |
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Canocapavir |
Chemical Drug |
Capsid protein |
Chronic hepatitis B |
Zhimeng Biotechnology (Shanghai) Inc. |
Phase III |
2025-06-25 |
Phase III |
2025-06-25 |
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Tobevibart |
Biologics; Monoclonal Antibody; Humanized/Fully Human |
HBsAg |
Hepatitis D virus infection; Hepatitis B virus infection; Viral encephalitis B; Chronic hepatitis B |
Vir Biotechnology Inc. |
Phase III |
2025-03-24 |
Phase I |
2023-10-07 |
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Elebsiran |
Chemical Drug; siRNA Conjugate |
ASGPR |
Hepatitis D virus infection; Hepatitis B virus infection; Chronic hepatitis B; Hepatitis |
Alnylam Pharmaceuticals Inc.; Vir Biotechnology Inc. |
Phase III |
2025-03-24 |
Phase II |
2020-06-28 |
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Libevitug |
Biologics; Monoclonal Antibody; Humanized/Fully Human |
L envelope protein |
Hepatitis D virus infection; Hepatitis B virus infection; Chronic hepatitis B |
HuaHui AnJian (Beijing) Biotechnology Co., Ltd. |
Registration |
2024-12-26 |
Registration |
2024-12-26 |
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Bepirovirsen |
Chemical Drug; Oligonucleotide; Antisense; 2′-OMe modified |
HBV |
HIV infection; Viral hepatitis B; Hepatitis B virus infection; Chronic hepatitis B |
Ionis Pharmaceuticals Inc.; GlaxoSmithKline (GSK) |
Phase III |
2022-10-12 |
Phase III |
2022-10-12 |
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Clevudine |
Chemical Drug |
HBV protein P |
SARS-CoV-2 infection; HBV-related hepatocellular carcinoma; Chronic hepatitis B; Liver cirrhosis |
Bukwang Pharmaceutical Co Ltd; Yale University |
Registration |
2010-12-31 |
Registration |
2010-12-31 |
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HEPA-44 |
Biologics; Protein/Peptide |
Not specified |
Viral hepatitis B; Chronic hepatitis B |
Tasly Pharmaceutical Group Co., Ltd. |
Phase III |
N/A |
None |
N/A |
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Hydronidone |
Chemical Drug |
FGFR1; TGFB |
Hepatitis B virus infection; HBV-related liver fibrosis; Chronic hepatitis B; Liver dysfunction; Liver fibrosis |
Shanghai Genext Pharmaceutical Technology Co., Ltd.; Beijing Continent Pharmaceutical Co., Ltd. |
Phase III |
2021-10-09 |
Phase III |
2021-10-09 |
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Dasminapant |
Chemical Drug |
BIRC2; BIRC3; XIAP |
Viral hepatitis B; Solid tumors; Chronic hepatitis B; Lymphoma; Pancreatic ductal adenocarcinoma; Hematologic tumors |
Ascentage Pharma (Suzhou) Co., Ltd. |
Phase III |
N/A |
Phase I |
2015-04-03 |
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rSIFN-co |
Biologics; Interferon |
IFNA-2b |
COVID-19; Solid tumors; Chronic hepatitis B |
Sichuan Huiyang Life Science & Technology Co., Ltd. |
Registration |
2003-07-10 |
Registration |
2003-07-10 |
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εPA-44 |
Biologics; Protein/Peptide; Nanomedicine; Vaccine |
Not specified |
Chronic hepatitis B |
Third Military Medical University; Jiangsu Mendel Gene Technology Co., Ltd.; Chongqing Jiachen Biological Engineering Co., Ltd. |
Phase III |
2021-04-14 |
Phase III |
2021-04-14 |
IV: API and Formulation Registration Status (Including Chinese Companies with FDA Filings)
[Active Pharmaceutical Ingredient (API)]{.mark}
[Formulation]{.mark}
V: Market Information
Chronic HBV infection is a leading cause of liver disease worldwide. [According to World Health Organization (WHO) estimates, approximately 296 million people globally are chronically infected with the hepatitis B virus (HBV), resulting in over 820,000 deaths annually.]{.mark} Achieving a functional cure for hepatitis B has been a key challenge and focus in HBV research in recent years, representing a long-awaited hope for millions of patients. However, current treatments only allow a subset of patients to achieve clinical/functional cure.
The emergence of small nucleic acid drugs has brought new hope for a functional cure for HBV. Compared to traditional drugs, [small nucleic acid drugs offer high target specificity, binding to HBV mRNA or other key RNA sequences based on the principle of base complementarity. Furthermore, these drugs can impact the transcription process of cccDNA, potentially placing it in a "silent" state. This mechanism holds the promise of achieving functional cure for HBV, characterized by the disappearance of HBsAg from the blood, undetectable HBV DNA, normalized liver function, alleviated liver inflammation, and a significantly reduced risk of complications like cirrhosis and liver cancer.]{.mark}
Recent Hepatitis B Market Sales in China
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Note: Data source: Pharmadl. Represents hospital sales data only.
Top 20 Products for Hepatitis B Indication in China (2023-2024 Sales)
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Rank |
Product Name |
2023 Sales (10k RMB) |
2024 Sales (10k RMB) |
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1 |
Peginterferon Alfa-2b Injection |
154,720.81 |
194,820.04 |
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2 |
Tenofovir Alafenamide Fumarate Tablets |
86,345.67 |
76,971.39 |
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3 |
Thymalfasin for Injection |
88,764.92 |
73,380.11 |
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4 |
Entecavir Tablets |
69,834.36 |
84,545.16 |
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5 |
Sodium Cantharidinate and Vitamin B6 Injection |
61,130.16 |
64,782.85 |
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6 |
Tenofovir Amibufenamide Fumarate Tablets |
50,191.86 |
72,655.58 |
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7 |
Glutathione Tablets |
43,432.82 |
46,884.80 |
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8 |
Tenofovir Disoproxil Fumarate Tablets |
31,953.10 |
34,498.60 |
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9 |
Entecavir Dispersible Tablets |
31,505.93 |
22,323.24 |
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10 |
Thymopentin Injection |
24,706.37 |
24,834.17 |
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11 |
Thymosin Enteric-coated Tablets |
22,404.77 |
17,538.83 |
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12 |
Sodium Cantharidinate Injection |
26,272.77 |
7,643.29 |
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13 |
Recombinant Human Interferon Alfa-1b Injection |
20,488.96 |
12,768.58 |
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14 |
Entecavir Capsules |
12,719.33 |
9,061.76 |
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15 |
Lamivudine Tablets |
10,280.75 |
10,355.83 |
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16 |
Human Hepatitis B Immunoglobulin (pH4) for Intravenous Injection |
9,682.81 |
10,539.08 |
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17 |
Peginterferon Alfa-2a Injection |
17,261.33 |
2,308.82 |
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18 |
Ribonucleic Acid II for Injection |
9,235.58 |
9,375.25 |
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19 |
Coriolus Versicolor Glycopeptide Capsules |
8,631.22 |
7,784.06 |
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20 |
Human Hepatitis B Immunoglobulin |
9,211.99 |
7,196.77 |
Note: Data source: Pharmadl.
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