한글목차

약제 요약

BRII-836(VIR-2218)은 HBV를 표적으로 하는 피하투여형 siRNA로, 효과적인 면역반응을 자극하고 HBV와 HDV에 대한 직접적인 항바이러스 활성을 가지고 있습니다. 이 siRNA는 안정성을 높이고 오프타깃 활성을 최소화하는 ESC(Enhanced Stabilization Chemistry Plus) 기술이 적용된 최초의 임상용 siRNA로, 잠재적으로 치료 지수를 향상시킬 수 있는 잠재력을 가지고 있습니다.

또한 BRII-179(VBI-2601)는 Pre-S1, Pre-S2, S의 HBV 표면 항원을 발현하고 B세포와 T세포 면역증강을 유도하도록 설계된 새로운 재조합 단백질 기반 HBV 면역치료제 후보물질입니다. 백신으로부터 BRII-179(VBI-2601)의 라이선스를 획득하여 중국 본토, 중국 홍콩, 마카오, 대만 등 라이선스 지역에서 BRII-179(VBI-2601)에 대한 상업적 권리를 획득했습니다.

두 약제 모두 HBV 환자에서 기전이 입증되어 있으며, 병용투여시 기능적 치유를 기대할 수 있습니다. 이 약제는 siRNA 유전자 침묵을 통해 면역억제성 바이러스 항원을 제거하고, 면역요법 백신을 통해 숙주 HBV 특이적 면역을 자극하고 회복시키는 이중 작용기전을 포함하고 있습니다.

주요 7 시장(미국·독일·프랑스·이탈리아·스페인·영국·일본)과 중국 시장에서 B형 만성 간염용 BRII-835+BRII-179에 대해 조사분석했으며, 작용기서, 용법과 용량, 연구개발 활동에 관한 인사이트, 매출의 예측 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 B형 만성 간염에서의 BRII-835+BRII-179 개요

• 제품의 상세
• 임상 개발
  • 임상 연구
  • 임상시험 정보
  • 안전성과 유효성
• 기타 개발 활동
• 제품 개요

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 신치료법)

제5장 BRII-835+BRII-179시장 평가

• B형 만성 간염에서 BRII-835+BRII-179의 시장 전망
• 주요 7 시장과 중국 분석
  • 주요 7 시장과 중국에서 B형 만성 간염용 BRII-835+BRII-179의 시장 규모
• 시장 분석 : 국가별
  • 미국의 B형 만성 간염용 BRII-835+BRII-179의 시장 규모
  • 독일의 B형 만성 간염용 BRII-835+BRII-179의 시장 규모
  • 영국의 B형 만성 간염용 BRII-835+BRII-179의 시장 규모
  • 중국의 B형 만성 간염용 BRII-835+BRII-179의 시장 규모

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

"BRII-835 + BRII-179 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about BRII-835 + BRII-179 for chronic hepatitis B in the seven major markets and China. A detailed picture of the BRII-835 + BRII-179 for chronic hepatitis B in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China for the study period 2019 -2032 is provided in this report along with a detailed description of the BRII-835 + BRII-179 for chronic hepatitis B. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the BRII-835 + BRII-179 market forecast analysis for chronic hepatitis B in the 7MM and China, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in chronic hepatitis B.

Drug Summary:

BRII-836 (VIR-2218) is an investigational subcutaneously administered HBV-targeting siRNA that can stimulate an effective immune response and have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index.

Also, BRII-179 (VBI-2601) is a novel recombinant, protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens and is designed to induce enhanced B-cell and T-cell immunity. Brii Bio licensed BRII-179 (VBI-2601) from VBI Vaccines in December 2018, providing Brii Bio with commercial rights to BRII-179 (VBI-2601) in the licensed territories of Mainland China, China Hong Kong, Macau, and Taiwan.

Both agents have demonstrated proof of mechanism in HBV patients; a combination might be a potential functional cure. It encompasses dual mechanisms of action, removing immunosuppressive viral antigens by siRNA gene silencing followed by stimulating and restoring the host HBV-specific immunity with an immunotherapeutic vaccine.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the BRII-835 + BRII-179 description, mechanism of action, dosage and administration, research and development activities in chronic hepatitis B.
• Elaborated details on BRII-835 + BRII-179 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the BRII-835 + BRII-179 research and development activities in chronic hepatitis B across the United States, Europe, Japan, and China.
• The report also covers the patents information with expiry timeline around BRII-835 + BRII-179.
• The report contains forecasted sales of BRII-835 + BRII-179 for chronic hepatitis B till 2032.
• Comprehensive coverage of the late-stage emerging therapies for chronic hepatitis B.
• The report also features the SWOT analysis with analyst views for BRII-835 + BRII-179 in chronic hepatitis B.

Methodology:

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

BRII-835 + BRII-179 Analytical Perspective by DelveInsight

• In-depth BRII-835 + BRII-179 Market Assessment

This report provides a detailed market assessment of BRII-835 + BRII-179 for chronic hepatitis B in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China. This segment of the report provides forecasted sales data from 2027 to 2032.

• BRII-835 + BRII-179 Clinical Assessment

The report provides the clinical trials information of BRII-835 + BRII-179 for chronic hepatitis B covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for chronic hepatitis B is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence BRII-835 + BRII-179 dominance.
• Other emerging products for chronic hepatitis B are expected to give tough market competition to BRII-835 + BRII-179 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of BRII-835 + BRII-179 in chronic hepatitis B.
• Our in-depth analysis of the forecasted sales data of BRII-835 + BRII-179 from 2027 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the BRII-835 + BRII-179 in chronic hepatitis B.

Key Questions:

• What is the product type, route of administration and mechanism of action of BRII-835 + BRII-179?
• What is the clinical trial status of the study related to BRII-835 + BRII-179 in chronic hepatitis B and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the BRII-835 + BRII-179 development?
• What are the key designations that have been granted to BRII-835 + BRII-179 for chronic hepatitis B?
• What is the forecasted market scenario of BRII-835 + BRII-179 for chronic hepatitis B?
• What are the forecasted sales of BRII-835 + BRII-179 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China?
• What are the other emerging products available and how are these giving competition to BRII-835 + BRII-179 for chronic hepatitis B?
• Which are the late-stage emerging therapies under development for the treatment of chronic hepatitis B?

Table of Contents

1. Report Introduction

2. BRII-835 + BRII-179 Overview in Chronic hepatitis B

• 2.1. Product Detail
• 2.2. Clinical Development
  • 2.2.1. Clinical studies
  • 2.2.2. Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. BRII-835 + BRII-179 Market Assessment

• 5.1. Market Outlook of BRII-835 + BRII-179 in Chronic hepatitis B
• 5.2. 7MM and China Analysis
  • 5.2.1. Market Size of BRII-835 + BRII-179 in the 7MM and China for Chronic hepatitis B
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of BRII-835 + BRII-179 in the United States for Chronic hepatitis B
  • 5.3.2. Market Size of BRII-835 + BRII-179 in Germany for Chronic hepatitis B
  • 5.3.3. Market Size of BRII-835 + BRII-179 in France for Chronic hepatitis B
  • 5.3.4. Market Size of BRII-835 + BRII-179 in Italy for Chronic hepatitis B
  • 5.3.5. Market Size of BRII-835 + BRII-179 in Spain for Chronic hepatitis B
  • 5.3.6. Market Size of BRII-835 + BRII-179 in the United Kingdom for Chronic hepatitis B
  • 5.3.7. Market Size of BRII-835 + BRII-179 in Japan for Chronic hepatitis B
  • 5.3.8. Market Size of BRII-835 + BRII-179 in China for Chronic hepatitis B

6. SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options