한글목차

약제 요약

envafolimab으로도 알려진 ASC22는 만성 B형 간염(CHB)의 기능적 치료를 목표로 하는 최초의 피하 투여형 PD-L1 항체입니다. 이 항체는 피하 주사가 가능하고 상온에서 안정성이 높다는 장점이 있으며, Ascletis Pharma는 ASC22의 바이러스성 적응증에 대한 전 세계 독점 개발권 및 상업화 권리를 보유하고 있습니다.

현재 이 약은 CHB 치료에서 ASC22의 단회 및 다회 투여 후 안전성과 유효성을 평가하기 위한 임상 II상 시험(NCT04465890)을 진행 중입니다. 중국 임상 IIb상 중간 결과에 따르면 24주 동안 1mg/kg의 ASC22와 NA를 24주간 투여한 결과, CHB 환자에서 양호한 내약성을 보였습니다. 기준치 HBsAg가 100IU/mL 미만인 환자의 42.9%가 지속적인 HBsAg 소실을 보였으며, 이는 기능적 치료 가능성을 시사합니다.

주요 7 시장(미국·독일·프랑스·이탈리아·스페인·영국·일본)의 B형 만성 간염(CHB)용 ASC22에 대해 조사분석했으며, 작용기서, 용법과 용량, 연구개발 활동에 관한 인사이트, 매출의 예측 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 B형 만성 간염에서의 ASC22 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 ASC22 시장 평가

• B형 만성 간염에서 ASC22의 시장 전망
• 주요 7 시장과 중국 분석
  • 주요 7 시장과 중국의 B형 만성 간염용 ASC22의 시장 규모
• 시장 분석 : 국가별
  • 미국의 B형 만성 간염용 ASC22의 시장 규모
  • 독일의 B형 만성 간염용 ASC22의 시장 규모
  • 영국의 B형 만성 간염용 ASC22의 시장 규모
  • 중국의 B형 만성 간염용 ASC22의 시장 규모

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

"ASC22 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about ASC22 for chronic hepatitis B in the seven major markets and China. A detailed picture of the ASC22 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 ASC22 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 ASC22 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:

ASC22, also known as envafolimab, is a first-in-class, subcutaneously administered PD-L1 antibody for chronic hepatitis B (CHB) functional cure. It has the advantages of SC injection and good stability at room temperature. These would be of great value to improve patient's compliance and quality of life and to help realize the goal of long-term management of chronic diseases such as chronic hepatitis B. Ascletis Pharma retains the global and exclusive rights to develop and commercialize ASC22 on viral indications.

Currently, the drug is being evaluated in a Phase II (NCT04465890) trial to evaluate the safety and efficacy of ASC22 in treating CHB after single and multiple drug administration. Interim results from the China Phase IIb clinical trial showed 1 mg/kg of ASC22 plus NAs for 24-week treatment were well-tolerated in CHB patients. 42.9% of patients with baseline HBsAg <=100 IU/mL obtained sustained HBsAg loss, which indicates the potential of functional cure.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the ASC22 description, mechanism of action, dosage and administration, research and development activities in chronic hepatitis B.
• Elaborated details on ASC22 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the ASC22 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 ASC22.
• The report contains forecasted sales of ASC22 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 ASC22 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.

ASC22 Analytical Perspective by DelveInsight

• In-depth ASC22 Market Assessment

This report provides a detailed market assessment of ASC22 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.

• ASC22 Clinical Assessment

The report provides the clinical trials information of ASC22 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 ASC22 dominance.
• Other emerging products for chronic hepatitis B are expected to give tough market competition to ASC22 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 ASC22 in chronic hepatitis B.
• Our in-depth analysis of the forecasted sales data of ASC22 from 2027 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the ASC22 in chronic hepatitis B.

Key Questions:

• What is the product type, route of administration and mechanism of action of ASC22?
• What is the clinical trial status of the study related to ASC22 in chronic hepatitis B and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ASC22 development?
• What are the key designations that have been granted to ASC22 for chronic hepatitis B?
• What is the forecasted market scenario of ASC22 for chronic hepatitis B?
• What are the forecasted sales of ASC22 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 ASC22 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. ASC22 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. ASC22 Market Assessment

• 5.1. Market Outlook of ASC22 in Chronic hepatitis B
• 5.2. 7MM and China Analysis
  • 5.2.1. Market Size of ASC22 in the 7MM and China for Chronic hepatitis B
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of ASC22 in the United States for Chronic hepatitis B
  • 5.3.2. Market Size of ASC22 in Germany for Chronic hepatitis B
  • 5.3.3. Market Size of ASC22 in France for Chronic hepatitis B
  • 5.3.4. Market Size of ASC22 in Italy for Chronic hepatitis B
  • 5.3.5. Market Size of ASC22 in Spain for Chronic hepatitis B
  • 5.3.6. Market Size of ASC22 in the United Kingdom for Chronic hepatitis B
  • 5.3.7. Market Size of ASC22 in Japan for Chronic hepatitis B
  • 5.3.8. Market Size of ASC22 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