한글목차

약제 요약

CSL112(Apolipoprotein A-I(human))는 HDL의 주요 기능 성분인 혈장 유래 ApoA-I의 새로운 제제입니다. CSL112는 정맥 투여에 적합한 HDL 유사 입자로 재구성되며, 연구에 따르면 CSL112를 정맥주사하면 콜레스테롤 배출 능력이 빠르게 향상되고, 동맥경화성 플라크 병변을 빠르게 안정화시키는 새로운 접근법을 제공할 수 있으며, 급성 심근경색 급성 심근경색 환자의 조기 심혈관계 질환의 위험을 줄이기 위해 개발되고 있습니다.

기업의 R&D 투자자 설명회에 따르면 3상 임상시험(AEGIS-II) 모집은 2022년 12월 LPI를 향해 순조롭게 진행되고 있습니다. 시험은 진행 중이며, 80% 이상의 등록을 달성했고, 세 번째 중간 분석이 완료되었습니다. 임상은 2023년까지 완료될 예정이며, 출시는 2025년 4분기로 예정되어 있습니다.

주요 7 시장(미국·독일·프랑스·이탈리아·스페인·영국·일본)의 심근경색용 CSL112에 대해 조사분석했으며, 작용기서, 용법과 용량, 연구개발 활동에 관한 인사이트, 매출의 예측 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 심근경색에서의 CSL112 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 CSL112 시장 평가

• 심근경색에서 CSL112의 시장 전망
• 주요 7 시장 분석
  • 주요 7 시장 심근경색용 CSL112의 시장 규모
• 시장 분석 : 국가별
  • 미국의 심근경색용 CSL112의 시장 규모
  • 독일의 심근경색용 CSL112의 시장 규모
  • 영국의 심근경색용 CSL112의 시장 규모

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

"CSL112 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about CSL112 for myocardial infarction in the seven major markets. A detailed picture of the CSL112 for myocardial infarction in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the CSL112 for myocardial infarction. 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 CSL112 market forecast analysis for myocardial infarction in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in myocardial infarction.

Drug Summary:

CSL112, apolipoprotein A-I (human), is a novel formulation of plasma-derived apoA-I, the primary functional component of HDL. It is reconstituted to form HDL-like particles suitable for IV infusion. Studies have shown that infusion of CSL112 rapidly enhances cholesterol efflux capacity. CSL112 may offer a new approach for rapidly stabilizing atherosclerotic plaque lesions and is being developed to reduce the risk of early cardiovascular events in acute MI patients.

As per the company's R&D investor briefing presentation, recruitment of the Phase III study (AEGIS-II) is on track for LPI December 2022. The study is progressing with >80% enrolment achieved and the third interim analysis completed. The trial is expected to be completed by 2023, and the launch is expected for Q4 of 2025.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the CSL112 description, mechanism of action, dosage and administration, research and development activities in myocardial infarction.
• Elaborated details on CSL112 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the CSL112 research and development activities in myocardial infarction across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around CSL112.
• The report contains forecasted sales of CSL112 for myocardial infarction till 2032.
• Comprehensive coverage of the late-stage emerging therapies for myocardial infarction.
• The report also features the SWOT analysis with analyst views for CSL112 in myocardial infarction.

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.

CSL112 Analytical Perspective by DelveInsight

• In-depth CSL112 Market Assessment

This report provides a detailed market assessment of CSL112 for myocardial infarction in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2025 to 2032.

• CSL112 Clinical Assessment

The report provides the clinical trials information of CSL112 for myocardial infarction covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for myocardial infarction 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 CSL112 dominance.
• Other emerging products for myocardial infarction are expected to give tough market competition to CSL112 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 CSL112 in myocardial infarction.
• Our in-depth analysis of the forecasted sales data of CSL112 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the CSL112 in myocardial infarction.

Key Questions:

• What is the product type, route of administration and mechanism of action of CSL112?
• What is the clinical trial status of the study related to CSL112 in myocardial infarction and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the CSL112 development?
• What are the key designations that have been granted to CSL112 for myocardial infarction?
• What is the forecasted market scenario of CSL112 for myocardial infarction?
• What are the forecasted sales of CSL112 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available and how are these giving competition to CSL112 for myocardial infarction?
• Which are the late-stage emerging therapies under development for the treatment of myocardial infarction?

Table of Contents

1. Report Introduction

2. CSL112 Overview in myocardial infarction

• 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. CSL112 Market Assessment

• 5.1. Market Outlook of CSL112 in myocardial infarction
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of CSL112 in the 7MM for myocardial infarction
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of CSL112 in the United States for myocardial infarction
  • 5.3.2. Market Size of CSL112 in Germany for myocardial infarction
  • 5.3.3. Market Size of CSL112 in France for myocardial infarction
  • 5.3.4. Market Size of CSL112 in Italy for myocardial infarction
  • 5.3.5. Market Size of CSL112 in Spain for myocardial infarction
  • 5.3.6. Market Size of CSL112 in the United Kingdom for myocardial infarction
  • 5.3.7. Market Size of CSL112 in Japan for myocardial infarction

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