Menin抑制剂的全球市场 - 价格，销售额，临床试验趋势(2028年)

全球 Menin 抑制剂市场 - 价格、销售和临床试验趋势 (2028) 报告结果和亮点

• 全球市场规模及预测：2024-2028
• 全球 Menin 抑制剂市场机会：超过 4 亿美元
• 已获批准药物剂量、价格和销售额洞察
• 按公司、适应症和阶段细分的 Menin 抑制剂临床试验洞察
• 临床试验中的 Menin 抑制剂数量：超过 15 种
• 各公司开发技术平台洞察
• 竞争格局

对 Menin 抑制剂的需求及本报告的意义

Menin 抑制剂的出现标誌着精准医疗领域最重大的变革之一，尤其是在高风险白血病的治疗。 Menin是致癌基因转录调控的关键辅助因子，特别适用于KMT2A (MLL)重排和NPM1突变的白血病。这些分子亚型占急性骨髓性白血病 (AML) 和急性淋巴细胞白血病 (ALL) 的大多数，并且通常与不良预后和有限的治疗选择有关。 Menin抑制剂尤其适合满足这项尚未满足的需求，它提供针对生物标记的标靶疗法，特异性地抑制白血病形成过程。

本报告旨在为不断发展的全球Menin抑制剂市场格局提供富有洞察力、及时性和策略性的视角。随着市场迅速从胚胎研究转向商业化，利害关係人需要及时可靠的讯息，包括产品线开发、临床试验结构、新技术平台和合作机会。本报告透过将跨地区、适应症和开发阶段的复杂数据转化为可用且可操作的格式来满足这一需求。

报告包含临床试验洞察

本报告详细分析了所有处于不同临床开发阶段的menin抑制剂候选药物。这些临床试验涵盖从早期I期试验到最终获得监管部门批准的后期试验。报告涵盖美国、欧洲、中国和澳洲等多个地区，研究范围涵盖血液系统恶性肿瘤和新兴非肿瘤疾病。

资料重点包括癌症亚型（例如KMT2A重排AML、NPM1突变AML、ALL等）、治疗方法（单药治疗与合併治疗）及试验类型。报告中还列出了每个计画的合作伙伴、学术资助方、试验地点和技术授权方。此外，报告还指出了在主要国际会议上报告的关键指标，例如缓解率、MRD阴性率、安全性和抗药性数据。这些综合见解使读者能够了解哪些临床项目进展最有效，以及其科学和商业吸引力所在。

从事 Menin 抑制剂研发的主要公司

许多领先的公司处于全球 Menin 抑制剂研发工作的前沿。 Syndax Pharmaceuticals 于 2024 年 10 月创造了历史，其 revumenib (Revforge) 获批用于治疗 KMT2A 重排 AML。

Kura Oncology 和 Kyowa Kirin 已提交 diftomenib 用于治疗復发/难治性 NPM1 突变 AML 的新药申请。其他活跃的公司包括住友製药、强生和 Biomea Fusion。这些公司正在透过血液学、糖尿病甚至早期实体瘤领域的研究，采取不同的方法。

技术平台、合作与协议

该领域的创新由专有平台和策略联盟驱动。 CHARM Therapeutics 就是一个例子，该公司正在利用其 DragonFold AI 平台开发下一代menin抑制剂，可保留对抗抗药性突变的活性。这些分子特异性结合menin-KMT2A介面，即使在抗药性菌株中也能保持疗效，并最大限度地降低QTc延长和药物交互作用等风险。 CHARM的策略可望为復发性或难治性AML患者提供更安全、更具韧性的治疗方案。

重要的许可和合作协议也在定义这一领域。例如，Kura与协和麒麟的全球合作涵盖了超过11亿美元的潜在里程碑，而施维雅则与BioNova的BN104合作，这是一款处于早期阶段的药物，在KMT2A和NPM1 AML亚群中拥有良好的初始数据。

一份描绘 Menin 抑制剂领域未来方向的报告

Menin 抑制剂的下一阶段研究将重点关注多个方面，包括将适应症从 AML 扩展到实体瘤和糖尿病；透过新一代设计改善安全性和抗药性；以及透过地域扩张和合作试验最大限度地扩大市场准入。随着临床数据的成熟和差异化竞争者的进入，该领域有望继续创新并产生持久影响。

本报告捕捉了 Menin 抑制剂从开发到全球商业化的转型时刻，并为利害关係人提供了探索复杂 Menin 抑制剂领域潜力的重要指南。

目录

第1章 调查手法

第2章 Menin抑制剂的简介

第3章 Menin抑制剂的临床意义及影响

第4章 Menin抑制剂的作用机制

第5章 Menin抑制剂的各适应症应用和临床试验

• 血液癌症
• 固体癌
• 糖尿病

第六章：Revforge (Revmenib)：首个核准的Menin抑制剂

• 概要与专利资讯
• 价格和剂量
• 销售洞察

第7章 全球Menin抑制剂市场形势

• 目前市场Scenario
• 未来临床及商业化的机会

第8章 Menin抑制剂的各地区临床调查革新趋势

• 美国
• 欧洲
• 其他地区

第9章 各企业Menin抑制剂开发技术平台

• FUSION™ 系统 - Biomea Fusion
• 创新平台 - 荣昌製药
• 下一代方法 - CHARM Therapeutics
• 独特方法 - Eilean Therapeutics

第10章 全球Menin抑制剂市场动态

• 促进因素和机会
• 课题与阻碍因素

第11章 Menin抑制剂的临床试验概要

• 各企业
• 各国
• 各适应症
• 各相

第12章 Menin抑制剂的临床试验(各企业，各适应症，各相)

• 前临床
• 第一阶段
• 第一/二阶段
• 第二阶段
• 第三阶段
• 预註册

第13章 已上市Menin抑制剂的临床试验(各企业，各适应症，各相)

第14章 竞争情形

• Beyang Therapeutics
• Biomea Fusion
• BioNova Pharmaceuticals
• Daiichi Sankyo Company
• Easton Biopharmaceuticals
• Eilean Therapeutics
• HitGen
• Janssen Research & Development
• Rongchang Pharmaceuticals
• Sumitomo Pharma

Global Menin Inhibitors Drug Market, Price, Sales & Clinical Trials Insight 2028 Report Findings & Highlights:

• Global Market Size & Future Market Projection: 2024 Till 2028
• Global Menin Inhibitors Drug Market Opportunity: > USD 400 Million
• Approved Drug Dosage, Pricing & Sales Insight
• Menin Inhibitors Drugs Clinical Trials Insight By Company, Indication & Phase
• Number Of Menin Inhibitors Drugs In Clinical Trials: > 15 Drugs
• Insight On Development Technologies Platforms By Companies
• Competitive Landscape

Menin Inhibitors Need & Why This Report?

The advent of menin inhibitors is one of the most significant shifts in the landscape of precision medicine, especially that for the treatment of high risk acute leukemias. Menin is a pivotal cofactor in the transcriptional regulation of oncogenes, especially in leukemias that have KMT2A (MLL) rearrangements or NPM1 mutations. These molecular subtypes are responsible for the majority of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) cases and have a traditional connection with poor prognosis and few treatment alternatives. Menin inhibitors are particularly well suited to address this unmet need, providing biomarker targeted therapy that specifically interferes with the leukemogenic process.

This report is intended to deliver an insightful, timely, and strategic perspective of the evolving menin inhibitor global landscape. As the market quickly moves from nascent research to commercial reality, stakeholders require timely and credible information regarding pipeline advancement, structures of clinical trials, new technology platforms, and opportunities for partnership. This report fills that requirement by reducing the complexity of data across geography, indication, and stages of development into a usable and actionable format.

Clinical Trials Insight Included In Report

Report presents a detailed analysis on all menin inhibitor candidates across different stages of clinical development. These range from early Phase 1 to late stage trials with pending regulatory submissions. The trials cover several geographies, ranging from the US, Europe, China, and Australia, and address both hematologic malignancies and new non-oncologic diseases.

Key points of data are subtypes of cancer (e.g., KMT2A-rearranged AML, NPM1-mutant AML, and ALL), therapeutic approach (monotherapy vs. combination), and study type. The document also specifies certain collaborators, academic sponsors, trial locations, and technology licensors on each program. It also points out significant metrics like remission rates, MRD-negativity, safety profiles, and resistance data reported at top-tier global meetings. Combined, these findings enable readers to know which clinical programs are progressing most effectively and where scientific and commercial traction is.

Leading Companies Engaged In R&D Of Menin Inhibitors

A number of major companies are now at the forefront of worldwide R&D efforts in menin inhibition. Syndax Pharmaceuticals made history with the October 2024 approval of revumenib (Revuforj) for KMT2A-rearranged AML, and is seeking a supplemental indication for NPM1-mutant AML, with a forthcoming decision due by October 2025.

Kura Oncology and Kyowa Kirin have filed a New Drug Application (NDA) for ziftomenib for relapsed/refractory NPM1-mutant AML, another underserved subset with few targeted therapies. Other companies active in the field are Sumitomo Pharma, Johnson & Johnson and Biomea Fusion. These companies are taking different approaches throughout hematology, diabetes, and even early solid tumor investigation.

Technology Platforms, Collaborations & Agreements

Innovation in the field is being expedited by proprietary platforms and strategic collaborations. A case in point is CHARM Therapeutics, who is employing its DragonFold AI platform to engineer next-generation menin inhibitors with retained activity against resistance mutations. These molecules bind specifically at the menin-KMT2A interface, with retained efficacy even in resistant strains and minimized risks such as QTc prolongation or drug-drug interactions. CHARM's strategy has the potential to provide a safer, more resilient option for relapsed or treatment resistant AML patients.

Significant licensing and partnership deals are also defining the space. For instance, Kura's worldwide partnership with Kyowa Kirin encompasses more than US$ 1.1 Billion in milestones potential, whereas Servier has partnered with BioNova's BN104, an early-stage asset with encouraging early data in KMT2A and NPM1 AML subsets.

Report Indicating Future Direction Of Menin Inhibitors Segment

The next phase of menin inhibitors will target several fronts: broadening indications beyond AML to solid tumors and diseases such as diabetes; improving safety and resistance profiles with next-generation design; and maximizing market access through geographic expansion and partnered trials. With clinical data ripening and differentiated players entering the market, this segment will continue to be innovated and have a lasting impact.

This report is a critical guide for stakeholders as they navigate the increasing complexity and opportunity of the menin inhibitor space, capturing a moment of transformation in its development from discovery to worldwide commercialization.

Table of Contents

1. Research Methodology

2. Introduction To Menin Inhibitors

• 2.1 Background & Clinical Evolution
• 2.2 Advancements In Clinical Development

3. Clinical Relevance & Impact Of Menin Inhibitors

4. Menin Inhibitors Mechanism Of Action

• 4.1 Overview
• 4.2 Mechanistic Insights Of Some Novel Menin Inhibitors

5. Menin Inhibitors Application & Clinical Trials By Indication

• 5.1 Hematological Cancers
• 5.2 Solid Cancers
• 5.3 Diabetes

6. Revuforj (Revumenib ) First Approved Menin Inhibitor Drug

• 6.1 Overview & Patent Insight
• 6.2 Pricing & Dosing
• 6.3 Sales Insight

7. Global Menin Inhibitors Market Landscape

• 7.1 Current Market Scenario
• 7.2 Future Clinical & Commercialization Opportunities

8. Menin Inhibitors Clinical Research Innovation Trends By Region

• 8.1 US
• 8.2 Europe
• 8.3 Rest Of World

9. Menin Inhibitors Development Technologies Platforms By Companies

• 9.1 FUSION(TM) System - Biomea Fusion
• 9.2 Innovation Platform - Rongchang Pharmaceuticals
• 9.3 Next-generation Approach - CHARM Therapeutics
• 9.4 Proprietary Approach - Eilean Therapeutics

10. Global Menin Inhibitor Market Dynamics

• 10.1 Drivers & Opportunities
• 10.2 Challenges & Restraints

11. Global Menin Inhibitors Drugs Clinical Trials Overview

• 11.1 By Company
• 11.2 By Country
• 11.3 By Indication
• 11.4 By Phase

12. Global Menin Inhibitors Drugs Clinical Trials By Company, Indication & Phase

• 12.1 Preclinical
• 12.2 Phase-I
• 12.3 Phase-I/II
• 12.4 Phase-II
• 12.5 Phase-III
• 12.6 Preregistration

13. Marketed Menin Inhibitors Drugs Clinical Trials By Company, Indication & Phase

14. Competitive Landscape

• 14.1 Beyang Therapeutics
• 14.2 Biomea Fusion
• 14.3 BioNova Pharmaceuticals
• 14.4 Daiichi Sankyo Company
• 14.5 Easton Biopharmaceuticals
• 14.6 Eilean Therapeutics
• 14.7 HitGen
• 14.8 Janssen Research & Development
• 14.9 Rongchang Pharmaceuticals
• 14.10 Sumitomo Pharma

List of Figures

• Figure 2-1: MEN1 Gene & Menin Protein Function In Cell Cycle Regulation & Tumor Suppression
• Figure 2-2: Mechanism Of Menin Inhibition In Leukemia Cells
• Figure 2-3: Historical Timeline Of MEN1 Discovery & Research
• Figure 2-4: Role Of Menin In Oncogenesis & Action Of Menin Inhibitors
• Figure 4-1: Revumenib - Mechanism Of Action In KMT2A-Rearranged AML
• Figure 4-2: Revumenib - Mechanism Of Action In NPM1-Mutant AML
• Figure 4-3: Ziftomenib - Mechanism Of Action In Menin-KMT2A Pathway
• Figure 4-4: Icovamenib - Mechanism Of Action In Leukemia
• Figure 4-5: Icovamenib - Mechanism Of Action In Type 2 Diabetes Mellitus
• Figure 5-1: Menin In Leukemia: A Paradoxical Oncogenic Co-Factor
• Figure 5-2: AUGMENT-101 Phase I/II (NCT04065399) Study - Initiation & Completion Years
• Figure 5-3: EVOLVE-2 Phase III (NCT06652438) Study - Initiation & Completion Years
• Figure 5-4: NCI-2024-00534 Phase II (NCT06229912) Study - Initiation & Completion Years
• Figure 5-5: NCI-2023-00503 Phase II (NCT05761171) Study - Initiation & Completion Years
• Figure 5-6: KOMET-001 Phase I/II (NCT04067336) Study - Initiation & Completion Years
• Figure 5-7: KOMET-007 Phase I (NCT05735184) Study - Initiation & Completion Years
• Figure 5-8: KOMET-001 Phase I/II (NCT04067336) Study - Initiation & Completion Years
• Figure 5-9: KOMET-008 Phase I (NCT06001788) Study - Initiation & Completion Years
• Figure 5-10: cAMeLot-2 Phase III (NCT06852222) Study - Initiation & Completion Years
• Figure 5-11: KO-MEN-015 Phase I (NCT06655246) Study - Initiation & Completion Years
• Figure 5-12: Menin - Role in B-Cell Dynamics & Diabetes
• Figure 5-13: Diabetes - Menin Inhibition
• Figure 6-1: Revuforj - Cost Per Unit & Supply (US$), July'2025
• Figure 6-2: Revuforj - Global Annual Sales (US$ Million), 2024-2025
• Figure 6-3: Revuforj - Global Quarterly Sales (US$ Million), Q1 & Q2'2025
• Figure 6-4: Revuforj - Global Quarterly Sales (US$ Million), Q4'2024
• Figure 7-1: Global - Menin Inhibitor Drug Market (US$ Million), 2024 -2025
• Figure 7-2: BAML-16-001 Phase I/II (NCT03013998) Study - Initiation & Completion Years
• Figure 7-3: Global - Menin Inhibitor Drug Market (US$ Million), 2026 - 2028
• Figure 7-4: Menin Inhibitor Market - Future Opportunities
• Figure 9-1: FUSION(TM) System - Biomea Fusion
• Figure 9-2: Innovation Platform - Rongchang Pharmaceuticals
• Figure 9-3: DragonFold Platform - Development Candidate Highlights
• Figure 9-4: Proprietary Approach - Eilean Therapeutics
• Figure 10-1: Global Menin Inhibitor Market - Drivers & Opportunities
• Figure 10-2: Global Menin Inhibitor Market - Key challenges & Strategic Solutions
• Figure 11-1: Global - Menin Inhibitor Drugs Clinical Trials by Company (Numbers), 2025 Till 2028
• Figure 11-2: Global - Menin Inhibitor Drugs Clinical Trials by Country (Numbers), 2025 Till 2028
• Figure 11-3: Global - Menin Inhibitor Drugs Clinical Trials by Indication (Numbers), 2025 Till 2028
• Figure 11-4: Global - Menin Inhibitor Drugs Clinical Trials by Phase (Numbers), 2025 Till 2028

List of Tables

• Table 5-1: Genetic Mutations In AML & Their Clinical Relevance
• Table 6-1: Revuforj - Recommended Management & Dosage Modifications for Adverse Reactions
• Table 6-2: Revuforj - Dosage Reduction For Adverse Reactions In Patients Not On Strong CYP3A4 Inhibitors
• Table 6-3: Revuforj - Dosage Reduction for Adverse Reactions in Patients on Strong CYP3A4 Inhibitors
• Table 6-4: Revuforj - Recommended Reduced Dosage Using Tablets for Patients Weighing Less than 40 kg