Menin抑制劑的全球市場 - 價格，銷售額，臨床試驗趨勢(2028年)

全球 Menin 抑制劑市場 - 價格、銷售和臨床試驗趨勢 (2028) 報告結果和亮點

• 全球市場規模及預測：2024-2028
• 全球 Menin 抑制劑市場機會：超過 4 億美元
• 已獲批准藥物劑量、價格和銷售額洞察
• 按公司、適應症和階段細分的 Menin 抑制劑臨床試驗洞察
• 臨床試驗中的 Menin 抑制劑數量：超過 15 種
• 各公司開發技術平台洞察
• 競爭格局

對 Menin 抑制劑的需求及本報告的意義

Menin 抑制劑的出現標誌著精準醫療領域最重大的變革之一，尤其是在高風險白血病的治療。 Menin是致癌基因轉錄調控的關鍵輔助因子，特別適用於KMT2A (MLL)重排和NPM1突變的白血病。這些分子亞型佔急性骨髓性白血病 (AML) 和急性淋巴細胞白血病 (ALL) 的大多數，並且通常與不良預後和有限的治療選擇有關。 Menin抑制劑尤其適合滿足這項尚未滿足的需求，它提供針對生物標記的標靶療法，特異性地抑制白血病形成過程。

本報告旨在為不斷發展的全球Menin抑制劑市場格局提供富有洞察力、及時性和策略性的視角。隨著市場迅速從胚胎研究轉向商業化，利害關係人需要及時可靠的訊息，包括產品線開發、臨床試驗結構、新技術平台和合作機會。本報告透過將跨地區、適應症和開發階段的複雜數據轉化為可用且可操作的格式來滿足這一需求。

報告包含臨床試驗洞察

本報告詳細分析了所有處於不同臨床開發階段的menin抑制劑候選藥物。這些臨床試驗涵蓋從早期I期試驗到最終獲得監管部門批准的後期試驗。報告涵蓋美國、歐洲、中國和澳洲等多個地區，研究範圍涵蓋血液系統惡性腫瘤和新興非腫瘤疾病。

資料重點包括癌症亞型（例如KMT2A重排AML、NPM1突變AML、ALL等）、治療方法（單藥治療與合併治療）及試驗類型。報告中還列出了每個計畫的合作夥伴、學術資助方、試驗地點和技術授權方。此外，報告還指出了在主要國際會議上報告的關鍵指標，例如緩解率、MRD陰性率、安全性和抗藥性數據。這些綜合見解使讀者能夠了解哪些臨床項目進展最有效，以及其科學和商業吸引力所在。

從事 Menin 抑制劑研發的主要公司

許多領先的公司處於全球 Menin 抑制劑研發工作的前沿。 Syndax Pharmaceuticals 於 2024 年 10 月創造了歷史，其 revumenib (Revforge) 獲批用於治療 KMT2A 重排 AML。

Kura Oncology 和 Kyowa Kirin 已提交 diftomenib 用於治療復發/難治性 NPM1 突變 AML 的新藥申請。其他活躍的公司包括住友製藥、強生和 Biomea Fusion。這些公司正在透過血液學、糖尿病甚至早期實體瘤領域的研究，採取不同的方法。

技術平台、合作與協議

該領域的創新由專有平台和策略聯盟驅動。 CHARM Therapeutics 就是一個例子，該公司正在利用其 DragonFold AI 平台開發下一代menin抑制劑，可保留對抗抗藥性突變的活性。這些分子特異性結合menin-KMT2A介面，即使在抗藥性菌株中也能保持療效，並最大限度地降低QTc延長和藥物交互作用等風險。 CHARM的策略可望為復發性或難治性AML患者提供更安全、更具韌性的治療方案。

重要的許可和合作協議也在定義這一領域。例如，Kura與協和麒麟的全球合作涵蓋了超過11億美元的潛在里程碑，而施維雅則與BioNova的BN104合作，這是一款處於早期階段的藥物，在KMT2A和NPM1 AML亞群中擁有良好的初始數據。

一份描繪 Menin 抑制劑領域未來方向的報告

Menin 抑制劑的下一階段研究將重點關注多個方面，包括將適應症從 AML 擴展到實體瘤和糖尿病；透過新一代設計改善安全性和抗藥性；以及透過地域擴張和合作試驗最大限度地擴大市場准入。隨著臨床數據的成熟和差異化競爭者的進入，該領域有望繼續創新並產生持久影響。

本報告捕捉了 Menin 抑制劑從開發到全球商業化的轉型時刻，並為利害關係人提供了探索複雜 Menin 抑制劑領域潛力的重要指南。

目錄

第1章 調查手法

第2章 Menin抑制劑的簡介

第3章 Menin抑制劑的臨床意義及影響

第4章 Menin抑制劑的作用機制

第5章 Menin抑制劑的各適應症應用和臨床試驗

• 血液癌症
• 固體癌
• 糖尿病

第六章：Revforge (Revmenib)：首個核准的Menin抑制劑

• 概要與專利資訊
• 價格和劑量
• 銷售洞察

第7章 全球Menin抑制劑市場形勢

• 目前市場Scenario
• 未來臨床及商業化的機會

第8章 Menin抑制劑的各地區臨床調查革新趨勢

• 美國
• 歐洲
• 其他地區

第9章 各企業Menin抑制劑開發技術平台

• FUSION™ 系統 - Biomea Fusion
• 創新平台 - 榮昌製藥
• 下一代方法 - CHARM Therapeutics
• 獨特方法 - Eilean Therapeutics

第10章 全球Menin抑制劑市場動態

• 促進因素和機會
• 課題與阻礙因素

第11章 Menin抑制劑的臨床試驗概要

• 各企業
• 各國
• 各適應症
• 各相

第12章 Menin抑制劑的臨床試驗(各企業，各適應症，各相)

• 前臨床
• 第一階段
• 第一/二階段
• 第二階段
• 第三階段
• 預註冊

第13章 已上市Menin抑制劑的臨床試驗(各企業，各適應症，各相)

第14章 競爭情形

• 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