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30 多年来,美纳里尼一直致力于推动研发,为受严重健康问题影响的患者提供创新且有效的药物和医疗保健解决方案。

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亚太地区的医疗行业正在快速增长。美纳里尼亚太隶属于世界领先的意大利生物制药公司,在该地区13个主要市场拥有强大的布局。

作为众多全球医疗保健公司的首选合作伙伴,我们参与整个药品开发生命周期,挖掘增长机会并扩大其品牌影响力。在此过程中,我们还为医务工作者和患者提供优质医疗产品和技术支持,以提高标准并为未来缔造健康生活。

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A. MENARINI ASIA-PACIFIC HOLDINGS PTE LTD
A. MENARINI ASIA-PACIFIC PRIVATE LIMITED
A. MENARINI SINGAPORE PTE LTD
A. MENARINI BIOMARKERS SINGAPORE PTE LTD

30 Pasir Panjang Road,
Mapletree Business City,
#08-32 Singapore 117440
Tel: +65-6494-7200
Fax: +65-6999-1787

 

新闻

2021 - 11 - 04

Menarini Receives FDA Orphan Drug Designation for SEL24/MEN1703, a first in class, dual PIM/FLT3 inhibitor for the Treatment of Acute Myeloid Leukemia

Florence (Italy) November 4th, 2021 – The Menarini Group announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to SEL24/MEN1703 for the treatment of Acute Myeloid Leukemia (AML). SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini from Ryvu Therapeutics, and currently investigated in the DIAMOND-01 trial as a single agent for the treatment of patients with relapsed/refractory AML.

ODD is granted by the FDA to therapies intended for the treatment of conditions that impact fewer than 200,000 people in the US and provides companies with several incentives to support the development of therapeutics and diagnostics for rare diseases. Of note, ODD does not influence the process of regulatory approval, and drugs for rare diseases go through the same rigorous scientific review process established for any other drug.

“FDA orphan drug designation represents an important milestone for SEL24/MEN1703 program” said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. “SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor that can contribute to finding new treatment paradigms for AML where significant unmet needs exist especially as resistance develops in later lines. We look forward to advancing the clinical development of SEL24/MEN1703 in AML with a goal to ultimately provide patients with a new therapeutic option for this hard-to-treat disease”.

DIAMOND-01 (CLI24-001; clinicaltrials.gov identifier NCT03008187) is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24/MEN1703, investigated as a single agent for the treatment of patients with relapsed/refractory AML.

In the dose escalation part of the DIAMOND-01 trial, SEL24/MEN1703 demonstrated a manageable safety profile up to the recommended dose (RD) of 125 mg/day, along with initial evidence of anti-leukemic activity as single agent. This evidence has been confirmed in the cohort expansion part of the study, which also showed preliminary single agent efficacy in relapsed/refractory AML, particularly in patients with IDH mutant disease, either naïve - or previously exposed - to IDH inhibitors.

The trial is currently recruiting AML patients bearing IDH1 or IDH2 mutation, to further investigate the activity of SEL24/MEN1703 in this molecularly defined sub-population of patients.

About SEL24/MEN1703

SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini from Ryvu Therapeutics. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) for the treatment of relapsed/refractory Acute Myeloid Leukemia.

About Menarini in Oncology

At Menarini, we understand that patients’ hope for a longer and healthier life is inextricably linked to the progress of scientific and medical research – that is what drives us forward.

Menarini Group has a strong commitment to oncology research and development, focused both on therapeutics and diagnostics. We invest in the development of precision medicine through our pipeline of investigational drugs, which includes both small molecules and biologics investigated for the treatment of hematologic and solid tumors. We are also committed to developing innovative technologies for the detection and analysis of circulating tumor cells through the work of Menarini Silicon Biosystems.

The acquisition of Stemline Therapeutics, a New York-based biopharmaceutical company in 2020, marked the entry of the Menarini Group into the U.S. biopharmaceutical oncology market and, together with the license agreement reached with Radius Health, strengthened Menarini’s oncology portfolio with the addition of both commercial and clinical-stage assets.

For further information about Menarini’s pipeline, please visit the dedicated page on our website at https://www.menarini.com/en-us/innovation-research/our-pipeline-and-products

About Menarini

The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.2 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 10 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com

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