Hikma收购了Novugen的FDA批准的曲美替尼ANDA-动脉网

Hikma acquires Novugen's FDA-approved ANDA for trametinib

CISION 等信源发布 2025-04-18 01:10

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LONDON

伦敦

，

April 17, 2025

2025年4月17日

/PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma..

/PRNewswire/ -- 跨国制药公司Hikma Pharmaceuticals PLC（Hikma）今日宣布，已从Novugen收购了FDA批准的曲美替尼片剂的简略新药申请（ANDA）。Hikma还宣布与Novugen达成商业协议，根据协议，Hikma将负责该产品在美国的所有销售和营销工作，而Novugen将负责生产并向Hikma供应该产品。

Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of US generic market sales exclusivity for this product.

曲美替尼是一种口服给药的激酶抑制剂药物，用于治疗某些癌症。一旦上市，Hikma将拥有该产品在美国仿制药市场180天的独家销售权。

'Hikma's Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers,' said Dr. Hafrun Fridriksdottir, president of Hikma Generics. 'Our acquisition of this cancer treatment strengthens our broad US pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans.'.

Hikma仿制药业务总裁Hafrun Fridriksdottir博士表示：“Hikma的仿制药业务正在加快努力，通过开发和收购美国患者和医疗保健提供者最需要的增长治疗领域中的重要药物来扩大其产品线。我们对这种癌症治疗药物的收购增强了我们在美国广泛的产品线，并将进一步提升我们每天为数百万美国人实现更好健康的能力。”

'As cancer treatment remains a critical healthcare challenge, our partnership with Hikma reflects a shared commitment to ensuring the availability of effective, cost-efficient, and high-quality oncology treatments in the US,' said

“由于癌症治疗仍然是一个关键的医疗挑战，我们与Hikma的合作反映了我们共同致力于确保在美国提供有效、成本效益高且高质量的肿瘤治疗。”

Rahil Mahmood

拉希勒·马哈茂德

, Chief Executive Officer of Novugen. 'This exclusive first-to-file molecule is a testament to Novugen's innovation, regulatory excellence, and dedication to expanding access to high-barrier, niche products with limited alternatives—ensuring life-changing treatments reach more US patients. With Hikma's strong market presence and commercial capabilities, this collaboration represents an excellent strategic synergy.'.

，Novugen的首席执行官。“这一独家的首仿分子证明了Novugen的创新能力、法规卓越性以及致力于扩大高门槛、小众产品的可及性，这些产品替代品有限，确保改变生命的治疗能够惠及更多美国患者。凭借Hikma强大的市场地位和商业能力，此次合作代表了极佳的战略协同效应。”

According to IQVIA, US sales of trametinib, sold under the brand name Mekinist

根据IQVIA的数据，trametinib（品牌名称为Mekinist）在美国的销售额

(trametinib) Tablets, were approximately

（曲美替尼）片剂，大约

$436 million

4.36亿美元

in the 12 months ending

在截至的12个月中

December 2024

2024年12月

。

Hikma's Generics business supplies a range of oral, inhalation and other generic and specialty products in the North American market, and has expertise in complex technologies, such as nasal sprays, where we are the largest supplier by volume in the US

Hikma的仿制药业务在北美市场提供一系列口服、吸入及其他仿制和特种产品，并在鼻喷雾等复杂技术方面拥有专长，我们在美国是此类产品的最大供应商。

。

IQVIA MAT

December 2024

2024年12月

, volumes by eaches

，每单位的体积

Mekinist

迈吉宁

is a registered trademark of Novartis Pharma AG

是诺华制药公司的注册商标

This product has been approved for marketing in

该产品已获准上市销售

the United States

美国

by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside

由美国食品药品监督管理局（FDA）批准。该产品批准并不赋予Hikma或任何其他方在境外市场销售该产品的权利。

the United States

美国

。

Enquiries

查询

Hikma Pharmaceuticals PLC

Susan Ringdal

苏珊·林达尔

EVP, Strategic Planning and Global Affairs

执行副总裁，战略规划与全球事务

+44 (0)20 7399 2760/ +44 7776 477050

+44 (0)20 7399 2760 / +44 7776 477050

Steven Weiss

史蒂文·韦斯

US Communications

美国通信

+1 732 788 8279

About Hikma

关于Hikma

(LSE: HIK) (NASDAQ

（伦敦证券交易所：HIK）（纳斯达克

Dubai

迪拜

: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/positive Fitch)

：海康威视）（场外交易：HKMPY）（标普评级BBB-/稳定，惠誉评级BBB-/正面）

Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across

Hikma每天帮助世界各地数百万人实现更好的健康。四十多年来，我们一直致力于生产高品质药物，并将其提供给需要的人。我们总部位于英国，是一家全球性公司，在多个国家和地区拥有本地业务。

North America

北美

, the

，这个

Middle East

中东地区

and

和

North Africa

北非

(MENA) and

中东和北非地区

Europe

欧洲

, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines.

，并且我们运用我们的独特见解和专业知识，将尖端科学转化为创新解决方案，从而改变人们的生活。我们致力于服务我们的客户以及他们所关心的人群，并通过创造性思维和务实行动，为他们提供广泛的品牌和非品牌仿制药。

Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: .

我们的 9500 名同事正在共同努力，打造一个更健康的世界，丰富我们所有的社区。我们是领先的授权合作伙伴，并通过我们的风险投资部门，帮助将创新的健康技术带给世界各地的人们。欲了解更多信息，请访问：。

www.hikma.com

About Novugen

关于Novugen

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of expertise in the healthcare industry. The company has successfully ventured into strategic healthcare businesses and developed world-class healthcare facilities worldwide. Driven by a passion for science and a bold global strategy, Novugen specializes in niche, difficult-to-formulate generics across various therapeutic areas, including general and oncology pharmaceuticals, while adhering to stringent global quality standards.

Novugen 是 SciTech International 的全资子公司，该集团总部位于阿联酋，在医疗保健行业拥有超过 30 年的专业经验。公司成功涉足战略性医疗保健业务，并在全球范围内建立了世界级的医疗设施。凭借对科学的热情和大胆的全球战略，Novugen 专注于各种治疗领域的小众、难以配方的仿制药，包括普通药物和肿瘤药物，同时严格遵守全球质量标准。

With vertical integration from research and development to manufacturing in .

通过从研发到制造的垂直整合。

Malaysia

马来西亚

, Novugen maintains full control over its supply chain. Its state-of-the-art manufacturing facilities, comply with USFDA, EMA, PIC/S, and WHO regulatory requirements. Novugen is also the first in Malaysia and the only in Southeast Asia with USFDA-approved pharmaceutical manufacturing facilities dedicated to oral solid dosage forms for general medicines and highly potent oncology drugs.

，Novugen完全掌控其供应链。其最先进的制造设施符合美国食品药品监督管理局（USFDA）、欧洲药品管理局（EMA）、国际药品认证合作组织（PIC/S）和世界卫生组织（WHO）的监管要求。Novugen也是马来西亚首家、东南亚唯一一家拥有美国食品药品监督管理局（USFDA）批准的、专注于普通药物和高效抗癌药物口服固体剂型的制药生产设施的企业。

This accreditation positions Novugen as the first in Malaysia to manufacture and export high-quality medicines for the U.S. market. Novugen is committed to expanding early access to complex pharmaceutical products that often lack robust generic alternatives. Through continuous innovation, we strive to lead the way in delivering high-quality, technology-driven pharmaceuticals globally..

这一认证使 Novugen 成为马来西亚首家为美国市场生产和出口高质量药品的公司。Novugen 致力于扩大对通常缺乏强有力仿制药替代品的复杂药物的早期使用。通过持续创新，我们力求在全球范围内引领高质量、技术驱动型药品的交付。

SOURCE Hikma Pharmaceuticals

来源：Hikma Pharmaceuticals

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