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Intas Pharmaceuticals和Accord BioPharma通过收购UDENYCA®,成为培非格司亭全球最大的供应商之一

Intas Pharmaceuticals and Accord BioPharma Become One of the Largest Global Suppliers of Pegfilgrastim with Acquisition of UDENYCA®

PHARMA FOCUS ASIA 等信源发布 2025-08-07 14:57

可切换为仅中文


Intas Pharmaceuticals in collaboration with its global subsidiaries operating under the Accord brand, has solidified its position as one of the world's leading suppliers of pegfilgrastim following the successful acquisition of UDENYCA® (pegfilgrastim-cbqv) from Coherus BioSciences, Inc.

Intas Pharmaceuticals与其在全球范围内以Accord品牌运营的子公司合作,成功从Coherus BioSciences, Inc.收购UDENYCA®(培非格司亭-cbqv)后,进一步巩固了其作为全球领先的培非格司亭供应商之一的地位。

UDENYCA, a biosimilar to Neulasta® (pegfilgrastim), significantly expands Intas and Accord's FDA-approved biosimilar portfolio and accelerates their strategic growth in the global biosimilar market. Accord is already a pegfilgrastim market leader in Europe—having been the first to commercialize a biosimilar pegfilgrastim and the only company to launch an autoinjector— has maintained its leadership despite intense competition.

UDENYCA是Neulasta®(培非格司亭)的生物类似药,显著扩展了Intas和Accord经FDA批准的生物类似药产品组合,并加速了它们在全球生物类似药市场的战略增长。Accord已经是欧洲培非格司亭市场的领导者——作为首个商业化推出生物类似药培非格司亭的公司,也是唯一一家推出自动注射器的企业——尽管竞争激烈,依然保持了其领导地位。

This acquisition further strengthens the company's presence and impact in both the U.S. and international biosimilar landscapes..

此次收购进一步增强了该公司在美国和国际生物仿制药领域的影响力。

With the acquisition, Accord BioPharma, the U.S. specialty business of Intas, continues the commercialization of UDENYCA to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

通过此次收购,Intas旗下的美国专业业务部门Accord BioPharma将继续推广UDENYCA,以降低接受与临床显著发热性中性粒细胞减少症相关的骨髓抑制类抗癌药物的非髓系恶性肿瘤患者的感染发生率(以发热性中性粒细胞减少症为表现)。

UDENYCA offers three patient-friendly administration options—autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS)—providing flexibility for treatment at home, on-the-go, or in clinical settings. Since its commercial launch, over 300,000 patients have been treated with UDENYCA and more than 1.4 million units have been distributed..

UDENYCA 提供三种患者友好的给药方式——自动注射器 (AI)、贴身注射器 (OBI) 和预充式注射器 (PFS),为在家、外出或临床环境中的治疗提供了灵活性。自其商业化推出以来,已有超过 30 万名患者接受 UDENYCA 治疗,并分发了超过 140 万支。

The acquisition not only expands Accord BioPharma's product offerings but also brings a wealth of talent from Coherus BioSciences. Key Coherus employees across multiple functions, including Sales, Marketing, Finance, Supply Chain, and Quality and Manufacturing, who have joined Accord BioPharma, will play a crucial role in supply and services continuity/transition and expanding the company's work around UDENYCA..

此次收购不仅扩大了Accord BioPharma的产品供应,还带来了来自Coherus BioSciences的众多人才。已加入Accord BioPharma的Coherus关键员工涵盖销售、市场、财务、供应链以及质量与制造等多个职能部门,他们将在供应和服务的连续性/过渡中发挥重要作用,并推动公司围绕UDENYCA开展更多工作。

Chrys Kokino, U.S. President of Accord BioPharma, commented:

克里·科基诺,Accord BioPharma美国总裁评论道:

'The completion of the UDENYCA acquisition marks a pivotal moment for Accord BioPharma, as it not only strengthens our market presence but broadens our capabilities as we endeavour to innovate and expand in the biosimilar space.'

“完成对UDENYCA的收购标志着Accord BioPharma的一个关键时刻,这不仅增强了我们的市场地位,还拓展了我们的能力,因为我们致力于在生物仿制药领域进行创新和扩展。”

Paul Tredwell, EMENA Executive Vice-President of Accord, added:

保羅·特雷德韋爾,Accord EMENA執行副總裁,補充說:

'With the Accord Biopharma team now fully commercializing UDENYCA® in three different formulations, this development strengthens Accord's offering and advances our goal of becoming the world's leading supplier of pegfilgrastim.'

“随着Accord Biopharma团队现在全面商业化推广三种不同剂型的UDENYCA®,这一进展增强了Accord的产品供应,并推动了我们成为全球领先的培非格司亭供应商的目标。”

Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals, said:

印度英特赛斯制药公司董事长兼董事总经理比尼什·楚德加尔表示:

'We are energized by this addition to Accord BioPharma's portfolio because it exemplifies our commitment to improving patient access to high-quality treatments that meet the evolving needs of both patients and healthcare providers. This acquisition cements our position as a global leader in pegfilgrastim and allows us to further expand our specialty division across key international markets.'.

“我们对Accord BioPharma产品组合的这一新增内容感到振奋,因为它体现了我们致力于改善患者获取高质量治疗的机会,以满足患者和医疗保健提供者不断变化的需求。此次收购巩固了我们在培非格司亭领域的全球领导地位,并使我们能够进一步扩大我们在关键国际市场的专业部门。”

UDENYCA® (pegfilgrastim-cbqv) INDICATION

UDENYCA® (培非格司亭-cbqv) 适应症

UDENYCA is a leukocyte growth factor indicated to:

UDENYCA是一种白细胞生长因子,适用于:

Limitations of Use

使用限制

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

UDENYCA 不适用于造血干细胞移植的外周血祖细胞动员。

Important Safety Information

重要安全信息

CONTRAINDICATION: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

禁忌症:对培非格司亭产品或非格司亭产品有严重过敏反应史的患者。反应包括过敏性休克。

Warnings and Precautions:

警告和注意事项:

ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

不良反应:最常见的不良反应(与安慰剂相比发生率差异≥5%)为骨痛和四肢疼痛。

To report SUSPECTED ADVERSE REACTIONS, contact 1-800-4-UDENYCA (1-800-483-3692) or notify the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

要报告可疑的不良反应,请联系1-800-4-UDENYCA(1-800-483-3692)或通知FDA,电话1-800-FDA-1088,或访问www.fda.gov/medwatch。

UDENYCA® Prefilled Syringe: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.

UDENYCA®预填充注射器:6毫克/0.6毫升,单剂量预填充注射器,仅限手动使用。

UDENYCA® Autoinjector: 6 mg/0.6 mL in a single-dose prefilled autoinjector.

UDENYCA® 自动注射器:6毫克/0.6毫升,单剂量预填充自动注射器。

UDENYCA ONBODY®: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector for UDENYCA®.

UDENYCA ONBODY®:6毫克/0.6毫升,单剂量预充注射器,与UDENYCA®的体戴式注射器共同包装。

Advisors

顾问

Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. acted as legal counsel to Accord and Intas with respect to the Transaction.

史密斯、安德森、布朗特、多塞特、米切尔和杰尼根律师事务所(Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P.)在本次交易中担任Accord和Intas的法律顾问。

About Intas Pharmaceuticals

关于英特斯制药公司

Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses in India. Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies in India.

印度英特赛斯制药公司在生物类似药领域处于领先地位,开发并推出了印度数量最多的本土生物类似药。英特赛斯制药公司有着悠久的历史,致力于让印度大众获得优质的生物类似药。其产品如Neukine(非格司亭)、Pegasta(培非格司亭)、Mabtas(利妥昔单抗)、Razumab(雷珠单抗)和Bevatas(贝伐单抗)已经改变了这些药物在印度的治疗管理模式。

Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality care to the masses in India. Intas' biosimilars are manufactured at Intas Pharmaceuticals' European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat.

Eleftha 是 Intas「仿制药惠及亿万大众」理念的最新例证,履行了其为印度大众提供高质量医疗的承诺。Intas 的生物仿制药是在位于古吉拉特邦艾哈迈达巴德附近、经欧盟良好生产规范(EU-GMP)认证的 Intas 制药生物技术工厂生产的。

For more information, visit www.intaspharma.com.  .

欲了解更多信息,请访问 www.intaspharma.com。

About Accord BioPharma

关于Accord BioPharma

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives.

Accord BioPharma, Inc. 是 Intas Pharmaceuticals 的美国专业部门,致力于在肿瘤学、免疫学和重症护理领域提供经济实惠、易于获取且以患者为中心的治疗方案。Accord BioPharma 专注于改善患者体验,超越药物的生物学本身,从患者的角度看待疾病,并开发对患者生活产生影响的高质量疗法。

Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com..

Accord BioPharma相信生物类似药能够增加多种生物药物的可及性,过去由于成本高昂,这些药物可能未被考虑用于患者。Accord BioPharma期待提供业内最丰富的生物类似药产品组合之一。欲了解更多信息,请访问AccordBioPharma.com。

About Coherus BioSciences

关于Coherus生物科学公司

Coherus BioSciences, Inc. is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with its proven commercial capabilities in oncology..

Coherus BioSciences, Inc. 是一家商业阶段的生物制药公司,专注于研究、开发和商业化创新的免疫疗法以治疗癌症。Coherus 正在开发一条创新的免疫肿瘤学管线,预计将与其在肿瘤学领域经过验证的商业能力产生协同效应。

References:

参考文献:

Source: prnewswire.com

来源:prnewswire.com