AHMEDABAD,

艾哈迈达巴德，

India

印度

,

，

Aug. 7, 2025

2025年8月7日

/PRNewswire/ -- 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..

/PRNewswire/ -- 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）的一种生物类似药，显著扩展了Intas和Accord经FDA批准的生物类似药产品组合，并加速了他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——作为首家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公司——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..

此次收购进一步加强了该公司在美国和国际生物仿制药领域的地位和影响力。

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旗下的美国专业公司Accord BioPharma继续推广UDENYCA，用于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抗癌药物的非髓系恶性肿瘤患者因发热性中性粒细胞减少症而导致的感染发生率。

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 offerings，还带来了Coherus BioSciences的丰富人才。来自Coherus的关键员工已经加入Accord BioPharma，涵盖了销售、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，同时推动公司围绕UDENYCA开展更多工作。

Chrys Kokino

克里斯·科基诺

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

，阿科德生物制药公司的美国总裁评论道：

'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，因为我们正努力在生物仿制药领域进行创新和扩展。”

Paul Tredwell

保罗·特雷德威尔

, EMENA Executive Vice-President of Accord, added:

，阿科德公司EMENA执行副总裁补充道：

'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UDENYCA®的三种不同制剂，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

比尼什·楚德加尔

, Chairman and Managing Director of Intas Pharmaceuticals, said:

，Intas Pharmaceuticals的董事长兼总经理表示：

'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产品组合的这一补充感到振奋，因为它体现了我们致力于改善患者获得高质量治疗的机会，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：

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.

降低接受与临床显著的发热性中性粒细胞减少症相关的骨髓抑制性抗癌药物的非髓系恶性肿瘤患者，因发热性中性粒细胞减少症而导致的感染发生率。

Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

提高急性暴露于骨髓抑制剂量辐射（急性放射综合征的造血亚综合征）患者的生存率。

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

重要的安全信息

CONTRAINDICATION:

禁忌症：

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

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。反应包括过敏反应。

WARNINGS AND PRECAUTIONS:

警告和注意事项：

•

•

Fatal splenic rupture

脾破裂致命

:

：

Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

评估报告左上腹部或肩部疼痛的患者是否有脾脏肿大或脾破裂。

•

•

Acute respiratory distress syndrome (ARDS):

急性呼吸窘迫综合征 (ARDS):

Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.

评估出现发热、肺浸润或呼吸窘迫的患者。对于出现ARDS的患者，停止使用UDENYCA。

•

•

Serious allergic reactions, including anaphylaxis:

严重的过敏反应，包括过敏性休克：

The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions.

大多数报告的事件发生在初次接触时。包括过敏反应（如过敏性休克）在内的过敏反应可能在停止初始抗过敏治疗后的几天内复发。对于出现严重过敏反应的患者，应永久停用UDENYCA。

•

•

Allergies to Acrylics (UDENYCA ONBODY

对丙烯酸过敏 （UDENYCA ONBODY）

®

®

only):

仅限）：

The on-body injector (OBI) for UDENYCA uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

UDENYCA的体内注射器（OBI）使用丙烯酸粘合剂。对于对丙烯酸粘合剂有反应的患者，使用该产品可能会导致严重反应。

•

•

Sickle cell crises:

镰状细胞危象：

Severe and sometimes fatal crises have occurred. Discontinue UDENYCA if sickle cell crisis occurs.

严重且有时致命的危象已经发生。如果发生镰状细胞危象，请停止使用UDENYCA。

•

•

Glomerulonephritis:

肾小球肾炎:

The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.

诊断基于氮质血症、血尿（显微镜下和肉眼可见）、蛋白尿以及肾活检。通常，事件在减量或停药后得到解决。如果可能存在因果关系，评估并考虑减少UDENYCA的剂量或中断给药。

•

•

Leukocytosis:

白细胞增多：

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.

接受培非格司亭产品治疗的患者曾观察到白细胞计数（WBC）达到或超过100 x 10^9/L。在使用UDENYCA治疗期间，建议监测全血细胞计数（CBC）。

•

•

Thrombocytopenia:

血小板减少症：

Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

已有报道接受培非格司亭治疗的患者出现血小板减少症。监测血小板计数。

•

•

Capillary Leak Syndrome:

毛细血管渗漏综合征：

Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care..

在使用G-CSF（包括培非格司亭产品）后已有报道，其特征为低血压、低白蛋白血症、水肿和血液浓缩。发作的频率和严重程度各异，如果治疗延误可能危及生命。如果出现症状，需密切监测并给予标准的对症治疗，可能需要重症监护。

•

•

Potential for Tumor Growth Stimulatory Effects on Malignant Cells:

对恶性细胞肿瘤生长的潜在刺激作用：

The granulocyte colony stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded..

粒细胞集落刺激因子（G-CSF）受体已被发现在肿瘤细胞系上，培非格司亭产品和非格司亭产品均通过该受体发挥作用。不能排除培非格司亭产品可作为任何肿瘤类型（包括髓性恶性肿瘤和骨髓增生异常综合征等该产品未获批准的疾病）的生长因子的可能性。

•

•

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer:

乳腺癌和肺癌患者中的骨髓增生异常综合征 (MDS) 和急性髓系白血病 (AML)：

MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

使用培非格司亭联合化疗和/或放疗治疗乳腺癌和肺癌患者时，曾发现与MDS和AML相关。在这些情况下，应监测患者是否出现MDS/AML的体征和症状。

•

•

Potential Device failures (UDENYCA ONBODY only)

潜在设备故障 （仅限UDENYCA ONBODY）

: Missed or partial doses have been reported for products administered via on-body injectors due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered.

由于设备未按预期工作，通过身体注射器给药的产品报告了漏服或部分剂量的情况。如果发生漏服或部分剂量，患者可能面临比正确给药时更高的中性粒细胞减少、发热性中性粒细胞减少和/或感染等事件的风险。

Instruct patients using the OBI to notify their healthcare professional immediately to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended..

指示使用 OBI 的患者，如果怀疑设备可能未按预期执行，应立即通知其医疗专业人员，以确定是否需要替换剂量的 UDENYCA。

•

•

Aortitis:

主动脉炎:

Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count).

在接受培非格司亭产品治疗的患者中已有报告，最早可在治疗开始后的第一周发生。表现可能包括全身性症状和体征，如发热、腹痛、不适、背痛以及炎症标志物升高（例如，C反应蛋白和白细胞计数）。

Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected..

如果出现不明原因的体征和症状，应考虑主动脉炎的可能性。如果怀疑为主动脉炎，请停止使用UDENYCA。

•

•

Nuclear Imaging:

核成像：

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.

骨髓对生长因子治疗的造血活性增加与短暂的骨显像阳性变化有关。在解读骨显像结果时应考虑此因素。

ADVERSE REACTIONS:

不良反应：

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

最常见的不良反应（与安慰剂相比发生率差异≥5%）是骨痛和四肢疼痛。

To report SUSPECTED ADVERSE REACTIONS, contact 1-800-4-UDENYCA (1-800-483-3692) or notify the FDA at 1-800-FDA-1088 or

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 或者

www.fda.gov/medwatch

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仿制药领域处于领先地位，已开发并推出了众多本土生物仿制药。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仿制药。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）已经改变了印度相关治疗领域的管理模式。

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「仿制药惠及亿万民众」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 .

欲了解更多信息，请访问。

www.intaspharma.com

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、可及且以患者为中心的治疗方案。通过关注提升患者体验，Accord BioPharma 不仅超越了药物生物学本身，更从患者角度看待疾病，开发能够影响患者生活的高质量疗法。

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 .

Accord BioPharma相信生物类似药能够增加多种生物药物的可及性，这些药物在过去由于高昂的成本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

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. 是一家处于商业化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，预计这将与其在肿瘤学领域已证明的商业化能力产生协同效应。

References:

参考文献：

1. UDENYCA Prescribing Information. Coherus BioSciences; December 2023.

1. UDENYCA处方信息。Coherus生物科学；2023年12月。

All trademarks, logos and brand names are the property of their respective owners.

所有商标、徽标和品牌名称均为其各自所有者的财产。

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