Approval gives Accord BioPharma the most comprehensive granulocyte colony-stimulating factor

批准使Accord BioPharma拥有最全面的粒细胞集落刺激因子

(G-CSF)

（粒细胞集落刺激因子）

biosimilar portfolio in the U.S., with two pegfilgrastim options and a filgrastim

美国的生物类似药产品组合，包括两种聚乙二醇化非格司亭选项和一种非格司亭

RALEIGH, N.C.

北卡罗来纳州罗利

,

，

July 9, 2026

2026年7月9日

/PRNewswire/ --

/美通社/ --

Accord BioPharma

Accord BioPharma

, the U.S. specialty division of

，美国的特种部门

Intas Pharmaceuticals, Ltd.

英塔斯制药有限公司

, focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved ENNUMO™ (pegfilgrastim-pccg), a biosimilar to NEULASTA® (pegfilgrastim). ENNUMO is indicated in adults and pediatric patients aged newborn and older 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, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)..

，专注于肿瘤学、免疫学和中枢神经系统（CNS）疗法开发的公司，今日宣布美国食品药品监督管理局（FDA）已批准ENNUMO™（pegfilgrastim-pccg），这是一种NEULASTA®（pegfilgrastim）的生物类似药。ENNUMO适用于成人及新生儿及以上年龄的儿科患者，用于降低因接受与发热性中性粒细胞减少症临床显著发生率相关的骨髓抑制性抗癌药物治疗的非髓系恶性肿瘤患者的感染发生率（表现为发热性中性粒细胞减少症），并提高急性暴露于骨髓抑制剂量辐射（急性辐射综合征的造血子系统）患者的生存率。

1

1

ENNUMO is approved by the FDA for the same indications as its reference product, NEULASTA.

ENNUMO 已获美国食品药品监督管理局（FDA）批准，其适应症与参照药 NEULASTA 相同。

With this approval, Accord BioPharma is now the only company in the U.S. offering two distinct pegfilgrastim biosimilars — ENNUMO and UDENYCA® (pegfilgrastim-cbqv) — alongside FILKRI™ (filgrastim-laha), its short-acting granulocyte colony-stimulating factor (G-CSF) biosimilar approved in February 2026.

凭借此次获批，Accord BioPharma 成为美国唯一一家提供两种不同聚乙二醇化非格司亭生物类似药（ENNUMO 和 UDENYCA® [pegfilgrastim-cbqv]）的公司，同时还拥有其短效粒细胞集落刺激因子（G-CSF）生物类似药 FILKRI™（filgrastim-laha），该药于 2026 年 2 月获得批准。

Together, these three products form a G-CSF portfolio designed to meet the diverse clinical and operational needs of oncology practices, hospitals, and the patients they serve..

这三款产品共同构成了一个G-CSF产品组合，旨在满足肿瘤科诊所、医院及其所服务患者的多样化临床和运营需求。

'

'

Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies,' said Chrys Kokino, President, Accord North America. 'With ENNUMO, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company.

Accord北美公司总裁Chrys Kokino表示：“每一次获得美国食品药品监督管理局（FDA）批准，都标志着我们在扩大患者获取高质量、可负担的生物制剂治疗方面迈出了坚实的一步。凭借ENNUMO，我们现在向医疗保健提供者提供来自单一生物类似药公司的全球最大G-CSF产品组合。”

We are on track to deliver 20 biosimilars by 2030. We recognize that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings. Most importantly we are proud that we have and will continue to increase patient access to these critically important medicines.

我们正按计划推进，确保到2030年交付20种生物类似药。我们认识到，随着我们不断拓展肿瘤产品线，患者和肿瘤诊疗机构都长期倚赖我们的支持。最为重要的是，我们自豪地表示，我们已并将继续提高患者获取这些至关重要药物的可及性。

.'

。'

Expanding Access Through Portfolio Breadth

通过产品组合的广度扩大覆盖范围

Febrile neutropenia is one of the most serious and frequently occurring complications of myelosuppressive chemotherapy, contributing to treatment delays, dose reductions, hospitalizations, and increased mortality risk in patients with cancer.

发热性中性粒细胞减少症是骨髓抑制性化疗最严重且最常见的并发症之一，可导致癌症患者治疗延迟、剂量降低、住院以及死亡风险增加。

2

2

Granulocyte colony-stimulating factors have become a cornerstone of oncology supportive care, and biosimilars are playing an increasingly critical role in expanding access to these therapies across a range of clinical settings.

粒细胞集落刺激因子已成为肿瘤支持治疗的基石，而生物类似药在扩大这些疗法 across 各种临床环境中的可及性方面正发挥着日益关键的作用。

'From speaking with our customers, we know the needs of oncology practices are not one-size-fits-all, and we've built our portfolio to address this reality,' said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. 'With ENNUMO and UDENYCA, we have pegfilgrastim biosimilar options to offer—alongside FILKRI for short-acting G-CSF—so we can meet physicians and their patients where they are.'.

Accord BioPharma 数字与营销战略及运营高级副总裁 Nuvan Dassanaike 表示：“通过与客户的交流，我们深知肿瘤科诊所的需求并非千篇一律，因此我们构建了多元化的产品组合以应对这一现实。凭借 ENNUMO 和 UDENYCA，我们可提供聚乙二醇化非格司亭生物类似药选择，并结合短效 G-CSF 产品 FILKRI，从而满足医生及其患者的多样化需求。”

Part of a Broader Biosimilar Growth Story

生物类似药更广泛增长故事的一部分

The approval of ENNUMO marks the latest milestone in Accord BioPharma's rapid portfolio expansion. The company has set a strategic goal to launch 20 biosimilar products in the U.S. by 2030, building on a growing commercial portfolio that now spans oncology and immunology, with an aim to further expand into central nervous system therapies.

ENNUMO的获批标志着Accord BioPharma在快速产品组合扩张中取得的最新里程碑。该公司制定了到2030年在美国推出20种生物类似药产品的战略目标，依托目前涵盖肿瘤学和免疫学的不断扩大的商业化产品组合，并旨在进一步拓展至中枢神经系统治疗领域。

Backed by Intas Pharmaceuticals, Ltd., one of the world's largest and most experienced biosimilar developers with nearly five decades of global pharmaceutical expertise, Accord BioPharma is uniquely positioned to deliver on this ambition..

Accord BioPharma 由 Intas Pharmaceuticals, Ltd. 支持，后者是全球最大且经验最丰富的生物类似药开发商之一，拥有近五十年的全球制药专业知识，这使得 Accord BioPharma 在实现这一雄心方面具有独特的优势。

'ENNUMO's approval is another proof point that what we're building at Accord BioPharma can genuinely change the treatment landscape for patients in the U.S.,' said Binish Chudgar,

“ENNUMO的批准是另一个证明，表明我们在Accord BioPharma所构建的产品能够真正改变美国患者的治疗格局。”Binish Chudgar表示。

Chairman and

主席和

Managing Director, Intas Pharmaceuticals, Ltd. 'Our goal of 20 biosimilars by 2030 is not just a number. It reflects the depth of our pipeline and our determination to deliver.'

Intas Pharmaceuticals, Ltd. 常务董事：“我们到2030年推出20种生物类似药的目标不仅仅是一个数字。它反映了我们产品管线的深度以及我们兑现承诺的决心。”

Contact:

联系方式：

[email protected]

[email protected]

IMPORTANT SAFETY INFORMATION

重要安全信息

Contraindications:

禁忌症：

ENNUMO is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

对于有对聚乙二醇化非格司亭产品或非格司亭产品严重过敏反应史的患者，禁用ENNUMO。此类反应包括过敏性休克。

Splenic Rupture:

脾破裂：

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Patients who report left upper abdominal or shoulder pain after receiving ENNUMO should be evaluated for an enlarged spleen or splenic rupture.

使用聚乙二醇化非格司亭产品后可能发生脾破裂，包括致命病例。在接受ENNUMO治疗后报告左上腹或肩部疼痛的患者应接受评估，以排查脾肿大或脾破裂。

Acute Respiratory Distress Syndrome:

急性呼吸窘迫综合征：

Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients for ARDS who develop fever, lung infiltrates or respiratory distress after receiving ENNUMO. Discontinue ENNUMO in patients with ARDS.

接受聚乙二醇化非格司亭类产品的患者可能发生急性呼吸窘迫综合征（ARDS）。对于在接受ENNUMO治疗后出现发热、肺部浸润或呼吸窘迫的患者，应评估其是否患有ARDS。对于发生ARDS的患者，应停用ENNUMO。

Serious Hypersensitivity Reactions:

严重超敏反应：

Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial therapies to manage the reaction. Permanently discontinue ENNUMO in patients with serious hypersensitivity reactions..

接受聚乙二醇化非格司亭类药物治疗的患者可能发生严重的超敏反应，包括过敏性休克。大多数报告的事件发生在首次暴露时，并且在停止用于处理该反应的初始治疗后数天内可能复发。对于出现严重超敏反应的患者，应永久停用ENNUMO。

Use in Patients with Sickle Cell Disorders:

在镰状细胞病患者中的使用：

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue ENNUMO if sickle cell crisis occurs.

接受聚乙二醇化非格司亭产品的镰状细胞病患者可能发生严重且有时致命的镰状细胞危象。如果发生镰状细胞危象，应停用ENNUMO。

Glomerulonephritis:

肾小球肾炎：

Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products.

接受聚乙二醇化非格司亭产品的患者中曾发生肾小球肾炎。诊断依据包括氮质血症、血尿（镜下和肉眼）、蛋白尿以及肾活检。通常情况下，在减少剂量或停用聚乙二醇化非格司亭产品后，肾小球肾炎事件得以缓解。

If glomerulonephritis is suspected, evaluate for cause and if likely, consider dose-reduction or interruption of ENNUMO..

如果怀疑肾小球肾炎，应评估病因，若可能性较大，则考虑减少ENNUMO剂量或中断用药。

Leukocytosis

白细胞增多症

: White blood cell (WBC) counts of 100 x 10

：白细胞（WBC）计数为 100 x 10

9

9

/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during ENNUMO therapy is recommended.

在接受聚乙二醇化非格司亭产品的患者中，曾观察到/L或更高的数值。建议在ENNUMO治疗期间监测全血细胞计数（CBC）。

Thrombocytopenia:

血小板减少症：

Pegfilgrastim products can cause thrombocytopenia. Monitor platelet counts during ENNUMO therapy.

聚乙二醇化非格司亭产品可能导致血小板减少症。在ENNUMO治疗期间应监测血小板计数。

Capillary Leak Syndrome:

毛细血管渗漏综合征：

Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (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.

已有报道指出，在使用粒细胞集落刺激因子（G-CSF），包括聚乙二醇化非格司亭制剂后，可能出现毛细血管渗漏综合征，其特征为低血压、低白蛋白血症、水肿和血液浓缩。发作频率和严重程度各异，若治疗延迟，可能危及生命。

Closely monitor patients who develop symptoms of capillary leak syndrome and provide standard symptomatic treatment, which may include a need for intensive care..

密切监测出现毛细血管渗漏综合征症状的患者，并提供标准的对症治疗，可能需要重症监护。

Potential for Tumor Growth Stimulatory Effects on Malignant Cells:

对恶性肿瘤细胞具有潜在的肿瘤生长刺激作用：

The 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..

在肿瘤细胞系上已发现聚乙二醇化非格司亭制剂和非格司亭制剂作用的G-CSF受体。不能排除聚乙二醇化非格司亭制剂作为任何类型肿瘤（包括髓系恶性肿瘤和骨髓增生异常综合征，这些疾病尚未批准使用聚乙二醇化非格司亭制剂）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 products 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.

：在乳腺癌和肺癌患者中，聚乙二醇化非格司亭产品与化疗和/或放疗联合使用已与骨髓增生异常综合征（MDS）和急性髓系白血病（AML）的发生相关。在这些情况下，应监测患者是否出现 MDS/AML 的体征和症状。

Aortitis

主动脉炎

: Aortitis has been reported in patients receiving pegfilgrastim products and may occur 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).

：已有报道指出，接受聚乙二醇化非格司亭产品的患者可能发生主动脉炎，且在治疗开始后第一周即可出现。临床表现可能包括全身性体征和症状，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 in patients who develop these signs and symptoms without known etiology. Discontinue ENNUMO if aortitis is suspected..

对于出现这些体征和症状但病因不明的患者，应考虑主动脉炎的可能性。若怀疑发生主动脉炎，应停用ENNUMO。

Nuclear Imaging

核医学成像

: Increased hematopoietic activity of the bone marrow in response to growth factor therapy, including pegfilgrastim products, has been associated with transient positive bone imaging changes and should be considered when interpreting bone imaging results.

骨髓对包括聚乙二醇化非格司亭制剂在内的生长因子治疗产生的造血活性增加，与一过性骨显像阳性改变相关，在解读骨显像结果时应予以考虑。

Most Common Adverse Reactions:

最常见的不良反应：

Most common adverse reactions (≥ 5% higher 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%）为骨痛和四肢疼痛。

INDICATIONS

适应症

ENNUMO is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to:

ENNUMO 是一种白细胞生长因子，适用于成人及新生儿及以上年龄的儿童患者，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.

降低接受与临床上显著发热性中性粒细胞减少发生率相关的骨髓抑制性抗癌药物的非髓系恶性肿瘤患者的感染发生率，其表现包括发热性中性粒细胞减少。

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：

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

ENNUMO 不用于动员外周血祖细胞以进行造血干细胞移植。

To

到

report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or

报告疑似不良反应，请致电 1-866-941-7875 联系 Accord BioPharma Inc，或

FDA

美国食品药品监督管理局

at

在

1-800-FDA-1088

1-800-FDA-1088

or

或

www.fda.gov/medwatch

www.fda.gov/medwatch

.

。

ENNUMO (pegfilgrastim-pccg) injection for manual use is supplied in a 6 mg/0.6 mL single-dose prefilled syringe.

ENNUMO（pegfilgrastim-pccg）注射液供手动使用，以6 mg/0.6 mL的单剂量预充式注射器形式提供。

Click here for

点击此处获取

full Prescribing Information

完整处方信息

.

。

NEULASTA

纽拉司塔

®

®

(pegfilgrastim) is a registered trademark of Amgen Inc.

（培非格司亭）是安进公司的注册商标。

About Accord BioPharma

关于 Accord BioPharma

Accord BioPharma, Inc. is the U.S. specialty division of Intas Pharmaceuticals, Ltd., one of the world's most experienced biosimilar developers. Focused on the therapeutic areas of oncology, immunology, and CNS, Accord BioPharma is committed to expanding patient access to high-quality, affordable biologic therapies.

Accord BioPharma, Inc. 是 Intas Pharmaceuticals, Ltd. 的美国专科业务部门，而 Intas Pharmaceuticals, Ltd. 是全球经验最丰富的生物类似药开发商之一。Accord BioPharma 专注于肿瘤学、免疫学和中枢神经系统（CNS）治疗领域，致力于扩大患者对高质量、可负担的生物制剂疗法的可及性。

The company's FDA-approved commercial portfolio includes UDENYCA® (pegfilgrastim-cbqv) – a biosimilar to NEULASTA® (pegfilgrastim); FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim); IMULDOSA® (ustekinumab-srlf) – a biosimilar to STELARA® (ustekinumab); HERCESSI™ (trastuzumab-strf) – a biosimilar to HERCEPTIN® (trastuzumab); and CAMCEVI® (leuprolide mesylate) injectable emulsion.

该公司获美国食品药品监督管理局（FDA）批准的商业产品组合包括：UDENYCA®（pegfilgrastim-cbqv），一种NEULASTA®（聚乙二醇化非格司亭）的生物类似药；FILKRI™（filgrastim-laha），一种NEUPOGEN®（非格司亭）的生物类似药；IMULDOSA®（ustekinumab-srlf），一种STELARA®（乌司奴单抗）的生物类似药；HERCESSI™（trastuzumab-strf），一种HERCEPTIN®（曲妥珠单抗）的生物类似药；以及CAMCEVI®（亮丙瑞林甲磺酸盐）注射用乳剂。

Accord BioPharma has received FDA approval on additional products including OSVYRTI® (denosumab-desu) – a biosimilar to Prolia® (denosumab), JUBEREQ® (denosumab-desu) – a biosimilar to Xgeva® (denosumab), IMMGOLIS™ (golimumab-sldi) – a biosimilar to Simponi® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) – a biosimilar to Simponi Aria® (golimumab).

Accord BioPharma 已获得美国食品药品监督管理局（FDA）对更多产品的批准，包括：OSVYRTI®（denosumab-desu），一种 Prolia®（地舒单抗）的生物类似药；JUBEREQ®（denosumab-desu），一种 Xgeva®（地舒单抗）的生物类似药；IMMGOLIS™（golimumab-sldi），一种 Simponi®（戈利木单抗）的生物类似药；以及 IMMGOLIS INTRI™（golimumab-sldi），一种 Simponi Aria®（戈利木单抗）的生物类似药。

The company's strategic goal is to launch 20 biosimilar products in the U.S. by 2030. For more information, visit .

该公司的战略目标是在2030年前在美国推出20种生物类似药产品。更多信息，请访问。

www.accordbiopharma.com

www.accordbiopharma.com

.

。

References

参考文献

ENNUMO™ (pegfilgrastim-pccg) Prescribing Information. Accord BioPharma.

ENNUMO™（培非格司亭-pccg）处方信息。Accord BioPharma。

Tai E, Guy GP, Dunbar A, Richardson LC. Cost of cancer-related neutropenia or fever hospitalizations, United States, 2012.

Tai E, Guy GP, Dunbar A, Richardson LC. 2012年美国癌症相关中性粒细胞减少或发热住院的费用。

J Oncol Pract.

《肿瘤实践杂志》

2017;13(6):e552-e561.

2017;13(6):e552-e561.

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SOURCE Accord BioPharma

来源：Accord BioPharma

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