Celltrion获得美国FDA批准STOBOCLO®（地诺单抗-bmwo）和OSENVELT®（地诺单抗-bmwo）生物类似药，参照PROLIA®和XGEVA®-动脉网

Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®

CISION 等信源发布 2025-03-04 12:28

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STOBOCLO

(denosumab-bmwo) and OSENVELT

(denosumab-bmwo) 和 OSENVELT

(denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA

（denosumab-bmwo）获FDA批准用于参考产品PROLIA的所有适应症。

(denosumab) and XGEVA

（地诺单抗）和XGEVA

(denosumab) respectively

（地诺单抗）分别

[1], [2]

The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the reference products

FDA 的批准基于强有力的临床证据，这些证据显示与参比产品没有临床上有意义的差异。

With the FDA approval of STOBOCLO

随着STOBOCLO获得FDA批准

(denosumab-bmwo) and OSENVELT

(denosumab-bmwo) 和 OSENVELT

(denosumab-bmwo) Celltrion's biosimilar portfolio continues to grow, expanding treatment options to reach more patients

（地诺单抗-bmwo）Celltrion的生物类似药组合持续增长，扩大了治疗选择，惠及更多患者。

JERSEY CITY, N.J.

新泽西州泽西市

，

March 3, 2025

2025年3月3日

/PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO

/PRNewswire/ -- Celltrion今天宣布，美国食品药品监督管理局（FDA）已批准STOBOCLO。

(CT-P41, denosumab-bmwo) and OSENVELT

(CT-P41，地诺单抗-bmwo) 和 OSENVELT

(CT-P41, denosumab-bmwo), biosimilars referencing PROLIA

(CT-P41，denosumab-bmwo)，参照PROLIA的生物类似药

(denosumab) and XGEVA

（地诺单抗）和XGEVA

(denosumab) respectively for all indications of reference products.

（地诺单抗）分别用于参照产品的所有适应症。

[1], [2]

'The approval of STOBOCLO and OSENVELT is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events,' said

“STOBOCLO 和 OSENVELT 的获批是我们为提供具有成本效益和高质量的治疗方案所迈出的又一步，这些方案旨在解决与骨质疏松相关的骨折以及癌症相关的骨骼事件等关键未满足需求，”

Thomas Nusbickel

托马斯·努斯比克尔

, Chief Commercial Officer at Celltrion

Celltrion首席商务官

USA

美国

. 'Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives. We are committed to continuous innovation to meet these goals leveraging our experience and successful track record with biosimilar and novel biologics.'

“患者理应获得有可能对他们的治疗和生活产生真正影响的治疗选择。我们致力于利用我们在生物类似物和新型生物制品方面的经验与成功记录，不断进行创新以实现这些目标。”

The FDA approval is based on robust clinical evidence, including results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab. Study results demonstrated that CT-P41 had equivalent efficacy and PD to reference denosumab with similar PK and comparable safety and immunogenicity profiles..

FDA 的批准基于强有力的临床证据，包括针对绝经后骨质疏松症女性的 III 期临床试验结果，这些试验旨在评估 CT-P41 与参照药物地诺单抗的疗效、药效学 (PD)、药代动力学 (PK)、安全性及免疫原性。研究结果显示，CT-P41 与参照药物地诺单抗具有相当的疗效和 PD，相似的 PK，以及可比的安全性和免疫原性特征。

'Denosumab is used to improve or protect bone health in patients with osteoporosis or those undergoing various cancer treatments and as a therapy for a lifetime for postmenopausal osteoporosis (PMO) patients,' said Prof.

“地诺单抗用于改善或保护骨质疏松症患者的骨骼健康，或正在接受各种癌症治疗的患者，也可作为绝经后骨质疏松症（PMO）患者终生治疗的疗法，”教授表示。

Jean-Yves Reginster

让-伊夫·勒吉斯特

, Professor of Medicine, Protein Research Chair, Biochemistry Dept, College of Science, King Saud University,

医学教授，蛋白质研究主席，生物化学系，科学学院，国王沙特大学，

Riyadh

利雅得

，

Kingdom of Saudi Arabia

沙特阿拉伯王国

and Director WHO Collaborating Centre for Epidemiology of Musculoskeletal Health and Aging, Liège,

以及列日大学肌肉骨骼健康与老龄化流行病学世卫组织合作中心主任，

Belgium

比利时

. 'Biosimilars have expanded into new therapeutic areas such as immunology, oncology and ophthalmology as they continue to offer significant cost-saving potential while expanding patient access. Having a denosumab product with a clinically proven track record in quality and safety is a valuable addition for my patients.'.

“生物类似药已经扩展到新的治疗领域，如免疫学、肿瘤学和眼科，因为它们在扩大患者用药可及性的同时，继续提供显著的成本节约潜力。拥有一种在质量和安全性方面有临床验证记录的denosumab产品，对我的患者来说是一个宝贵的补充。”

In accordance with a settlement agreement with Amgen Inc., STOBOCLO and OSENVELT are expected to be available in the U.S. in

根据与安进公司的和解协议，STOBOCLO 和 OSENVELT 预计将在美国上市。

June 2025

2025年6月

。

About

关于

STOBOCLO

斯托博克洛

(denosumab-bmwo)

(地诺单抗-bmwo)

STOBOCLO

斯托博克洛

(denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA

(denosumab-bmwo) 是一种参照PROLIA的NF-κB配体（RANKL）受体激活剂抑制剂

(denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

（地诺单抗）。STOBOCLO 60 mg/mL 注射剂已获得 FDA 批准，基于确认其与 PROLIA 治疗等效性的全面数据和临床证据。在美国，STOBOCLO 被批准用于治疗骨折高风险的绝经后女性骨质疏松症，增加骨折高风险男性骨质疏松症患者的骨量，治疗骨折高风险男性和女性的糖皮质激素诱发的骨质疏松症，增加接受非转移性前列腺癌雄激素剥夺疗法的骨折高风险男性的骨量，以及增加接受乳腺癌辅助芳香酶抑制剂治疗的骨折高风险女性的骨量。

STOBOCLO was .

STOBOCLO曾是。

also approved by the European Medicines Agency (EMA) in

同时获得欧洲药品管理局 (EMA) 批准

February 2025

2025年2月

。

INDICATIONS

适应症

STOBOCLO

斯托博克洛

(denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment:

(denosumab-bmwo) 是一种 RANK 配体 (RANKL) 抑制剂，适用于治疗：

的

postmenopausal women

绝经后妇女

with osteoporosis at high risk for fracture

骨质疏松症且骨折高风险患者

至

increase bone mass in men

增加男性骨密度

with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer

骨质疏松症患者骨折高风险者，或接受雄激素剥夺治疗的非转移性前列腺癌男性患者骨折高风险者

的

glucocorticoid-induced osteoporosis

糖皮质激素诱导的骨质疏松症

in men and women at high risk for fracture

在骨折高风险的男性和女性中

至

increase bone mass in women

增加女性骨密度

at high risk for fracture receiving a adjuvant aromatase inhibitor therapy for breast cancer

高骨折风险的乳腺癌患者接受辅助芳香化酶抑制剂治疗

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE

警告：晚期肾病患者严重低钙血症

Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities.

晚期慢性肾病患者，包括那些接受透析的患者，在使用地诺单抗后面临严重低钙血症的更高风险，已有报道称相关病例导致住院、危及生命的情况以及死亡。

The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients

慢性肾脏病-矿物质骨病（CKD-MBD）的存在显著增加了这些患者低钙血症的风险。

Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD.

在晚期慢性肾病患者开始使用STOBOCLO®（地诺单抗-bmwo）之前，应评估CKD-MBD。治疗应由有诊断和管理CKD-MBD经验的医疗保健提供者监督。

STOBOCLO is contraindicated in

STOBOCLO 禁用于

hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab.

低钙血症、孕妇以及对地诺单抗已知过敏的患者。

Severe Hypocalcemia:

严重低钙血症：

Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia.

确保摄入足够的钙和维生素D；监测严重低钙血症。

Drug Products with Same Active Ingredient:

具有相同活性成分的药品：

Do not use with other denosumab products.

请勿与其他地诺单抗产品合用。

Hypersensitivity

超敏反应

：

If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO.

如果发生过敏性反应或其他具有临床意义的过敏反应，请启动适当的治疗并停止进一步使用STOBOCLO。

Osteonecrosis of the Jaw (ONJ):

颌骨骨坏死 (ONJ):

ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops.

ONJ 可能会在使用 STOBOCLO 的患者中发生。治疗前进行口腔检查；保持口腔卫生；若出现 ONJ，请考虑停用 STOBOCLO。

Atypical Subtrochanteric and Diaphyseal Femoral Fractures:

非典型的股骨转子下骨折和骨干骨折:

Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis.

监测大腿、臀部或腹股沟疼痛；评估骨折情况。应根据个体情况，权衡利弊后考虑是否暂停STOBOCLO治疗。

Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment:

停止治疗后多发性椎体骨折（MVF）：

Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO.

停用迪诺单抗后风险增加；如果停用STOBOCLO，应过渡到替代疗法。

Serious Infections:

严重感染：

Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop.

使用地诺单抗的风险较高；评估获益-风险概况，特别是免疫功能低下的患者。在开始使用STOBOCLO之前评估获益-风险概况，如果出现严重感染，应重新考虑其使用。

Dermatologic Adverse Reactions:

皮肤不良反应:

Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur.

如果出现严重的皮炎、湿疹或皮疹，应考虑停止使用STOBOCLO。

Musculoskeletal Pain:

肌肉骨骼疼痛:

Consider discontinuation of STOBOCLO if severe pain develops.

如果出现严重疼痛，请考虑停止使用STOBOCLO。

Bone Turnover Suppression:

骨转换抑制：

In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes.

在绝经后骨质疏松症女性的临床试验中，地诺单抗显著抑制了骨重建；应监测患者的这些结果。

Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta:

小儿骨质疏松症患者的高钙血症:

Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products.

不适用于儿科；有报告称使用地诺单抗产品的成骨不全症患者出现高钙血症。

Most common Adverse Reactions:

最常见的不良反应：

In (>5%) of patients with:

在（> 5%）的患者中：

Postmenopausal osteoporosis

绝经后骨质疏松症

were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.

背部疼痛、四肢疼痛、高胆固醇血症、肌肉骨骼疼痛和膀胱炎。在临床试验中已有胰腺炎的报道。

Male osteoporosis

男性骨质疏松症

were back pain, arthralgia, and nasopharyngitis.

背部疼痛、关节痛和鼻咽炎。

Glucocorticoid-induced osteoporosis

糖皮质激素诱导的骨质疏松症

(> 3%) were back pain, hypertension, bronchitis, and headache.

(> 3%) 为背痛、高血压、支气管炎和头痛。

Bone loss due to hormone ablation for cancer

因癌症激素消融导致的骨质流失

(≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.

(≥10%)的患者出现关节痛和背痛。在临床试验中也有报道四肢疼痛和肌肉骨骼疼痛。

For more information, see

有关更多信息，请参见

Full Prescribing Information

完整处方信息

。

About

关于

OSENVELT

罗斯福

(denosumab-bmwo)

(地诺单抗-bmwo)

OSENVELT

罗斯福

(denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA

(denosumab-bmwo) 是 NF-κB 配体受体激活剂 (RANKL) 的抑制剂，参考自 XGEVA。

(denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

（地诺单抗）。OSENVELT 120 mg/1.7 mL（70 mg/mL）注射剂已获FDA批准，基于一项强有力的临床试验和确证与XGEVA治疗等效性的综合数据。在美国，OSENVELT适用于预防多发性骨髓瘤患者的骨骼相关事件以及实体瘤骨转移患者的骨骼相关事件，用于治疗无法切除或手术切除可能导致严重病态的成人和骨骼成熟的青少年骨巨细胞瘤患者，并用于治疗对双膦酸盐类药物治疗无效的恶性肿瘤相关的高钙血症。

。

OSENVELT was also approved by the European Medicines Agency (EMA) in

OSENVELT 也获得了欧洲药品管理局 (EMA) 的批准

February 2025

2025年2月

。

INDICATION

适应症

OSENVELT

罗斯福

(denosumab-bmwo) is indicated for:

(denosumab-bmwo) 适用于：

Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

预防多发性骨髓瘤患者和实体瘤骨转移患者的骨骼相关事件。

Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

治疗成人和骨骼成熟的青少年骨巨细胞瘤，该肿瘤无法切除或手术切除可能导致严重并发症。

Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

恶性肿瘤引起的高钙血症对双膦酸盐治疗无效的处理。

IMPORTANT SAFETY INFORMATION

重要安全信息

Contraindications:

禁忌症：

Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products.

低钙血症患者或对地诺单抗产品有已知临床显著过敏反应的患者。

Drug Products with Same Active Ingredient.

具有相同活性成分的药物产品。

Patients receiving OSENVELT should not receive other denosumab products concomitantly.

接受奥森维尔治疗的患者不应同时接受其他地诺单抗产品。

Hypersensitivity.

超敏反应。

If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT.

如果发生过敏性反应或其他临床上显著的过敏反应，应启动适当的治疗并停止进一步使用OSENVELT。

Hypocalcemia.

低钙血症。

Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake.

严重低钙血症可能会发生，并且已有致命病例报告。监测钙水平以及钙和维生素D的摄入量。

Osteonecrosis of the Jaw (ONJ):

颌骨坏死 (ONJ):

ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops.

使用OSENVELT的患者可能会发生ONJ。在治疗前和治疗期间进行口腔检查并采取适当的预防性牙科措施；保持口腔卫生，避免侵入性牙科手术；如果发生ONJ，考虑停止使用OSENVELT。

Atypical Subtrochanteric and Diaphyseal Femoral Fractures:

非典型股骨转子下骨折和骨干骨折:

Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis.

监测大腿、臀部或腹股沟疼痛；评估是否有骨折。应根据个体情况，权衡利弊后考虑是否暂停OSENVELT治疗。

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons.

骨巨细胞瘤患者和骨骼生长患者治疗中断后出现高钙血症。

Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation.

在骨巨细胞瘤或骨骼生长的患者中，停止使用地诺单抗后的一年内可能会出现具有临床意义的高钙血症，可能需要住院治疗；停药后应监测血清钙水平，并管理钙和维生素D的需求。

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation.

治疗中断后多发性椎体骨折（MVF）。

Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT.

停用地诺单抗后风险增加；停用OSENVELT后评估椎体骨折风险。

Embryo-Fetal Toxicity.

胚胎-胎儿毒性。

Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose.

地诺单抗可能对胎儿造成伤害；在开始使用OSENVELT之前确认妊娠状态，并建议在治疗期间及最后一剂后的5个月内采取有效避孕措施。

Most common Adverse Reactions:

最常见的不良反应：

Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea.

实体瘤（≥ 25%）骨转移的症状为疲劳/虚弱、低磷血症和恶心。

In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.

在患者（≥10%）中：多发性骨髓瘤患者出现腹泻、恶心、贫血、背痛、血小板减少、外周水肿、低钙血症、上呼吸道感染、皮疹和头痛；骨巨细胞瘤患者出现关节痛、头痛、恶心、背痛、疲劳和四肢疼痛。

Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.

恶性肿瘤高钙血症（> 20%）的症状包括恶心、呼吸困难、食欲减退、头痛、外周水肿、呕吐、贫血、便秘和腹泻。

For more information, see

有关更多信息，请参见

Full Prescribing Information

完整处方信息

。

About Celltrion

关于Celltrion

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar.

Celltrion是一家领先的生物制药公司，专注于研究、开发、制造、营销和销售创新疗法，这些疗法改善了全世界人民的生活。Celltrion是生物类似药领域的先驱，推出了全球首个单克隆抗体生物类似药。

Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines.

我们的全球制药产品组合涵盖了多个治疗领域，包括免疫学、肿瘤学、血液学、眼科和内分泌学。除了生物仿制药产品外，我们还致力于通过创新药物推进研发管线，突破科学创新的界限，提供高质量的药物。

For more information, please visit our website .

欲了解更多信息，请访问我们的网站。

www.celltrion.com/en-us

www.celltrion.com/zh-cn

. and stay updated with our latest news and events on our social media -

并关注我们的社交媒体，获取最新消息和活动动态 -

领英

，

Instagram

，

, and

，以及

Facebook

。

About Celltrion

关于Celltrion

USA

美国

Celltrion

细胞社

USA

美国

is Celltrion's U.S. subsidiary established in 2018. Headquartered in

是Celltrion于2018年成立的美国子公司。总部位于

New Jersey

新泽西州

, Celltrion

，Celltrion

USA

美国

is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has seven biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), STEQEYMA® (Ustekinumab-stba), and AVTOZMA® (tocilizumab-anoh) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb).

致力于扩大美国患者获得创新生物制剂的机会，以改善治疗效果。Celltrion目前有七种生物类似药获得美国FDA批准：INFLECTRA®（英夫利昔单抗-dyyb）、TRUXIMA®（利妥昔单抗-abbs）、HERZUMA®（曲妥珠单抗-pkrb）、VEGZELMA®（贝伐珠单抗-adcd）、YUFLYMA®（阿达木单抗-aaty）、STEQEYMA®（乌司奴单抗-stba）和AVTOZMA®（托珠单抗-anoh），以及一种新型生物制剂ZYMFENTRA®（英夫利昔单抗-dyyb）。

Celltrion .

细胞社。

USA

美国

will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit

将继续利用Celltrion在生物技术领域的独特传承、卓越的供应链以及一流的销售能力，为美国患者提供更易获取的高质量生物制药。欲了解更多信息，请访问

www.celltrionusa.com

, and stay updated with our latest news and events on our social media -

，并通过我们的社交媒体了解我们的最新消息和活动 -

领英

FORWARD-LOOKING STATEMENT

前瞻性声明

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.

本新闻稿中包含的某些信息涉及我们未来业务和财务表现以及与Celltrion Inc.及其子公司相关的未来事件或发展的陈述，这些陈述可能构成证券法相关法规下的前瞻性陈述。

These statements may be also identified by words such as 'prepares', 'hopes to', 'upcoming', 'plans to', 'aims to', 'to be launched', 'is preparing', 'once gained', 'could', 'with the aim of', 'may', 'once identified', 'will', 'working towards', 'is due', 'become available', 'has potential to', the negative of these words or such other variations thereon or comparable terminology..

这些陈述也可能通过诸如“准备”、“希望”、“即将到来”、“计划”、“旨在”、“即将推出”、“正在准备”、“一旦获得”、“可能”、“旨在”、“或许”、“一旦确定”、“将”、“朝着……努力”、“预计”、“变得可用”、“有潜力”、这些词的否定形式或类似变化或可比术语来识别。

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.

此外，我们的代表可能会做出口头的前瞻性陈述。这些陈述基于Celltrion Inc.及其子公司管理层的当前预期和某些假设，其中许多超出了其控制范围。

Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them..

前瞻性声明旨在让潜在投资者有机会了解管理层对未来的信念和看法，以便他们可以将这些信念和看法作为评估投资的一个因素。这些声明并非未来表现的保证，不应过度依赖它们。

Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements..

此类前瞻性陈述必然涉及与公司业务相关的已知和未知的风险及不确定性，包括其年度报告和/或季度报告中披露的风险因素，这些因素可能导致未来期间的实际业绩和财务结果与任何前瞻性陈述中明示或暗示的未来业绩或结果存在重大差异。

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.

Celltrion Inc. 及其子公司在情况或管理层的估计或意见发生变化时，不承担更新前瞻性声明的义务，除非适用的证券法要求。

Trademarks

商标

STOBOCLO

and OSENVELT

和罗斯福

are registered trademarks of Celltrion Inc.

是Celltrion公司的注册商标。

PROLIA

普罗利亚

and XGEVA

和XGEVA