仿制药提供商Sun Pharmaceutical完成对Checkpoint Therapeutics的收购-动脉网

Sun Pharma Completes its Acquisition of Checkpoint Therapeutics

CISION 等信源发布 2025-05-30 22:39

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可切换为仅中文

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MUMBAI, India

印度孟买

and

和

PRINCETON, N.J.

普林斯顿，新泽西州

，

May 30, 2025

2025年5月30日

/PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, 'Sun Pharma')) today announced the successful completion of its acquisition of Checkpoint Therapeutics, Inc. ('Checkpoint'), an immunotherapy and targeted oncology company.

/PRNewswire/ -- Sun Pharmaceutical Industries Limited（路透社：SUN.BO，彭博社：SUNP IN，NSE：SUNPHARMA，BSE：524715（连同其子公司和/或关联公司，统称为“Sun Pharma”））今天宣布成功完成对免疫疗法和靶向肿瘤学公司Checkpoint Therapeutics, Inc.（“Checkpoint”）的收购。

As part of the acquisition, Sun Pharma acquires UNLOXCYT.

作为收购的一部分，太阳制药收购了UNLOXCYT。

™

, the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma.

，首个也是唯一一个获FDA批准的用于晚期皮肤鳞状细胞癌的抗PD-L1治疗。

'This acquisition exemplifies Sun Pharma's commitment to supporting patients and growing its innovative therapies business,' said

“此次收购体现了太阳制药公司致力于支持患者并发展其创新疗法业务的承诺，”

Dilip Shanghvi

稀土金属

, Chairman & Managing Director of Sun Pharma. 'By adding UNLOXCYT

，太阳制药董事长兼董事总经理。“通过添加UNLOXCYT

™

商标符号

, we will be able to leverage our leadership in the onco-derm space to help patients access an important treatment option while growing our product portfolio.'

“我们将能够利用我们在肿瘤皮肤病学领域的领导地位，帮助患者获得重要的治疗选择，同时扩大我们的产品组合。”

Financial Terms

金融术语

Sun Pharma has acquired all outstanding shares of Checkpoint at a price of

太阳制药以每股价格收购了检查点公司的所有已发行股份

$4.10

4.10美元

per share in cash, without interest, plus one non-tradable contingent value right (CVR) per share representing the right to receive up to an additional

每股现金，不计利息，另加一股不可交易的或有价值权（CVR），代表获得额外收益的权利，最高可达

$0.70

0.70美元

in cash, without interest, if certain specified milestones are met, as set out in the terms and conditions of the contingent value rights agreement.

如果满足某些特定的里程碑条件，将按照或有价值权利协议的条款和条件，以现金形式支付，不计利息。

About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050)

关于太阳制药工业有限公司（CIN - L24230GJ1993PLC019050）

Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in

太阳制药是全球领先的专业仿制药公司，在专科、仿制药和消费保健产品领域均有涉足。它是最大的制药公司之一。

India

印度

and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries.

并且是美国以及全球新兴市场领先的仿制药公司。太阳制药高增长的全球专科药物组合涵盖皮肤病学、眼科学和肿瘤皮肤病学的创新产品，占公司销售额的18%以上。公司垂直整合的业务为超过100个国家的医生和消费者提供值得信赖的高质量药品。

Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit .

其生产设施遍布六大洲。太阳制药为拥有来自 50 多个国家的多元文化员工队伍而感到自豪。欲了解更多信息，请访问。

www.sunpharma.com

and follow us on LinkedIn & X (Formerly Twitter).

在LinkedIn和X（原Twitter）上关注我们。

About Cutaneous Squamous Cell Carcinoma

关于皮肤鳞状细胞癌

Cutaneous squamous cell carcinoma ('cSCC') is the second-most common type of skin cancer in

皮肤鳞状细胞癌（'cSCC'）是第二常见的皮肤癌类型，

the United States

美国

, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, each year approximately 40,000 cases become advanced and an estimated 15,000 people in .

根据皮肤癌基金会的数据，估计每年的发病率约为180万例。cSCC的重要风险因素包括慢性紫外线暴露和免疫抑制状态。虽然大多数病例是可治愈的局部肿瘤，但每年大约有40,000例发展为晚期，估计有15,000人。

the United States

美国

die from this disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region, and that invade blood vessels, nerves and vital organs, such as the eye or ear.

死于这种疾病。除了是一种危及生命的疾病外，cSCC还因常见于头颈部的肿瘤引发严重的功能障碍和美容缺陷，并侵袭血管、神经和重要器官，如眼睛或耳朵。

UNLOXCYT

解锁细胞

™

INDICATION and IMPORANT SAFETY INFORMATION

适应症和重要安全信息

INDICATION

适应症

UNLOXCYT

解锁细胞

™

(cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or curative radiation.

（cosibelimab-ipdl）适用于治疗无法接受治愈性手术或治愈性放疗的转移性皮肤鳞状细胞癌（cSCC）或局部晚期皮肤鳞状细胞癌（cSCC）成人患者。

IMPORTANT SAFETY INFORMATION

重要安全信息

Severe and Fatal Immune-Mediated Adverse Reactions

严重和致命的免疫介导不良反应

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, and occur at any time after starting a PD-1/PD-L1 blocking antibody, including UNLOXCYT.

本文列出的免疫介导的不良反应可能未包含所有可能的严重和致命的免疫介导不良反应。免疫介导的不良反应（可能是严重或致命的）可以发生在任何器官系统或组织中，并且可以在开始使用PD-1/PD-L1阻断抗体（包括UNLOXCYT）后的任何时间发生。

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. While immune-mediated adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously.

虽然免疫介导的不良反应通常在治疗期间表现出来，但在停止使用PD-1/PD-L1阻断抗体后也可能出现。影响多个身体系统的免疫介导不良反应可能同时发生。

Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection.

密切监测免疫介导的不良反应的体征和症状。在治疗开始前和治疗期间定期评估肝酶、肌酐和甲状腺功能测试。对于疑似免疫介导的不良反应，启动适当的检查以排除其他可能病因，包括感染。

Institute medical management promptly, including specialty consultation as appropriate..

立即实施医学管理，包括适时的专业会诊。

Withhold or permanently discontinue UNLOXCYT

暂停或永久停止使用UNLOXCYT

™

depending on the severity of the adverse reaction (see Dosage and Administration in Prescribing Information). In general, if UNLOXCYT

根据不良反应的严重程度（见处方信息中的剂量和用法）。一般来说，如果UNLOXCYT

™

requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids..

如果需要中断或停止治疗，给予全身性皮质类固醇（每天1至2毫克/千克泼尼松或等效药物），直到改善至1级或更低。一旦改善至1级或更低，开始逐渐减少皮质类固醇剂量，并在至少1个月内持续减量。对于那些使用皮质类固醇无法控制的免疫介导不良反应的患者，考虑给予其他全身性免疫抑制剂。

Immune-Mediated Pneumonitis

免疫介导性肺炎

UNLOXCYT

解锁细胞

™

can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1 blocking antibody, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 1% (3/223, Grade 2) of patients receiving UNLOXCYT

可能引起免疫介导的肺炎。在使用其他PD-1/PD-L1阻断抗体治疗的患者中，接受过胸部放疗的患者肺炎发生率更高。在接受UNLOXCYT治疗的患者中，1%（3/223，2级）发生了免疫介导的肺炎。

™

。

Immune-Mediated Colitis

免疫介导的结肠炎

UNLOXCYT

解锁细胞

™

can cause immune-mediated colitis, which may present with diarrhea, abdominal pain, and lower gastrointestinal bleeding. Cytomegalovirus infection/reactivation has occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

可能引起免疫介导的结肠炎，表现为腹泻、腹痛和下消化道出血。在接受PD-1/PD-L1阻断抗体治疗的皮质类固醇难治性免疫介导结肠炎患者中，已报告出现巨细胞病毒（CMV）感染/再激活的情况。对于皮质类固醇难治性结肠炎病例，应考虑重新进行感染相关检查以排除其他病因。

Immune-mediated colitis occurred in 0.4% (1/223, Grade 1) of patients receiving UNLOXCYT.

接受UNLOXCYT治疗的患者中有0.4%（1/223，1级）发生免疫介导的结肠炎。

™

。

Immune-Mediated Hepatitis

免疫介导的肝炎

UNLOXCYT

解锁细胞

™

can cause immune-mediated hepatitis.

可能导致免疫介导的肝炎。

Immune-Mediated Endocrinopathies

免疫介导的内分泌疾病

Adrenal Insufficiency

肾上腺功能不全

UNLOXCYT

解锁细胞

™

can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT

可能导致原发性或继发性肾上腺功能不全。对于2级或更高级别的肾上腺功能不全，根据机构指南启动对症治疗，包括根据临床需要进行激素替代治疗。暂停或永久停止使用UNLOXCYT。

™

depending on severity. Adrenal insufficiency occurred in 0.9% (2/223) of patients receiving UNLOXCYT

取决于严重程度。在接受UNLOXCYT治疗的患者中，0.9%（2/223）出现肾上腺功能不全。

™

, including Grade 2 in 0.4% (1/223) of patients.

，包括0.4%（1/223）的患者出现2级。

Hypophysitis

垂体炎

UNLOXCYT

解锁细胞

™

can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT.

可能导致免疫介导的垂体炎。垂体炎可能表现为与肿块效应相关的急性症状，如头痛、畏光或视野缺损。垂体炎可能导致垂体功能减退。根据临床需要开始激素替代治疗。暂停或永久停止使用UNLOXCYT。

™

depending on severity.

根据严重程度。

Thyroid Disorders

甲状腺疾病

UNLOXCYT

解锁细胞

™

can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue UNLOXCYT

可能引起免疫介导的甲状腺疾病。甲状腺炎可表现为有或没有内分泌病。甲状腺功能减退可能继发于甲状腺功能亢进。根据临床需要启动激素替代或治疗甲状腺功能亢进。暂停或永久停止使用UNLOXCYT。

™

depending on severity. Hypothyroidism occurred in 10% (22/223) of patients receiving UNLOXCYT

根据严重程度不同。在接受UNLOXCYT治疗的患者中，10%（22/223）出现甲状腺功能减退。

™

, including Grade 2 in 5% (10/223) of patients. Hyperthyroidism occurred in 5% (12/223) of patients receiving UNLOXCYT

，包括 5% (10/223) 的患者出现 2 级不良反应。在接受 UNLOXCYT 治疗的患者中，有 5% (12/223) 发生了甲状腺功能亢进。

™

, including Grade 2 in 0.4% (1/223) of patients.

，包括 0.4%（1/223）的患者为 2 级。

Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis

1型糖尿病，可表现为糖尿病酮症酸中毒

UNLOXCYT

解锁细胞

™

can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue UNLOXCYT

可能导致1型糖尿病，表现为糖尿病酮症酸中毒。监测患者的高血糖或其他糖尿病症状和体征。根据临床需要启动胰岛素治疗。暂停或永久停止使用UNLOXCYT。

™

商标符号

depending on severity.

根据严重程度。

Immune-Mediated Nephritis with Renal Dysfunction

免疫介导的肾炎伴肾功能障碍

UNLOXCYT

解锁细胞

™

商标符号

can cause immune-mediated nephritis.

可能引起免疫介导的肾炎。

Immune-Mediated Dermatologic Adverse Reactions

免疫介导的皮肤病不良反应

UNLOXCYT

解锁细胞

™

can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1 blocking antibody. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.

可能引起免疫介导的皮疹或皮炎。使用PD-1/PD-L1阻断抗体已报告出现大疱性和剥脱性皮炎，包括史蒂文斯-约翰逊综合征 (SJS)、中毒性表皮坏死松解症 (TEN)，以及伴有嗜酸性粒细胞增多和全身症状的药物反应 (DRESS)。局部润肤剂和/或局部皮质类固醇可能足以治疗轻度至中度的非大疱性/剥脱性皮疹。

Withhold or permanently discontinue UNLOXCYT.

暂停或永久停止使用UNLOXCYT。

™

depending on severity. Immune-mediated dermatologic adverse reactions occurred in 7% (15/223) of patients receiving UNLOXCYT

根据严重程度而定。在接受UNLOXCYT治疗的患者中，有7%（15/223）发生了免疫介导的皮肤病学不良反应。

™

, including Grade 3 in 0.9% (2/223) of patients and Grade 2 in 4% (9/223) of patients.

，包括 0.9%（2/223）的患者为 3 级，4%（9/223）的患者为 2 级。

Other Immune-Mediated Adverse Reactions

其他免疫介导的不良反应

The following clinically significant immune-mediated adverse reactions occurred in <1% of the 223 patients who received UNLOXCYT

在接受UNLOXCYT治疗的223名患者中，有不到1%的患者发生了以下具有临床意义的免疫介导的不良反应。

™

or were reported with the use of other PD-1/PD-L1 blocking antibody. Severe or fatal cases have been reported for some of these adverse reactions.

或在使用其他PD-1/PD-L1阻断抗体时被报告。其中一些不良反应已报告了严重或致命病例。

Cardiac/Vascular: Myocarditis, pericarditis, vasculitis.

心脏/血管：心肌炎、心包炎、血管炎。

Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.

神经系统：脑膜炎、脑炎、脊髓炎和脱髓鞘、重症肌无力综合征/重症肌无力（包括加重）、格林-巴利综合征、神经麻痹、自身免疫性神经病。

Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss..

眼部：葡萄膜炎、虹膜炎、其他眼部炎症毒性。某些病例可能与视网膜脱离相关。不同程度的视力损害，包括失明，可能发生。如果葡萄膜炎与其他免疫介导的不良反应同时发生，应考虑类似Vogt-Koyanagi-Harada综合征的可能性，因为这可能需要使用全身性类固醇治疗，以降低永久性视力丧失的风险。

Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis.

胃肠道：胰腺炎，包括血清淀粉酶和脂肪酶水平升高、胃炎、十二指肠炎。

Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.

肌肉骨骼和结缔组织：肌炎/多发性肌炎、横纹肌溶解及其相关后遗症，包括肾功能衰竭、关节炎、风湿性多肌痛。

Endocrine: Hypoparathyroidism.

内分泌：甲状旁腺功能减退症。

Other (Hematologic/Immune): Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection..

其他（血液/免疫）：自身免疫性溶血性贫血、再生障碍性贫血、噬血细胞性淋巴组织细胞增多症、全身炎症反应综合征、组织细胞坏死性淋巴结炎（Kikuchi淋巴结炎）、结节病、免疫性血小板减少症、实体器官移植排斥、其他移植（包括角膜移植）排斥。

Infusion-Related Reactions

输液相关反应

UNLOXCYT

联合国细胞技术中心

™

can cause severe or life-threatening infusion-related reactions. Infusion-related infusion reactions were reported in 11% (24/223) of patients, including Grade 2 in 5.8% (13/223) of patients receiving UNLOXCYT

可能引起严重或危及生命的输注相关反应。在11%（24/223）的患者中报告了输注相关反应，其中5.8%（13/223）的接受UNLOXCYT治疗的患者为2级反应。

™

。

Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue UNLOXCYT

监测患者是否出现与输液相关的反应的体征和症状。中断或减慢输液速度，或永久停止使用UNLOXCYT。

™

based on severity of reaction. Consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins.

根据反应的严重程度。对于既往对治疗性蛋白质输注出现过全身反应的患者，考虑使用退烧药和/或抗组胺药进行预处理。

Complications of Allogeneic HSCT

异基因造血干细胞移植的并发症

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause).

接受PD-1/PD-L1阻断抗体治疗之前或之后进行同种异体造血干细胞移植（HSCT）的患者可能会出现致命及其他严重并发症。移植相关并发症包括超急性移植物抗宿主病（GVHD）、急性GVHD、慢性GVHD、减强度预处理后的肝静脉闭塞病，以及需要使用类固醇的发热综合征（无明确感染原因）。

These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT..

尽管在PD-1/PD-L1阻断剂与异基因HSCT之间进行了干预治疗，仍可能出现这些并发症。密切监测患者移植相关并发症的迹象，并及时进行干预。在异基因HSCT前或后使用PD-1/PD-L1阻断抗体治疗时，请权衡治疗的益处与风险。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on its mechanism of action, UNLOXCYT

基于其作用机制，UNLOXCYT

™

can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with UNLOXCYT.

当给孕妇使用时，可能会对胎儿造成伤害。动物研究表明，抑制PD-1/PD-L1通路会增加免疫介导的对发育中胎儿的排斥风险，从而导致胎儿死亡。请告知孕妇对胎儿的潜在风险。建议有生育潜力的女性在使用UNLOXCYT治疗期间使用有效的避孕措施。

™

and for 4 months after the last dose.

在最后一剂后4个月内。

Common Adverse Reactions

常见不良反应

The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.

最常见的不良反应（≥10%）为疲劳、肌肉骨骼疼痛、皮疹、腹泻、甲状腺功能减退、便秘、恶心、头痛、瘙痒、水肿、局部感染和尿路感染。

Please see full

请查看完整内容

Prescribing Information

处方信息

。

Sun Pharma Contacts:

太阳制药联系方式：

Investors

投资者

Dr. Abhishek Sharma

阿比谢克·夏尔马博士