COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced new data from the ongoing phase 1/2 EPCORE™ NHL-1 clinical trial investigating epcoritamab (DuoBody® CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 82 percent, a complete response (CR) rate of 63 percent and minimal residual disease (MRD) negativity rate of 67 percent in patients with relapsed/refractory (R/R) follicular lymphoma (FL).

丹麦哥本哈根--（商业新闻短讯）--Genmab A/S（纳斯达克：GMAB）和AbbVie（纽约证券交易所：ABBV）今天宣布了正在进行的1/2期EPCORE的新数据™研究epcoritamab（DuoBody®CD3xCD20）的NHL-1临床试验表明，复发/难治性（R/R）滤泡性淋巴瘤（FL）患者的总体缓解率（ORR）为82%，完全缓解率（CR）为63%，最小残留病（MRD）阴性率为67%。

The presentation included data from an optimized step-up dosing schedule for FL patients showing a reduction in risk and severity of Grade 2+ cytokine release syndrome (CRS), a common side effect of T-cell engaging cancer treatments. These results were presented today at the 2023 65th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in San Diego, California, December 9-12, 2023 (Abstract #1655)..

该演讲包括来自FL患者优化的递增给药方案的数据，显示2级+细胞因子释放综合征（CRS）的风险和严重程度降低，这是T细胞参与癌症治疗的常见副作用。这些结果于2023年12月9日至12日在加利福尼亚州圣地亚哥举行的2023年第65届美国血液学会年会和博览会上发表（摘要#1655）。。

“Despite treatment advances for patients with follicular lymphoma whose disease has unfortunately progressed, treating relapsed or refractory follicular lymphoma remains highly challenging, particularly in the third-line plus setting,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris.

巴黎大学血液肿瘤系主任Catherine Thieblemont医学博士说：“尽管对疾病不幸进展的滤泡性淋巴瘤患者的治疗取得了进展，但治疗复发或难治性滤泡性淋巴瘤仍然极具挑战性，特别是在第三线加设置中。”，巴黎圣路易斯公共援助医院（APHP）。

“The patients in this trial represent a historically difficult-to-treat patient population. The data presented today are especially notable because they demonstrated high overall and complete response rates for this investigational follicular lymphoma therapy and a preview for its potential as an alternative treatment option.”.

“这项试验中的患者代表了一个历史上难以治疗的患者群体。今天提供的数据特别值得注意，因为他们证明了这种研究性滤泡性淋巴瘤治疗的总体和完全缓解率很高，并预览了其作为替代治疗选择的潜力。”。

Overall results from the pivotal cohort of 128 adult patients showed that:

128名成年患者关键队列的总体结果显示：

At a median follow-up of 17.4 months, the study’s primary endpoint ORR was 82 percent, which exceeded the protocol defined threshold for efficacy, with a CR rate of 63 percent, and 67 percent MRD negativity.

在中位随访17.4个月时，该研究的主要终点ORR为82%，超过了方案定义的疗效阈值，CR率为63%，MRD阴性率为67%。

The median time to response was 1.4 months and median time to CR was 1.5 months.

中位缓解时间为1.4个月，中位CR时间为1.5个月。

Median progression-free survival (PFS) for patients who achieved a CR was not reached nor was the median duration of response, duration of CR, MRD negativity and overall survival.

未达到CR患者的中位无进展生存期（PFS），中位反应持续时间，CR持续时间，MRD阴性和总生存期也未达到。

An estimated 85 percent and 74 percent of patients who experienced a CR remained in response at 12 and 18 months, respectively.

据估计，分别有85%和74%的CR患者在12个月和18个月时仍有反应。

Among prespecified subgroups, ORR and CR rates were generally consistent with the overall patient population. Notably, high-risk patients who were refractory to both anti-CD20 therapy and an alkylating agent achieved a 76 percent ORR and 56 percent CR; patients who were refractory to last prior treatment achieved a 74 percent ORR and 51 percent CR rate; and patients whose disease progressed within two years of first-line immunochemotherapy (POD24) achieved an 80 percent ORR and 61 percent CR..

在预先指定的亚组中，ORR和CR率通常与总体患者人群一致。值得注意的是，对抗CD20治疗和烷化剂均难治的高危患者的ORR和CR分别为76%和56%；最后一次治疗难治的患者的ORR率为74%，CR率为51%；一线免疫化疗（POD24）两年内病情进展的患者ORR为80%，CR为61%。。

Safety findings were consistent with previous epcoritamab trials, and epcoritamab was generally well tolerated. Following an optimized step-up dose regimen for FL patients (n=50) to reduce the risk and severity of CRS, 40 percent of patients experienced Grade 1 CRS and 8 percent experienced Grade 2 (no Grade 3 or higher CRS were reported) and no Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was reported.

安全性研究结果与之前的epcoritamab试验一致，epcoritamab通常耐受性良好。在对FL患者（n=50）进行优化的递增剂量方案以降低CRS的风险和严重程度后，40%的患者经历了1级CRS，8%的患者经历了2级（未报告3级或更高的CRS），并且没有报道免疫效应细胞相关神经毒性综合征（ICANS）。

This data may support outpatient administration. Additional common treatment-emergent adverse events (TEAEs) from the pivotal cohort (>20 percent) were injection-site reaction (57 percent), COVID-19 (40 percent), fatigue (30 percent), neutropenia (29 percent), diarrhea (27 percent) and pyrexia (25 percent).

这些数据可能支持门诊管理。来自关键队列（>20%）的其他常见治疗紧急不良事件（TEAE）是注射部位反应（57%），新型冠状病毒肺炎（40%），疲劳（30%），中性粒细胞减少（29%），腹泻（27%）和发热（25%）。

TEAEs leading to treatment discontinuation occurred in 19 percent of patients, and Grade 5 TEAEs occurred in 13 patients (10 percent)..

导致停止治疗的TEAE发生率为19%，5级TEAE发生率为13例（10%）。。

“Follicular lymphoma patients who have experienced a relapse following heavy pre-treatment, or whose disease is not responding to available therapies, are considered high risk and are in need of alternative therapeutic options,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “The data presented at ASH reinforce what we have seen from our epcoritamab research and believe that this investigational bispecific antibody could potentially represent an important treatment option for patients living with relapsed or refractory follicular lymphoma.

Genmab首席执行官Jan van de Winkel博士说：“滤泡性淋巴瘤患者在经过大量预处理后复发，或其疾病对现有疗法无反应，被认为是高风险的，需要替代治疗选择。”。“ASH提供的数据强化了我们从epcoritamab研究中看到的结果，并认为这种研究性双特异性抗体可能是复发或难治性滤泡性淋巴瘤患者的重要治疗选择。

Along with our partner AbbVie, we look forward to progressing epcoritamab in clinical trials and discussing the results with regulatory authorities and remain committed to developing epcoritamab as a potential future core therapy for B-cell malignancies.”.

与我们的合作伙伴AbbVie一起，我们期待着在临床试验中取得epcoritamab的进展，并与监管机构讨论结果，并继续致力于开发epcoritamab作为未来潜在的B细胞恶性肿瘤核心疗法。”。

About the Phase 1/2 EPCORE™ NHL-1 Trial

关于1/2期EPCORE™NHL-1试验

EPCORE™ NHL-1 an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a phase 1 first-in-human, dose escalation part; a phase 2a expansion part; and a phase 2a dose optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL), including FL.

EPCORE公司™NHL-1是epcoritamab的开放标签，多中心安全性和初步疗效试验，由三部分组成：第一阶段人体第一阶段，剂量递增部分；2a期扩建部分；和2a期剂量优化部分。该试验旨在评估皮下注射epcoritamab治疗复发，进行性或难治性CD20+成熟B细胞非霍奇金淋巴瘤（B-NHL）患者，包括FL。

In the phase 2a expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The dose optimization part evaluates the potential for alternative step-up dosing regimens to help further minimize Grade 2 cytokine release syndrome (CRS) and mitigate Grade ≥3 CRS.

在2a期扩展部分，招募了更多的患者，以进一步探索epcoritamab在三组不同类型复发/难治性B-NHL患者中的安全性和有效性，这些患者的治疗选择有限。剂量优化部分评估替代递增给药方案的潜力，以帮助进一步最小化2级细胞因子释放综合征（CRS）并减轻≥3级CRS。

The primary endpoint of the expansion part was ORR as assessed by an IRC. Secondary efficacy endpoints included DOR, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints..

扩展部分的主要终点是IRC评估的ORR。次要疗效终点包括DOR，完全缓解率，完全缓解持续时间，无进展生存期和由卢加诺标准确定的反应时间。总生存期，下一次治疗的时间和最小残留疾病阴性率也被评估为次要疗效终点。。

About Follicular Lymphoma (FL)

关于滤泡性淋巴瘤（FL）

FL is typically an indolent (or slow growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.i FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases, and represents 10-20 percent of all lymphomas in the western world.i,ii,iii Although FL is an indolent lymphoma, it is considered incurable with conventional therapyiv,v and patients who achieve remission also often experience relapse.vi.

FL通常是由B淋巴细胞产生的惰性（或生长缓慢）非霍奇金淋巴瘤（NHL）。i FL是NHL的第二常见形式，占所有NHL病例的20-30%，占西方世界所有淋巴瘤的10-20%。i，ii，iii虽然FL是一种惰性淋巴瘤，但它被认为是常规治疗无法治愈的V，v和达到缓解的患者也经常复发。

About Epcoritamab

关于Epcoritamab

Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vii.

Epcoritamab是一种IgG1双特异性抗体，使用Genmab专有的DuoBody®技术创建并皮下给药。Genmab的DuoBody-CD3技术旨在选择性地引导细胞毒性T细胞，以引发针对靶细胞类型的免疫应答。Epcoritamab被设计为同时与T细胞上的CD3和B细胞上的CD20结合，并诱导T细胞介导的CD20+细胞杀伤。

Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Use of epcoritamab in FL is not approved in any country, including the U.S. and the EU. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

Epcoritamab（在美国和日本以品牌EPKINLY®和欧盟的TEPKINLY®获得批准）已在多个地区的某些淋巴瘤适应症中获得监管批准。包括美国和欧盟在内的任何国家均未批准在佛罗里达州使用epcoritamab。Epcoritamab由Genmab和AbbVie共同开发，作为公司肿瘤学合作的一部分。

The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization..

这些公司将在美国和日本分担商业责任，AbbVie负责进一步的全球商业化。。

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes three ongoing phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494) compared to investigators choice chemotherapy, a phase 3 trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label clinical trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066).

Genmab和AbbVie继续评估使用epcoritamab作为单一疗法，并在一系列血液系统恶性肿瘤的治疗中联合使用。这包括三项正在进行的3期开放标签随机试验，包括一项与研究者选择化疗相比，评估依科他单抗作为R/R DLBCL患者单药治疗的试验（NCT:04628494），一项评估依科他单抗联合R-CHOP治疗新诊断DLBCL的成年受试者的3期试验（NCT:05578976），以及一项3期试验，开放标签临床试验评估依科他单抗联合利妥昔单抗和来那度胺治疗R/R FL患者（NCT:05409066）。

Epcoritamab is not approved to treat newly diagnosed patients with DLBCL or FL. The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information..

Epcoritamab未被批准用于治疗新诊断的DLBCL或FL患者。Epcoritamab的安全性和有效性尚未确定用于这些研究用途。有关更多信息，请访问clinicaltrials.gov。。

EPKINLY® (epcoritamab-bysp) U.S. IMPORTANT SAFETY INFORMATION

EPKINLY®（epcoritamab bysp）美国重要安全信息

Use

使用

EPKINLY is a prescription medicine used in the U.S. to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more treatments for their cancer..

EPKINLY是一种处方药，在美国用于治疗某些类型的弥漫性大B细胞淋巴瘤（DLBCL）和高度B细胞淋巴瘤的成年人，这些淋巴瘤已经复发或对以前的治疗无效（难治性），并且已经接受了两种或两种以上的癌症治疗。。

EPKINLY is approved based on patient response data. A study is ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.

EPKINLY是根据患者反应数据批准的。正在进行一项研究以确认EPKINLY的临床益处。目前尚不清楚EPKINLY对儿童是否安全有效。

Important Warnings—EPKINLY can cause serious side effects, including:

重要警告EPKINLY可能导致严重的副作用，包括：

Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you may receive other medicines before receiving EPKINLY and you will also be given smaller doses of EPKINLY for the first 2 doses (called “step-up” dosing).

细胞因子释放综合征（CRS），在EPKINLY治疗期间很常见，可能严重或危及生命。为了帮助降低CRS的风险，您可以在服用EPKINLY之前服用其他药物，并且在前两剂中也会服用较小剂量的EPKINLY（称为“递增”剂量）。

Your first full dose of EPKINLY will be given on day 15 of your first cycle of treatment and you should be hospitalized for 24 hours after due to risk of CRS and neurologic problems. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule..

您的第一个全剂量EPKINLY将在第一个治疗周期的第15天服用，由于CRS和神经系统问题的风险，您应该住院24小时。如果您的EPKINLY剂量因任何原因延迟，您可能需要重复递增剂量计划。。

Neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.

可能危及生命并导致死亡的神经系统问题。接受EPKINLY治疗后几天或几周可能会出现神经系统问题。

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss.

如果您发烧到100.4°F（38°C）或更高，请告诉您的医疗保健提供者或立即寻求医疗帮助；头晕或头晕；呼吸困难；寒战；心跳加快；感到焦虑；头痛；混乱；摇晃（震颤）；平衡和运动问题，如行走困难；说话或写作困难；困惑和迷失方向；困倦、疲倦或缺乏活力；肌肉无力；癫痫发作；或记忆力丧失。

These may be symptoms of CRS or neurologic problems. Do not drive or use heavy machinery or do other dangerous activities if you have any symptoms that impair consciousness until your symptoms go away..

这些可能是CRS或神经系统问题的症状。如果您有任何损害意识的症状，请不要驾驶或使用重型机械或进行其他危险活动，直到症状消失。。

EPKINLY can cause other serious side effects, including:

EPKINLY会引起其他严重的副作用，包括：

Infections that may lead to death. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell..

可能导致死亡的感染。如果您在治疗过程中出现任何感染症状，包括发烧100.4°F（38°C）或更高，咳嗽，胸痛，疲倦，呼吸急促，皮疹疼痛，喉咙痛，排尿时疼痛，或感觉虚弱或全身不适，请立即告知您的医疗保健提供者。。

Low blood cell counts are common during treatment with EPKINLY and can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems..

EPKINLY治疗期间血细胞计数低很常见，可能严重或严重。您的医疗保健提供者将在治疗期间检查您的血细胞计数。EPKINLY可能导致低血细胞计数，包括低白细胞（中性粒细胞减少症），这可能会增加感染风险；低红细胞（贫血），可导致疲劳和呼吸急促；和低血小板（血小板减少症），这可能导致瘀伤或出血问题。。

Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

您的医疗保健提供者将在EPKINLY治疗期间监测您的CRS症状，神经系统问题，感染和低血细胞计数。如果您出现某些副作用，您的医疗保健提供者可能会暂时停止或完全停止使用EPKINLY进行治疗。

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY.

在您接受EPKINLY之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否感染，是否怀孕或计划怀孕，是否正在母乳喂养或计划母乳喂养。如果您在怀孕期间接受EPKINLY，它可能会伤害您未出生的婴儿。如果您是一名可能怀孕的女性，您的医疗保健提供者应该在您开始使用EPKINLY治疗之前进行妊娠测试，并且您应该在治疗期间和最后一剂EPKINLY后的4个月内使用有效的节育（避孕）。

Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY..

如果您怀孕了，或者认为您在服用EPKINLY期间可能怀孕了，请告诉您的医疗保健提供者。在服用EPKINLY期间以及服用最后一剂EPKINLY后的4个月内，不要母乳喂养。。

The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. These are not all the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.

EPKINLY最常见的副作用包括CRS，疲劳，肌肉和骨骼疼痛，注射部位反应，发烧，胃（腹部）疼痛，恶心和腹泻。这些并不是EPKINLY所有可能的副作用。打电话给你的医生，询问有关副作用的医疗建议。

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

鼓励您通过（800）FDA-1088或www.FDA.gov/medwatch向FDA报告副作用，或通过1-855-4GENMAB（1-855-443-6622）向Genmab US，Inc.报告副作用。

Please see the Full Prescribing Information and Medication Guide, including Important Warnings.

请参阅完整的处方信息和药物指南，包括重要警告。

About Genmab

关于Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.

Genmab是一家国际生物技术公司，其核心宗旨是指导其不可阻挡的团队通过创新和差异化的抗体疗法努力改善患者的生活。20多年来，其充满激情，创新和合作的团队发明了下一代抗体技术平台，并利用了转化研究和数据科学，这产生了一条专有的管道，包括双特异性T细胞参与者，下一代免疫检查点调节剂，效应功能增强的抗体和抗体-药物偶联物。

To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines..

为了帮助开发和向患者提供新型抗体疗法，Genmab与生物技术和制药公司建立了20多个战略合作伙伴关系。到2030年，Genmab的愿景是彻底改变癌症和其他严重疾病患者的生活（KYSO™)抗体药物。。

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.

Genmab成立于1999年，总部位于丹麦哥本哈根，在荷兰乌得勒支、美国新泽西州普林斯顿和日本东京设有办事处。有关更多信息，请访问Genmab.com并在Twitter.com/Genmab上关注我们。

This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements.

本媒体发布包含前瞻性声明。“相信”、“期望”、“预期”、“打算”和“计划”等词语以及类似的表达方式代表了前瞻性陈述。实际结果或表现可能与此类声明明示或暗示的任何未来结果或表现存在重大差异。

The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors.

可能导致我们的实际结果或表现产生重大差异的重要因素包括与产品的临床前和临床开发相关的风险，与临床试验结果和进行相关的不确定性，包括不可预见的安全问题，与产品制造相关的不确定性，我们的产品缺乏市场接受度，我们无法管理增长，与我们的业务领域和市场相关的竞争环境，我们无法吸引和留住合适的合格人员，我们的专利和专有权不可执行或缺乏保护，我们与附属实体的关系，可能导致我们的产品或技术过时的技术变化和发展，和其他因素。

For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov.

有关这些风险的进一步讨论，请参阅Genmab最新财务报告中的风险管理部分（可在www.Genmab.com上找到），以及Genmab最新年度报告（表20-F）中包含的风险因素以及向美国证券交易委员会（SEC）提交的其他文件（可在www.SEC.gov上找到）。

Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law..

除非法律要求，否则Genmab没有义务更新或修改本媒体发布中的前瞻性声明，也没有义务确认这些声明以反映制定日期后的后续事件或情况或与实际结果相关的情况。。

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO™. EPCORE™, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd..

Genmab A/S和/或其子公司拥有以下商标：Genmab®；Y形Genmab徽标®；Genmab结合Y形Genmab徽标®；HuMax®；DuoBody®；HexaBody®；DuoHexaBody®、HexElect®和KYSO™.EPCORE公司™,EPKINLY®、TEPKINLY®及其设计是AbbVie Biotechnology Ltd.的商标。。

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我淋巴瘤研究基金会官方网站。https://lymphoma.org/aboutlymphoma/nhl/fl/.2023年6月访问。

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vi淋巴瘤研究基金会官方网站。https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/.2023年11月访问。

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