At three years, over 80% of patients with moderately to severely active UC who were in remission with mirikizumab sustained long-term remission and relief from disruptive symptoms, including bowel urgency

在三年的时间里，超过80%的中度至重度活动性UC患者在接受米利珠单抗缓解后持续长期缓解并缓解了破坏性症状，包括肠道急迫

Mirikizumab also helped over 50% of patients with moderately to severely active Crohn's disease sustain long-term endoscopic remission for up to five years

Mirikizumab还帮助超过50%的中度至重度活动性克罗恩病患者维持长达五年的长期内镜缓解

INDIANAPOLIS, Oct. 28, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results from two, multi-year, Phase 3 studies that showed patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease.

印第安纳波利斯，2024年10月28日/PRNewswire/--礼来公司（纽约证券交易所：LLY）宣布了两项多年期3期研究的结果，这些研究表明，接受米利珠单抗治疗的患者在两种类型的炎症性肠病（IBD），溃疡性结肠炎（UC）和克罗恩病中持续稳定，长期缓解。

Data from the two trials – LUCENT-3 in moderately to severely active UC and VIVID-2 in moderately to severely active Crohn's disease – will be presented at the American College of Gastroenterology (ACG) Annual Meeting from October 25-30, 2024 in Philadelphia..

这两项试验的数据-朗讯-3治疗中度至重度活动性UC和VIVID-2治疗中度至重度活动性克罗恩病-将于2024年10月25日至30日在费城举行的美国胃肠病学会（ACG）年会上公布。。

Mirikizumab is an interleukin-23p19 (IL23p19) antagonist that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. Inflammation due to the overactivation of the IL-23 pathway plays a critical role in pathogenesis of UC and Crohn's disease. Inflammation from UC and Crohn's disease can lead to disruptive symptoms, including bowel urgency, that can result in decreased health-related quality of life and potentially irreversible complications for patients if left untreated. Mirikizumab is approved in the United States (U.S.) for the treatment of moderately to severely active UC in adults and is under review with the U.S.

Mirikizumab是一种白细胞介素-23p19（IL23p19）拮抗剂，可选择性结合IL-23的p19亚基并抑制其与IL-23受体的相互作用。由于IL-23途径过度活化引起的炎症在UC和克罗恩病的发病机制中起关键作用。。Mirikizumab在美国被批准用于治疗成人中度至重度活动性UC，目前正在与美国进行审查。

Food and Drug Administration (FDA) for moderately to severely active Crohn's disease..

美国食品和药物管理局（FDA）针对中度至重度活动性克罗恩病。。

'Mirikizumab is the first and only IL23p19 antagonist to report multi-year, long-term sustained efficacy data in both ulcerative colitis and Crohn's disease,' said Mark Genovese, M.D., senior vice president of Lilly Immunology development. 'This achievement reflects our commitment to help people with immune system conditions sustain long-standing remission and relieve disease burden.'.

礼来免疫学发展高级副总裁马克·吉诺维斯医学博士说：“米利珠单抗是第一个也是唯一一个报告溃疡性结肠炎和克罗恩病多年长期持续疗效数据的IL23p19拮抗剂。”这一成就反映了我们致力于帮助免疫系统疾病患者维持长期缓解并减轻疾病负担。”。

Long-Term Data in Adults with UCIn LUCENT-3, mirikizumab helped patients with moderately to severely active UC achieve long-term outcomes, including histologic-endoscopic mucosal remission, defined as mucosal healing. Mirikizumab also provided sustained benefit across symptomatic, clinical, endoscopic and histologic endpoints for up to three years, regardless of previous failure to TNF inhibitors, tofacitinib or other biologics. Among those who achieved clinical remission with mirikizumab at one year in the LUCENT-2 study, the following results were achieved based upon observed case analysis after an additional two years of treatment (up to three years total): .

长期数据在患有UCIn-LUCENT-3的成年人中，mirikizumab帮助中度至重度活动性UC患者获得长期结果，包括组织学内镜下粘膜缓解，定义为粘膜愈合。Mirikizumab还可以在症状，临床，内镜和组织学终点提供长达三年的持续益处，无论之前TNF抑制剂，托法替尼或其他生物制剂是否失败。在LUCENT-2研究中，在一年内使用mirikizumab获得临床缓解的患者中，经过另外两年的治疗（总共三年），根据观察到的病例分析，获得了以下结果：。

81% of patients maintained long-term clinical remission

81%的患者保持长期临床缓解

82% achieved long-term endoscopic remission

82%达到长期内镜缓解

72% had mucosal healing

72%有粘膜愈合

79% achieved corticosteroid-free clinical remission

79%达到无皮质类固醇临床缓解

Patients demonstrated a sustained clinically meaningful improvement in symptom score reduction for bowel urgency (-4.72)

患者表现出持续的临床意义上的改善，症状评分降低肠道急迫（-4.72）

These results were also evaluated using a modified non-responder imputation and are presented in the About the Mirikizumab Ulcerative Colitis Program section below.

这些结果也使用改进的无应答者插补进行了评估，并在下面的关于Mirikizumab溃疡性结肠炎计划部分进行了介绍。

Among patients receiving mirikizumab in the LUCENT-3 study, 7.4% of patients reported a serious adverse event (AE), while 5.3% discontinued treatment due to an AE. The long-term safety profile in patients with moderately to severely active UC was consistent with the already known safety profile of mirikizumab.

在LUCENT-3研究中接受mirikizumab治疗的患者中，7.4%的患者报告有严重不良事件（AE），而5.3%的患者因AE而停止治疗。中度至重度活动性UC患者的长期安全性与mirikizumab已知的安全性一致。

These data were recently published in Inflammatory Bowel Diseases. .

这些数据最近发表在炎症性肠病上。。

Long-Term Data in Adults with Crohn's DiseaseNew data from patients in the Phase 2 program who enrolled into the VIVID-2 long-term extension study showed that patients with moderately to severely active Crohn's disease treated with mirikizumab maintained high rates of clinical and endoscopic remission over time.

成人克罗恩病的长期数据来自参加VIVID-2长期扩展研究的2期项目患者的新数据显示，用mirikizumab治疗的中度至重度活动性克罗恩病患者随着时间的推移保持了较高的临床和内镜缓解率。

The following results were achieved based upon observed case analysis after an additional three years of treatment (up to five years total):.

经过另外三年的治疗（总共五年），根据观察到的病例分析，获得了以下结果：。

96% of patients had clinical response as measured by the Crohn's Disease Activity Index (CDAI)

根据克罗恩病活动指数（CDAI）测量，96%的患者有临床反应

87% were in clinical remission as measured by CDAI

根据CDAI的测量，87%的患者处于临床缓解期

76% had endoscopic response

76%有内镜反应

54% of patients were in endoscopic remission

54%的患者处于内镜缓解期

These results were also evaluated using a modified non-responder imputation and are presented in the About the Mirikizumab Crohn's Disease Program section below.

这些结果也使用改进的无应答者插补进行了评估，并在下面的关于Mirikizumab克罗恩病计划部分中介绍。

'Despite continued advances, people living with ulcerative colitis and Crohn's disease are still seeking treatments that can address difficult-to-manage symptoms such as bowel urgency, and provide lasting results over time,' said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr.

BruceSands医学博士、医学硕士、伯里尔·克罗恩（BurrillB.Crohn）博士（Dr。

Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. 'These multi-year data show mirikizumab is a targeted therapy that can provide intestinal healing over time and improvement in key symptoms that matter most to patients.' .

西奈山伊坎医学院胃肠病学系亨利·贾诺维茨（HenryD.Janowitz）这些多年的数据显示，mirikizumab是一种靶向治疗，可以随着时间的推移提供肠道愈合，并改善对患者最重要的关键症状。”。

Among these patients who enrolled into the VIVID-2 long-term extension study, 8.5% reported a serious AE and 1.9% discontinued treatment due to an AE. The long-term safety profile in patients with moderately to severely active Crohn's disease was consistent with the already known safety profile of mirikizumab.

在参加VIVID-2长期扩展研究的这些患者中，8.5%报告有严重AE，1.9%因AE停止治疗。中度至重度活动性克罗恩病患者的长期安全性与mirikizumab已知的安全性一致。

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Omvoh® (mirikizumab-mrkz) was approved by the FDA in October 2023 as the first IL23p19 antagonist for the treatment of moderately to severely active UC in adults and is also approved in 44 countries around the world. Lilly submitted marketing applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Canada, Europe, Japan and China.

Omvoh®（mirikizumab mrkz）于2023年10月被FDA批准为第一种IL23p19拮抗剂，用于治疗成人中度至重度活动性UC，并在世界44个国家获得批准。礼来公司在全球范围内提交了米利珠单抗治疗克罗恩病的营销申请，包括美国、加拿大、欧洲、日本和中国。

Additional global regulatory submissions are planned..

计划提交更多的全球监管报告。。

Additionally, Lilly has a combination study in UC with mirikizumab and eltrekibart, a humanized monoclonal antibody that binds to the seven ligands that signal through the CXCR1 and CXCR2 chemokine receptors involved in neutrophil movement to sites of inflammation (NCT06598943). There are also ongoing studies in both UC (NCT05611671) and Crohn's disease (NCT06226883) with MORF-057, a selective oral small molecule alpha-4/beta-7 integrin inhibitor that may improve outcomes and expand treatment options for people with IBD..

此外，礼来在UC中与mirikizumab和eltrekibart进行了联合研究，eltrekibart是一种人源化单克隆抗体，与七种配体结合，这些配体通过参与中性粒细胞向炎症部位运动的CXCR1和CXCR2趋化因子受体发出信号（NCT06598943）。在UC（NCT05611671）和克罗恩病（NCT06226883）中也正在进行MORF-057的研究，MORF-057是一种选择性口服小分子α-4/β-7整合素抑制剂，可改善IBD患者的预后并扩大治疗选择。。

Disclosure: Dr. Sands is a paid consultant for Lilly. He has not been compensated for any media work.

披露：桑兹博士是礼来公司的有偿顾问。他没有得到任何媒体工作的补偿。

About the Mirikizumab Ulcerative Colitis ProgramMirikizumab was studied in two, Phase 3 clinical trials which evaluated the efficacy and safety of mirikizumab in adults with moderately to severely active ulcerative colitis (UC) and included patients who had never tried a biologic (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed.

关于Mirikizumab溃疡性结肠炎计划Mirikizumab在两项3期临床试验中进行了研究，该试验评估了Mirikizumab在中度至重度活动性溃疡性结肠炎（UC）成人中的疗效和安全性，其中包括从未尝试过生物制剂（生物制剂天真）的患者，以及以前服用过生物制剂失败的患者更难治疗。

The induction LUCENT-1 and maintenance LUCENT-2 studies were randomized, double-blind, and placebo-controlled and included those who had inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, immunomodulators (6-mercaptopurine and azathioprine), biologic therapy (TNF blocker, vedolizumab) or Janus kinase inhibitors (JAKi, tofacitinib).

诱导LUCENT-1和维持LUCENT-2研究是随机，双盲和安慰剂对照的，包括那些反应不足，反应丧失或不能耐受以下任何一种的患者：皮质类固醇，免疫调节剂（6-巯基嘌呤和硫唑嘌呤），生物疗法（TNF阻滞剂，维多珠单抗）或Janus激酶抑制剂（JAKi，托法替尼）。

Additionally, 41% of patients in LUCENT-1 had failed at least one biologic, 3% had failed a JAKi and 57% were biologic and JAKi-naïve..

此外，LUCENT-1中41%的患者至少有一种生物学失败，3%的JAKi失败，57%的患者生物学和JAKi幼稚。。

LUCENT-3, the ongoing long-term Phase 3 extension of LUCENT-1 and LUCENT-2 evaluated the efficacy and safety of mirikizumab in patients with UC for up to three years. Using a modified non-responder imputation analysis to handle discontinuation and missing data, among Week 52 mirikizumab remitters, 70% maintained long-term clinical remission at Week 152, and response rates for major efficacy endpoints (including endoscopic remission, histologic-endoscopic mucosal remission, corticosteroid-free remission and clinical response) ranged from 63% to 85%..

LUCENT-3是LUCENT-1和LUCENT-2正在进行的长期3期延长，评估了mirikizumab在UC患者中长达三年的疗效和安全性。使用改进的无应答者插补分析来处理停药和缺失数据，在第52周的mirikizumab缓解者中，70%在第152周保持长期临床缓解，主要疗效终点（包括内镜缓解，组织学内镜粘膜缓解，无皮质类固醇缓解和临床缓解）的缓解率在63%至85%之间。。

About the Mirikizumab Crohn's Disease ProgramVIVID-1 was a Phase 3, randomized, double-blind, treat-through study that evaluated the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn's disease. Patients randomized to mirikizumab were administered 900 mg of mirikizumab intravenously every four weeks from Week 0-12, then 300 mg subcutaneously every four weeks from Weeks 12-52.

关于Mirikizumab克罗恩病计划VIVID-1是一项3期，随机，双盲，治疗通过研究，评估Mirikizumab与安慰剂和活性对照（ustekinumab）相比在中度至重度活动性克罗恩病成人中的安全性和有效性。随机接受mirikizumab治疗的患者从第0-12周开始每四周静脉注射900 mg mirikizumab，然后从第12-52周开始每四周皮下注射300 mg。

In this study, 49% of patients taking mirikizumab or placebo had experienced a prior biologic failure..

在这项研究中，49%服用mirikizumab或安慰剂的患者曾经历过生物学失败。。

SERENITY, the Phase 2, multi-center, randomized, parallel-arm, double-blind, placebo-controlled trial was designed to assess the safety and efficacy of mirikizumab in patients with moderately to severely active Crohn's disease. At baseline, participants were randomized with a 2:1:1:2 allocation across four treatment arms (placebo, mirikizumab 200 mg, mirikizumab 600 mg and mirikizumab 1000 mg).

SERENITY是一项2期多中心随机平行双盲安慰剂对照试验，旨在评估mirikizumab在中度至重度活动性克罗恩病患者中的安全性和有效性。在基线时，参与者在四个治疗组（安慰剂，mirikizumab 200 mg，mirikizumab 600 mg和mirikizumab 1000 mg）中以2:1:1:2的比例随机分配。

The primary endpoint was endoscopic response as determined by the proportion of participants achieving at least 50% reduction from baseline on the Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. In May 2019, Lilly reported Phase 2 results showing more patients with moderate to severe Crohn's disease receiving mirikizumab compared with placebo achieved clinical response and remission at 12 weeks.

主要终点是内镜反应，这是由参与者在第12周时克罗恩病简单内镜评分（SES-CD）比基线降低至少50%的比例决定的。2019年5月，礼来公司报告的第二阶段结果显示，与安慰剂相比，接受mirikizumab治疗的中度至重度克罗恩病患者在12周时达到临床反应和缓解。

Overall, the safety profile at 12 weeks was consistent with that of mirikizumab in studies of ulcerative colitis and with the IL23p19 class..

总体而言，12周时的安全性与溃疡性结肠炎研究中的mirikizumab和IL23p19类一致。。

VIVID-2, the ongoing long-term Phase 3 extension of SERENITY and the VIVID-1 study, evaluated the efficacy and safety of mirikizumab in patients with Crohn's disease for up to five years. Using a modified non-responder imputation analysis to handle discontinuation and missing data, 61% and 44% achieved endoscopic response and endoscopic remission, respectively, at Week 156.

VIVID-2是SERENITY正在进行的长期3期延长和VIVID-1研究，评估了mirikizumab在克罗恩病患者中长达五年的疗效和安全性。使用改进的无应答者插补分析来处理中断和缺失数据，分别有61%和44%在第156周达到内镜反应和内镜缓解。

In addition, 79% and 72% achieved clinical response and clinical remission, respectively, at Week 156..

此外，在第156周，分别有79%和72%达到了临床反应和临床缓解。。

Indications and Usage for Omvoh® (mirikizumab-mrkz) (in the United States)

Omvoh® is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Omvoh®适用于治疗成人中度至重度活动性溃疡性结肠炎。

Important Safety Information for Omvoh (mirikizumab-mrkz)

Omvoh（mirikizumab mrkz）的重要安全信息

CONTRAINDICATIONS - Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

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WARNINGS AND PRECAUTIONS

警告和注意事项

Hypersensitivity ReactionsSerious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment..

超敏反应据报道，Omvoh给药会产生严重的超敏反应，包括静脉输注期间的过敏反应。诱导期间报告了输注相关的超敏反应，包括粘膜皮肤红斑和瘙痒。如果发生严重的超敏反应，立即停用Omvoh并开始适当的治疗。。

InfectionsOmvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh.

感染SOMVOH可能会增加感染风险。。对于有慢性感染或反复感染史的患者，在开具Omvoh之前，请考虑其风险和益处。

Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves..

如果出现临床上重要的急性或慢性感染的体征或症状，指导患者寻求医疗建议。如果发生严重感染或感染对标准治疗无效，请密切监测患者，在感染消退之前不要服用Omvoh。。

TuberculosisEvaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

结核病在开始使用Omvoh治疗之前评估患者的结核病（TB）感染。不要给活动性结核病感染患者服用Omvoh。在服用Omvoh之前开始治疗潜伏性结核病。对于有潜伏性或活动性结核病病史且无法确定适当疗程的患者，在开始Omvoh之前考虑抗结核治疗。

Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening..

在Omvoh治疗期间和之后监测患者活动性结核病的体征和症状。在临床试验中，如果受试者有活动性结核病的证据，有活动性结核病的病史，或者在筛查时被诊断出患有潜伏性结核病，则将其排除在外。。

HepatotoxicityDrug-induced liver injury in conjunction with pruritus was reported in a clinical trial patient following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment.

肝毒性在一名临床试验患者中报告了药物诱导的肝损伤伴瘙痒症，其诱导方案比推荐的诱导方案更长。Omvoh已停产。肝脏检查异常最终恢复到基线水平。在基线和至少24周的治疗中评估肝酶和胆红素。

Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded.

随后根据常规患者管理进行监测。考虑肝硬化患者的其他治疗选择。建议立即调查肝酶升高的原因，以确定潜在的药物性肝损伤病例。如果怀疑药物引起的肝损伤，则中断治疗，直到排除该诊断。

Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction..

如果患者出现肝功能障碍的症状，指导患者立即就医。。

ImmunizationsAvoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines.

。与免疫系统相互作用的药物可能会增加接种活疫苗后的感染风险。在开始治疗之前，根据当前的免疫指南完成所有适合年龄的疫苗接种。

No data are available on the response to live or non-live vaccines in patients treated with Omvoh..

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ADVERSE REACTIONSMost common adverse reactions (≥2%) associated with Omvoh treatment are upper respiratory tract infections and arthralgia during induction, and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during maintenance.

不良反应与Omvoh治疗相关的最常见不良反应（≥2%）是诱导期间的上呼吸道感染和关节痛，以及维持期间的上呼吸道感染，注射部位反应，关节痛，皮疹，头痛和疱疹病毒感染。

During induction, Omvoh is available as a single dose vial for intravenous infusion containing 300 mg/15 mL that is administered in a healthcare facility. During maintenance, Omvoh is available as a one-time use prefilled pen or syringe with 100 mg/mL for subcutaneous injections. See Prescribing Information for dosing information..

在诱导期间，Omvoh可作为单剂量小瓶用于静脉输注，其中含有300 mg/15 mL，在医疗机构中给药。在维护期间，Omvoh可作为一次性使用的预填充笔或注射器，100 mg/mL用于皮下注射。有关剂量信息，请参阅处方信息。。

MR HCP ISI 31JUL2024

HCP先生ISI 2024年7月31日

Please click for Prescribing Information and Medication Guide for Omvoh. Please click for Instructions for Use included with the device.

请单击以获取Omvoh的处方信息和用药指南。请单击以获取设备附带的使用说明。

About Omvoh®  Omvoh® (mirikizumab-mrkz) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of ulcerative colitis.

关于Omvoh®Omvoh®（mirikizumab mrkz）是一种白细胞介素-23p19拮抗剂，用于治疗成人中度至重度活动性溃疡性结肠炎。Omvoh选择性靶向IL-23的p19亚基并抑制IL-23途径。IL-23途径过度激活引起的炎症在溃疡性结肠炎的发病机制中起关键作用。

Treatment of ulcerative colitis with Omvoh starts with 300-mg IV infusions, once every four weeks for a total of three infusions, and transitions to two, 100-mg subcutaneous injections every four weeks during maintenance treatment. .

用Omvoh治疗溃疡性结肠炎始于300 mg IV输注，每四周一次，共输注三次，并在维持治疗期间每四周过渡到两次100 mg皮下注射。。

Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.

Omvoh及其交付设备底座是礼来公司拥有的商标。

About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases.

关于礼来礼来是一家将科学转化为治疗的医药公司，旨在让世界各地的人们生活得更好。近150年来，我们一直在开创改变生活的发现，今天，我们的药物帮助了全球数以千万计的人。利用生物技术、化学和遗传医学的力量，我们的科学家正在迫切推进新发现，以解决世界上一些最重大的健康挑战：重新定义糖尿病护理；治疗肥胖并减少其最具破坏性的长期影响；推进与阿尔茨海默病的斗争；为一些最致命的免疫系统疾病提供解决方案；。

With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn.

在迈向更健康世界的每一步中，我们都有一个动机：让数百万人的生活变得更好。这包括提供反映我们世界多样性的创新临床试验，并努力确保我们的药物可获得且负担得起。要了解更多信息，请访问Lilly.com和Lilly.com/news，或在Facebook、Instagram和LinkedIn上关注我们。

P-LLY.

P-LLY。

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about mirikizumab as a potential treatment for people with moderately to severely active ulcerative colitis and Crohn's disease and the timeline for future readouts, presentations, and other milestones relating to mirikizumab and its clinical trials, and reflects Lilly's current beliefs and expectations.

关于前瞻性声明的警示声明本新闻稿包含关于mirikizumab作为中度至重度活动性溃疡性结肠炎和克罗恩病患者的潜在治疗方法的前瞻性声明（该术语在1995年《私人证券诉讼改革法案》中有定义），以及与mirikizumab及其临床试验有关的未来读数，演示和其他里程碑的时间表，并反映了礼来目前的信念和期望。

However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that mirikizumab will prove to be a safe and effective treatment for Crohn's disease, that mirikizumab will receive regulatory approval, or that Lilly will execute its strategy as expected.

然而，与任何药品一样，药物研究，开发和商业化过程中存在重大风险和不确定性。除其他外，无法保证计划或正在进行的研究将按计划完成，未来的研究结果将与迄今为止的研究结果一致，mirikizumab将被证明是克罗恩病的安全有效治疗方法，mirikizumab将获得监管部门的批准，或者礼来将按预期执行其策略。

For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release..

有关这些以及其他可能导致实际结果与礼来预期不同的风险和不确定性的进一步讨论，请参阅礼来向美国证券交易委员会提交的表格10-K和表格10-Q。除法律要求外，礼来没有义务更新前瞻性声明以反映本发布日期后的事件。。

Refer to:     Cathy Buck; cathy.buck@lilly.com; +1-317-982-1153 (Lilly media)                    Joe Fletcher; jfletcher@lilly.com; 317-296-2884; (Lilly investors)

参考：凯西·巴克；cathy.buck@lilly.com；+1-317-982-1153（礼来传媒）乔·弗莱彻；jfletcher@lilly.com；317-296-2884；（礼来投资）

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SOURCE Eli Lilly and Company

来源：礼来公司