MORF-057

Landmark VIVID-2 data showed more than 90% of patients who achieved steroid-free remission at one year maintained steroid-free control through three years 具有里程碑意义的VIVID-2数据显示，超过90%的患者在一年内实现了无类固醇缓解，并在三年内保持了无类固醇控制。Additional new data revealed exceptionally low surgery and hospitalization rates in Omvoh-treated patients across both Crohn's disease and ulcerative colitis (UC), underscoring its potential to fundamentally change disease trajectory 额外的新数据显示，接受Omvoh治疗的克罗恩病和溃疡性结肠炎（UC）患者的手术率和住院率极低，凸显了其从根本上改变疾病进程的潜力。Omvoh now stands alone as the only IL-23p19 inhibitor to show strong and durable efficacy with simple, consistent monthly dosing over four years in UC and three years in Crohn's disease Omvoh 现在是唯一一个在溃疡性结肠炎（UC）四年和克罗恩病三年中，通过简单一致的每月一次给药，展现出强大且持久疗效的IL-23p19抑制剂。INDIANAPOLIS 印第安纳波利斯, ，Feb. 19, 2026 2026年2月19日/PRNewswire/ -- New long-term data from /PRNewswire/ -- 新的长期数据来自Eli Lilly and Company 礼来公司(NYSE: LLY) showed Omvoh (mirikizumab-mrkz) delivered durable efficacy through three years in adults with moderately to severely active Crohn's disease. (NYSE: LLY) 显示，Omvoh（mirikizumab-mrkz）在中度至重度活动性克罗恩病成人患者中三年内持续有效。1 1These data from the Phase 3 VIVID-2 open-label extension study were presented at the 21st 这些来自第 3 阶段 VIVID-2 开放标签扩展研究的数据在第 21 届Congress 国会of the European Crohn's and 欧洲克罗恩病和Colitis Organisation 结肠炎组织(ECCO) in (ECCO) 在Stockholm 斯德哥尔摩. Additional data presented from the Phase 3 VIVID-1 (Crohn's disease) and LUCENT-3 (UC) clinical trials showed Omvoh-treated patients experienced minimal hospitalizations and surgeries across both major types of inflammatory bowel disease (IBD). 来自三期VIVID-1（克罗恩病）和LUCENT-3（溃疡性结肠炎）临床试验的更多数据显示，接受Omvoh治疗的患者在两种主要炎症性肠病（IBD）中住院和手术的情况极少。2,3 2,3Omvoh is the first and only IL-23p19 inhibitor to show strong and durable efficacy over four years in UC and three years in Crohn's disease, with proven reduction of disease complications. Omvoh 是首个也是唯一一个在溃疡性结肠炎（UC）中展现四年强效持久疗效、在克罗恩病中展现三年强效持久疗效的 IL-23p19 抑制剂，并已证明可减少疾病并发症。'Too many people with inflammatory bowel disease never achieve lasting remission, leaving them vulnerable to cumulative damage from poorly controlled inflammation that can result in emergency hospitalizations or surgery,' said “太多炎症性肠病患者从未获得持久的缓解，这使他们容易受到控制不佳的炎症造成的累积损害，从而可能导致紧急住院或手术，”Adrienne Brown 阿德里安娜·布朗, executive vice president and president of Lilly Immunology. 'Omvoh is redefining what durable disease control can look like, with long-term data showing patients treated with Omvoh stayed in remission and experienced fewer serious complications over three years, underscoring its potential to alter the course of the disease.' . ，执行副总裁兼礼来免疫学总裁。'Omvoh正在重新定义持久疾病控制的可能性，长期数据显示，使用Omvoh治疗的患者在三年内保持缓解，并经历了较少的严重并发症，凸显了其改变疾病进程的潜力。'Long-Term Remission and Bowel Urgency Improvements in Crohn's Disease 克罗恩病的长期缓解与肠道紧迫感改善In VIVID-2, patients who achieved an endoscopic response at one year with Omvoh in the Phase 3 VIVID-1 clinical trial experienced long-term efficacy, with the majority remaining in clinical and corticosteroid-free remission and sustaining bowel urgency improvements through three years of continuous Omvoh treatment.. 在VIVID-2试验中，参与3期VIVID-1临床试验的患者在使用Omvoh一年后达到内镜应答，并表现出长期疗效。大多数患者在连续三年使用Omvoh治疗期间保持临床缓解且无需使用皮质类固醇，同时肠道紧迫感的改善也得以维持。1 1Efficacy results at 152 weeks* 152周时的疗效结果* Clinical remission 临床缓解† †92.4 % ‌ 92.4 %Corticosteroid-free clinical remission 无皮质类固醇临床缓解‡ ‡91.2 % 91.2 %≥3-point reduction on the Urgency ≥3点的紧迫性降低Numeric Rating Scale (UNRS) 数字评分量表 (UNRS)§ §82.1 % 82.1 %UNRS ≤2 联合国决议 ≤2¶ ¶71.7 % 71.7 %* Among patients who achieved each specified outcome at Week 52 in VIVID-1 and continued treatment in the * 在VIVID-1研究中，第52周达到每个特定结果的患者中，继续接受治疗的VIVID-2 extension; observed cases. These data were also evaluated using a modified non-responder imputation VIVID-2 扩展；观察到的病例。这些数据还使用了改良的无应答者填补方法进行了评估。(mNRI), presented in the About VIVID Clinical Trial Program section below. (mNRI)，在下面的关于VIVID临床试验计划部分中提出。† Crohn's Disease Activity Index (CDAI) total score <150. 克罗恩病活动指数（CDAI）总分 <150。‡ CDAI score <150 with no corticosteroid use for prior 12 weeks. CDAI评分<150且前12周未使用皮质类固醇。§ UNRS is the patient-centric scale of 0-10 that evaluates bowel urgency severity, with 0 being no bowel urgency § UNRS 是一个以患者为中心的 0-10 级评分量表，用于评估肠道紧迫感的严重程度，其中 0 表示无肠道紧迫感。and 10 being worst possible bowel urgency. 最严重的肠道紧迫感为10。¶ ¶Among patients with baseline UNRS ≥3. 基线 UNRS ≥3 的患者中。'For people with Crohn's disease, unpredictable flares and abdominal pain can persist when remission isn't achieved or sustained. Additionally, ongoing symptoms like urgent trips to the bathroom and fatigue can continue to disrupt daily life when the disease is not adequately controlled,' said “对于克罗恩病患者来说，当病情缓解未能实现或维持时，不可预测的突发症状和腹痛可能会持续存在。此外，当疾病未得到充分控制时，诸如紧急如厕和疲劳等持续症状可能继续扰乱日常生活，”Edward Barnes 爱德华·巴恩斯, M.D. MPH, Associate Professor of Medicine, 医学博士，公共卫生硕士，医学副教授，University of North Carolina at Chapel Hill 北卡罗来纳大学教堂山分校. 'Seeing more than 90% of patients maintain steroid-free remission through three years on consistent monthly dosing, with 80% also experiencing relief from the disruptive symptoms of bowel urgency, gives providers confidence in Omvoh for outcomes that can last.' “在持续每月一次的用药情况下，看到超过90%的患者在三年内保持无类固醇缓解，其中80%的患者还经历了肠道急迫症状的缓解，这使医生对Omvoh的持久疗效充满信心。”These new long-term Crohn's disease data also showed Omvoh-treated patients who achieved endoscopic response at one year experienced sustained improvement in inflammation, as measured by the continued decrease in inflammatory biomarkers (C-reactive protein and fecal calprotectin) up to three years. 这些新的克罗恩病长期数据还显示，接受奥姆沃治疗的患者在一年时达到内镜应答后，炎症持续改善，这可以通过炎性生物标志物（C反应蛋白和粪便钙卫蛋白）持续减少长达三年来衡量。1 1The long-term safety profile in patients with moderately to severely active Crohn's disease was consistent with the known safety profile of Omvoh. Common adverse events reported from the end of year one through the end of year three (≥5% of Omvoh-treated patients who achieved endoscopic response at one year) included COVID-19, nasopharyngitis, and upper respiratory tract infection.. 中度至重度活动性克罗恩病患者的长期安全性特征与Omvoh的已知安全性特征一致。从第一年结束到第三年结束报告的常见不良事件（≥5%的在一年时达到内镜下应答的Omvoh治疗患者）包括COVID-19、鼻咽炎和上呼吸道感染。1 1Consistently Low Rates of Severe Disease‑Related Complications in IBD IBD中持续较低的严重疾病相关并发症发生率Complementing the three-year Crohn's disease results, additional post hoc data presented from the VIVID-1 (Crohn's disease) and LUCENT-3 (UC) clinical trials showed patients treated with Omvoh experienced consistently low rates of severe disease-related complications. In VIVID-1, Omvoh reduced Crohn's disease-related hospitalizations and/or surgeries by nearly half versus placebo in the first 12 weeks (incidence rate: 16.9 vs. 补充三年克罗恩病结果的还有来自 VIVID-1（克罗恩病）和 LUCENT-3（溃疡性结肠炎）临床试验的更多事后数据显示，接受 Omvoh 治疗的患者严重疾病相关并发症的发生率始终较低。在 VIVID-1 中，与安慰剂相比，Omvoh 在前 12 周内使克罗恩病相关的住院和/或手术减少了近一半（发生率：16.9 vs.30.9 per 100 patient-years), and by nearly 70% during weeks 12 to 52 (4.5 vs. 14.0*).. 每100患者年30.9例），在第12至52周之间降低了近70%（4.5 vs. 14.0*）。2 2In LUCENT-3, one UC-related hospitalization and no UC-related surgeries were reported by patients treated with Omvoh during the three-year long-term extension (incidence rates 0.1 and 0 per 100 patient-years, respectively). 在LUCENT-3研究中，接受Omvoh治疗的患者在三年长期延长期期间报告了一次与溃疡性结肠炎相关的住院，且未发生与溃疡性结肠炎相关的手术（发生率分别为0.1和0每100患者年）。3 3* Placebo rates during weeks 12 to 52 only include placebo patients who were in clinical response at week 12. * 第12周至第52周的安慰剂比率仅包括在第12周时处于临床应答状态的安慰剂患者。Together, these findings expand the growing body of long-term data on Omvoh in IBD, building on previously disclosed 这些发现共同扩大了关于Omvoh在IBD中的长期数据，基于此前披露的数据。two-year results 两年结果in Crohn's disease and 克罗恩病和four-year results 四年结果in UC. 在 UC 中。Lilly is advancing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies in UC with eltrekibart ( 礼来公司正在推进mirikizumab的联合研究，旨在实现突破性的诱导疗效，同时保持长期缓解和安全性。这些研究包括在溃疡性结肠炎（UC）中与eltrekibart联合使用的研究（NCT06598943) NCT06598943）, a monoclonal antibody that targets neutrophil-driven inflammation, and with LY4268989 (MORF-057) ( ，一种针对中性粒细胞驱动的炎症的单克隆抗体，并与LY4268989（MORF-057）结合（NCT07186101 NCT07186101), an oral α4β7 integrin inhibitor. Lilly is also advancing novel science to uncover the potential of incretins in immunology and has initiated the COMMIT-UC ( ），一种口服的α4β7整合素抑制剂。礼来公司还在推进新的科学发现，以揭示肠促胰岛素在免疫学中的潜力，并已启动了COMMIT-UC（NCT06937086 NCT06937086) and COMMIT-CD ( ) 和 COMMIT-CD (NCT06937099 NCT06937099) trials evaluating the efficacy and safety of mirikizumab used concomitantly with an incretin-based therapy in adults with ulcerative colitis or Crohn's disease who also have obesity or are overweight with at least one weight-related comorbidity. In addition, trials of mirikizumab in pediatric patients are ongoing in UC (. ）评估mirikizumab与基于肠促胰岛素疗法联合使用在患有溃疡性结肠炎或克罗恩病且同时存在肥胖或超重并至少有一种体重相关并发症的成人中的疗效和安全性的试验。此外，mirikizumab在儿科患者中的试验正在UC中进行（。NCT05784246 NCT05784246) and Crohn's disease ）和克罗恩病(NCT05509777) (NCT05509777). 。Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 47 countries around the world. Omvoh 已获得治疗中度至重度活动性溃疡性结肠炎（UC）和中度至重度活动性克罗恩病的监管批准，适用于成人，并已在全世界47个国家获得批准。About the VIVID Clinical Trial Program 关于VIVID临床试验计划VIVID-1 was a Phase 3 randomized, double-blind, placebo-controlled 52-week study in adults with moderately to severely active Crohn's disease. Patients randomized to Omvoh received Omvoh 900mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8 followed by a maintenance dose of 300mg by subcutaneous injection (SC) at Week 12 and then every 4 weeks (Q4W) for 40 weeks.. VIVID-1 是一项针对中度至重度活动性克罗恩病成年患者的 III 期随机、双盲、安慰剂对照的 52 周研究。随机分配到 Omvoh 组的患者在第 0 周、第 4 周和第 8 周通过静脉 (IV) 注射接受 900mg 的 Omvoh，随后在第 12 周通过皮下注射 (SC) 接受 300mg 的维持剂量，之后每 4 周 (Q4W) 一次，持续 40 周。4 4Participants who completed VIVID-1, including the Week 52 endoscopy, were eligible for VIVID-2. In VIVID-2, the primary objective is to evaluate the long-term effect of Omvoh in clinical remission by CDAI and endoscopic response at Week 52 of treatment in VIVID-2 (totaling 104 weeks of continuous treatment). 完成 VIVID-1 并包括第 52 周内镜检查的参与者有资格参与 VIVID-2。在 VIVID-2 中，主要目标是通过 CDAI 和 VIVID-2 治疗第 52 周的内镜反应，评估 Omvoh 在临床缓解中的长期效果（总计 104 周的连续治疗）。Safety is being assessed from the first dose in VIVID-2.. 从VIVID-2的第一次剂量开始，安全性正在被评估。1 1Using a modified non-responder imputation method, among Omvoh endoscopic responders at year one, 82.8% of patients maintained CDAI clinical remission through three years, 81.1% maintained corticosteroid-free clinical remission, 72.7% maintained clinically meaningful improvement in bowel urgency and 64.0% of patients maintained bowel urgency remission.. 使用改良的无应答者填补法，在第一年的Omvoh内镜应答者中，82.8%的患者在三年内维持了CDAI临床缓解，81.1%维持了无皮质类固醇临床缓解，72.7%维持了在排便紧迫感方面有临床意义的改善，64.0%的患者维持了排便紧迫感的缓解。1 1About the LUCENT Clinical Trial Program 关于LUCENT临床试验计划Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed biologic or Janus kinase inhibitors (JAKi). The randomized, double‑blind, placebo‑controlled LUCENT‑1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT‑2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT‑1.. Omvoh 在两项 III 期临床试验中进行了研究，评估了 Omvoh 在中度至重度活动性溃疡性结肠炎（UC）成人患者中的疗效和安全性，包括生物制剂初治患者和既往对生物制剂或 Janus 激酶抑制剂（JAKi）治疗失败的患者。随机、双盲、安慰剂对照的 LUCENT-1（诱导）研究纳入了对皮质类固醇、免疫调节剂、生物疗法或 JAKi 反应不足、失去反应或不耐受的患者，而 LUCENT-2（维持）研究则评估了在 LUCENT-1 中对 Omvoh 产生临床反应的患者继续治疗与安慰剂的效果对比。5 5LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of Omvoh in patients with UC for an additional three years of treatment (up to four years total). LUCENT-3 是 LUCENT-1 和 LUCENT-2 的单臂长期第三阶段开放标签扩展研究，评估了 Omvoh 在 UC 患者中额外三年治疗（总计长达四年）的疗效和安全性。About Omvoh 关于OmvohOmvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease 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 inflammatory bowel disease.. Omvoh（mirikizumab-mrkz）是一种白细胞介素-23p19（IL-23p19）拮抗剂，用于治疗中度至重度活动性溃疡性结肠炎和成人克罗恩病。Omvoh选择性靶向IL-23的p19亚基并抑制IL-23通路。IL-23通路过度激活导致的炎症在炎症性肠病的发病机制中起关键作用。6 6Omvoh and its delivery device base are trademarks owned by Omvoh及其输送装置底座是以下公司拥有的商标Eli Lilly and Company 礼来公司. 。Indications and Usage for Omvoh® (mirikizumab-mrkz) (in Omvoh®（mirikizumab-mrkz）的适应症和用法the United States 美国) )Omvoh is an interleukin-23 antagonist indicated for adults with: Omvoh是一种白细胞介素-23拮抗剂，适用于以下情况的成人：Moderately to severely active ulcerative colitis 中度至重度活动性溃疡性结肠炎Moderately to severely active Crohn's disease 中度至重度活动性克罗恩病Important Safety Information for Omvoh (mirikizumab-mrkz) Omvoh（mirikizumab-mrkz）的重要安全信息CONTRAINDICATIONS 禁忌症Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients. Omvoh 禁用于对 mirikizumab-mrkz 或任何辅料有严重过敏反应史的患者。WARNINGS AND PRECAUTIONS 警告和注意事项Hypersensitivity Reactions 超敏反应Serious 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.. 据报道，使用奥姆沃（Omvoh）可能会引发严重的超敏反应，包括静脉输注期间的过敏反应。在诱导期曾报告过与输注相关的超敏反应，包括黏膜皮肤红斑和瘙痒。如果发生严重超敏反应，应立即停止使用奥姆沃，并开始适当的治疗。Infections 感染Omvoh 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. Omvoh可能会增加感染风险。在患者有临床重要的活动性感染时，不要开始使用Omvoh治疗，直至感染消退或得到适当治疗。对于慢性感染或有反复感染史的患者，在开Omvoh处方前应权衡风险和益处。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.. 指导患者如果出现临床重要的急性或慢性感染的体征或症状，应寻求医疗建议。如果发生严重感染或感染对标准治疗无反应，应密切监测患者，并在感染解决之前不要给予Omvoh。Tuberculosis 结核病Evaluate 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. 在使用Omvoh治疗前，评估患者是否感染结核病（TB）。不要对活动性结核病患者使用Omvoh。在给予Omvoh前，开始治疗潜伏性结核病。对于有潜伏性或活动性结核病史且无法确认已接受足够疗程的患者，考虑在开始使用Omvoh前进行抗结核治疗。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治疗期间及之后，监测患者是否有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、活动性结核病史或在筛查时被诊断为潜伏性结核病，则被排除在外。Hepatotoxicity 肝毒性Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject 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. 在一项临床试验中，有受试者在使用超过推荐时间的诱导方案后报告了药物性肝损伤并伴有瘙痒。Omvoh被停用，肝功能测试异常最终恢复到基线水平。应在基线时以及治疗至少24周期间评估肝酶和胆红素。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. 此后根据常规患者管理进行监测。对于有肝硬化证据的患者，考虑其他治疗方案。建议及时调查肝酶升高的原因，以识别潜在的药物性肝损伤病例。如果怀疑药物性肝损伤，应中断治疗，直到排除此诊断。Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.. 指导患者如果出现提示肝功能障碍的症状，立即寻求医疗关注。Immunizations 免疫接种Avoid 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. 避免在使用Omvoh治疗的患者中使用活疫苗。与免疫系统相互作用的药物可能会增加接种活疫苗后感染的风险。在开始治疗前，应根据现行免疫指南完成所有适龄疫苗接种。No data are available on the response to live or non-live vaccines in patients treated with Omvoh.. 目前尚无关于使用Omvoh治疗的患者对活疫苗或非活疫苗反应的数据。ADVERSE REACTIONS 不良反应Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2). 在溃疡性结肠炎治疗中，与Omvoh相关的最常见不良反应（≥2%的受试者，且发生率高于安慰剂）在诱导研究（UC-1）中为上呼吸道感染和关节痛，在维持研究（UC-2）中为上呼吸道感染、注射部位反应、关节痛、皮疹、头痛和疱疹病毒感染。Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.. 在克罗恩病研究（CD-1）中，与Omvoh相关的最常见的不良反应（≥5%的受试者，并且发生频率高于安慰剂组）包括上呼吸道感染、注射部位反应、头痛、关节痛和肝功能测试异常。Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information. Omvoh注射剂有300毫克/15毫升溶液，单剂量小瓶装，用于静脉输注；还有100毫克/毫升溶液或200毫克/2毫升溶液，单剂量预填充笔或预填充注射器装，用于皮下注射。有关剂量信息，请参阅处方信息。MR HCP ISI CD APP 先生医疗保健专业人员国际睡眠障碍分类应用Click to access provided 点击以访问提供的内容Prescribing Information 处方信息and 和Medication Guide 药品指南. See Instructions for Use provided with the device. 请参阅设备附带的使用说明。About Lilly 莉莉简介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. 礼来是一家医药公司，将科学转化为治疗手段，以改善世界各地人们的生活。近150年来，我们一直在开创改变生命的发现，如今我们的药物帮助了全球数千万人。通过利用生物技术、化学和基因医学的力量，我们的科学家正在加速推进新的发现，以解决一些全球最重要的健康挑战：重新定义糖尿病护理；治疗肥胖症并遏制其最具破坏性的长期影响；推动对抗阿尔茨海默病的斗争；为一些最严重的免疫系统疾病提供解决方案；并将最难治疗的癌症转化为可管理的疾病。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 . 每朝着更健康的世界迈出一步，我们都受到一个目标的激励：让数百万人的生活变得更好。这包括开展反映世界多样性的创新临床试验，并努力确保我们的药品可及且负担得起。欲了解更多信息，请访问。Lilly.com 莉莉网and 和Lilly.com/news Lilly.com/新闻, or follow us on ，或者关注我们Facebook Facebook, ，Instagram Instagram, and ，以及LinkedIn 领英. P-LLY . P-LLYTrademarks and 商标和Trade Names 商标名称All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. 本新闻稿中提到的所有商标或商号均为该公司所有，或者，若涉及属于其他公司的商标或商号，则归其各自所有者所有。仅为方便起见，本新闻稿中提及的商标和商号未附带®和™符号，但此类引用不应被解释为表示该公司或在适用情况下其各自所有者不会根据适用法律最大限度地主张公司或其对此类权利的所有权。We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.. 我们无意使用或展示其他公司的商标和商号来暗示我们与其他公司存在关联，或得到其他公司的认可或赞助。Cautionary Statement Regarding Forward-Looking Statements 关于前瞻性陈述的谨慎声明This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. 本新闻稿包含关于Omvoh（mirikizumab-mrkz）用于治疗中度至重度溃疡性结肠炎和中度至重度克罗恩病患者的前瞻性声明（该术语定义见1995年《私人证券诉讼改革法案》），并反映了礼来公司当前的信念和期望。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 Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. 然而，与任何药物产品一样，在药物研发、开发和商业化过程中存在重大风险和不确定性。其中，不能保证计划中或正在进行的研究会按计划完成，未来的研究结果会与迄今为止的研究结果一致，Omvoh 会获得额外的监管批准，或者 Omvoh 会在商业上取得成功。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 . 有关可能导致实际结果与礼来公司预期不同的这些风险和其他不确定性的进一步讨论，请参阅礼来公司向美国证券交易委员会提交的Form 10-K和Form 10-Q报告。United States Securities and Exchange Commission 美国证券交易委员会. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 除非法律要求，礼来公司没有义务更新前瞻性声明以反映本发布日期之后的事件。References 参考文献1 1Laharie D, et al. P0563 Mirikizumab demonstrated sustained and durable long-term efficacy and favorable safety in week 52 endoscopic responders with Crohn's disease: 3-year VIVID-2 open-label extension interim results. Laharie D, 等。P0563 Mirikizumab 在第52周内镜应答的克罗恩病患者中显示出持续且长期的疗效和良好的安全性：3年VIVID-2开放标签扩展中期结果。Journal of Crohn's and Colitis 《克罗恩病与结肠炎杂志》. 。2026;20(Suppl 1):jjaf231.744. 2026年；20卷（增刊1）：jjaf231.744。https://doi.org/10.1093/ecco-jcc/jjaf231.744 https://doi.org/10.1093/ecco-jcc/jjaf231.7442 2Sands B, et al. Mirikizumab treatment reduces Crohn's disease–related surgery and hospitalization rates: analyses from VIVID-1. Sands B, 等。Mirikizumab 治疗可降低克罗恩病相关手术和住院率：来自 VIVID-1 的分析。Journal of Crohn's and Colitis 克罗恩病和结肠炎杂志. 2026;20(Suppl 1):jjaf231.042. . 2026;20(补充 1):jjaf231.042.https://doi.org/10.1093/ecco-jcc/jjaf231.042 https://doi.org/10.1093/ecco-jcc/jjaf231.0423 3Magro F, et al. Mirikizumab treatment decreases ulcerative colitis–related surgery and hospitalisation rates: 4-year LUCENT studies results. Magro F, 等。Mirikizumab 治疗降低溃疡性结肠炎相关手术和住院率：4年 LUCENT 研究结果。Journal of Crohn's and Colitis 《克罗恩病与结肠炎杂志》. 。2026;20(Suppl 1):jjaf231.1300. 2026;20(补充1):jjaf231.1300.https://doi.org/10.1093/ecco-jcc/jjaf231.1300 https://doi.org/10.1093/ecco-jcc/jjaf231.13004 4Ferrante M, et al. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. 费兰特 M 等。Mirikizumab 在中度至重度活动性克罗恩病患者中的疗效与安全性：一项三期、多中心、随机、双盲、安慰剂对照和活性对照的贯穿治疗研究。The Lancet 柳叶刀. 2024;404(10470):2423-2436. . 2024;404(10470):2423-2436.5 5Sands, B, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflammatory Bowel Diseases, 2024;izae253, Sands, B, 等。持续治疗溃疡性结肠炎152周后，mirikizumab的三年疗效与安全性：来自LUCENT-3开放标签扩展研究的结果。《炎症性肠病》，2024年；izae253。https://doi.org/10.1093/ibd/izae253 https://doi.org/10.1093/ibd/izae2536 6Omvoh. Prescribing Information. 奥姆沃。处方信息。Lilly USA, LLC 美国礼来公司. 。Refer to: 参考：Kelly Hoffman 凯莉·霍夫曼; ；kelly.hoffman@lilly.com 凯莉·霍夫曼@礼来公司.com; 765-736-2555 (Lilly media) ；765-736-2555（礼来媒体）Michael Czapar; 迈克尔·查帕尔；czapar_michael_c@lilly.com czapar_michael_c@lilly.com; 317-617-0983 (Investors) ；317-617-0983（投资者）View original content to download multimedia: 查看原始内容以下载多媒体： https://www.prnewswire.com/news-releases/patients-with-crohns-disease-maintained-steroid-free-remission-for-three-years-with-lillys-omvoh-mirikizumab-mrkz-302691766.html https://www.prnewswire.com/news-releases/克罗恩病患者使用礼来的omvoh-mirikizumab-mrkz维持三年无类固醇缓解-302691766.htmlSOURCE 源代码Eli Lilly and Company 礼来公司

礼来的创新逻辑，藏着全球IBD赛道的未来。 撰文丨大眼怪 今日（2月11日），礼来的米吉珠单抗获得国家药品监督管理局批准，用于治疗成人中重度活动性克罗恩病（CD）及成人中重度活动性溃疡性结肠炎（UC）。 米吉珠单抗是一种特异性靶向白介素-23（IL-23）p19亚基的IgG4型单克隆抗体，可选择性抑制IL-23通路，调节由其驱动的免疫炎症反应。该药于2023年成为全球首个获批用于治疗中重度活动性UC的IL-23p19抑制剂，目前已在包括美国、欧盟和日本在内的多个国家和地区获批用于治疗中重度活动性UC和CD。今日在中国获批，也是礼来中国在消化免疫领域获批的首款创新药物。 炎症性肠病（IBD）包括克罗恩病与溃疡性结肠炎，其特点是不可治愈、终身复发、且具有致残性。不断增长的患者群体以及患者长期用药需求，催生了庞大的市场空间，并成为“重磅炸弹药”的沃土，因此也是全球制药巨头的必争赛道，艾伯维、强生、默沙东、罗氏等均已重金布局。 礼来自2023年起，凭借自主研发与并购加速跑步进场。在强手如林的IBD赛道，这家制药大厂究竟具备怎样的竞争力？ 以生物制剂打开市场大门 礼来在IBD赛道的系统性布局不算早，但从2023年开始，礼来开始在该赛道发力。礼来切入IBD市场的关键棋子就是米吉珠单抗（Mirikizumab）。 Mirikizumab是一种特异性靶向白介素-23（IL-23）p19亚基的IgG4型单克隆抗体，可选择性抑制IL-23通路，调节由其驱动的免疫炎症反应。 在治疗UC的III期LUCENT-1/-2研究中，Mirikizumab第12周临床缓解率为24.2%，显著优于安慰剂组的13.3%，且疗效随时间增强，第40周缓解率高达49.9%。 2025年1月，美国FDA批准米吉珠单抗用于治疗成人中度至重度活动性克罗恩病。III期研究显示，对现有疗法治疗不充分的患者，治疗一年时，53%的患者达到临床缓解，46%达到内镜应答，显著优于安慰剂组。礼来宣称，这是15年来首个在获批时即公开两年III期数据的克罗恩病疗法，为其建立了强大的临床信誉。 2026年2月11日，米吉珠单抗获得国家药品监督管理局批准，用于治疗用于治疗成人中重度活动性克罗恩病及成人中重度活动性溃疡性结肠炎。 炎症性肠病（IBD）是一种可累及全消化道的慢性非特异性肠道炎症性疾病，目前尚无法被治愈，存在巨大未被满足的临床需求。 根据Evaluate Pharma数据显示，2022年全球IBD药物市场规模已达约230亿美元，随着患者群体扩容与创新疗法迭代，预计2028年将稳步攀升至280亿美元。 在IBD赛道，礼来凭借生物制剂米吉珠单抗成功切入市场，而在高手云集、竞争日趋白热化的IBD领域，礼来还握有哪些后手布局？ 押注口服疗法 对于需要长期用药的IBD患者而言，传统注射类生物制剂（如抗TNF单抗、注射用IL-23抑制剂等）虽疗效明确，但频繁的医院访视、注射操作的不便，极大地影响了患者的用药依从性。 在Mirikizumab站稳脚跟后，礼来并未停下脚步，而是将目光投向了更具便利性和市场潜力的口服疗法。 口服制剂凭借居家给药、便捷高效的优势，天然适配IBD患者长期维持治疗的需求，已成为IBD赛道的下一个核心竞争焦点。 礼来自2024年起，通过一系列针对性的战略并购与管线布局，构建多元化的口服IBD疗法矩阵，加速从注射时代向口服时代跨越。 2024年7月，礼来宣布以约32亿美元收购生物制药公司Morphic Therapeutic。这笔交易的核心目标，正是锁定后者处于临床阶段的资产口服小分子α4β7整合素抑制剂MORF-057（收购后更名为LY4268989）。α4β7整合素是IBD领域经过充分临床验证的“黄金靶点”，武田的注射用维得利珠单抗（Vedolizumab）即是该靶点药物。维得利珠单抗2014年上市，凭借优异的安全性与疗效，2024年全球销售额已突破60亿美元，成为IBD领域的重磅产品。 MORF-057的差异化优势之一在于其口服属性，相较于维得利珠单抗每8周一次的静脉注射给药方式，MORF-057采用每日口服的给药方案，在给药便捷性和患者依从性上实现了提升。从临床数据来看，在II期EMERALD-1研究中，治疗12周后，25.7%的中重度UC患者达到临床缓解，同时Robarts组织病理学指数评分显著下降。 2025年2月，礼来宣布收购Organovo Holdings公司的FXR项目，核心资产为法尼醇X受体（FXR）激动剂FXR314。FXR作为一种核激素受体，在调节肠道炎症、维持肠道屏障功能与代谢平衡中发挥着关键作用。 FXR314的首发适应症最初并非IBD，而是代谢功能相关性脂肪性肝炎（MASH），但Organovo与礼来都看到了在肠道炎症疾病中的治疗潜力。那么，FXR314又为何吸引了礼来的出手呢？ Organovo以3D人体组织模型技术推进IBD药物开发是其优势策略。FXR314正是利用这个开发模型筛选与验证的候选药物，这种开发模式能够更精准地模拟人体病理状态。FXR314已在2025年启动治疗溃疡性结肠炎的IIa期临床试验患者入组，预计2026年上半年将读出临床结果。 2026年1月，礼来以12亿美元收购Ventyx Biosciences，标志着正式全面进军口服抗炎药物领域，进一步完善了口服IBD疗法的靶点布局。 Ventyx Biosciences的竞争力在于其专注于炎症介导疾病的创新口服小分子药物研发，管线覆盖NLRP3抑制剂、S1P1R调节剂、TYK2抑制剂等多个前沿靶点，且多款产品已进入临床阶段。 其中，VTX3232和VTX2735是NLRP3抑制剂，NLRP3是人体免疫反应中的重要开关，过度激活被认为是多种慢性疾病的核心驱动力。Tamuzimod是一款S1P1R调节剂，已完成针对溃疡性结肠炎的II期临床试验。VTX958是一款TYK2抑制剂，已在克罗恩病、斑块状银屑病、银屑病关节炎等人群中取得积极的II期研究数据。 2026年初市场传出消息，礼来拟以约150亿欧元的价格收购生物制药公司Abivax，而这笔潜在收购的核心吸引力，正是Abivax旗下处于后期临床阶段的口服溃疡性结肠炎药物Obefazimod（靶向miR-124）。在2025年7月公布的III期8周诱导试验中，Obefazimod表现亮眼，在ABTECT-1试验中，25mg、50mg剂量组患者的临床缓解率分别达到23.8%、21.7%，显著高于安慰剂组的2.5%。 尽管该传闻尚未得到双方正式确认，但从这一系列密集的并购动作不难看出，礼来正通过锁定口服新机制创新疗法的战略，快速抢占未来IBD市场竞争的制高点。 巨头博弈下的破局之道 在礼来跑步进场之前，IBD赛道早已是强手如云，形成了由艾伯维、强生、武田等巨头主导的竞争格局。 强生凭借英夫利西单抗（抗TNF单抗）和乌司奴单抗（IL-12/23单抗）等产品，长期占据全球IBD市场的重要地位，其中乌司奴单抗凭借优异的疗效、每12周一次的长给药间隔以及价格优势，近年来市场份额持续强势攀升。 艾伯维的修美乐（阿达木单抗）能兼容广泛的患者群体，虽然现已失去市场独占期，但是艾伯维接棒的产品乌帕替尼（JAK抑制剂）和利生奇珠单抗（IL-23单抗）表现亮眼，2025年销售额分别达到83亿美元和176亿美元，成功延续了艾伯维在IBD领域的统治力。 武田则凭借维得利珠单抗（α4β7整合素单抗）的肠道特异性优势，专注于UC和CD两大核心适应症，销售额持续稳步增长，成为IBD领域的重要玩家。 激烈的市场竞争之下，并非所有参与者都能实现突围。2023年6月，阿斯利康宣布终止其IL-23单抗Brazikumab在IBD领域的II期临床开发，该产品的终止并非出于安全性问题，阿斯利康明确表示，开发进度滞后与市场竞争格局是放弃该项目的主要原因。这一案例充分说明，在IBD赛道，尤其是在已被巨头占据的核心靶点领域，后发企业若缺乏差异化优势，将难以突破现有竞争壁垒。 因此，要在强手如林的市场中实现破局，礼来的差异化策略也很清晰。 在生物制剂领域，礼来的米吉珠单抗作为先锋，重点抢占中重度患者的市场。 口服制剂相较于注射剂，在患者便利性、生活质量提升方面具有优势。礼来通过收购Morphic、Ventyx Biosciences等企业，快速布局α4β7、NLRP3、S1P1R、TYK2等多个靶点的口服疗法，形成了多靶点、多机制的口服管线矩阵，有望为患者提供多样化的口服治疗选择。 更能打开想象空间的是，不同机制药物间的联合疗法（如IL-23抑制剂与口服α4β7抑制剂的联用）已成为难治性IBD患者的一种探索方向，礼来内部管线的协同为开展此类临床研究提供了便利性。 近年来，IBD赛道并购火热，默沙东、罗氏等制药巨头也纷纷重金收购TL1A靶点相关资产。凭借在糖尿病和减重领域的成果，礼来积累了雄厚的财力，未来能够以有竞争力的溢价锁定稀缺的优质资产，快速补齐管线短板。 结语 礼来在IBD领域的布局路径，对于正在发力自身免疫性疾病领域，寻求海外授权（License-out）与国际化突破的中国Biotech而言，具有重要的指引意义。深耕前沿靶点，做出具备全球竞争力与差异化创新，这样的Biotech才能在国际舞台上获得巨头青睐。 END 往期精彩内容 胡善联教授：全球药物定价改革的困局与破局 超5成青年医生加入“网红医生”行列，他们想要怎样的数字化工具？ 最高88.5亿美元！信达生物第7次与礼来达成合作