To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.

开始日期2023-12-27

申办/合作机构

Tarsus Pharmaceuticals, Inc.

NCT06054217

/ Active, not recruiting临床2期

Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation

The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.

开始日期2023-08-01

申办/合作机构

Tarsus Pharmaceuticals, Inc.

NCT05838170

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of TP-04 in Participants With Papulopustular Rosacea

This study is being done to evaluate the safety, tolerability, and efficacy of the study drug, TP-04, in participants with papulopustular rosacea (PPR).

开始日期2023-03-01

申办/合作机构

Tarsus Pharmaceuticals, Inc.

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100 项与洛替拉纳相关的专利（医药）

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项与洛替拉纳相关的文献（医药）

2025-07-01·CURRENT OPINION IN OPHTHALMOLOGY

Pediatric blepharokeratoconjunctivitis: review of epidemiology, pathophysiology, and current treatments

Review

作者: Khan, Wajid Ali ; Khan, Shama ; Awan, Rija

Purpose of review:

This review aims to provide a comprehensive overview of the epidemiology and clinical features of pediatric blepharokeratoconjunctivitis (BKC), with a focus on elucidating the underlying pathophysiology and evaluating new therapeutic strategies.

Recent findings:

Ongoing research continues to refine the management of pediatric BKC. Recent evidence suggests that disease remission can be achieved in approximately 95% of cases through an integrated approach involving topical or systemic antibiotics, corticosteroids, topical immunosuppressants, and lid hygiene. Notably, a significant advancement in the treatment of Demodex blepharitis is the FDA approval of 0.25% lotilaner ophthalmic solution, which has demonstrated safety and efficacy with twice-daily application over six weeks.

Summary:

Pediatric blepharokeratoconjunctivitis is a chronic inflammatory condition affecting the eyelids, conjunctiva, and cornea. It is underdiagnosed and associated with significant vision-threatening complications. While there is no established consensus on the most effective therapeutic strategy, management currently includes lid hygiene, topical/systemic antibiotics, corticosteroids, immunosuppressants, lubricants, and dietary supplements. Challenges arise from its chronicity, recurrence, and lack of standardized treatment protocols. This underscores the importance of early diagnosis, education, and continued research on treatment methods to prevent severe outcomes.

2025-05-01·JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS

Lotilaner for Demodex Blepharitis: The Journey from Veterinary Use to Human Medicine

Review

作者: Sharma, Akanksha ; Sharma, Pankaj Kumar ; Kompella, Uday B.

In 2023, Xdemvy® (0.25% lotilaner ophthalmic solution) was approved by the U.S. FDA for treating Demodex blepharitis in humans. This article reviews lotilaner's history, physicochemical properties, pharmacokinetics, pharmacology, clinical outcomes, and other indications for which it is being evaluated clinically. Furthermore, the article discusses Demodex blepharitis, alternative treatments used in the clinic to ameliorate its symptoms, and other drugs in development. Prior to its approval in humans, lotilaner found extensive application in treating parasitic infections in cats and dogs. Lotilaner was previously approved in 2017 as an oral veterinary medicine (Credelio®) for canines to treat demodicosis, other mite infections, and tick infections. Lotilaner belongs to the isoxazoline class of drugs and is a potent arthropod-selective gamma-aminobutyric acid-gated chloride ion channel inhibitor. Like several other drugs in the isoxazoline class, lotilaner has a long plasma half-life and high plasma protein binding of about 99.9%. When used as indicated, lotilaner treats infested Demodex blepharitis in 42 days, with its antiparasitic action starting within 24 h. Furthermore, lotilaner is also being evaluated for its efficacy in other conditions such as Lyme disease and dry eye disease. Other products evaluated for treating Demodex blepharitis include ivermectin eye ointment, ivermectin-metronidazole gel, permethrin cream, terpinen-4-ol wipes, and hypochlorous acid spray. Along with these, azithromycin eye drop, azithromycin/loteprednol eye drop, and other treatments are being evaluated for treating blepharitis. Other drugs from the isoxazoline drug class including afoxolaner, sarolaner, and fluralaner, could also be potentially explored for human use.

2025-03-01·Ophthalmology and Therapy

Safety and Efficacy of Lotilaner Ophthalmic Solution (0.25%) in Treating Demodex Blepharitis: Pooled Analysis of Two Pivotal Trials

Article

作者: Simmons, Blake ; Dhamdhere, Kavita ; Peterson, Jared D ; Whitson, William E ; Boehmer, Blair E ; Berdy, Gregg J ; Neervannan, Sesha ; Yeu, Elizabeth ; Meyer, John ; Ciolino, Joseph B ; Paauw, James D ; Whitley, Walter O ; Periman, Laura M ; Koetting, Cecelia ; Bloomenstein, Marc R ; Vollmer, Patrick

INTRODUCTION:

Lotilaner ophthalmic solution (0.25%) is the first United States Food and Drug Administration (US FDA)-approved drug for treating Demodex blepharitis. In pivotal trials, it was found to be well tolerated and demonstrated a significant reduction in collarettes and mite density after a 6-week treatment regimen. This study aimed to report the safety and efficacy profile of lotilaner ophthalmic solution (0.25%) from a pooled analysis of two pivotal trials in patients with Demodex blepharitis.

METHODS:

Pooled data were analyzed from two randomized, double-masked, vehicle-controlled clinical trials [phase 2b/3 Saturn-1 (NCT04475432) and phase 3 Saturn-2 (NCT04784091)] in which patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution (0.25%) (study group) or the vehicle formulation without lotilaner (control group), twice daily for 6 weeks. The outcome measures were the proportion of patients with 0-2 collarettes (grade 0 collarettes), mite eradication, erythema cure, and the proportion of patients with ≤ 10 collarettes (grade 0 or 1 collarettes) at day 43.

RESULTS:

Overall, 833 participants were randomized to receive either the study drug (N = 415) or vehicle (N = 418). On day 43, 49.8% of patients in the study group vs. 9.9% in the control group (p < 0.0001) had collarette grade 0 (0-2 collarettes). A reduction to ≤ 10 collarettes (grade 0 or 1 collarettes) was achieved in 85.1% of patients in study group vs. 28.0% in control group (p < 0.0001). The proportion of patients achieving mite eradication (60.2% vs. 16.1%, p < 0.0001) and erythema cure (24.9% vs. 7.9%, p < 0.0001) were also statistically significantly higher in the study group compared to the control group. The rates of adverse events were low in both studies, with no serious drug-related ocular adverse events reported. As many as 92% of patients rated the study drop as neutral to very comfortable.

CONCLUSIONS:

Twice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures compared to the vehicle control, with low rates of adverse events and a high rate of drop comfort.

129

项与洛替拉纳相关的新闻（医药）

2025-05-26

·GBIHealth

诺和盈展现心脏保护新证据，疗效早于明显减重

药械追踪No.1 / 远大医药眼科新药GPN01768在中国澳门获批，治疗蠕形螨睑缘炎2025年5月26日，远大医药（0512.HK）宣布，其用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768（TP-03，洛替拉纳滴眼液，0.25%）已获得中国澳门特别行政区政府药物监督管理局批准上市。蠕形螨是导致蠕形螨睑缘炎的根本原因，GPN01768是一款对昆虫和蛛形纲动物体内的γ-氨基丁酸门控氯离子通道（GABA-Cl）具有选择性的非竞争性拮抗剂，通过选择性抑制蠕形螨体内的GABA-Cl，使虫体麻痹和死亡，进而治疗蠕形螨睑缘炎。此外，GPN01768具有高度亲脂性，可促进其在螨虫栖息的睫毛毛囊油脂中的吸收。GPN01768由Tarsus Pharmaceuticals, Inc.（以下简称“Tarsus”）开发，是首款也是唯一一款获得美国食品药品监督管理局（FDA）批准用于治疗蠕形螨睑缘炎的产品。2024年3月，远大医药与Tarsus达成产品引进战略合作协定，并从联拓生物科技有限公司取得GPN01768在大中华区（中国大陆及港澳台）的独家开发、生产及商业化权益。->点击文末阅读原文，解锁完整双语新闻No.2 / 济民可信伊立替康脂质体注射液获批，带来晚期胰腺癌新选择5月22日，济民可信（603222.SH）宣布，其自主研发的抗肿瘤药物济立安（盐酸伊立替康脂质体注射液）已获国家药品监督管理局批准上市。该产品为国内第二家批准上市并视同通过一致性评价的仿制药，将为晚期胰腺癌患者带来新的治疗选择。与传统伊立替康注射液相比，济立安采用脂质体技术，具有更好的靶向性和生物相容性，可显著降低骨髓抑制、腹泻等毒副反应，提高治疗耐受性。国际研究表明，伊立替康脂质体联合5-FU/LV方案能显著延长转移性胰腺癌患者的中位无进展生存期和总生存期。2022年4月，原研施维雅易安达获得国家药品监督管理局正式批准，与5-氟尿嘧啶和亚叶酸联合用于接受吉西他滨治疗后进展的转移性胰腺癌患者。济民可信研发的仿制药济立安在临床实验中表现出色，试验结果显示该产品与原研制剂对比人体生物等效性完全一致。济立安是济民可信今年内第二个获批上市的脂质体产品。->点击文末阅读原文，解锁完整双语新闻No.3 / 诺和盈展现心脏保护新证据，疗效早于明显减重5月23日，诺和诺德（NYSE:NVO）宣布，旗下GLP-1类药物司美格鲁肽2.4 mg（诺和盈）在SELECT研究的二次分析中显示出显著的早期心脏保护作用。研究发现，在治疗前三个月内，诺和盈可将超重或肥胖且患有心血管疾病的成人患者主要不良心血管事件（MACE）风险降低37%；六个月内，心血管死亡风险降低50%，心衰相关住院或因心血管疾病死亡的综合风险下降59%。值得关注的是，这些益处出现在体重尚未显著下降（减重≤5%）阶段，说明诺和盈的心脏保护效应不仅依赖于减重。此前的研究也已证实，诺和盈在平均近39.8个月的治疗中，可将MACE风险降低20%。诺和盈目前已在中国获批用于BMI≥30的肥胖人群，或BMI≥27且合并高血压等体重相关疾病的成人长期体重管理。新一轮数据进一步强化了其在高危人群中的干预价值。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 欧洲药监局推荐艾力雅8mg扩展至每6个月用药一次2025年5月23日，拜耳公司宣布，欧洲药品管理局（EMA）的人用药品委员会（CHMP）已发布积极意见，推荐扩展艾力雅8 mg（阿柏西普8 mg，114.3 mg/ml注射液）的使用标签，将治疗间隔延长至最长6个月，用于治疗两种主要的视网膜疾病：新生血管性（湿性）年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）。预计欧洲委员会将在未来几周内做出决定，如果获得批准，艾力雅8 mg将成为欧盟唯一一种在nAMD和DME治疗中可延长至6个月治疗间隔的抗血管内皮生长因子（VEGF）治疗药物。2025年2月，拜耳向EMA提交该上市申请。阿柏西普由拜耳和再生元合作开发，是一款VEGFR-Fc融合蛋白，最早于2011年11月在美国获批上市，商品名艾力雅，至今获批用于治疗新生血管性老年性黄斑变性（AMD）、视网膜静脉阻塞、糖尿病性视网膜病变和其他眼部疾病。->点击文末阅读原文，解锁完整双语新闻No.2 / 罗氏PI3Kα抑制剂伊那利塞获欧盟积极批准意见2025年5月23日，罗氏（SIX：RO，ROG；OTCQX：RHHBY）宣布，欧洲药品管理局（EMA）的人用药品委员会（CHMP）对伊那利塞（商品名：伊赫莱/Itovebi）联合哌柏西利（商品名：爱博新/Ibrance）和氟维司群用于治疗成人PIK3CA突变、雌激素受体（ER）阳性、人表皮生长因子受体2（HER2）阴性、局部晚期或转移性乳腺癌患者采纳了积极意见。伊那利塞是一种口服靶向治疗药物，已证明在PIK3CA突变、激素受体阳性、HER2阴性晚期乳腺癌患者中能够提供耐受性良好且持久的疾病控制，这些患者通常预后较差，急需新的治疗选择。伊那利塞旨在帮助最小化治疗的整体负担和毒性，与其他PI3K抑制剂相比，其独特之处在于对PI3Kα亚型具有高选择性和特异性，能够促进突变PI3Kα的降解。->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

上市批准一致性评价

2025-05-14

·抗体圈

数十年磨一剑：远大医药以全球首创核药矩阵点燃创新药“核爆点”

中美地缘政治高度不确定性的扰动背景下，远大医药近6个交易日累计上涨近40%，无惧行业波动。值得注意的是，国际大行中金在5月13日上调目标价20.0%至9.6港币，这是中金年内第三次上调远大医药的目标价。大涨背后是远大医药密集的创新进展等积极消息的释放，包括：脓毒症创新药STC3141的二期临床成功、创新核素偶联药物TLX591加入国际多中心三期申请获受理、诊断RDC产品TLX591-CDx完成三期患者全部入组并计划在年内递交上市、肝癌创新精准诊断RDC产品GPN02006临床结果将亮相SNMMI大会，以及公司成都温江核药基地计划今年投入运营等等，这充分印证了公司厚积薄发的科技创新战略正在逐渐兑现，2025年公司创新药布局爆发正当时。随着公司更多的创新药布局一一开花结果，公司的投资与成长逻辑已全面蜕变，凸显港股创新药龙头气势。01核药爆发：批量颠覆性大品种蓄势待发核药板块，是远大医药创新药布局的最强尖兵之一。公司首个商业化核药品种为易甘泰®（钇[90Y]微球注射液），为全球唯一获批用于结直肠癌肝转移选择性内放射治疗（SIRT）的产品，2022-2024年分别实现销售额超过6000万港元、2亿港元和4.9亿港元，呈现了高速放量增长。易甘泰®的增长潜力还远远未被释放，其未来不仅有望惠及国内每年36万新发的肝癌患者，并且有望进一步探索后线治疗的潜力（如肝癌术后辅助治疗、联合靶向治疗等）。易甘泰®只是“商业化先锋”，远大医药核药板块处于一个全面爆发的关键窗口，要探析公司的强劲布局，诺华便是一个很好的对标或参照例子。2024年诺华核药两大商业化核心产品Pluvicto、Lutathera分别实现13.92亿美元（yoy+42%）、7.24亿美元（yoy+20%），整体板块收入超过20亿美元，而Jefferies更是给出了Pluvicto销售峰值将超过50亿美金的预测，另外Lutathera在2024年扩大适应症纳入了12岁及以上SSTR+胃肠胰神经内分泌肿瘤儿童患者，也即将步入10亿美元分子行列。‌显然，无论是Pluvicto还是Lutathera都分别在前列腺癌、神经内分泌适应症中展现了强大市场扩张力，这一势头未有减弱迹象并且有着加速迹象。远大医药，目前在Pluvicto、Lutathera对应的PSMA靶点、SSTR靶点核药RDC上分别布局了对应的me-better管线TLX591和ITM-11，如今正在奔向关键临床里程碑。TLX591是一款基于J591单抗的RDC药物，其通过抗体靶向PSMA，搭载治疗性放射性核素177Lu，精准输送至肿瘤部位。相比诺华Pluvicto，TLX591在多个方面具备潜在me better的特质：1）更精准的靶向治疗： TLX591通过抗体特异性除了更精准外，药物在PSMA阳性肿瘤的穿透性和滞留时间更长，有望达到更好的疗效；2）给药依从性：相比市面上长达六周期、持续30周的放射性配体治疗方案，TLX591仅需间隔14天的双剂给药（总周期约1个月），大幅缩短治疗周期；3）安全性：TLX591通过肝脏代谢清除，有效避免了肾脏毒性，而且其大分子结构使其对唾液腺和泪腺的摄取率极低，减少口干症和干眼症等常见不良反应发生率，改善患者生活质量。核药诊疗一体化的组合可以进一步发挥产品的效能。基于PSMA成像的优越性，TLX591-CDx是欧美最受医患青睐的诊断性核药，其基于放射性核素-小分子偶联技术的靶向PSMA（在90%以上的原发性和转移性前列腺癌细胞表面过表达），可用于检测基于血清PSA水平升高的复发前列腺癌患者。2024年TLX591-CDx实现近5.17亿美元的销售额，并于2025Q1取得近1.51亿美元的销售额，同比增长近35%。目前Pluvicto尚未在国内上市，随着TLX591-CDx预计在年内递交NDA，远大医药TLX591-CDx将有望在Pluvicto上市后搭乘其放量的东风；同时，待未来TLX591顺利加入国际多中心三期临床，其与TLX591-CDx有望为国内前列腺疾病患者带来更精准、高效的诊疗方案，并为远大医药实现前列腺癌的“诊疗一体化”。ITM-11是一款无载体177Lu与生长抑素类似物结合的RDC，其同样是一款潜在me better产品。其具体优势包括：1）ITM-11采用无载体技术，更高的比活度和纯度，生产杂质少，可提升肿瘤靶向效率；2）ITM-11半衰期更长，其采用每8周一次间隔给药，具备更高的患者依从性；3）ITM-11的潜在安全性更高，在过往临床中未观察到严重不良事件（SAE）。药物有效性来看，ITM-11的全球三期临床COMPOSE研究显示：在侵袭性2/3级SSTR阳性的胃肠或胰腺来源的神经内分泌肿瘤GEP-NETs患者中，患者的mPFS高达34.5个月，且未观察到严重的不良事件。与Lutathera非头对头数据比较下，ITM-11有望在整体的疗效（mPFS显著提升，Lutathera一线治疗在22个月左右）、安全性上成为同类最佳产品。目前诺华Lutathera并未在国内上市，远大医药ITM-11国内三期临床在今年三月已经实现首例患者入组，其有望成为国内首个商业化靶向SSTR的RDC产品，享受市场独占期。多款创新核药的管线为远大医药未来增长赋予了稳健的确定性，同时核药的商业化供应背后必须有着强大的产业链保障，经过多年深耕，远大医药在核药领域已实现了研发、生产、销售、监管资质等多个环节的全方位布局，建立了完整的产业链。同时，远大医药预计投入30亿的成都温江放射性药物全球研发及生产基地，将于今年投入运营，有望加速创新核药管线的落地，并进一步公司核药领域的领先地位。该基地是全球首个零辐射智能核药工厂，是目前国际范围内核素种类最全、自动化程度最高的智能工厂，未来将巩固远大医药全球核药研发中心网络的布局，其预计将于今年年底至2026年陆续实现产品的FDA临床申报。值得一提的是，今天远大医药还公布了其用于治疗肝细胞癌（HCC）的创新RDC产品GPN02006将于2025年SNMMI（核医学与分子影像学会）年会公布重磅临床结果。GPN02006是一款基于放射性核素-抗体偶联技术的靶向磷脂酰肌醇蛋白聚糖3 (GPC-3)的诊断型放射性药物。该产品早前临床研究数据展现了卓越的安全性和显像效能：所有受试者给药后均未报告任何药物相关不良反应，安全耐受性表现优异；给药后30分钟即可实现高质量显像，充分满足肝细胞癌临床快速诊断需求。本次其亮相SNMMI，不仅体现了GPN02006的潜力——有望成为全球首个针对GPC-3靶点的HCC诊断类RDC产品，同时也标志着远大医药核药产业全球化发展迈入新的阶段。02STC3141：全球脓毒症创新药FIC远大医药自研创新药STC3141脓毒症临床结果一鸣惊人，让市场重新审视公司的创新实力。脓毒症是全球市场公认最难攻克的适应症之一，由于发病机制复杂且病理过程涉及感染、免疫反应、代谢紊乱等多重机制，难以通过单一靶点药物全面干预，这也让远大医药的STC3141价值凸显。脓毒症领域缺乏有效治疗药物，目前抗生素类、免疫调节剂等传统药物为主，21世纪以来仅有重组活化蛋白C获批治疗脓毒症（后因疗效不确切撤市）。但由于脓毒症是美国住院患者的第一大死因（死亡率高达35% ~54%），并且中国每年约有近250万脓毒症患者，市场空间广阔；据Wise Guy Reports数据，2024年全球脓毒症治疗药物市场规模为125.4亿美元，预计到2032年市场规模将达到193.7亿美元，年均复合增长率为5.58%。远大医药STC3141的治疗机制围绕脓毒症治疗的核心目标——维持免疫稳态，其活性成分是一种多阴离子分子，研究表明脓毒症患者体内循环组蛋白水平升高与疾病严重程度相关，STC3141能够通过中和细胞外游离组蛋白和中性粒细胞陷阱网（NETs），减少炎症反应和组织损伤。STC3141国内治疗脓毒症二期临床结果显示，高剂量治疗组在主要终点第7天序贯器官衰竭评估（SOFA）评分较基线变化的表现显著优于安慰剂组，同时次要终点趋势与主要终点一致，患者安全性、耐受性良好。尽管未披露具体数据，但从“显著优于安慰剂组”的口径在脓毒症这样危重症适应症来说显然是大获成功。另外，STC3141的疗效和安全性也可以在过往的早期临床中初见端倪，STC3141在多个临床中帮助患者脱离呼吸机、脱离升压药和缩短ICU住院时间等有效性指标方面均体现了积极信号。值得注意的是，2024年底NIH公示的STC3141一期临床研究，在26名SOFA评分≥2的脓毒症患者中，大部分患者安全性、耐受性良好，有18名（69.2%）完成了ICU第8天的完整治疗方案，其余8名患者有4名提前出院、1名过早出ICU、1名SAE、1名需要其他治疗和1名死亡，这彰显了STC3141在患者中的安全性与耐受性。STC3141在国内二期临床明确了初步成药性的背景下，成为全球脓毒症潜在First in class药物候选毋庸置疑，若未来远大医药顺利申请STC3141突破性治疗药物资格，该产品的开发也有望进一步提速，并早日惠及广大脓毒症患者。而更大的悬念，在于STC3141对外授权的价值判断。由于脓毒症验证性创新临床管线稀缺，并且欧美住院患者用药花费不菲，巨额BD是可以预期的。从过往可参考的案例看，脓毒症药物开发商AM-Pharma的重组人碱性磷酸酶ilofotase alfa在脓毒症相关急性肾损伤适应症曾经未达到二期临床终点的背景下，仍基于对肾功能显著、渐进和持续改善潜力被协和麒麟看中，后2021年协和麒麟以2000万欧元首付+3000万欧元及1.95亿欧元监管里程碑费用买下日本开发权益。远大医药STC3141作为疗效、安全性已被验证并且拥有部分海外人群临床数据的FIC药物，拿下总额巨大的BD，想必市场不会感到意外。除了STC3141之外，远大医药还布局了一款脓毒症新药APAD，通过拮抗多种病原体相关分子（PAMPs），抑制免疫细胞过度活化，阻断脓毒症早期炎症风暴的启动，据介绍APAD与STC3141存在协同作用。03逻辑体系转变随着多年创新药的布局在2025年开始爆发，远大医药显然形成一套全新成长性逻辑。首先是各个创新药板块未来两年有一大批产品将迎来商业化放量，这些产品的体量将至少“再造一个”远大医药：（图源：远大医药2024年年报）1）核药领域除了易甘泰®（预计未来国内销售峰值有望超过50亿人民币）之外，公司诊断性核药TLX591-CDx国内三期临床完成全部患者入组并将于年内递交国内NDA申请、肾透明细胞癌诊断产品TLX250-CDx国内III期已完成首例入组、治疗性核药ITM-11国际多中心III期临床国内完成首例入组，以及治疗性核药TLX591加入国际多中心III期临床获受理，未来这些后期产品预计至少能贡献30亿人民币的收入（核心为治疗性核药），这还没有考虑后续其他早期管线。2）眼药方面，目前公司干眼症FIC产品酒石酸伐尼克兰鼻喷雾剂OC-01已经商业化，鉴于目前干眼症常规药物人工泪液玻璃酸钠滴眼液等药物在2023年均突破10亿规模，OC-01未来市场潜力亦值得期待；同时公司两款治疗蠕形螨睑缘炎滴眼液GPN01768和白内障术后抗炎滴眼液GPN00833均处于商业化冲刺阶段，两者销售峰值均有望冲刺10亿人民币的规模。3）吸入制剂方面公司拥有国内针对过敏性鼻炎的轻、中、重症全方位布局，目前包括已上市的布地奈德鼻喷雾剂及丙酸氟替卡松鼻喷剂、冲击商业化阶段的糠酸莫米松鼻喷雾剂，以及处于新药上市审核阶段的Ryaltris创新复方鼻喷剂，尽管前三款是仿制药，但具备良好的竞争格局和一定剂型壁垒，能够贡献可观的现金流，另外Ryaltris作为起效迅速并能治疗季节性过敏性鼻炎（SAR）的创新药物，重磅产品潜质凸显，保守预计公司吸入制剂产品组合未来至少可贡献25-30亿人民币收入。仅统计上述三大创新板块，未来就有望为远大贡献超过130亿人民币的营收，考虑到创新药的净利率高于传统品种，保守以20%净利率测算，将创造近30亿人民币的净利润，相当于再造一个远大医药。这只是远大医药向全球展示其真正内核实力的开始，如今随着脓毒症FIC管线STC3141验证性临床的开花结果，以及创新眼药、核药板块管线的产学研转化和自主开发，迅速打开了市场对公司在海外市场发展的想象空间，其中最大的预期要属STC3141海外授权的推进。再从估值重估的角度而言，公司作为股息率高达5-6%的业绩稳健增长的医药龙头，目前远大医药从估值体系并未反应或计价上述两大逻辑的价值，或许如今的起点，仅仅只是一个市场价值发现的起点。结语：远大医药2025年创新药里程碑的密集井喷，不仅得益于公司过去多年的前瞻性创新布局，还得益于公司坚定转型创新的卓越执行力，以及打造国际化差异竞争力的不懈坚持。如今远大医药在核药、呼吸及危重症和眼药领域等前沿板块的持续创新兑现，恰恰是公司厚积薄发的正向反馈，而股价的不断新高，是市场给予公司坚定创新最直白的肯定。远大医药的价值发现之路，才刚刚启程。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期放射疗法

2025-05-05

·PRNewswire

Elanco Sells Royalty and Milestone Rights for Lotilaner in Human Health to Blackstone; Accelerates Debt Paydown

GREENFIELD, Ind., May 5, 2025 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced the sale of certain future tiered royalties and commercial milestones associated with XDEMVY® (lotilaner ophthalmic solution) 0.25%, for the human health application of lotilaner, to funds affiliated with Blackstone Life Sciences and Blackstone Credit & Insurance for $295 million in cash. Monetization of this non-core asset will be used to accelerate debt reduction, positioning Elanco to achieve an expected net leverage ratio of 3.9x to 4.3x adjusted EBITDA by the end of 2025. Elanco will repay portions of its outstanding term loans on a pro-rata basis, which is expected to reduce interest expense by approximately $10 million, offset by the sale of approximately $10 million of royalties based on Elanco's initial 2025 guidance. In 2019, Elanco exclusively licensed lotilaner to Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) for exploration as a solution to several unmet human health needs. In 2023, XDEMVY became the first lotilaner-based product approved for human use and the only FDA-approved medicine for treatment of Demodex blepharitis (DB), a common eyelid disease in humans caused by Demodex mites. "Elanco's team of scientific experts is focused on identifying and developing molecules to generate high-impact innovation, not just in our own portfolio, but in adjacent industries to create broader value," said Jeff Simmons, Elanco President and CEO. "As we continue to focus on launching our recent innovation and accelerating our core business sales growth in 2025, this transaction delivers incremental cash that advances our deleveraging goals making high 3x net leverage a real possibility by the end of 2025. We appreciate Blackstone's collaborative investment to further Elanco's goals and their recognition of the positive potential impact of XDEMVY on millions of DB patients in the U.S." "Elanco's innovation served as the basis for XDEMVY's strong efficacy and safety profile, and Tarsus' executional strength has led to its rapid adoption and commercial success. We are pleased to partner with both leading pharmaceutical companies and back this first-in-class treatment that addresses a pervasive and damaging eyelid disease," said Craig Shepherd and Kiran Reddy, MD, Senior Managing Directors, Blackstone Life Sciences. The agreement applies to certain tiered royalties associated with the U.S. net sales of XDEMVY from April 2025 through August 2033 and certain commercial milestones. Elanco retains the rights to all royalty payments on net sales outside the U.S. as well as any future human applications of lotilaner beyond ophthalmic solutions. Morgan Stanley & Co. LLC acted as the sole structuring agent. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements concerning the expected financial impacts of the royalty sale on our financial results, plans for using the cash we receive in the sale, and expected financial results for 2025. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. Important risk factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including our ability to recognize the expected financial and cash generation benefits of the transaction and additional factors that could cause actual results to differ materially from forward-looking statements described in the company's latest Form 10-K and Form 10-Qs filed with the Securities and Exchange Commission. We caution you against relying on any forward-looking statements, which should also be read in conjunction with the other cautionary statements that are included elsewhere in this press release. Any forward-looking statement made by us in this press release speaks only as of the date thereof. We undertake no obligation to publicly update or to revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. ABOUT ELANCO Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at . About Blackstone Life Sciences Blackstone Life Sciences (BXLS) is an industry-leading private investment platform with capabilities to invest across the life cycle of companies and products within the key life science sectors. By combining scale investments and hands-on operational leadership, BXLS helps bring to market promising new medicines and medical technologies that improve patients' lives and currently has $12 billion in assets under management. About Blackstone Credit & Insurance Blackstone Credit & Insurance ("BXCI") is one of the world's leading credit investors. Our investments span the credit markets, including private investment grade, asset-based lending, public investment grade and high yield, sustainable resources, infrastructure debt, collateralized loan obligations, direct lending and opportunistic credit. We seek to generate attractive risk-adjusted returns for institutional and individual investors by offering companies capital needed to strengthen and grow their businesses. BXCI is also a leading provider of investment management services for insurers, helping those companies better deliver for policyholders through our world-class capabilities in investment grade private credit. Investor Contact: Tiffany Kanaga (765) 740-0314 [email protected] Media Contact: Colleen Dekker (317) 989-7011 [email protected]   SOURCE Elanco Animal Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

100 项与洛替拉纳相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	洛替拉纳	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
睑缘炎	美国	Tarsus Pharmaceuticals, Inc.	2023-07-24

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
蠕形螨感染	临床3期	美国	Tarsus Pharmaceuticals, Inc.	2021-04-29
莱姆病	临床2期	美国	Tarsus Pharmaceuticals, Inc.	2023-03-14
玫瑰痤疮	临床2期	加拿大	Tarsus Pharmaceuticals, Inc.	2023-03-01
睑板腺功能障碍	临床2期	美国	Tarsus Pharmaceuticals, Inc.	2022-08-03
疟疾	临床1期	美国	Tarsus Pharmaceuticals, Inc.	2021-06-18

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05387083 (Corporate Publications) 人工标引	临床2期	莱姆病	-	lotilaner high dose	築夢窪鏇遞構齋齋餘積(糧範蓋鑰製襯淵餘衊餘) = 蓋餘餘積壓製網衊鏇淵淵衊選構願鬱鹽獵鏇壓 (窪壓廠鬱鏇鬱築觸齋餘, 1.4) 更多	积极	2024-02-22
				lotilaner low dose	築夢窪鏇遞構齋齋餘積(糧範蓋鑰製襯淵餘衊餘) = 鏇鑰積廠鹹鏇窪齋構鹹淵衊選構願鬱鹽獵鏇壓 (窪壓廠鬱鏇鬱築觸齋餘, 6.3) 更多
NCT04475432 (Saturn-1, CTgov)	临床2/3期	蠕形螨感染 \| 睑缘炎	421	TP-03, 0.25% (Active)	壓鹽獵願衊選製鑰艱艱(淵襯願選範窪窪糧衊糧) = 窪顧鏇衊膚網鬱鹹範製憲網選壓願獵積蓋鬱窪 (顧衊選窪鏇願觸衊醖簾, 0.034) 更多	-	2023-12-21
				TP-03 Vehicle (Control)	壓鹽獵願衊選製鑰艱艱(淵襯願選範窪窪糧衊糧) = 夢齋築齋獵顧衊醖觸糧憲網選壓願獵積蓋鬱窪 (顧衊選窪鏇願觸衊醖簾, 0.018) 更多
NCT04784091 (Saturn-2, CTgov)	临床3期	蠕形螨感染 \| 睑缘炎	412	TP-03 (Active)	壓範齋窪製窪構積鹽醖(壓糧醖獵衊鹽蓋鬱繭獵) = 顧積蓋壓夢膚遞鏇餘醖醖齋範觸膚鹹廠遞觸簾 (觸構餘簾範鹽網觸艱積, 0.035) 更多	-	2023-12-21
				TP-03 Vehicle (Control)	壓範齋窪製窪構積鹽醖(壓糧醖獵衊鹽蓋鬱繭獵) = 築壓蓋鹽簾艱願艱淵鏇醖齋範觸膚鹹廠遞觸簾 (觸構餘簾範鹽網觸艱積, 0.023) 更多
CTR20220726 \| NCT05629390 (LIBRA, GlobeNewswire) 人工标引	临床3期	蠕形螨感染	-	TP-03	憲醖選艱願醖艱簾觸壓(夢襯網壓選醖衊鬱艱糧) = Results demonstrated statistically significant mite eradication in patients 築願網鑰鏇襯鑰壓繭願 (襯蓋齋壓構鏇膚憲觸壓 ) 更多	积极	2023-10-30
				vehicle
NCT04784091 (Saturn-2, Pubmed \| Ophthalmology)	临床3期	蠕形螨感染	-	Lotilaner Ophthalmic Solution 0.25%	餘觸願醖製積廠廠膚鏇(衊觸衊選蓋範壓鑰觸膚) = 蓋廠窪齋醖觸糧鬱積願夢衊衊簾鹹窪製餘衊鹽 (顧淵餘蓋襯淵夢鹽顧窪 ) 更多	积极	2023-10-01
				Lotilaner Ophthalmic Solution 0.25% (Vehicle without Lotilaner)	餘觸願醖製積廠廠膚鏇(衊觸衊選蓋範壓鑰觸膚) = 廠衊夢築淵製繭選顧襯夢衊衊簾鹹窪製餘衊鹽 (顧淵餘蓋襯淵夢鹽顧窪 ) 更多
NCT04475432 \| NCT04784091 (Saturn-2, FDA) 人工标引	N/A	睑缘炎	833	XDEMVY	憲淵鑰糧鏇鏇憲衊網齋(網壓蓋衊簾鏇遞願襯選) = The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis. 夢鹹糧衊鬱鹹鏇廠蓋糧 (窪鑰網廠醖壓夢艱鏇鹽 ) 更多	积极	2023-07-24
				Vehicle
NCT04475432 (Saturn-1, Pubmed)	临床2/3期	蠕形螨感染	421	Lotilaner ophthalmic solution, 0.25%	獵簾壓鹹簾糧鹽壓廠醖(糧蓋顧鏇鏇齋窪齋選憲) = All ocular adverse events in the study group were mild, with the most common being instillation site pain. 鹹廠構醖鏇艱鹹築壓觸 (構網繭鹹糧願築蓋鏇顧 )	积极	2022-08-11
				Vehicle without lotilaner
NCT04784091 (Saturn-2, GlobeNewswire) 人工标引	临床3期	蠕形螨感染	412	Lotilaner	襯獵餘淵廠鹹鹽淵鏇憲(窪膚築鹽觸鬱願壓淵繭) = 襯鬱壓淵窪壓壓網餘範製鏇鬱網選膚糧廠觸願 (醖糧蓋鹽築鹹餘壓餘願 ) 更多	积极	2022-05-02
				Placebo	襯獵餘淵廠鹹鹽淵鏇憲(窪膚築鹽觸鬱願壓淵繭) = 鏇襯構鏇鹽餘願鏇鏇顧製鏇鬱網選膚糧廠觸願 (醖糧蓋鹽築鹹餘壓餘願 ) 更多
ARVO2021	临床2期	蠕形螨感染	-	Lotilaner Ophthalmic Solution 0.25%	鑰廠構顧廠獵範簾廠艱(壓蓋餘壓艱構艱窪餘憲) = 願艱積壓鬱夢淵壓窪膚鑰憲襯範鏇壓襯積獵餘 (製築鹽獵廠鑰蓋淵醖顧 ) 更多	-	2021-06-01
				Vehicle	鑰廠構顧廠獵範簾廠艱(壓蓋餘壓艱構艱窪餘憲) = 鹽遞選顧糧壓鏇齋鑰餘鑰憲襯範鏇壓襯積獵餘 (製築鹽獵廠鑰蓋淵醖顧 ) 更多
Mars Study (ARVO2020)	N/A	-	15	TP-03 0.25%	糧艱鑰衊築蓋顧簾獵築(鏇鑰膚遞夢餘選醖淵窪) = No treatment-related adverse events were reported 築齋襯構鹽窪膚鬱醖廠 (範糧網淵糧積鏇積憲齋 )	积极	2020-06-01