A Phase 2a Randomized, Dose Ranging, Double-Blind, 3-Arm Study to Investigate Orally Administered Abrocitinib Compared With Placebo in Non-Hospitalized Symptomatic Adult Participants With Severe Fatigue From Post COVID Condition

The primary purpose of this study is to compare the efficacy of abrocitinib to placebo in improving severe fatigue in non-hospitalized adults with symptomatic Post-COVID Condition (PCC). We are also interested in learning if abrocitinib is effective in improving overall health status in this cohort. Eligible participants with a confirmed diagnosis of PCC and FACIT-Fatigue score meeting inclusion will be randomized (1:1:1) to receive abrocitinib at a dose of 50 mg, 100 mg, or placebo orally once daily for 12 weeks (84 days). Participants will be randomly assigned to study intervention. Approximately 90 participants will be randomized into the study. Participants will be screened within 28 days (4 weeks) before randomization. Eligible participants will receive abrocitinib or placebo orally every day for 12 weeks (84 days). The total study duration is up to 20 weeks with study intervention Day 1 through Day 84 (12 weeks). There will be 6 study visits and study procedures include a discussion about the individual&#39;s medication and medical history, blood draws, nasal swab, skin swabs if indicated, urine sample collection, and answering questionnaires weekly and during study visits.

开始日期2024-12-27

申办/合作机构

Beth Israel Deaconess Medical Center, Inc.

[+1]

NCT06573593 / RecruitingN/AIIT

Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study

The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.

开始日期2024-07-29

申办/合作机构

浙江大学医学院附属第二医院

NCT06283550 / Not yet recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.

开始日期2024-04-01

申办/合作机构

Innovaderm Research, Inc.

100 项与阿布昔替尼相关的临床结果

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100 项与阿布昔替尼相关的转化医学

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100 项与阿布昔替尼相关的专利（医药）

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262

项与阿布昔替尼相关的文献（医药）

2024-12-31·JOURNAL OF MEDICAL ECONOMICS

Short- and long-term cost-effectiveness of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis in China

Article

作者: Guan, Haijing ; Shi, Yin ; Zhou, Yanwu ; Li, Shuishi ; Liu, Shao

BACKGROUNDS:

Biologics and JAK inhibitors were the most effective innovative systemic treatments for moderate-to-severe atopic dermatitis (AD). However, their cost-effectiveness in China remains unclear. This study aims to compare both the short- and long-term cost-effectiveness of abrocitinib and dupilumab in adults with moderate-to-severe AD from the perspective of the Chinese healthcare system.

METHODS:

A hybrid decision tree and Markov model were developed to simulate the costs and health outcomes of interventions on both short-term and long-term horizons. Short- and long-term horizons were employed to reflect the 26-week induction treatment and model the extended 10-year maintenance treatment period, respectively. The cost-effectiveness of strategies was measured by incremental cost-effectiveness ratios (ICERs), which were then compared with the willingness-to-pay threshold (WTP) that was equivalent to the gross domestic product (GDP) per capita of China in 2023 ($12,681 [€11679.26]). One-way and probabilistic sensitivity analyses were conducted to validate the robustness of the model.

RESULTS:

Over the short-term horizon, the QALYs (quality-adjusted life years) gained were 0.43 for the abrocitinib group and 0.42 for the dupilumab group, with the costs being $2,716.01 (€2501.46) and $3,940.33 (€3629.06), respectively. Over the long-time horizon, abrocitinib therapy yields higher QALYs (6.60 versus 6.53) and incurs a lower cost ($22,765.15 [€20966.81] versus $30,683.38 [€28259.54]) compared to dupilumab. The probability of abrocitinib being cost-effective was nearly 100% under the current WTP. Both short- and long-term results showed that abrocitinib was more effective and less costly than dupilumab, making abrocitinib the dominant option.

CONCLUSIONS:

Abrocitinib was dominant compared to dupilumab both over the short- and long-term horizon for moderate-to-severe AD in China. Future research incorporating real-world evidence and long-term efficacy outcomes could further refine these economic evaluations.

2024-12-31·The Journal of dermatological treatment

Oral abrocitinib in the treatment of granuloma annulare: a case report

Article

作者: Chen, Weifeng ; Tian, Xin ; Zhu, Junhui ; Yu, Yihui ; Liang, Jingyao ; Zhang, Xibao ; Liu, Wenyan

Aim: To evaluate the therapeutic efficacy and safety of JAK inhibitor abrocitinib in patients with localized granuloma annulare (GA) and to review the available cases documented in English.Methods: We presented a patient who had a persistent, localized granuloma anulare (GA) for one year and did not respond to traditional therapies. This patient was treated with oral abrocitinib at a dosage of 150 mg daily.Results: After 6 weeks of treatment with abrocitinib, the patient exhibited notable symptom improvement with no new lesions. No adverse events or recurrences were reported during the 5-month follow-up period.Conclusions: Abrocitinib may be a promising and safe treatment option for patients with localized GA who do not respond to traditional therapies.

2024-09-16·Dermatitis

Successful Treatment of Dupilumab-Induced Erythroderma with Abrocitinib: A Case Report.

Letter

作者: Lin, Kesheng ; Wu, Liming ; Shen, Weijie

157

项与阿布昔替尼相关的新闻（医药）

2024-09-19

·药智网

前有强敌，后有追兵！康诺亚司普奇拜单抗如何破局？

近日，康诺亚生物宣布其自主研发的1类新药司普奇拜单抗注射液正式获国家药品监督管理局批准上市，用于治疗成人中重度特应性皮炎。值得一提的是，司普奇拜单抗是国内首个、全球范围第二个申报并获批上市的IL-4Rα抗体药物，填补了国产特应性皮炎生物制剂领域的空白。前浪作为康诺亚首个获得监管批准上市的药物，司普奇拜单抗能否成功商业化至关重要。“打铁还需自身硬”，首先来看下司普奇拜单抗自身。从结构上看，与头号竞争对手度普利尤单抗相比，司普奇拜单抗具有全新的CDR序列，而CDR决定了抗体结合抗原的特异性。同样条件下，司普奇拜单抗能够完全阻断IL-4Rα与IL-4的结合，而度普利尤单抗仅能达到部分阻断的效果。疗效方面，已公布的司普奇拜单抗治疗中重度特应性皮炎的临床试验数据显示：16周时，司普奇拜单抗组达到EASI-75的受试者比例为66.9%，达到IGA评分为0/1分（IGA 0/1，即皮损完全清除或基本清除）且较基线下降≥2分的受试者比例为44.2%，均优于安慰剂组（分别为25.8%及16.1%）。52周时，司普奇拜单抗组和安慰剂转司普奇拜单抗组的EASI-75应答率分别为92.5%和88.7%；EASI-90应答率分别为77.1%和65.6%；IGA评分为0或1分且较基线下降≥2分的应答率分别为67.3%和64.2%；每日PP-NRS评分周平均值较基线降低≥4分的应答率分别为67.3%和60.5%。而已公布的度普利尤单抗治疗中国成人中重度特应性皮炎的3期临床试验数据显示：16周时，度普利尤单抗组达到EASI-75的受试者比例为57.3%，达到IGA评分达到0/1分且较基线下降≥2分的患者比例为26.8%。仅从16周数据来看，司普奇拜单抗疗效更加显著，而且司普奇拜单抗还提出了更高的治疗目标概念，开启EASI-90新时代。但由于并不是头对头研究，入组患者的情况等可能存在一定的区别，直接对比两项临床试验数据并不十分科学，有待进一步深入研究。临床使用上，司普奇拜单抗和度普利尤单抗均通过皮下注射给药，每两周给药一次。价格上，度普利尤单抗已进入国家医保，在医院终端的定价为300mg:2ml/支（预充式）2780.8元，200mg(1.14mL)*2支/盒（达必妥）价格为4077.52元。而司普奇拜单抗获批时间较晚，错过了今年医保谈判时间，但其价格并不算高，据悉300mg（2ml）/支（皮下注射）为2488元一盒（1支/盒），且有买二赠一优惠政策，折合一支1659元。若明年通过医保谈判进入国家医保，司普奇拜单抗有望在价格上占据明显优势。除了同靶点药物，司普奇拜单抗在中重度特应性皮炎治疗领域还面临其他新药的竞争，如辉瑞的阿布昔替尼和艾伯维的乌帕替尼。这两款药物均属于小分子JAK1抑制剂，其中阿布昔替尼于2022年4月被NMPA批准用于治疗难治性成人中重度特应性皮炎。乌帕替尼于2022年2月被NMPA批准用于治疗对其他系统治疗（如激素或生物制剂）应答不佳或不适宜上述治疗的成人和12岁及以上青少年的难治性、中重度特应性皮炎。这两款药物均通过口服给药，且均进入国家医保。值得一提的是，2024年4月，艾伯维宣布乌帕替尼VS度普利尤单抗治疗成人中重度特应性皮炎的一项开放标签IIIb/IIII期LEVEL UP研究达到主要终点：第16周时，乌帕替尼治疗中重度特应性皮炎的表现优于度普利尤单抗，达到了严重程度指数评分较基线至少改善90%（EASI 90）和最严重瘙痒数字评定量表（WP-NRS）评分0/1（完全或几乎完全瘙痒消退）的主要终点。整体来看，司普奇拜单抗要想在中重度特应性皮炎领域站稳一席之地，势必要与上述几款新药展开激烈竞争，而要想从竞争中胜出，可以在价格和疗效上宣传上多下功夫。后浪除了上述已上市药物，司普奇拜单抗在中重度特应性皮炎领域还有很多后继竞争者，详见下表。表1 国内部分在研治疗中重度特应性皮炎（AD）新药数据来源：公开资料整理恒瑞医药的JAK1抑制剂艾玛昔替尼进展较快，其用于治疗对局部外用治疗或其他系统性治疗应答不充分或不耐受的成人和12岁及以上青少年中度至重度特应性皮炎的新适应症上市申请于2023年11月获CDE受理。艾玛昔替尼是我国首个自主研发的新一代高选择性JAK1抑制剂，对JAK1的选择性是对JAK2的16倍。因其对JAK2的抑制性极低，也能尽量降低发生中性粒细胞减少症与贫血的风险。 ICP-332是诺诚健华研发的一款高效、高选择性的新型口服TYK2抑制剂。目前全球还无TYK2抑制剂获批治疗特应性皮炎，ICP-332是高选择性TYK2抑制剂在特应性皮炎领域进展最快的新药。来金珠单抗(lebrikizumab)是Almirall和礼来联合开发的一款IL-13靶向单抗，目前已在欧盟、日本和美国被批准用于治疗成人和12岁及以上中重度特应性皮炎。目前，Amlitelimab治疗中重度特应性皮炎的II期STREAM-AD研究已达到主要终点。近日，该药在国内针对12岁及以上中重度特应性皮炎患者的3期临床试验启动。商业化做足准备纵观各大Biotech商业化之战，几乎各有打法，其中有些Biotech在自研产品获批之前就提早布局商业化，通过授权引进产品以获中国区商业化权益来“练手”，从而更好赋能后续自研产品的商业化。有些Biotech针对不同产品建立独立销售团队，以更精准且专业化抵达终点。而更多的Biotech则把眼光放至合作。对于Biotech公司，搭建一个销售渠道并不是易事，况且新药研发超级烧钱，大多Biotech公司没有充足的资金来组织自己的销售团队。康诺亚在司普奇拜单抗商业化上选择了部分合作：2021年3月，康诺亚与石药集团达成合作，将司普奇拜单抗在中国地区（不包括港澳台）针对中重度哮喘和慢性阻塞性肺病等呼吸系统疾病的开发和商业化权益授权给石药集团。据协议，石药集团将支付7000万元首付款及1亿元的开发里程碑付款。司普奇拜单抗首个获批的适应症是特应性皮炎，其商业化权利还在康诺亚手中。为了快速推进产品商业化，康诺亚已经快速搭建起了商业化核心团队，预计到2024年底规模有望突破250人。此外，康诺亚在司普奇拜单抗生产方面也做了准备，据悉公司已拥有18600升的产能。结语作为康诺亚首个获批上市的药物，司普奇拜单抗肩负重任，未来能否率先在中重度特应性皮炎领域站稳脚跟？值得期待。参考来源： 1.《2024 AAD︱恒瑞自免1类创新药艾玛昔替尼治疗中重度特应性皮炎Ⅲ期研究亮相口头报告》.恒瑞医药.2024年03月11日 2.《世界AD日|特应性皮炎领域百花齐放，首个中国自主原研的高选择性JAK1抑制剂绽放光芒》.优麦会讯.2024年09月14日 3.《2周见效，效果持续一年！礼来创新湿疹疗法获FDA批准》.药明康德.2024年09月14日声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 白娇姣转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

临床结果上市批准临床3期临床2期

2024-09-09

·BioSpace

The Highly Anticipated FDA Approvals of Galderma’s Nemolizumab and Eli Lilly’s Lebrikizumab are Expected to Shift Dermatologists’ Perceptions of the Atopic Dermatitis Market

While reported use of Sanofi/Regeneron’s Dupixent has declined with the adoption of LEO’s Adbry, Pfizer’s Cibinqo, and AbbVie’s Rinvoq, the overall population receiving advanced treatments is on the rise, according to Spherix Global Insights. EXTON, PA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Since its 2017 debut as the first advanced systemic treatment for atopic dermatitis (AD), Sanofi/Regeneron’s Dupixent has dominated the US market. However, the introduction of LEO Pharma’s Adbry, Pfizer’s Cibinqo, and AbbVie’s Rinvoq has started to disrupt the treatment landscape. While Dupixent still holds the highest market share by a significant margin, its dominance is gradually diminishing with the rising adoption of these newer treatments and is expected to continue declining as additional therapies emerge. Spherix Global Insights has been closely monitoring the AD market since before Dupixent’s launch, providing quarterly updates through the RealTime Dynamix™ service. The latest quarterly results indicate that despite a mixed initial reception, Adbry has significantly grown and now competes closely with Rinvoq, whose usage has plateaued since 2022. Despite the evolution of the treatment landscape, results from the study also reveal dermatologist (n=105) estimates of the adult population receiving advanced systemic treatments have grown over the past two years, now capturing two-fifths of adult atopic dermatitis patients. This growth highlights the increasing demand for effective AD treatments and underscores the need for new options in the market. With a growing pipeline and increased competition, manufacturers will need to differentiate their assets. According to Spherix’s latest quarterly report, specific efficacy attributes including itch reduction as well as mechanism of action are considered key differentiators, both of which Galderma’s nemolizumab brings to the market. Further, physicians report the highest unmet needs for patients on a second-line advanced systemic and those with severe itch, two patient types manufacturers are keen to capture. The potential approvals of Galderma’s nemolizumab and Eli Lilly’s lebrikizumab are poised to further shift physician perceptions. Preference for the IL-13 mechanism has been steadily declining over the past few years in favor of the IL-31 mechanism, now on par with JAK inhibitors. As such, the percentage of dermatologists that prefer nemolizumab to gain FDA approval is more than double that of lebrikizumab, however, dermatologists are anticipating adopting both therapies at the expense of Dupixent. Of note, the potential adoption of nemolizumab is further supported by the anticipated prescriber experience from nemolizumab’s recent approval for prurigo nodularis , a skin condition characterized by chronic itch. Spherix Global Insights remains dedicated to tracking these developments, offering critical insights into the evolving atopic dermatitis market and guiding stakeholders through the shifting treatment landscape. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix’s unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit  spherixglobalinsights.com  or connect through  LinkedIn .  For more details on Spherix’s primary market research reports and interactive dashboard offerings, visit or register here:  NOTICE : All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement. CONTACT: Gianna Melendez, Dermatology Franchise Head Spherix Global Insights 4848794284 gianna.melendez@spherixglobalinsights.com

上市批准

2024-09-06

·精准药物

恒瑞盯上400亿斑秃市场：JAK1抑制剂艾玛昔替尼

近日，恒瑞医药的硫酸艾玛昔替尼片的新适应症上市申请获CDE受理，用于成人重度斑秃患者。关于艾玛昔替尼艾玛昔替尼是2代JAK抑制剂，可通过抑制JAK1信号传导发挥抗炎和抑制免疫的生物学效应；该药物具有高选择性、高效和延长的血浆半衰期的特点，这样优化的特性旨在提供更大的治疗窗。 2018年1月，恒瑞医药与Arcutis公司达成协议，将用于治疗免疫系统疾病的艾玛昔替尼项目有偿许可给后者；Arcutis获得艾玛昔替尼在美国、欧盟和日本的独家临床开发、注册和市场销售的权利。恒瑞医药最多可获得共2.23亿美元的首付款和里程碑款，外加销售提成。目前，艾玛昔替尼已开展了包括溃疡性结肠炎、银屑病关节炎等多领域的临床研究，绝大多数已进入III期临床试验。其中，在特应性皮炎、强直性脊柱炎、类风湿性关节炎适应症上，均已提交上市申请。 2024年6月，一项在成人重度斑秃患者中评价硫酸艾玛昔替尼片的有效性和安全性的随机、双盲和安慰剂对照III期研究显示，在8mg和4mg两个剂量组，艾玛昔替尼在主要终点上均显著优于安慰剂组，且在成人重度斑秃患者中长期治疗的安全性、有效性良好，与其他JAK1抑制剂相比未发现新的安全性信号。关于JAK抑制剂 Janus 激酶（JAK）家族是一类与细胞因子受体组成性相关的非受体酪氨酸激酶家族，包括JAK1、JAK2、JAK3和TYK2四个成员。JAK是多种细胞因子、干扰素等的重要信号传感器，当细胞因子和细胞表面受体结合后导致构象改变，激活JAK使其跨膜磷酸化，进而磷酸化下游信号传导及转录激活因子（STAT），使其由单体形成二聚体（pSTAT）。pSTAT转入细胞核内后，与特定的启动子结合，增加基因表达。 JAK 抑制剂作为可选择性抑制JAK激酶的药物，能够调控炎性因子的信号传导通路，从而发挥抗炎和免疫调节的作用，治疗自身免疫性疾病。目前全球已有多款JAK抑制剂获批上市，市场规模持续增长，主要产品包括诺华/Incyte 的芦可替尼、辉瑞的托法替布、礼来的巴瑞替尼和艾伯维的乌帕替尼。中国JAK 抑制剂市场起步较晚，2017 年芦可替尼、托法替布在中国获批，2019 年巴瑞替尼在中国获批；2024年6月，迪哲医药的戈利昔替尼获NMPA批准上市，用于既往至少接受过一线系统性治疗的复发或难治的外周T细胞淋巴瘤（r/r PTCL）成人患者，成为用于淋巴瘤领域全球首个且唯一高选择性JAK1抑制剂。据不完全统计，目前国内在研的JAK药物约百余种，将处于III期以上阶段的药物统计如下： 2022 年以来多款新型JAK 抑制剂产品（乌帕替尼、阿布昔替尼、氘可来昔替尼、利特昔替尼）密集获批上市，市场有望迎来加速增长，弗罗斯特沙利文预计中国JAK1 抑制剂市场有望在2030 年增长至481 亿元。关于斑秃斑秃（AA）是一种典型的自身免疫性疾病，通常认为是由于单核细胞介导的炎症环境中，Tc细胞（细胞毒性T细胞）分泌细胞因子或是直接杀伤导致毛囊细胞受到破坏。斑秃根据严重程度不同在临床上可分为斑片型、网状型、带状型、中央型型、弥漫型、全秃以及普秃。其中斑片型症状最轻且易于恢复，全秃为所有头发脱落，而最严重的普秃则是全身毛发均脱落。约半数患者反复发作，可迁延数年或数十年。斑秃的全球患病率约为千分之一，终生患病风险为2%；据发表于《国际皮肤性病学杂志》上的文章数据，全球大约有1.47亿斑秃患者。流行病学研究显示，我国斑秃的患病率为0.27%；据弗罗斯特沙利文测算，2020 年中国约有381.2 万斑秃患者，预计到2030 年患者人数将达到464.9万人。斑秃治疗方式包括一般治疗、局部治疗以及系统治疗。局部治疗方式包括糖皮质激素、局部免疫疗法、米诺地尔、钙调磷酸酶抑制剂以及前列腺素类似物等。系统治疗方面，首推系统性糖皮质激素治疗，免疫抑制剂如环孢素等可作为非一线用药使用。据《中国斑秃诊疗指南(2019)》，针对斑秃的临床疗法主要分为局部治疗和系统治疗，治疗手段主要为糖皮质激素和广谱免疫抑制剂，缺乏切实有效的靶向药物，整体疗效不佳。从JAK类药物的发展来看，最先被应用的是真菌提取物托法替布，随后是在托法替布基础上发明的芦可替尼，以及结构与芦可替尼类似的巴瑞替尼等。治疗斑秃方面，仅有的上市药物为巴瑞替尼与利特昔替尼。除艾玛昔替尼外，泽璟制药的杰克替尼（吉卡昔替尼）针对斑秃已于2024年6 月达到III 期主要临床终点；艾伯维的乌帕替尼处于3期临床。据统计，2021年斑秃的全球市场规模达到了71亿美元。据弗若斯特沙利文，中国脱发市场规模预计在2026年将达到412亿元，年均复合增长率接近12%。关于恒瑞医药上月，恒瑞医药发布2024年上半年业绩：公司实现营业收入136.01亿元，同比增长21.78%；其中，创新药收入达到66.12亿元，同比增长33.25%，对外许可收入1.6亿欧元。2024H1，归属于上市公司股东的净利润34.32亿元，同比增长48.67%；归属于上市公司股东的扣除非经常性损益的净利润34.90亿元，同比增长55.58%。自2021年集采开始落地以来，公司营收半年报从未超过2021年的高点133亿；本次出色的业绩说明公司终于走出了集采的影响，重新进入业绩高增通道。公司不断完善已建立成熟的化药（含多肽、PROTAC）、单/双抗体药、ADC 药物、小核酸、核药、多特异性抗体、双抗ADC 平台等技术平台，初步建成PDC、AOC、DAC、mRNA 等新分子模式平台，并不断开拓结构生物学、AI 药物研发等平台。目前共计18 个创新药产品及适应症已处于NDA 阶段，在研ADC 管线超10 款。公司报告期内研发管线进展情况（2024 年1 月1 日至2024 年7 月31 日）此外，公司创新药出海取得成效，成为业绩增长的第二引擎。据统计，截至目前恒瑞医药一共对外授权了11个创新药项目，出海总金额103.5亿美元，首付款金额为3.15亿美元。参考资料 1、公司官网 2、国泰君安证券、中信建投、开源证券 3、猎药人俱乐部药物筛选中心（暨南大学）对外提供新药筛选服务声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

上市批准临床3期引进/卖出

100 项与阿布昔替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11400	阿布昔替尼	D11AH	DB14973

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
特应性皮炎	英国	Pfizer Inc.	2021-09-08

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
湿疹	临床3期	美国	Pfizer Inc.	2018-06-11
湿疹	临床3期	中国	Pfizer Inc.	2018-06-11
湿疹	临床3期	阿根廷	Pfizer Inc.	2018-06-11
湿疹	临床3期	比利时	Pfizer Inc.	2018-06-11
湿疹	临床3期	巴西	Pfizer Inc.	2018-06-11
湿疹	临床3期	保加利亚	Pfizer Inc.	2018-06-11
湿疹	临床3期	加拿大	Pfizer Inc.	2018-06-11
湿疹	临床3期	智利	Pfizer Inc.	2018-06-11
湿疹	临床3期	德国	Pfizer Inc.	2018-06-11
湿疹	临床3期	以色列	Pfizer Inc.	2018-06-11

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临床结果

适应症

分期

评价

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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


NCT05375929 (CTgov)	临床3期	特应性皮炎	200	Abrocitinib 200 mg (Abrocitinib 200 mg)	鏇築窪膚餘憲遞獵願構(廠窪鹽鬱襯鬱憲餘遞範) = 繭獵艱鏇廠選鹽願積艱鬱齋醖選願簾願繭醖鬱 (壓廠積構積夢醖觸築鏇, 鬱醖憲觸齋蓋製鏇鬱衊 ~ 願網選鏇壓膚鑰鹽願鹹) 更多	-	2024-09-19
				Abrocitinib 100 mg (Abrocitinib 100 mg)	鏇築窪膚餘憲遞獵願構(廠窪鹽鬱襯鬱憲餘遞範) = 願構蓋膚獵鏇夢醖餘範鬱齋醖選願簾願繭醖鬱 (壓廠積構積夢醖觸築鏇, 衊廠艱壓構鹽窪齋願壓 ~ 襯網餘憲壓繭醖廠憲壓) 更多
JADE MONO-1, MONO-2, COMPARE, TEEN, psoriasis trial, REGIMEN (Pubmed)	临床3期	特应性皮炎	453	Abrocitinib 100 mg	憲範遞繭壓鹽願鏇艱積(願選夢構夢選願簾襯鏇) = 築鑰製衊齋醖齋廠襯鹹淵淵齋廠窪範膚醖膚憲 (網簾積選網觸繭遞鹽淵 ) 更多	积极	2024-06-19
NCT05038982 (Pubmed)	临床2期	结节性痒疹 \| 瘙痒	25	Abrocitinib 200 mg	憲顧願積醖餘網築積夢(繭夢醖憲廠齋鏇膚範顧) = 範糧範觸醖簾壓鹽遞餘範顧獵顧願鬱簾觸窪構 (夢簾鹽選襯觸醖醖餘窪, -118.5 ~ -38.1) 更多	积极	2024-06-05
				Placebo	憲顧願積醖餘網築積夢(繭夢醖憲廠齋鏇膚範顧) = 遞觸膚獵衊築襯齋鹽繭範顧獵顧願鬱簾觸窪構 (夢簾鹽選襯觸醖醖餘窪, -98.8 ~ -8.6) 更多
NCT05067439 (CTgov)	临床1期	-	26	Omeprazole+Efavirenz+Caffeine (Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg)	繭選憲鑰願壓願鬱淵鏇(淵鏇鬱網選糧襯糧廠鹹) = 獵選憲觸齋鬱遞齋簾顧糧壓鹹選願襯遞顧積積 (餘簾築齋鏇製鹹窪簾淵, 鑰鬱顧範襯製鏇鬱製艱 ~ 積鹹鏇繭壓願網艱選糧) 更多	-	2024-05-31
				Omeprazole+Efavirenz+Abrocitinib+Caffeine (Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg)	繭選憲鑰願壓願鬱淵鏇(淵鏇鬱網選糧襯糧廠鹹) = 糧齋憲廠夢鏇廠淵顧淵糧壓鹹選願襯遞顧積積 (餘簾築齋鏇製鹹窪簾淵, 選廠繭憲觸鬱鏇獵範鹹 ~ 膚窪膚廠遞觸築繭壓艱) 更多
NCT03575871 \| NCT03422822 \| NCT03349060 \| NCT02780167 \| NCT03720470 (Pubmed \| Skin Health Dis) 人工标引	临床2/3期	特应性皮炎	-	Abrocitinib 100 mg	廠壓襯繭夢觸鏇襯遞醖(顧餘蓋鑰膚艱鹽簾襯夢) = 遞襯衊廠窪簾餘醖構膚憲膚糧鹹糧範獵齋憲膚 (鬱選繭窪構齋簾壓顧齋 ) 更多	积极	2024-05-05
				Abrocitinib 200 mg	廠壓襯繭夢觸鏇襯遞醖(顧餘蓋鑰膚艱鹽簾襯夢) = 膚鬱製獵糧糧築範鬱鹹憲膚糧鹹糧範獵齋憲膚 (鬱選繭窪構齋簾壓顧齋 ) 更多
NCT04345367 (JADE DARE, EADV2023)	临床3期	特应性皮炎	727	Abrocitinib 200 mg	廠顧夢醖觸構餘顧選壓(獵範衊鏇網夢膚範衊鏇) = For the most stringent EASI categories ( EASI 90-99 and EASI-100 ) , and at all 3 visits, this effect was more pronounced with abrocitinib than with dupilumab 醖築齋壓築壓糧醖夢鑰 (顧鹹築鏇繭糧觸鏇範蓋 )	-	2023-10-11
				Dupilumab 300 mg
NCT03422822 (JADE EXTEND, EADV2023)	临床3期	特应性皮炎	-	Abrocitinib 200 mg	鹹艱顧夢艱願鑰獵繭窪(憲遞鹹膚鏇餘艱糧願齋) = 築夢餘簾鹽艱願積顧鹽憲壓廠範積選夢選淵鑰 (膚鬱繭蓋鹹糧醖憲醖鬱 )	积极	2023-10-11
				Abrocitinib 100 mg	鹹艱顧夢艱願鑰獵繭窪(憲遞鹹膚鏇餘艱糧願齋) = 範選醖鬱糧範醖廠淵構憲壓廠範積選夢選淵鑰 (膚鬱繭蓋鹹糧醖憲醖鬱 )
NCT03915496 (JADE MOA, EADV2023)	临床2期	特应性皮炎 IL-6 \| IFNGR1/2 \| MX1 ... 更多	46	Abrocitinib 200 mg	願範鏇鬱網窪憲鏇網選(鏇醖繭憲選壓鹽製鏇鹹) = 壓顧製網積淵衊夢構壓蓋網糧鏇壓鏇網製膚憲 (築網艱鏇壓顧夢鬱壓鹹 )	-	2023-10-11
				Abrocitinib 100 mg	願範鏇鬱網窪憲鏇網選(鏇醖繭憲選壓鹽製鏇鹹) = 襯窪壓範製齋鬱鏇壓觸蓋網糧鏇壓鏇網製膚憲 (築網艱鏇壓顧夢鬱壓鹹 )
JADE (EADV2023)	临床3期	瘙痒 \| 特应性皮炎	875	Abrocitinib 200 mg	壓簾繭簾膚鏇製壓醖繭(齋觸窪選艱遞憲製鏇艱) = 鏇淵築繭膚製積構鏇壓齋鬱構蓋廠獵蓋膚艱遞 (蓋構鏇範餘構衊選觸淵 ) 更多	-	2023-10-11
				Dupilumab 300 mg	壓簾繭簾膚鏇製壓醖繭(齋觸窪選艱遞憲製鏇艱) = 顧獵鬱鏇夢憲願鏇遞餘齋鬱構蓋廠獵蓋膚艱遞 (蓋構鏇範餘構衊選觸淵 ) 更多
JADE Clinical Trial Program (EADV2023)	临床2/3期	-	1,384	Hormone replacement therapies (HRT)	襯鬱壓夢衊鹹襯顧鹽築(鑰製齋顧獵顧窪襯廠廠) = 構壓糧壓願夢衊構淵蓋鹽選願觸夢廠淵鹽遞夢 (積夢鏇顧網鬱遞觸鑰鬱 )	-	2023-10-11