A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome

The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified classification criteria according to Kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the VAS scale greater than or equal to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.

开始日期2023-12-13

申办/合作机构

Medical Research Agency

CTRI/2023/11/059887 / Not yet recruiting临床4期

Effect of Transforaminal Epidural Etanercept on Lumbar Radicular Pain: A Prospective Interventional Study - NIL

开始日期2023-11-20

申办/合作机构-

NCT05950724 / Enrolling by invitation早期临床1期IIT

RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

The purpose of this study is to assess whether TNFa antibody use before lung transplant can prevent kidney injury after lung transplant.

开始日期2023-09-17

申办/合作机构

Northwestern University

100 项与依那西普相关的临床结果

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100 项与依那西普相关的转化医学

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100 项与依那西普相关的专利（医药）

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9,260

项与依那西普相关的文献（医药）

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Prescribing patterns and persistence of biological therapies for psoriasis management: a retrospective cohort study from Saudi Arabia

Article

作者: Fazel, Mohammad ; Alyazidi, Wejdan ; Alkaff, Tuqa ; Almalki, Ziyad ; Alomar, Mukhtar ; Almakki, Sarah ; Alamer, Ahmad ; Mobarki, Fatimah ; Aldosari, Saad ; Alahmari, Abdullah

BACKGROUND:

Biological therapies are effective for psoriasis, but patient responses vary, often requiring therapy switching or discontinuation.

OBJECTIVES:

To identify physicians' prescribing patterns of biological therapies at a referral tertiary center in Saudi Arabia and assess the probability of biologic persistence following treatment initiation.

METHODS:

We conducted a retrospective study of biologic-naïve adult psoriasis patients who initiated therapy from October 2013 to July 2022 in Dammam. Descriptive statistics and a Kaplan-Meier analysis evaluated treatment persistence at 6, 12, 24, and 36 months.

RESULTS:

A total of 151 patients received adalimumab (n = 89), etanercept (n = 17), risankizumab (n = 30), ustekinumab (n = 14), and ixekizumab (n = 1). At 6 months, all therapies demonstrated 100% persistence. At 12 months, persistence was highest for ustekinumab (100%) and lowest for etanercept (88.2%). At 24 months, ustekinumab maintained 100% persistence, followed by risankizumab (96.6%), adalimumab (94.3%), and etanercept (76.4%). At 36 months, risankizumab had the highest persistence (96.6%), followed by adalimumab (83.1%), ustekinumab (78%), and etanercept (70.6%). The most common reasons for discontinuation were lack of effectiveness and intolerability.

CONCLUSION:

This study shows changing psoriasis treatment patterns with new therapies. Risankizumab demonstrated high long-term persistence, while etanercept and ustekinumab showed declining persistence, suggesting evolving treatment considerations.

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Frequency and outcomes of treatment dose escalation with biologics in moderate-to-severe psoriasis: a Swedish register study

Article

作者: Wennerström, Christina ; Hjelm, Fredrik ; Ståhle, Mona ; Tjärnlund, Anna ; Svedbom, Axel

BACKGROUND:

The advent of biosimilars may increase the frequency of dose escalation with biologics in psoriasis.

OBJECTIVE:

To explore the frequency and outcomes of dose escalation with adalimumab etanercept, and ustekinumab.

METHODS:

Data were extracted from DermaReg-Pso, a psoriasis register in Stockholm, Sweden. The main exposure was treatment, and the main outcome was dose escalation. We describe outcomes with dose escalation by estimating drug survival and changes in the Psoriasis Area and Severity Index (PASI).

RESULTS:

554 patients had 946 treatment episodes with adalimumab, etanercept, or ustekinumab. The cumulative incidence of dose escalation was 4.1 per 100 treatment years. The Hazard Ratios (HRs) for dose escalation with ustekinumab vs adalimumab and ustekinumab vs etanercept were 1.93 (95% CI: 1.25-2.98), and 2.20 (95% CI: 1.42-3.41), respectively. After dose escalation, the HRs for treatment discontinuation with adalimumab and etanercept compared with ustekinumab were 3.10 (95% CI: 1.56-6.18) and 7.15 (95% CI: 3.96-12.94), respectively. PASI was higher after compared to before dose escalation for etanercept (p = 0.036), but not for adalimumab (p = 0.832) or ustekinumab (p = 0.300).

CONCLUSIONS:

Dose escalation was comparatively more frequent with ustekinumab than with adalimumab or etanercept; however, treatment discontinuation after dose escalation was more common with adalimumab and etanercept than ustekinumab.

2024-12-01·Molecular biology reports

Oxidative stress in Alzheimer’s disease: current knowledge of signaling pathways and therapeutics

Review

作者: Sharma, Prajjwal ; Singh, Sunil K ; Dhapola, Rishika ; Beura, Samir K ; HariKrishnaReddy, Dibbanti

Alzheimer's disease's pathophysiology is still a conundrum. Growing number of evidences have elucidated the involvement of oxidative stress in the pathology of AD rendering it a major target for therapeutic development. Reactive oxygen species (ROS) generated by altered mitochondrial function, dysregulated electron transport chain and other sources elevate aggregated Aβ and neurofibrillary tangles which further stimulating the production of ROS. Oxidative stress induced damage to lipids, proteins and DNA result in neuronal death which leads to AD. In addition, oxidative stress induces apoptosis that is triggered by the modulation of ERK1/2 and Nrf2 pathway followed by increased GSK-3β expression and decreased PP2A activity. Oxidative stress exaggerates disease condition by interfering with various signaling pathways like RCAN1, CREB/ERK, Nrf2, PP2A, NFκB and PI3K/Akt. Studies have reported the role of TNF-α in oxidative stress stimulation that has been regulated by drugs like etanercept increasing the level of anti-oxidants. Other drugs like pramipexole, memantine, carvedilol, and melatonin have been reported to activate CREB/RCAN1 and Nrf2 pathways. In line with this, epigallocatechin gallate and genistein also target Nrf2 and CREB pathway leading to activation of downstream pathways like ARE and Keap1 which ameliorate oxidative stress condition. Donepezil and resveratrol reduce oxidative stress and activate AMPK pathway along with PP2A activation thus promoting tau dephosphorylation and neuronal survival. This study describes in detail the role of oxidative stress in AD, major signaling pathways involving oxidative stress induced AD and drugs under development targeting these pathways which may aid in therapeutic advances for AD.

326

项与依那西普相关的新闻（医药）

2024-09-20

·PipelineReview

Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ™

INCHEON, South Korea and CAMBRIDGE, MA, USA I September 20, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea 2 (aflibercept), also known as SB15. OPUVIZ has been recommended for approval in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). “We are pleased to have our second ophthalmology biosimilar OPUVIZ recommended for approval in Europe. This marks another significant milestone for Samsung Bioepis and more importantly for people living with retinal disorders as we are making a step forward in enhancing the availability of the essential treatment,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies. We will continue our work to transform the way biologic therapies are brought to patients and enhance the lives of patients, through our pioneering and innovative use of science and technology,” she added. “We are excited about the positive CHMP recommendation for OPUVIZ in Europe and the potential for it to serve as a meaningful therapeutic option for individuals impacted by retinal vascular disorders,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Biosimilars could help broaden access and offer significant healthcare savings through the treatment of these complex and often debilitating ophthalmic diseases.” The CHMP’s positive opinion was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL. 3, 4 This CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant a marketing authorization for OPUVIZ. If a marketing authorization is granted by the EC, OPUVIZ would become the second ophthalmology biosimilar approved in Europe and fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen, which includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the U.S., Canada, Europe, Japan and Australia. About the SB15 Phase 3 study 3 The study is a randomized, double-masked, parallel group phase 3 study conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were randomized 1:1 to receive either SB15 (n = 224) or AFL (n = 225). At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56. Key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra or sub-retinal fluid. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . SOURCE: Samsung Bioepis

临床3期临床结果引进/卖出上市批准

2024-09-20

·BioSpace

Senate Bill Seeks to Spare Small Biotechs from IRA’s Drug Price Negotiations

iStock, Simon van Hemert While unlikely to pass this year, given the Democrats’ control over the White House and Senate, the proposed legislation might be a harbinger of the Republicans’ agenda next year for the Inflation Reduction Act should they win the November elections. Sen. Bill Cassidy (R-La.) has filed a bill that would give small biotech companies a reprieve from the Medicare Drug Price Negotiation Program under the Inflation Reduction Act. The legislative proposal, dubbed the Small Biotech Innovation Act, seeks to exempt small R&D-intensive companies from drug price negotiations starting in 2029 and beyond. The current Inflation Reduction Act (IRA) program already excludes these firms through 2028. However, Cassidy’s bill introduces a new definition scheme for small biotechs, relying on a company’s R&D expense relative to the number of its single-source products, or drugs that only it can manufacture. According to the proposed legislation, a small biotech company is defined as a “manufacturer that has five or less qualifying single source drugs.” At this level, a company must invest in R&D at least 70% of its net revenue from the average of the previous three years to qualify for exemption, according to Cassidy’s bill. While the bill is unlikely to pass this year, given the Democrats’ control over the White House and Senate, it might be a sign of what Republicans are gearing up for should they win the November elections. Axios reported earlier this week that “multiple high-ranking Republicans” want to scrap the IRA’s drug price negotiations program if they win the elections. “I would try to remove that and replace it,” Sen. Mike Crapo (R-Idaho) told Axios , however noting that he can’t say yet how exactly the negotiation program could change. Crapo is projected to be the next chairperson of the Senate Finance Committee if Republicans become the majority in the legislative body. Cassidy’s bill comes weeks after the Centers for Medicare and Medicaid Services (CMS) unveiled the results of the first round of drug price negotiations with manufacturers. After months of back-and-forth, CMS negotiated lower prices for some of the most widely prescribed medicines, including AstraZeneca’s Farxiga, J&J’s Stelara and BMS’ Eliquis. While the White House initially hailed the negotiations as a huge victory—claiming that it would save the government about $6 billion just in its first year of implementation—analysts and industry observers quickly voiced their skepticism , pointing out that many of these initial 10 drugs were already selling well below their list prices. Last month, the Brookings Institution released a report noting that the bulk of CMS’ estimated $6 billion savings will come from just three drugs : Eliquis, Stelara and Amgen’s Enbrel (etanercept). Meanwhile, drugs that already had large rebates before the IRA were only minimally affected by the negotiations. The savings that Medicare beneficiaries would see as a result of the negotiations remain unclear.

2024-09-19

·CPHI制药在线

收藏 | 从重磅药物排名看小分子与单抗药物在肿瘤学和免疫学的未来

关注并星标CPHI制药在线 2024年Q2财报显示出了肿瘤学与免疫学产品的一个巨大差异，而且是趋势越来越明显的差异，即肿瘤学超级重磅炸弹基本上是小分子与单抗药物平分秋色的局面，而免疫学则基本上成为了单抗和蛋白的天下。 1. 肿瘤学与免疫学重磅药物模态分化 2024年第二季度销售额前十名的肿瘤学产品见表1。Keytruda仍然无可撼动地雄霸着销售榜首的位置。肿瘤学产品前十名中出现了六款小分子药物的身影，剩下的四个名额被单抗药物瓜分（图1）。从销售额的层面来看，得益于Keytruda优秀的表现，前十名中的单抗类肿瘤学药物的销售额达到136.9亿美元，占据62%份额，六款小分子肿瘤学药物的销售总额为84.6亿美元，占比38%（图2）。表1. 2024年Q2销售额排名前十的肿瘤学产品图1. 2024 Q2肿瘤学Top10药物模态数量图。图2. 2024 Q2肿瘤学Top10药物模态销售额。与肿瘤学小分子和单抗药物几乎平分秋色形成鲜明对比的是，2024年Q2免疫学Top10的队列几乎完全是单抗和蛋白“溥天之下，莫非王土”的局面（表2）。销售额排名前十的免疫学药物中有7款为单抗类药物，2款为融合蛋白，只有一款小分子药物跻身该榜单（图3），即艾伯维的新贵Rinvoq（Upadacitinib）。这款Janus 激酶小分子抑制剂药物2019年8月才获得FDA的批准，如今已经打进免疫类药物销售额的前十名。在2024年第二季度收获了14.3亿美元的销售收入，而且同比增长高达56%，表现非常强劲。然而Rinvoq在免疫类产品中只是一个孤例，即便我们把榜单扩大到15名，Rinvoq依然是唯一一款小分子免疫药物，因为11至15名均为单抗类药物（Tremfya（强生，9.1亿美元）、Taltz（礼来，8.2亿美元）、Actemra（罗氏，7.4亿美元）、Nucala（GSK，6.1亿美元）、Simponi（强生， 5.4亿美元））。从销售额的角度来看，作为孤例的小分子药物Rinvoq的销售额仅占前十名总额的7%，而蛋白与单抗则分别占据了11%和82%的份额，对小分子免疫药物形成了压倒性的优势。表2. 2024年Q2销售额排名前十的免疫学产品图3. 2024 Q2免疫学Top10药物模态数量图。图4. 2024 Q2肿瘤学Top10药物模态销售额。 2. 肿瘤学与免疫学药物重磅药物组成成分小分子和单抗的阵营都可能孕育出免疫学和肿瘤学重磅药物。肿瘤学重磅药物 ● 小分子药物：通常是激酶抑制剂，针对癌细胞生存和增殖所必需的特定突变或通路。例如诺华的imatinib (Gleevec) 和基因泰克的erlotinib (Tarceva)。 ● 单抗：这些药物针对癌细胞上的特定抗原。例如默沙东的Keytruda和百时美施贵宝的Opdivo。 ● ADCs：小分子药物和单抗结合的产物，将单抗与细胞毒性药物结合，提供靶向化疗。例如基因泰克的ado-trastuzumab emtansine (Kadcyla)。 ● CAR-T细胞疗法：涉及修改患者的T细胞，使其能够更好地识别和攻击癌细胞。例如Kite Pharma的Yescarta (axicabtagene ciloleucel)。免疫学重磅药物 ● 单抗：常用于中和参与自身免疫反应的特定细胞因子或细胞表面蛋白，例如艾伯维的Humira (adalimumab)。 ● 融合蛋白：工程化的蛋白质，通过模仿天然抑制剂来抑制免疫反应，例如安进/辉瑞的etanercept (Enbrel)。 ● 小分子药物：这些药物包括干扰免疫反应信号通路的JAK抑制剂，例如辉瑞的tofacitinib (Xeljanz)。 3. 肿瘤学与免疫学重磅药物模态组成何以出现分化肿瘤学和免疫学领域的重磅药物在治疗的模式上往往有所不同，这是由于它们所针对的疾病性质和所需的作用机制不同所致。他们的主要差异表现在以下几个方面： ✓ 靶点特异性：肿瘤学药物通常针对癌细胞特有的突变或蛋白质，而免疫学药物则针对免疫系统的成分以调节其活性。 ✓ 作用机制：肿瘤治疗可能涉及直接的细胞毒性作用或通过免疫系统调节来攻击癌细胞，而免疫学治疗主要集中在减少不适当的免疫反应。 ✓ 治疗目标：在肿瘤学中，目标通常是消除癌细胞或显著减少肿瘤负担。而在免疫学中，目标是控制或防止自身免疫和炎症反应。这些差异反映了癌症与自身免疫疾病的基本病理生理学差异，以及有效管理这些疾病所需的治疗策略。免疫学与肿瘤学中单克隆抗体和小分子药物的应用差异可以归因于与疾病性质、所需作用机制以及治疗目标相关的多种因素。免疫学重磅药物 ● 靶向特异性和调节 ✓ 精确性：单克隆抗体具有高度的特异性，能够精确靶向并调节免疫系统的特定成分，如细胞因子或细胞表面受体。在治疗自身免疫性疾病时，这种精确性尤为重要，因为目标是减弱过度活跃的免疫反应，而不广泛抑制免疫系统。 ✓ 长半衰期：单克隆抗体通常具有较长的半衰期，这对于需要持续调节免疫系统的慢性疾病治疗非常有利。例如，adalimumab（Humira）和infliximab（Remicade）等药物通过靶向TNF-alpha来减少自身免疫疾病中的炎症反应。 ● 作用机制 ✓ 阻断特定通路：单抗可以阻断与疾病病理相关的特定免疫通路。例如，通过靶向IL-4受体α，单抗可以有效减少哮喘和特应性皮炎等疾病中的炎症反应。 ✓ 免疫调节：单抗可以调节免疫检查点或其他调节通路，以恢复免疫系统的平衡，如靶向IL-8或OX40受体的药物。肿瘤学重磅药物 ● 多样化的机制和靶点 ✓ 广泛的靶点范围：小分子药物可以靶向多种细胞内通路和蛋白质，包括参与细胞增殖、凋亡和DNA修复的那些。这种多样性在肿瘤学中至关重要，因为癌细胞通常具有多种突变和失调的通路。 ✓ 口服生物利用度：许多小分子药物可以口服给药，这相比于单克隆抗体需要的注射给药更加方便。这可以提高患者的依从性和生活质量。 ● 快速作用和代谢 ✓ 快速起效：小分子药物通常具有较快的起效时间，这在快速进展的癌症中至关重要。例如，酪氨酸激酶抑制剂如imatinib（Gleevec）可以迅速抑制致癌激酶的活性。 ✓ 代谢灵活性：小分子药物代谢和排泄更快，便于剂量调整和副作用管理。 ● 组合疗法： ✓ 协同作用：小分子药物经常与其他疗法（包括单克隆抗体和化疗）联合使用，以实现协同效果。例如，将小分子抑制剂与免疫检查点抑制剂结合，可以增强抗肿瘤反应。总的来说，单抗的精确性、特异性和持续作用使其在调节自身免疫疾病的免疫系统中表现出色。小分子药物的多样性、快速作用以及能够靶向广泛细胞内通路的特性，使其在癌症治疗中至关重要。这种差异反映了自身免疫疾病与癌症之间不同的治疗需求和生物学复杂性，推动了免疫学中优先使用单克隆抗体，而肿瘤学中则偏好小分子药物。 4. 小分子药物在免疫疗法开发中是否成为明日黄花免疫学领域的趋势确实显示出单抗和其他生物制剂在逐渐取代小分子药物。这一变化可以归因于以下几个因素： ● 疗效和特异性前文提到，单抗体具有高度的特异性，能够精确靶向并调节免疫系统的特定成分，这种属性在治疗自身免疫性疾病时尤为重要。 ● 生物类似药的竞争生物类似药的推出表明单抗市场非常强劲。新上市的生物类似药不仅将夺取品牌生物制剂的市场份额，其相对低廉的价格也同样可能侵蚀小分子免疫药物的销售额。 ● 新批准和新适应症像赛诺菲的Dupixent这样的单抗持续获得FDA批准用于额外的适应症，进一步巩固了这些单抗药物的市场地位。 ● 开发商投资意愿制药公司正在大力投资于生物制剂的开发和商业化，因为这些药物具有高效性并能够获得高定价。公司将其研发管线重点放在生物制剂上，这些药物有望带来高回报并享有更长的价格决定期。 ● 小分子药物的挑战 ✓ 免疫调节的复杂性：免疫调节的复杂性通常需要生物制剂所具备的高特异性和定制化作用，而小分子药物可能无法如此有效地实现这些功能。 ✓ 法规和开发难题：开发能够安全有效地调节免疫系统且无脱靶效应或毒性的小分子药物极具挑战性，这导致生物制剂在这一治疗领域中更受青睐。尽管小分子药物将在免疫学领域继续发挥作用，尤其是在口服给药和快速起效具有优势的领域，但趋势表明单抗和其他生物制剂将在免疫学的重磅药物市场中占据主导地位。生物制剂的精确性、高效性以及有利的市场动态正推动这一转变，使得小分子药物在免疫学领域的重磅药物中变得越来越罕见。虽然生物制剂主导免疫学重磅药物已经成为了不争的事实，但小分子药物似乎并没有成为彻底的明日黄花。它们的内在优势仍然可以使小分子药物成为免疫学领域的重要组成，就像Rinvoq的表现那样。小分子药物持续优势可以表现在以下几个方面： ✓ 口服生物利用度：小分子药物通常可以口服给药，具有更高的患者便利性和依从性。这在慢性病和需要长期治疗的疾病中尤为重要。 ✓ 细胞内靶点：小分子药物能够进入细胞内部，靶向细胞内的蛋白质和信号通路。 ✓ 快速起效和灵活性：小分子药物通常具有快速的起效时间，并且由于其代谢和排泄速度较快，可以更灵活地调整剂量，这在治疗某些急性或快速进展的疾病时尤其有用。 ✓ 开发成本和时间：相比于生物制剂，小分子药物的开发成本和时间通常较低。生物制剂的开发往往涉及复杂的生物工程和生产过程，而小分子药物的合成更为直接，允许更快的药物开发周期。尽管生物制剂目前在免疫疗法中占据主导地位，但小分子药物仍然在不断创新，探索新的治疗途径。例如，小分子免疫调节剂正在研究中，试图通过调节特定的免疫信号通路来增强或抑制免疫反应。这类药物可能在未来的免疫疗法中发挥更大的作用。此外，小分子药物与生物制剂的组合疗法正在成为一种有前途的策略。这种组合可以充分利用两类药物的优势，例如，通过小分子药物快速靶向细胞内通路，同时使用生物制剂调节特定的免疫反应，从而实现更为全面的治疗效果。 5. 小分子药物在肿瘤学产品开发中的未来尽管单抗和细胞疗法等生物制剂在癌症治疗中日益突出，小分子药物在肿瘤学领域的前景依然广阔。这是由小分子肿瘤学药物内在的优势所决定的： ● 靶向细胞内通路小分子药物能够穿透细胞膜，靶向细胞内的蛋白质和通路，而这些是较大的生物制剂往往无法接触到的。这种能力对于抑制激酶、转录因子以及其他与癌细胞增殖和生存有关的细胞内靶点至关重要。 ● 口服给药许多小分子药物可以制成口服剂型，相较于可注射的生物制剂，提供了更大的便利性，并提高了患者的依从性。这对需要长期治疗的慢性癌症尤其有利。 ● 快速开发和审批与生物制剂相比，小分子药物的开发和监管审批过程通常更快，因为生物制剂通常需要更复杂的生产和验证过程。这可以加速新疗法的上市。 ● 精准医疗基因组学和分子生物学的进步正在推动小分子药物的发展，这些药物可以靶向癌细胞中的特定基因突变和分子异常。 ● 组合疗法小分子药物越来越多地与其他治疗方法结合使用，包括免疫疗法和传统化疗，以增强疗效并克服耐药性。例如，将小分子抑制剂与免疫检查点抑制剂结合使用，可以改善抗肿瘤反应。 ● 下一代抑制剂针对以前被认为是“不可药物化”蛋白质（如KRAS）的下一代小分子抑制剂的开发是一个重要的研究领域。小分子药物在共价抑制剂、分子胶和PROTACs等领域的开发为小分子肿瘤学产品开拓了崭新的天地。 ● 表观遗传调节剂小分子药物能够调节表观遗传调控因子，如组蛋白去乙酰化酶（HDAC）抑制剂和DNA甲基转移酶抑制剂，正在探索其逆转癌细胞中异常基因表达模式的潜力。小分子药物在肿瘤学中的未来前景光明，这得益于其独特的优势、持续的创新以及癌症治疗领域不断演变的格局。尽管生物制剂和其他先进疗法将继续发挥重要作用，但小分子药物仍将是肿瘤治疗武器库中的关键组成部分，为各种癌症提供靶向性、便利性和有效的治疗选择。 6. 展望展望未来，小分子药物和单克隆抗体在肿瘤学与免疫学中的应用将继续朝着高度专业化和分化的方向发展。小分子药物在肿瘤学中的角色将更加集中于精准靶向特定基因突变和信号通路，尤其是在癌症中难以利用大分子药物直接靶向的细胞内过程。这类药物在克服耐药性和开发组合疗法方面也将发挥更大的作用，进一步推动个性化癌症治疗的发展。与此同时，单克隆抗体在免疫学领域的主导地位将进一步巩固和扩展。未来，单抗药物将更加多样化和复杂化，如双特异性抗体和抗体药物偶联物，将继续优化其在自身免疫病和炎症性疾病中的应用。由于单抗能够精确调节免疫系统的特定成分，它们在治疗复杂免疫紊乱方面的潜力将不断扩大。此外，基于单抗的创新疗法，如融合蛋白和新型免疫调节剂，也将在免疫学中占据更重要的地位。随着这两类药物在各自领域内的持续发展，肿瘤学和免疫学中的治疗方法将更加个性化和精准。未来的治疗策略可能会越来越依赖于这种模式的分化趋势，通过结合小分子药物和单克隆抗体的优势来开发更为有效和耐受性更好的联合治疗方案，从而为患者提供更全面的治疗选择。 Ref. Regeneron Reports Second Quarter 2024 Financial and Operating Results. Regeneron Press Release. 01. 08. 2024. AbbVie Reports Second-Quarter 2024 Financial Results. AbbVie Press Release. Retrieved on 31. 08. 2024. Takeda Earnings Call Analysis. Takeda Press Release. Retrieved on 31. 08. 2024. Bristol Myers Squibb Reports Second Quarter Financial Results for 2024. BMS Press Release. 26. 07. 2024. Top 15 Immunology Medicines by Q2 2024 Sales. Maven Bio. 29. 08. 2024. Hopkins, C. Keytruda Sales Climb 16 Percent in Q2 as Merck Pursues New Oncology Candidates. Precision Medicine Online. 30. 07. 2024. Gil, B. Johnson & Johnson's cancer drug Darzalex could replace Stelara as its best-seller. Quartz. 17. 07. 2024. AstraZeneca H1 and Q2 Results. AZ Press Release. 25. 07. 2024. Bristol Myers Squibb Reports Second Quarter Financial Results for 2024. BMS Press Release. 26. 07. 2024. Pfizer Reports Strong Second-Quarter 2024 Results And Raises 2024 Guidance. Pfizer Press Release. 30. 07. 2024. Johnson & Johnson reports Q2 2024 results. J&J Press Release. 17. 07. 2024. AbbVie Reports Second-Quarter 2024 Financial Results. AbbVie Press Release. 25. 07. 2024. END END END END 【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

免疫疗法财报

100 项与依那西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00742	依那西普	L04AB01	DB00005

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
银屑病	中国	C.H. Boehringer Sohn AG & Co. KG	2010-02-26
多关节型幼年特发性关节炎	美国	Immunex Corp.	2002-01-15
AS	欧盟	Pfizer Europe MA EEIG	2000-02-02
AS	冰岛	Pfizer Europe MA EEIG	2000-02-02
AS	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
AS	挪威	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
AxSpA	欧盟	Pfizer Europe MA EEIG	2000-02-02
AxSpA	冰岛	Pfizer Europe MA EEIG	2000-02-02
AxSpA	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
AxSpA	挪威	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
幼年特发性关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
幼年特发性关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02

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
疼痛	临床3期	美国	Amgen, Inc.	2016-11-29
疼痛	临床3期	波多黎各	Amgen, Inc.	2016-11-29
青少年少关节慢性关节炎	临床3期	澳大利亚	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	比利时	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	哥伦比亚	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	捷克	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	法国	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	德国	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	匈牙利	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	意大利	Pfizer Inc.	2011-10-10

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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


EULAR2024	N/A	幼年特发性关节炎一线	118	Etanercept (ETN)	製齋鏇窪蓋顧製願構獵(鹹壓衊鬱夢醖壓鹹鹹廠) = 範願齋廠觸蓋遞膚憲顧鹽繭廠鬱糧鬱積夢觸網 (顧鹽範夢衊蓋簾鑰鑰顧 )	积极	2024-06-05
				Adalimumab (ADA)	製齋鏇窪蓋顧製願構獵(鹹壓衊鬱夢醖壓鹹鹹廠) = 膚鹽壓獵網觸顧淵觸觸鹽繭廠鬱糧鬱積夢觸網 (顧鹽範夢衊蓋簾鑰鑰顧 )
EULAR2024	N/A	-	-	Etanercept bio-originator	衊鹹淵襯簾襯齋憲網遞(窪艱廠顧憲夢餘觸願構) = 28% vs 22%, mostly injection site reactions 蓋觸願簾觸糧築鹽鬱簾 (遞艱遞繭顧餘廠餘鬱繭 ) 更多	-	2024-06-05
				Etanercept biosimilar SB4
NCT02464878 (CTgov)	临床2期	1型糖尿病	2	Islet Transplantation+Thymoglobulin+Basiliximab+Alpha 1-Antitrypsin+Etanercept	觸膚選廠鏇膚簾網餘觸(觸窪構鏇齋襯夢蓋選築) = 範廠膚醖鑰憲獵艱願顧壓鏇襯簾範窪顧衊遞簾 (願窪淵觸鹽膚鬱繭醖製, 鏇醖鑰構願鏇廠遞顧選 ~ 鏇夢獵醖遞廠壓膚廠夢) 更多	-	2023-12-22
ACR2023	临床1期	类风湿关节炎	10	Etanercept 25 mg NTM infusions	廠範構範顧齋壓顧艱廠(艱襯遞獵範鬱衊獵觸壓) = decreased by 77% 製顧醖顧憲艱鬱襯壓簾 (壓餘範願鏇艱鏇選糧衊 ) 更多	积极	2023-11-12
NCT03636373 (CTgov)	临床4期	原发性痛风	5	Etanercept (Etanercept)	鏇淵壓衊鏇築觸廠鹹鹹(糧齋願衊獵糧襯遞願淵) = 願窪範窪壓鏇餘衊築鹽築襯壓鬱積獵衊醖遞繭 (願鬱鑰選鏇齋鏇襯鹽齋, 蓋範鏇鑰廠齋窪獵顧遞 ~ 鬱製壓選築繭願鑰壓壓) 更多	-	2023-10-27
				Triamcinolone Acetonide (Triamcinolone Acetonide)	鏇淵壓衊鏇築觸廠鹹鹹(糧齋願衊獵糧襯遞願淵) = 顧築範蓋襯製選鏇鑰鹹築襯壓鬱積獵衊醖遞繭 (願鬱鑰選鏇齋鏇襯鹽齋, 糧醖築築糧簾齋蓋繭範 ~ 鬱壓淵願鑰糧繭鹽願繭) 更多
FDA 人工标引	N/A	斑块状银屑病	211	Placebo	獵壓積艱鏇壓醖築齋餘(衊鹹獵醖壓網繭獵積淵) = 齋壓鏇窪鹽積鑰膚鹽構糧獵製憲艱積築鬱齋鬱 (廠積繭襯鬱糧範膚鬱網 ) 更多	积极	2023-10-18
				Enbrel 0.8 mg/kg	獵壓積艱鏇壓醖築齋餘(衊鹹獵醖壓網繭獵積淵) = 糧艱網齋壓夢膚網淵窪糧獵製憲艱積築鬱齋鬱 (廠積繭襯鬱糧範膚鬱網 ) 更多
CareRA2020 (EULAR2023)	N/A	-	276	Standard COBRA-Slim	鑰積鏇蓋艱廠繭壓簾壓(網鹹餘醖衊鹹鹹鑰積願) = 鏇繭製製顧願糧鹹鏇夢構襯構遞鬱簾餘廠膚獵 (積壓衊淵襯醖獵壓選糧 ) 更多	-	2023-05-31
				COBRA-Slim Bio-induction	鑰積鏇蓋艱廠繭壓簾壓(網鹹餘醖衊鹹鹹鑰積願) = 製鹽醖繭願齋築醖壓網構襯構遞鬱簾餘廠膚獵 (積壓衊淵襯醖獵壓選糧 ) 更多
EULAR2023	N/A	银屑病关节炎一线	54	Etanercept originator	糧襯淵獵獵淵艱簾築醖(齋範壓膚範餘糧襯遞衊) = 範繭淵艱膚鏇鹹選鬱繭範獵觸顧壓製夢憲遞築 (製簾壓網構顧構簾鏇齋 ) 更多	-	2023-05-31
				Adalimumab originator	糧襯淵獵獵淵艱簾築醖(齋範壓膚範餘糧襯遞衊) = 簾齋製鏇鹹願膚簾襯窪範獵觸顧壓製夢憲遞築 (製簾壓網構顧構簾鏇齋 ) 更多
EULAR2023	N/A	银屑病关节炎一线	-	Etanercept	膚窪製製膚鹽夢壓壓鹽(獵顧醖鏇鬱鬱餘鏇積襯) = 襯鹽窪鹹蓋簾餘憲鬱繭選構膚範衊壓窪選鏇窪 (鑰鬱窪憲觸憲淵夢顧淵 )	-	2023-05-31
				Monoclonal anti-TNF antibodies	膚窪製製膚鹽夢壓壓鹽(獵顧醖鏇鬱鬱餘鏇積襯) = 顧襯築廠壓範醖鑰觸壓選構膚範衊壓窪選鏇窪 (鑰鬱窪憲觸憲淵夢顧淵 )
EULAR2023	N/A	类风湿关节炎	1,063	adalimumab	壓範餘膚遞醖襯觸餘淵(觸鏇鑰鏇積鏇鏇鹹築積) = 衊膚製憲糧膚簾鏇夢網夢淵艱願艱顧繭窪窪範 (顧簾膚獵範網觸齋憲鬱 )	-	2023-05-31
				infliximab	壓範餘膚遞醖襯觸餘淵(觸鏇鑰鏇積鏇鏇鹹築積) = 製壓繭構淵鏇鏇夢廠獵夢淵艱願艱顧繭窪窪範 (顧簾膚獵範網觸齋憲鬱 ) 更多