The goal of this project is to evaluate galcanezumab transfer into maternal breastmilk, and to evaluate infant (growth, development, constipation, colic, infections) and maternal (headache) outcomes for dyads in which the mother was treated with galcanezumab and to compare outcomes for infants who were or were not breastfed after maternal treatment.
In this prospective observational study, the study team proposes to prospectively collect serial milk samples from 30 adult women who are treated with galcanezumab for migraine. Mothers who are interested in participating will be connected with us, the main clinical site, by neurologists across the USA. Mothers must carry a diagnosis of migraine, be aged 18-45 years, and be between 14 days and 9 months postpartum, and still nursing, at the time of enrollment.
This study will fill a significant unmet need as women of childbearing potential are over-represented in the migraine population, and yet they are excluded from clinical trials of migraine treatments during pregnancy and lactation.

开始日期2023-12-01

申办/合作机构

The University of California, San Francisco

[+1]

NCT05281770 / RecruitingN/AIIT

Non-interventional Study of the Austrian Headache Society: Monoclonal CGRP Antibodies for Migraine Prevention a Nationwide Real Life Study

The present non-interventional study on migraine prevention with monoclonal CGRP antibodies adresses questions concering safety, swichting from one CGRP mab to another, efficacy on auras in the real world setting.

开始日期2022-10-01

申办/合作机构

Medical University of Innsbruck

[+1]

NCT05492695 / Terminated临床4期

TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.

开始日期2022-10-01

申办/合作机构

Diamond Headache Clinic, Ltd.

100 项与加卡奈珠单抗相关的临床结果

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100 项与加卡奈珠单抗相关的转化医学

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100 项与加卡奈珠单抗相关的专利（医药）

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347

项与加卡奈珠单抗相关的文献（医药）

2024-02-18·Neurology international

Effectiveness of Switching CGRP Monoclonal Antibodies in Non-Responder Patients in the UAE: A Retrospective Study.

Article

作者: Reem Suliman ; Vanessa Santos ; Ibrahim Al Qaisi ; Batool Aldaher ; Ahmed Al Fardan ; Hajir Al Barrawy ; Yazan Bader ; Jonna Lyn Supena ; Kathrina Alejandro ; Taoufik Alsaadi

Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) have shown promising effectiveness in migraine management compared to other preventative treatment options. Many questions remain regarding switching between antibody classes as a treatment option in patients with migraine headaches. This preliminary retrospective real-world study explored the treatment response of patients who switched between CGRP mAb classes due to lack of efficacy or poor tolerability. A total of 53 patients with migraine headache switched between three of the CGRP mAbs types due to lack of efficacy of the original prescribed CGRP mAbs, specifically eptinezumab, erenumab, and galcanezumab. Fremanezumab was not included due to unavailability in the UAE. Galcanezumab and eptinezumab target the CGRP ligand (CGRP/L), while erenumab targets CGRP receptors (CGRP/R). The analysis of efficacy demonstrated that some improvements were seen in both class switch cohorts (CGRP/R to CGRP/L and CGRP/L to CGRP/R). The safety of switching between CGRP classes was well observed, as any adverse events presented before the class switch did not lead to the discontinuation of treatment following the later switch. The findings of this study suggest that switching between different classes of CGRP mAbs is a potentially safe and clinically viable practice that may have some applications for those experiencing side effects on their current CGRP mAb or those witnessing suboptimal response.

2024-02-17·Journal of clinical medicine

Anti-CGRP and Anti-CGRP Receptor Monoclonal Antibodies for Migraine Prophylaxis: Retrospective Observational Study on 209 Patients.

Article

作者: Vittorio Schweiger ; Paola Bellamoli ; Francesco Taus ; Leonardo Gottin ; Alvise Martini ; Marta Nizzero ; Eleonora Bonora ; Giovanna Del Balzo ; Katia Donadello ; Erica Secchettin ; Gabriele Finco ; Daniele De Santis ; Enrico Polati

BACKGROUND:

Migraine is a neurological disorder characterized by attacks of head pain with prevalent unilateral localization, moderate to high intensity and specifically associated accompanying symptoms.

METHODS:

In this retrospective observational study, we analyzed data regarding 209 patients who had previously been diagnosed with migraine and who were prescribed, between 2019 and 2022, subcutaneous injections of anti-CGRP monoclonal antibodies (mAbs) fremanezumab or galcanezumab or anti-CGRP receptors mAb erenumab regardless of the concomitant assumption of any other acute-phase or prophylactic migraine medication.

RESULTS:

Regarding efficacy, in the 205 analyzed patients, the change from baseline in terms of MIDAS, HIT-6, MMDs and MAD scores was statistically significant for erenumab and galcanezumab, while for fremanezumab a statistical significance was not achieved likely due to the small sample size. In the treated population, 36 patients (17.5%) reported AEs (pain during injection, transient injection site erythema, nausea, constipation and fatigue). Only 5 patients (2.4%) discontinued the treatment for AEs while 15 patients (7.3%) left for lack of efficacy.

CONCLUSIONS:

this retrospective study comes out in favor of both significant efficacy and safety of anti-CGRP and anti-CGRP receptors mAbs in migraine patients. Further methodologically stronger studies are necessary to validate our observation.

2024-02-12·The journal of headache and pain

Early and annual projected savings from anti-CGRP monoclonal antibodies in migraine prevention: a cost-benefit analysis in the working-age population.

Article

作者: Carlos Lazaro-Hernandez ; Edoardo Caronna ; Joana Rosell-Mirmi ; Victor J Gallardo ; Alicia Alpuente ; Marta Torres-Ferrus ; Patricia Pozo-Rosich

BACKGROUND:

Migraine is one of the main causes of disability worldwide. Anti-CGRP monoclonal antibodies (MAbs) have proven to be safe and efficacious as preventive migraine treatments. However, their use is restricted in many countries due to their apparently high cost. Cost-benefit studies are needed.

OBJECTIVE:

To study the cost-benefit of anti-CGRP MAbs in working-age patients with migraine.

METHODS:

This is a prospective cohort study of consecutive migraine patients treated with anti-CGRP MAbs (erenumab, fremanezumab and galcanezumab) following National reimbursement policy in a specialized headache clinic. Migraine characteristics and the work impact scale (WPAI) were compared between baseline (M0) and after 3 (M3) and 6 months (M6) of treatment. Using WPAI and the municipal average hourly wage, we calculated indirect costs (absenteeism and presenteeism) at each time point. Direct costs (emergency visits, acute medication use) were also analysed. A cost-benefit study was performed considering the different costs and savings of treating with MAbs. Based on these data an annual projection was conducted.

RESULTS:

From 256 treated working-age patients, 148 were employed (89.2% women; mean age 48.0 ± 8.5 years), of which 41.2% (61/148) were responders (> 50% reduction in monthly headache days (MHD)). Statistically significant reductions between M0 and M3/M6 were found in absenteeism (p < 0.001) and presenteeism (p < 0.001). Average savings in indirect costs per patient at M3 were absenteeism 105.4 euros/month and presenteeism 394.3 euros/month, similar for M6. Considering the monthly cost of anti-CGRP MAbs, the cost-benefit analysis showed savings of 159.8 euros per patient at M3, with an annual projected savings of 639.2 euros/patient. Both responders and partial responders (30-50% reduction in MHD) presented a positive cost-benefit balance. The overall savings of the cohort at M3/M6 compensated the negative cost-benefit balance for non-responders (< 30% reduction in MHD).

CONCLUSION:

Anti-CGRP MAbs have a positive impact in the workforce significantly reducing absenteeism and presenteeism. In Spain, this benefit overcomes the expenses derived from their use already at 3 months and is potentially sustainable at longer term; also in patients who are only partial responders, prompting reconsideration of current reimbursement criteria and motivating the extension of similar cost-benefit studies in other countries.

104

项与加卡奈珠单抗相关的新闻（医药）

2024-04-01

·医药观澜

2024年第一季度，NMPA批准超30款新药/新适应症（附PDF下载）

▎药明康德内容团队报道根据中国国家药监局（NMPA）官网批件信息统计：2024年第一季度共有17款新药*在中国首次获批上市，其中包括了6款1类新药，来自科济药业、科州制药、恒瑞医药、四环医药、罗氏（Roche）、卫材（Eisai）/渤健（Biogen）；同时也有18款新药在中国实现了新适应症或新剂型获批上市。在我们统计的超30个新药/新适应症的获批信息中，抗肿瘤适应症占比最多，其次是罕见病适应症；同时，阿尔茨海默病、偏头痛等神经系统疾病也迎来多款新疗法。本文就让我们来一起看看第一季度获批的新药有哪些亮点。（*新药统计范围包括化学药品1类和5.1类、治疗用生物制品1类和3.1类，未统计疫苗类产品）扫描下方二维码，可获取《2024年第一季度中国获批上市新药》完整数据PDF文件。亮点一、10多款抗肿瘤新药获批，单抗药物占55%从适应症来看，第一季度获批新药中，抗肿瘤新药占比最多，共有10多款新药获批用于治疗不同类型的肿瘤，包括肝细胞癌、胃癌、非小细胞肺癌、乳腺癌、胰腺癌、头颈部肿瘤、胆道癌、NTRK融合儿童实体瘤、多发性骨髓瘤、黑色素瘤等。这些新药的分子类型包括单抗、小分子药物和CAR-T细胞疗法。其中，有4款抗PD-1/L1单抗产品获批新适应症。包括：百济神州的替雷利珠单抗在中国获批第12项适应症，单药用于肝细胞癌患者的一线治疗；君实生物的特瑞普利单抗在中国获批第7项适应症，用于可切除非小细胞肺癌围手术期治疗；默沙东（MSD）的帕博利珠单抗在中国获批第13个适应症，用于局部晚期或转移性胆道癌患者的一线治疗；基石药业的舒格利单抗在中国获批第5项适应症，用于胃及胃食管结合部腺癌的一线治疗。PD-1/L1抑制剂之外，还有一些其它抗体药物获批肿瘤适应症。例如，罗氏的抗HER2单抗复方制剂帕妥珠曲妥珠单抗注射液（皮下注射），获批用于治疗成人HER2阳性早期和转移性乳腺癌患者。与标准静脉给药的数小时相比，这款皮下注射的复方制剂可以实现5~8分钟完成治疗，为乳腺癌患者带来更为便捷的治疗选择。此外，百泰生物的抗EGFR单抗尼妥珠单抗在中国获批头颈部鳞癌新适应症，该药此前已经在中国获批治疗鼻咽癌、胰腺癌。同时，第一季度还有4款小分子新药收获了肿瘤适应症。其中，科州制药的MEK抑制剂妥拉美替尼为首次获批，用于含PD-1/PD-L1治疗失败的NRAS突变的晚期黑色素瘤患者。此外，还有3款小分子新药获批新适应症，分别为：百时美施贵宝公司的注射用紫杉醇（白蛋白结合型），获批用于转移性胰腺癌的一线治疗；齐鲁制药的ALK/ROS1抑制剂伊鲁阿克，获批一线治疗ALK阳性非小细胞肺癌，将适应症拓展至覆盖全部ALK阳性局部晚期或转移性非小细胞肺癌者人群；罗氏的TRK/ROS1酪氨酸激酶抑制剂恩曲替尼胶囊，获批治疗1月龄以上NTRK融合儿童实体瘤患者，该产品具有中枢神经系统（CNS）活性，在针对颅外实体瘤或原发性CNS肿瘤儿童患者时表现出快速和持久的缓解。在细胞与基因疗法领域，科济药业靶向BCMA的自体CAR-T细胞疗法泽沃基奥仑赛注射液在中国获批上市，用于治疗经过至少3线治疗后进展的复发或难治性多发性骨髓瘤成人患者。公开资料显示，这也是中国获批上市的第5款CAR-T细胞疗法，以及第二款靶向BCMA的CAR-T细胞治疗药物。亮点二、优先审评助力，多款罕见病新药获批在今年第一季度获批的新药中，有7款为罕见病新药，其中有5款罕见病新药是通过优先审评程序获批。罗氏的新型抗C5循环单克隆抗体可伐利单抗在中国获批用于未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人和青少年患者，患者可进行每四周一次皮下注射。PNH是一种罕见且危及生命的血液疾病。值得一提的是，本次获批是可伐利单抗在全球所有国家中的首次获批，同时这也是罗氏第一次在中国实现一款创新药的全球首发。另一款在中国实现全球首发的新药是勃林格殷格翰（Boehringer Ingelheim）的罕见皮肤病创新药佩索利单抗（皮下注射制剂），获批用于减少12岁及以上青少年和成人的泛发性脓疱型银屑病（GPP）发作。GPP是一种罕见的、复发性或持续发作的严重皮肤疾病。佩索利单抗是一款皮下注射的抗IL-36R单抗，其在临床研究中能显著降低GPP发作风险84%长达48周。武田（Takeda）有两款罕见病新药在中国获批上市。其一是注射用替度格鲁肽获批治疗短肠综合征（SBS）成人和1岁及以上儿童患者。根据武田新闻稿，这也是中国首个治疗短肠综合征的人胰高血糖素样肽2（GLP-2）类似物，它可以帮助患者提高剩余肠管的吸收功能，帮助降低甚至摆脱对肠外营养支持的依赖。其二是重组猪FⅧ（rpFⅧ）药物注射用舒索凝血素α，在中国获批用于获得性血友病A成人患者按需治疗和出血事件的控制。图片来源：123RF其它获批的罕见病新药还包括：Orphalan公司的铜离子络合剂四盐酸曲恩汀薄膜衣片，获批治疗成人、青少年和≥5岁儿童的威尔逊病（又称肝豆状核变性）。威尔逊病是一种罕见的慢性遗传病，因肝脏铜转运受损而可能威胁生命。诺贝仁制药（Nobelpharma）的铜吸收抑制剂醋酸锌片也在中国获批治疗威尔逊病。作为一种锌制剂，该药能阻止铜在肠道的吸收，并清除沉积于组织中的铜，可作为威尔逊病的治疗方式之一。苏庇医药（Sobi）的IL-1受体拮抗剂阿那白滞素注射液则在中国获批两项新适应症，分别用于治疗斯蒂尔病（Still’s disease）和冷吡啉相关周期性综合征（CAPS）。值得一提的是，这两种罕见病均已经在中国被纳入《第二批罕见病目录》。亮点三：阿尔茨海默病、偏头痛等疾病迎来新疗法除了抗肿瘤和罕见病新药，第一季度在中国获批上市的新药还包括了至少4款精神/神经系统新药，适应症涵盖多动症、偏头痛、阿尔茨海默病等。其中，有两款CGRP受体拮抗剂在中国获批上市，分别为：礼来（Eli Lilly and Company）公司的加卡奈珠单抗注射液，获批用于成人偏头痛的预防性治疗；辉瑞公司（Pfizer）的瑞美吉泮口崩片，获批用于成年人有或无先兆偏头痛的急性治疗。偏头痛是一种失能性神经疾病，被世界卫生组织（WHO）列为10种致残性“最强”的内科疾病之一。CGRP信号通路已经成为治疗偏头痛的热门靶点。本次这两款新药相继在中国获批，无疑为中国的偏头痛患者带来福音。阿尔茨海默病领域也迎来好消息。卫材/渤健的仑卡奈单抗注射液在中国获批治疗早期阿尔茨海默病（AD）。仑卡奈单抗是一款抗可溶性β淀粉样蛋白（Aβ）单克隆抗体，也是近年来靶向β淀粉样蛋白的第二款创新阿尔茨海默病疗法。这是一类“疾病修饰治疗”方法，其核心在于其对阿尔茨海默病的疾病发病机制进行干预，靶向清除患者大脑中过多的Aβ原纤维和Aβ斑块，从“源头”解决问题，而不仅仅是缓解症状或对症状进行管理。图片来源：123RF另外，祐儿医药的盐酸哌甲酯缓释干混悬剂获批用于治疗6岁及6岁以上注意缺陷多动障碍（ADHD，俗称多动症）。这是一款长效液体剂型，口服后45分钟起效、作用时间持续长达12小时，且口服溶液对于不愿意吞咽的儿童接受度更高。这是祐儿医药的盐酸哌甲酯获批的第二个剂型，该产品的缓释咀嚼片已于去年12月在中国获批上市。除了上述提到的新药，2024年第一季度还有一些其它新药、2类改良型新药/复方制剂、疫苗、生物类似药等在中国获批，限于篇幅，本文不再一一介绍。祝贺这些药物在中国获批上市，它们的到来将使更多患者拥有新的治疗选择。扫描下方二维码，可获取《2024年第一季度中国获批上市新药》完整数据PDF文件。（PDF文件包含新药、2类改良型新药/复方制剂、疫苗、生物类似药等）参考资料：[1]中国国家药监局（NMPA）官网. From https://www.nmpa.gov.cn/zwfw/zwfwpjfbzs/index.html[2]各公司官方新闻稿本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

上市批准细胞疗法免疫疗法核酸药物疫苗

2024-03-20

·医药地理

【全球/中国新药研发月报】2024年1-2月新药事件盘点

报告缩略图节选2024年1月，FDA共批准2款药品，均为化药（1款是新分子实体）；2月，FDA批准了7款药品，包含6款化药（1款是新分子实体）和1款生物制品。全球药品研发情况如下图所示，具体的药品名单可扫描文末二维码加医药地理小助手微信获取完整报告。2. 2024年1-2月全球重磅获批药物分析2.1 首款获FDA批准治疗传染性软疣的家用药物Zelsuvmi (Berdazimer）Berdazimer是FDA在1月批准的新分子实体。2024年01月05日，美国FDA批准了Ligand Pharmaceuticals Incorporated的柏达姆钠 Berdazimer sodium（SB206），商品名：Zelsuvmi®，剂型：局部凝胶，用于成人和1岁及以上儿科患者传染性疣（MC）的局部治疗。传染性软疣，俗称“水瘊子”，是由传染性软疣病毒(MCV)引起的一种高度传染性的皮肤感染。其特征是皮肤颜色至红色病变，中央有脐状病毒核心。主要通过接触传播，包括皮肤与皮肤的直接接触（包含性传播）。感染者大部分是儿童和免疫功能低下的成年人，每年大约有600万美国人（主要是儿童）被感染。然而，高达73%的儿童未得到治疗。Berdazimer是由Ligand Pharmaceuticals于2023年9月从Novan收购的外用一氧化氮释放剂（凝胶），尽管其治疗传染性软疣的作用机制尚不清楚，但NO已知具有广谱抗菌和抗病毒活性。该药物是第一个也是唯一一个可以由患者、父母或护理人员在家中、医生办公室外或其他医疗场所使用的局部处方药，用于治疗这种高度传染性的病毒性皮肤感染。Berdazimer并不是FDA批准首个治疗传染性软疣的药物，在2023年7月24日FDA批准了Ycanth（斑蝥素）用于治疗2岁以上的传染性软疣患者。Ycanth(cantharidin，斑蝥素)是一种独特的药物-器械组合，一种起泡剂，包含斑蝥素(0.7%w/v)配方，通过一次性涂药器输送，用于精确的局部给药和靶向给药。Ycanth是美国FDA批准的第一种治疗传染性软疣的药物。值得注意的是：与很多皮肤病外用药不同，Ycanth仅限在医院中用。这是由于其活性成分斑蝥素的毒性大，不慎进入口中，可能导致严重伤害，甚至致命。而且，即使干燥后，斑蝥素也高度易燃。相比之下，Berdazimer最大的优势是可以在家中使用。2.2 全球首款补体因子D抑制剂Voydeya（Danicopan）在日本获批上市用于治疗阵发性睡眠性血红蛋白尿症2024年1月18日，日本厚生劳动省批准阿斯利康（AstraZeneca）的“first-in-class”口服小分子Voydeya（danicopan）作为标准疗法补体因子C5抑制剂Ultomiris（ravulizumab）或Soliris（eculizumab）的附加疗法，用于接受C5抑制剂治疗时发生显着血管外溶血（EVH）的阵发性睡眠性血红蛋白尿症（PNH）患者亚群。这是Danicopan在全球范围内的首次获批。PNH是获得性造血干细胞基因突变引起血细胞膜缺陷所致的慢性血管内溶血，常在睡眠时加重，可伴发作性血红蛋白尿、潜在的骨髓衰竭和血栓形成，已被纳入我国第一批罕见病目录。亚洲发病率高于欧美。而就在去年年底，2023年12月5日，FDA刚刚批准了诺华的补体因子B抑制剂伊普可泮Fabhalta（iptacopan）上市，用于成人阵发性睡眠性血红蛋白尿症（PNH）患者的治疗，是首个获FDA批准的口服单药治疗成人PNH的药物。相比C5抑制剂疗法，Danicopan和Iptacopan可选择性地抑制替代通路中的关键补体因子D/B，阻断C3转化酶生产而抑制替代通路活性，阻止C3b片段在患者血红细胞上的沉积，控制PNH患者红细胞分解与血管外溶血，解决PNH患者在接受C5抑制剂治疗时出现临床显著的血管外溶血（EVH）的需求。2.3 FDA批准新型抗生素组合Exblifep（Cefepime /Enmetazobactam）用于治疗复杂尿路感染该药物是FDA在2月批准的新分子实体。Exblifep是由Allecra Therapeutics研发的头孢吡肟（Cefepime，一种头孢菌素类抗菌药物）和恩美他唑巴坦（Enmetazobactam，一种β-内酰胺酶抑制剂）的联合用药，于2024年2月22日FDA批准上市。适用于18岁及以上由指定敏感微生物（大肠杆菌、肺炎克雷伯菌、铜绿假单胞菌、奇异变形杆菌和阴沟肠杆菌复合物）引起的复杂尿路感染（cUTI）患者，包括肾盂肾炎。复杂尿路感染cUTI通常是由革兰氏阴性菌引起，约占美国所有医疗保健相关感染的19%。这种组合旨在对抗革兰氏阴性菌的抗菌耐药性，特别是由广谱β内酰胺酶（ESBL）和头孢菌素酶（AmpC）介导的耐药性有显著作用。在2023年FDA也曾批准过一款抗生素组合疗法。2023年5月23日，FDA曾批准的Xacduro（β-内酰胺类抗生素舒巴坦+β-内酰胺酶抑制剂杜洛巴坦），用于治疗18岁及以上患有鲍曼不动杆菌（或称鲍曼-醋酸钙不动杆菌复合群）敏感菌株引起的医院获得性细菌性肺炎（HABP）和呼吸机相关性细菌性肺炎，是首个用于治疗鲍曼不动杆菌细菌性肺炎的组合抗菌疗法。3. 2024年1-2月主要临床试验与结果复宏汉霖靶向PD-1斯鲁利单抗联合化疗一线治疗晚期鳞状非小细胞肺癌的3期临床试验结果公布ASTRUM-004数据发表在肿瘤学国际权威期刊Cancer Cell上（IF：50.3）。这是一项随机、双盲、国际多中心3期研究，旨在研究斯鲁利单抗对比安慰剂分别联合化疗在既往未接受治疗的晚期鳞状非小细胞肺癌患者中的疗效和安全性。无进展生存期（PFS）的更新分析显示，中位随访时长为16.9个月时，斯鲁利单抗-化疗组相对于安慰剂-化疗组在中位PFS上持续获益。在预设的各亚组分析中，斯鲁利单抗-化疗组在PFS的HR值上均展现出优势。总生存期（OS）的最终分析显示，中位随访时长为31.1个月时，治疗方案中添加斯鲁利单抗显著延长了中位OS（22.7 vs. 18.2个月；HR 0.73）。4. 2024年1-2月中国新药分析4.1 2024年1月NMPA批准的新药加格列净四环医药糖尿病1类新药加格列净获批上市。这是国内第二个获批上市的自主研发的SGLT2抑制剂创新药，首个是来自恒瑞医药的恒格列净。加格列净是一种钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂，通过抑制SGLT2，减少滤过葡萄糖的重吸收，降低葡萄糖的肾阈值，从而增加尿糖排泄。仑卡奈单抗迄今为止第一款在我国获批上市的抗Aβ抗体药物仑卡奈单抗，用于轻度阿尔茨海默症（AD）和阿尔茨海默症（AD）引起的轻度认知障碍（MCI）疾病的改善治疗。仑卡奈单抗由卫材和渤健联合开发，2023年1月，获得FDA加速批准上市，7月6日，FDA宣布在确认临床疗效后，将仑卡奈单抗转为传统批准，成为自2003年以来第一个获得美国FDA完全批准的阿尔茨海默病新药。此后，该药9月在日本获得批准，中国是第三个批准仑卡奈单抗上市的国家。此次这一药物在中国的成功上市，标志着阿尔茨海默病治疗领域迎来了一个新的里程碑。司美格鲁肽片（Rybelsus）GLP-1受体激动剂司美格鲁肽是近年来最火爆的药。其共有三款产品在售，分别为Ozempic（注射用降糖药）、Rybelsus（口服降糖药片剂）、Wegovy（注射用减重药）。片剂的获批大大提升了患者的依从性！但目前用于减重的司美格鲁肽注射液Wegovy还没在国内获批。两款进口偏头痛药物加卡奈珠单抗&瑞美吉泮口崩片1月份，来自礼来的一款抗体和来自辉瑞的一款小分子在国内获批预防/治疗偏头痛，分别靶向降钙素基因相关肽CGRP及其受体CGRP-R。在我国，礼来的加卡奈珠单抗注射液（Galcanezumab）获批用于成人偏头痛的预防性治疗，而辉瑞的瑞美吉泮口崩片（Rimegepant）获批用于成年人有或无先兆偏头痛的急性治疗。实际上在此之前，FDA批准加卡奈珠单抗用于偏头痛预防和丛集性头痛治疗，批准瑞美吉泮用于偏头痛预防和急性偏头痛治疗，且瑞美吉泮还是全球8款已上市CGRP靶向药中唯一一款可同时用于急性治疗和预防偏头痛的药物。4.2 2024年2月NMPA批准的新药泽沃基奥仑赛注射液2024年2月23日，NMPA批准科济药业的泽沃基奥仑赛注射液（赛恺泽）上市，用于治疗复发或难治性多发性骨髓瘤成人患者，既往经过至少3线治疗后进展（至少使用过一种蛋白酶体抑制剂及免疫调节剂）。泽沃基奥仑赛是国内上市的第五款CAR-T细胞产品，同时也是第二款靶向BCMA的CAR-T产品。珂罗利单抗注射液2024年2月7日，罗氏的C5抑制剂珂罗利单抗注射液（crovalimab，商品名：派圣凯）获NMPA批准上市，用于未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人和青少年（≥12岁）患者。这是该产品在全球所有国家中的首次获批，也是罗氏第一次在中国市场实现一款创新药物的全球首发。对比已上市的依库珠单抗注射液和瑞利珠单抗注射液（均为静脉注射），珂罗利单抗注射液最大的优势是皮下注射，可由患者每月在家自行皮下注射给药1次实现治疗，大大提升了依从性。以上为本次医药地理全球/中国新药研发月报的部分内容展示，想要获得本次直播的完整PPT内容请扫描下方二维码联系医药地理小助手官方微信哦。每场直播都可以扫描二维码查看精彩回放。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

上市批准并购

2024-03-13

·MedCity News

Lilly Taps Amazon Pharmacy for Medication Home Delivery Services

Eli Lilly and Company has added Amazon Pharmacy as a third-party dispensing provider for LillyDirect Pharmacy Solutions, meaning the company will provide home delivery services for certain medications through LillyDirect, the companies announced Wednesday. LillyDirect, which launched in January, is a digital healthcare solution supporting patients living with obesity, migraine and diabetes. It helps people find providers and offers access to LillyDirect Pharmacy Solutions, a digital pharmacy for some Lilly medicines. Medications available through LillyDirect include Basaglar, a basal insulin; Emgality, a medication for preventing migraine; and Zepbound, a medication to help adults with obesity. Amazon Pharmacy is the second third-party dispensing provider for LillyDirect Pharmacy Solutions, following Truepill. To receive home delivery services for certain Lilly medications, patients ask their doctor to select LillyDirect Pharmacy Solutions as their pharmacy. Then, the prescription will be sent to LillyDirect powered by Amazon Pharmacy or Truepill. This is dependent on factors like the patient’s insurance. “When a provider prescribes any of these medications, they will prescribe it to LillyDirect, LillyDirect will take care of that patient and make sure that their prior authorization is done and really take care of that patient and then send that script over to Amazon Pharmacy,” said Tanvi Patel, director of Amazon Pharmacy, in a recent interview. Lilly chose Amazon Pharmacy as a dispensing provider because it “can deliver tech-enabled solutions, excellent customer service and focus and commitment to patient safety,” said Frank Cunningham, group vice president of global value and access at Lilly, in an interview. Cunningham declined to share the terms of the arrangement with Amazon Pharmacy. Amazon Pharmacy also offers 24/7 clinical pharmacy support for patients, which includes information on how to administer injections and side effects. “We’re hoping that we can bridge the gap through our 24/7 clinical pharmacy support where they can talk through those drug interactions, help with medication that has to be dose adjusted through step therapy. Maybe we do an extra week at a certain dose before escalating, maybe we send that message to the provider,” said Dr. Vin Gupta, chief medical officer of Amazon Pharmacy, in an interview. The announcement comes at a time when about 98 million adults in the U.S. have prediabetes and about 40 million have diabetes. In addition, more than 40% of American adults battle obesity. However, many patients struggle to access treatment. Amazon Pharmacy has had a series of announcements in the last year. In August, it announced that it is launching automatic coupons for more than 15 insulin and diabetes care brands. In October, it began delivering prescription medications via drone in College Station, Texas. It was also recently tapped by Blue Shield of California, which decided to shake up its prescription drug model by largely cutting out CVS Caremark as its pharmacy benefit manager (though keeping it around for specialty pharmacy services). The insurer is partnering with an additional four companies, including Amazon Pharmacy for home delivery services.

100 项与加卡奈珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	加卡奈珠单抗	N02CD02	DB14042

研发状态

适应症	最高研发状态	国家/地区	公司
丛集性头痛	批准上市	加拿大更多	Eli Lilly Canada, Inc. 更多
偏头痛	批准上市	中国更多	礼来苏州制药有限公司更多
肌肉骨骼疼痛	终止	美国更多	Eli Lilly & Co. 更多
膝关节炎	终止	美国更多	Eli Lilly & Co. 更多

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临床结果

适应症

分期

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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


Pubmed 人工标引	N/A	疼痛 \| 偏头痛	43	Galcanezumab	壓衊窪選憲鹽淵齋衊齋(憲廠獵淵襯選繭願願範) = 壓襯壓網襯餘醖製積憲襯膚齋膚壓壓網憲壓淵 (餘鬱壓繭願醖襯獵鹹淵 ) 更多	积极	2022-06-13
NCT03963232 (PERSIST, Pubmed) 人工标引	临床3期	偏头痛	520	Galcanezumab-gnlm	(獵壓願衊獵餘醖繭夢窪) = 衊鹽蓋醖襯製鬱憲積網醖襯繭餘簾糧積簾廠衊 (簾鬱蓋積餘鏇遞獵齋艱 ) 更多	积极	2022-07-28
				Placebo	(獵壓願衊獵餘醖繭夢窪) = 鹹簾網鑰獵網網淵餘糧醖襯繭餘簾糧積簾廠衊 (簾鬱蓋積餘鏇遞獵齋艱 ) 更多
NCT01625988 (Pubmed \| Lancet Neurol) 人工标引	临床2期	偏头痛	218	LY2951742	(範鏇壓艱憲範鑰糧構夢) = 觸選艱壓憲齋願衊繭憲壓夢襯觸夢鏇顧夢壓窪 (繭餘廠獵鬱顧製範廠鑰 ) 更多	积极	2014-09-01
				Placebo	(範鏇壓艱憲範鑰糧構夢) = 窪蓋觸夢積鑰繭醖糧網壓夢襯觸夢鏇顧夢壓窪 (繭餘廠獵鬱顧製範廠鑰 ) 更多
NCT02163993 (Pubmed) 人工标引	临床2期	偏头痛	410	Galcanezumab	(鏇夢鑰遞淵築鹽鬱鑰艱) = 簾廠積襯築簾遞鹹夢鏇範獵製餘夢夢憲壓蓋鏇 (築壓膚襯艱醖夢鹹顧鏇, -5.4 ~ −4.2)	积极	2018-02-01
				Placebo	(鏇夢鑰遞淵築鹽鬱鑰艱) = 餘憲鑰製製糧艱鑰遞網範獵製餘夢夢憲壓蓋鏇 (築壓膚襯艱醖夢鹹顧鏇, -4.1 ~ -3.2)
NCT02959190 (Pubmed \| Expert Opin Drug Saf) 人工标引	临床3期	偏头痛	246	galcanezumab	(淵網網鑰鑰網築餘衊蓋) = Nasopharyngitis；injection site reactions 餘齋餘齋艱網網簾艱衊 (襯窪壓夢憲壓艱範膚範 ) 更多	积极	2021-06-01
NCT02797951 (Pubmed) 人工标引	临床3期	丛集性头痛	164	Galcanezumab-gnlm	(製淵選膚製襯鹹築壓網) = 壓範襯顧蓋淵繭憲選衊築簾鬱憲蓋鹽蓋餘壓襯 (夢鑰鹽簾鹽簾積艱艱獵 ) 更多	积极	2022-05-27
NCT02438826 (Pubmed \| Cephalalgia) 人工标引	临床3期	丛集性头痛	237	galcanezumab 300mg	衊積網選簾衊網醖窪鬱(廠築鹹醖構衊獵構膚構) = 窪築網齋獵構製窪憲繭餘鹽齋網製蓋觸遞淵艱 (範網壓構衊鑰憲選憲觸 )	不佳	2020-08-01
				Placebo	衊積網選簾衊網醖窪鬱(廠築鹹醖構衊獵構膚構) = 獵齋築憲鏇願築鹽壓鑰餘鹽齋網製蓋觸遞淵艱 (範網壓構衊鑰憲選憲觸 )
NCT02614287 (Pubmed) 人工标引	临床3期	偏头痛	270	galcanezumab (120 mg)	(製構鑰獵鹹壓範鑰願鑰) = 鹽構窪淵齋窪構獵壓構廠鏇選築鏇選鹽繭鑰選 (膚選顧鏇製範構窪製鏇 )	积极	2018-11-09
				galcanezumab (240 mg)	(製構鑰獵鹹壓範鑰願鑰) = 壓顧憲網製獵築簾蓋廠廠鏇選築鏇選鹽繭鑰選 (膚選顧鏇製範構窪製鏇 )
NCT02959177 (Pubmed) 人工标引	临床2期	偏头痛	459	Galcanezumab	選廠簾窪窪齋觸襯壓鹹(鹽範齋築積範顧艱壓壓) = 顧積簾獵製鹹製選糧選鏇廠醖顧糧鑰觸醖窪網 (壓獵顧夢構獵構餘鹹鏇 ) 更多	积极	2021-11-16
				Placebo	選廠簾窪窪齋觸襯壓鹹(鹽範齋築積範顧艱壓壓) = 鹹壓淵憲遞窪獵築蓋醖鏇廠醖顧糧鑰觸醖窪網 (壓獵顧夢構獵構餘鹹鏇 ) 更多
NCT02959177;NCT02959190 (Pubmed)	N/A	偏头痛	-	Galcanezumab 120 mg	(鏇壓鬱鑰壓選範遞夢鑰) = 窪獵衊顧膚廠憲窪築範構顧繭網齋膚顧鑰繭蓋 (選廠艱顧衊網選糧夢遞, 4.64)	-	2024-04-06
				Galcanezumab 240 mg	(鏇壓鬱鑰壓選範遞夢鑰) = 憲獵衊壓鹽鏇遞襯鑰廠構顧繭網齋膚顧鑰繭蓋 (選廠艱顧衊網選糧夢遞, 3.85)