排名前五的靶点	数量

ASN(天冬酰胺)	2
DNA-directed DNA polymerase(DNA-指导DNA聚合酶)	1
LRRK2(富含亮氨酸重复的丝氨酸/苏氨酸蛋白激酶-2)	1
IDH1 x IDH2	1
CD19(B淋巴细胞抗原CD19)	1

关联

项与 Servier Pharmaceuticals LLC 相关的药物

Vorasidenib

靶点

IDH1 x IDH2

作用机制

IDH1抑制剂 [+1]

在研机构

Institut de Recherches Intern Servier [+6]

原研机构

Celgene Corp.

在研适应症

IDH1突变胶质瘤 [+13]

非在研适应症

急性髓性白血病 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2024-08-06

Calaspargase Pegol-MKNL(Shire Plc)

靶点

ASN

作用机制

ASN抑制剂

在研机构

Servier Pharmaceuticals LLC初创企业 [+4]

原研机构

Shire Plc

在研适应症

急性淋巴细胞白血病 [+8]

非在研适应症

胰腺导管癌 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2018-12-20

Ivosidenib

艾伏尼布

靶点

IDH1

作用机制

IDH1抑制剂

在研机构

Institut de Recherches Intern Servier [+10]

原研机构

Celgene Corp.

在研适应症

骨髓增生异常综合征 [+17]

非在研适应症

晚期胆道癌 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2018-07-20

项与 Servier Pharmaceuticals LLC 相关的临床试验

NCT05609994 / Not yet recruiting临床1期IIT

ViCToRy: Vorasidenib in Combination with Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas

The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.

开始日期2025-01-01

申办/合作机构

Duke University

[+1]

NCT05615818 / Recruiting临床3期IIT

Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.
The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

开始日期2024-05-29

申办/合作机构

UNICANCER

[+8]

NCT06081829 / Active, not recruiting临床2期

A Phase 2, Open-label, Multicenter Study of Orally Administered Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

This study will enroll participants with nonresectable or metastatic cholangiocarcinoma with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have previously received at least 1, but no more than 2, prior regimens for advanced disease. All participants will receive ivosidenib daily throughout multiple 28 day cycles. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), every other week during Cycles 2 and 3, and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an end of treatment and a post-treatment follow-up visit, and participants will be followed to assess overall survival. Study visits may include a tumor assessment, physical exam, electrocardiogram (ECG), blood and urine analysis, and questionnaires.

开始日期2023-10-10

申办/合作机构

Servier Pharmaceuticals LLC初创企业

100 项与 Servier Pharmaceuticals LLC 相关的临床结果

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0 项与 Servier Pharmaceuticals LLC 相关的专利（医药）

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项与 Servier Pharmaceuticals LLC 相关的文献（医药）

2024-11-01·Leukemia

Determinants of survival after first relapse of acute lymphoblastic leukemia: a Children’s Oncology Group study

Article

作者: Larsen, Eric ; Ji, Lingyun ; Winter, Stuart S ; Matloub, Yousif ; Bowman, W. Paul ; Kairalla, John A. ; Raetz, Elizabeth A ; Raetz, Elizabeth A. ; Gore, Lia ; Wood, Brent L ; Hunger, Stephen P ; Dunsmore, Kimberly P. ; Heerema, Nyla A ; Rheingold, Susan R. ; Angiolillo, Anne L ; Loh, Mignon L. ; Bhojwani, Deepa ; Carroll, William L ; Wood, Brent L. ; Kairalla, John A ; Mattano, Leonard A. ; Carroll, William L. ; Asselin, Barbara L. ; Borowitz, Michael ; Heerema, Nyla A. ; Breidenbach, Heather ; Loh, Mignon L ; Winick, Naomi J ; Asselin, Barbara L ; Shago, Mary ; Angiolillo, Anne L. ; Carroll, Andrew J. ; Bowman, W Paul ; Hilden, Joanne M ; Carroll, Andrew J ; Maloney, Kelly ; Devidas, Meenakshi ; Xu, Xinxin ; Dreyer, ZoAnn E ; Hunger, Stephen P. ; Hilden, Joanne M. ; Brown, Patrick ; Winick, Naomi J. ; Dunsmore, Kimberly P ; Rheingold, Susan R ; Mattano, Leonard A ; Dreyer, ZoAnn E. ; Winter, Stuart S.

AbstractLimited prognostic factors have been associated with overall survival (OS) post-relapse in childhood Acute Lymphoblastic Leukemia (ALL). Patients enrolled on 12 Children’s Oncology Group frontline ALL trials (1996–2014) were analyzed to assess for additional prognostic factors associated with OS post-relapse. Among 16,115 patients, 2053 (12.7%) relapsed. Relapse rates were similar for B-ALL (12.5%) and T-ALL (11.2%) while higher for infants (34.2%). Approximately 50% of B-ALL relapses occurred late (≥36 months) and 72.5% involved the marrow. Conversely, 64.8% of T-ALL relapses occurred early (<18 months) and 47.1% involved the central nervous system. The 5-year OS post-relapse for the entire cohort was 48.9 ± 1.2%; B-ALL:52.5 ± 1.3%, T-ALL:35.5 ± 3.3%, and infant ALL:21.5 ± 3.9%. OS varied by early, intermediate and late time-to-relapse; 25.8 ± 2.4%, 49.5 ± 2.2%, and 66.4 ± 1.8% respectively for B-ALL and 29.8 ± 3.9%, 33.3 ± 7.6%, 58 ± 9.8% for T-ALL. Patients with ETV6::RUNX1 or Trisomy 4 + 10 had median time-to-relapse of 43 months and higher OS post-relapse 74.4 ± 3.1% and 70.2 ± 3.6%, respectively. Patients with hypodiploidy, KMT2A-rearrangement, and TCF3::PBX1 had short median time-to-relapse (12.5-18 months) and poor OS post-relapse (14.2 ± 6.1%, 31.9 ± 7.7%, 36.8 ± 6.6%). Site-of-relapse varied by cytogenetic subtype. This large dataset provided the opportunity to identify risk factors for OS post-relapse to inform trial design and highlight populations with dismal outcomes post-relapse.

2024-08-13·Blood Advances

Final phase 1 substudy results of ivosidenib for patients with mutant IDH1 relapsed/refractory myelodysplastic syndrome

Article

作者: DiNardo, Courtney D ; Stein, Anthony ; Arellano, Martha L. ; DiNardo, Courtney D. ; Kapsalis, Stephanie M ; Madanat, Yazan F ; Roboz, Gail J. ; Madanat, Yazan F. ; Marchione, Dylan M ; Sallman, David A. ; de Botton, Stéphane ; Roboz, Gail J ; Fathi, Amir T. ; Watts, Justin M ; Kapsalis, Stephanie M. ; Prince, Gabrielle T. ; Marchione, Dylan M. ; Patel, Prapti A. ; Sallman, David A ; Foran, James M ; Hossain, Mohammad ; Bai, Xiaofei ; Prince, Gabrielle T ; Fathi, Amir T ; Foran, James M. ; Garcia-Manero, Guillermo ; Arellano, Martha L ; Patel, Prapti A ; Baratam, Praneeth ; Watts, Justin M.

AbstractIvosidenib is a first-in-class mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor with efficacy and tolerability in patients with advanced mIDH1 hematologic malignancies, leading to approval in frontline and relapsed/refractory (R/R) mIDH1 acute myeloid leukemia. We report final data from a phase 1 single-arm substudy of once-daily ivosidenib in patients with R/R mIDH1 myelodysplastic syndrome (MDS) after failure of standard-of-care therapies. Primary objectives were to determine safety, tolerability, and clinical activity. The primary efficacy end point was the complete remission (CR) + partial remission (PR) rate. Nineteen patients were enrolled; 18 were included in the efficacy analysis. Treatment-related adverse events occurred in 8 (42.1%) patients, including a grade 1 QT interval prolongation in 1 (5.3%) patient and grade 2 differentiation syndrome in 2 (10.5%) patients. Rates of CR + PR and objective response (CR + PR + marrow CR) were 38.9% (95% confidence interval [CI], 17.3-64.3) and 83.3% (95% CI, 58.6-96.4), respectively. Kaplan-Meier estimates showed a 68.6% probability of patients in CR achieving a remission duration of ≥5 years, and a median overall survival of 35.7 months. Of note, 71.4% and 75.0% baseline red blood cell (RBC)- and platelet-transfusion-dependent patients, respectively, became transfusion independent (TI; no transfusion for ≥56 days); 81.8% and 100% of baseline RBC and platelet TI patients, respectively, remained TI. One (5.3%) patient proceeded to a hematopoietic stem cell transplant. In conclusion, ivosidenib is clinically active, with durable remissions and a manageable safety profile observed in these patients. This trial was registered at www.ClinicalTrials.gov as #NCT02074839.

2024-07-12·Science

Mutant IDH1 inhibition induces dsDNA sensing to activate tumor immunity

Article

作者: Kato, Hiroyuki ; Katsuda, Takeshi ; Yates, Kathleen B ; Dhiab, Sofiene ; Kammula, Ashwin V ; Mostoslavsky, Raul ; Kattel, Prabhat ; Cahill, Daniel ; Tron, Adriana E ; Haas, Wilhelm ; Sun, Yi ; Cho, Hyo Min ; Saatcioglu, Duygu Hatice ; Wu, Meng-Ju ; Bardeesy, Nabeel ; McBrayer, Samuel K ; Shi, Diana D ; Merritt, Joshua ; Kitagawa, Yosuke ; Avila, Omar I ; Gritti, Ilaria ; Eccleston, Jason ; Olander, Kira ; Savani, Milan R ; Xiao, Yi ; Sussman, Jonathan ; Cleary, James M ; Tassinari, Ania ; Vijay, Vindhya ; Shi, Lei ; Wakimoto, Hiroaki ; Jenkins, Russell W ; Manguso, Robert T ; Kondo, Hiroshi ; Slater, Chloe J ; Paik, Jihye ; Xu, Qin ; Smith, Bailey C

Isocitrate dehydrogenase 1 ( IDH1 ) is the most commonly mutated metabolic gene across human cancers. Mutant IDH1 (mIDH1) generates the oncometabolite (R)-2-hydroxyglutarate, disrupting enzymes involved in epigenetics and other processes. A hallmark of IDH1 -mutant solid tumors is T cell exclusion, whereas mIDH1 inhibition in preclinical models restores antitumor immunity. Here, we define a cell-autonomous mechanism of mIDH1-driven immune evasion. IDH1 -mutant solid tumors show selective hypermethylation and silencing of the cytoplasmic double-stranded DNA (dsDNA) sensor CGAS , compromising innate immune signaling. mIDH1 inhibition restores DNA demethylation, derepressing CGAS and transposable element (TE) subclasses. dsDNA produced by TE-reverse transcriptase (TE-RT) activates cGAS, triggering viral mimicry and stimulating antitumor immunity. In summary, we demonstrate that mIDH1 epigenetically suppresses innate immunity and link endogenous RT activity to the mechanism of action of a US Food and Drug Administration–approved oncology drug.

项与 Servier Pharmaceuticals LLC 相关的新闻（医药）

2024-10-21

·BioSpace

FDA Approves NGS-Based Companion Diagnostic for First Targeted Therapy for Patients with Grade 2 IDH-Mutant Glioma

Oncomine Dx Target Test to Identify Patients Eligible for Servier’s VORANIGO® (vorasidenib) tablet, the only FDA-approved treatment for Grade 2 IDH-mutant glioma CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO® (vorasidenib) tablets. VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection. As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options. Gliomas are the most common malignant primary brain tumor in adults, representing approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation and testing for these mutations is essential for accurate treatment decisions. Further, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend IDH mutation testing in all patients with a glioma, noting its impact on diagnosis and prognosis of gliomas. IDH mutation status has been a key factor in the NCCN treatment guidelines for years. With the FDA approval of VORANIGO, determining the IDH mutation status of patients with glioma will be even more critical. “VORANIGO is the first and only targeted therapy for patients living with grade 2 IDH mutant glioma, a relentless and incurable type of brain cancer that hasn’t seen treatment advances in nearly 25 years,” said David K. Lee, CEO of Servier Pharmaceuticals. “As more targeted therapies become available to patients, identifying key driver mutations is essential to help the right patients find the right treatment, at the right time.” In addition to the approval for IDH-mutant diffuse glioma, the Oncomine Dx Target Test, has also previously received approvals for indications in non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC). As a distributable companion diagnostic, the test simultaneously delivers biomarker results for multiple targeted therapies from one sample, helping quickly match patients with the right targeted therapies. “As the healthcare system works to realize the impact of precision medicine, patients must have access to the proper testing that helps unlock targeted treatment options based on their unique genomic pro This access is the driving motivation behind the extensive work we do with pharma partners to help connect the right patients to new therapies as soon as they are approved,” said Kathy Davy, president, clinical next-generation sequencing at Thermo Fisher Scientific. “The work we do every day reflects our Mission, and combining our CDx technology with Servier’s breakthrough therapy will help dramatically impact care for patients with aggressive brain tumors.” Today’s approval expands clinical indications for the Oncomine Dx Target Test, which is currently approved and reimbursed by government and commercial insurers in 19 countries, including the U.S., Japan, South Korea and countries across Europe and the Middle East, covering more than 550 million lives globally. Following this approval, the two organizations will continue to collaborate on an additional companion diagnostics with the Ion Torrent™ Oncomine Dx Express Test.* Available on the Ion Torrent Genexus™ Dx System*, the Oncomine Dx Express Test can return results in as little as a single day, dramatically accelerating the pace with which patients can be matched with optimal treatments based on their genomic results. *The Oncomine Dx Express Test and the Genexus Dx System are currently available only in countries that accept the CE mark. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit . Contacts Media Contact Information: Amanda Strickland Phone: (910) 622-8752 E-mail: amanda.strickland@thermofisher.com Jessika Parry Phone: 419-266-4016 Email: jparry@greenoughagency.com

上市批准临床研究诊断试剂

2024-10-21

·Pharmaceutical Technology

Thermo Fisher’s Oncomine gains FDA approval as brain tumor diagnostic

The Ion Torrent Oncomine Dx Target Test is the first FDA-approved next generation sequencing-based diagnostic. Credits: JHVEPhoto / Shutterstock. Thermo Fisher Scientific has announced that its in vitro diagnostic test, Oncomine, has won US Food and Drug Administration (FDA) approval for use as a companion diagnostic in grade 2 IDH-mutant glioma. As per the 21 October press announcement, Oncomine is now approved to be used to identify patients who are eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets. Voranigo, which gained FDA approval in August 2024, is the first and only targeted therapy available for patients with grade 2 IDH-mutant glioma. The French drugmaker gained control over the asset in 2020 after purchasing Agios’ oncology pipeline for $1.8bn in 2020. Agios has since sold its royalty stake in Voranigo to Royalty Pharma for $905m. Under the terms of the agreement, Royalty Pharma will gain a 12% royalty on annual US sales up to $1bn and a 12% royalty on net US sales over $1bn. As a once-daily oral inhibitor of IDH1 and IDH2 enzymes, Voranigo is indicated for use in grade 2 IDH-mutant glioma patients following surgery, including biopsy or gross total resection. The Ion Torrent Oncomine Dx Target Test is the first FDA-approved sequencing-based diagnostic. Oncomine received its first approval as a companion diagnostic in 2017 and subsequently gained approval in August 2022 as a companion diagnostic for identifying non-small cell lung cancer (NSCLC) patients eligible for treatment with Daiichi Sankyo ’s Enhertu (fam-trastuzumab deruxtecan-nxki). See Also: FDA approves Astellas’ VYLOY for gastric cancer treatment Intercept’s liver disease drug Ocaliva faces FDA approval delay Oncomine is also approved for use in cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC). Daiichi and AstraZeneca ’s Enhertu has seen several wins this year. The drug gained conditional approval in China earlier this month and a breakthrough therapy designation for a specific type of breast cancer in August 2024. Additionally, in April, the treatment was granted accelerated approval for the treatment of unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive [immunohistochemistry (IHC) 3+] solid tumours. According to GlobalData’s consensus forecasts, Voranigo is expected to generate sales of $37m in 2030. Enhertu is projected to generate total sales of $13bn in 2030. GlobalData is the parent company of Pharmaceutical Technology .

上市批准免疫疗法突破性疗法引进/卖出

2024-10-10

·BiG生物创新社

2024年FDA批准新药汇总

作者｜momo 截止目前，FDA已经批准35款新药上市，其中多款药物具有里程碑意义。 01 2024年FDA已批准药物 1.1.Zelsuvmi (berdazimer) 适应症：局部传染性软疣批准日期：2024年1月5日企业：Novan Inc. 1.2.Exblifep (cefepime and enmetazobactam) 适应症：尿路感染靶点：LACTB、PBP 批准日期：2024年2月22日企业：Orchid Chemicals & Pharmaceuticals Ltd. 1.3.Letybo (letibotulinumtoxin a-WLBG) 适应症：中度至重度眉间纹的外观改善靶点：BoNT/A 批准日期：2024年2月29日企业：Hugel Inc. 1.4.Tevimbra (tislelizumab-JSGR) 适应症：不可切除、局部晚期或转移性食管鳞状细胞癌靶点：PD-1 批准日期：2024年3月13日企业：百济神州 1.5.Rezdiffra (resmetirom) 适应症：中晚期非肝硬化性非酒精性脂肪性肝炎靶点：THR-β 批准日期：2024年3月14日企业：罗氏 1.6.Tryvio 适应症：高血压靶点：ET-A、ET-B 批准日期：2024年3月19日企业：Idorsia. 1.7.Duvyzat 适应症：杜氏肌营养不良症靶点：HDAC 批准日期：2024年3月21日企业：Italfarmaco Spa. 1.8.Winrevair (sotatercept-CSRK) 适应症：肺动脉高压靶点：INHBA 批准日期：2024年3月26日企业：Acceleron Pharma Inc. 1.9.Vafseo 适应症：成人慢性肾脏疾病引起的贫血靶点：HIF 批准日期：2024年3月27日企业：宝洁 1.10.Voydeya 适应症：阵发性夜间血红蛋白尿治疗血管外溶血靶点：CFD 批准日期：2024年3月29日企业：Achillion Pharmaceuticals Inc. 1.11.Zevtera (ceftobiprole medocaril sodium) 适应症：血液感染、细菌性皮肤和相关组织感染、社区获得性细菌性肺炎靶点：PBP 批准日期：2024年4月3日企业：Roche 1.12.Lumisight 适应症：乳腺癌荧光成像批准日期：2024年4月17日企业：Lumicell Inc., 杜克大学 1.13.Anktiva (nogapendekin alfa inbakicept-pmln) 适应症：膀胱癌靶点：IL-15R 批准日期：2024年4月22日企业：Altor Bioscience Corp. 1.14.Ojemda (tovorafenib) 适应症：复发或难治性儿童低级别胶质瘤靶点:RAF 批准日期：2024年4月23日企业：Viracta Therapeutics Inc. 1.15.Xolremdi (mavorixafor) 适应症：治疗12岁及以上患有WHIM综合征的患者靶点：CXCR4 批准日期：2024年4月26日企业：赛诺菲 1.16.Imdelltra (tarlatamab-dlle) 适应症：广泛期小细胞肺癌靶点：CD3E、DLL3 批准日期：2024年5月16日企业：Amgen Inc. 1.17.Rytelo (imetelstat) 适应症：低危骨髓增生异常综合征伴输血依赖性贫血靶点：Telomerase 批准日期：2024年6月6日企业：Geron Corp. 1.18.Iqirvo (elafibranor) 适应症：原发性胆汁性胆管炎靶点：PPARɑ/γ 批准日期：2024年6月10日企业：Genfit SA 1.19.Sofdra (sofpironium) 适应症：原发性腋窝多汗症靶点：AChR 批准日期：2024年6月18日企业：Bodor Laboratories Inc. 1.20.Piasky (crovalimab-akkz) 适应症：阵发性睡眠性血红蛋白尿症靶点：C5 批准日期：2024年6月20日企业：Sino-Foreign Pharmaceutical Co., Ltd. 1.21.Ohtuvayre（Ensifentrine）适应症：治疗慢性阻塞性肺病靶点：PDE3/4 批准日期：2024年6月26日企业：Verona Pharma. 1.22.Kisunla（Donanemab-azbt）适应症：阿尔兹海默病靶点：pGlu3Aβ 批准日期：2024年7月2日企业：lilly 1.23.Leqselvi（Deuruxolitinib）适应症：严重斑秃靶点：JAK 批准日期：2024年7月25日企业：Sun Pharmaceuticals 1.24.Voranigo（vorasidenib）适应症：IDH1或IDH2易感突变的2级星形细胞瘤或少突胶质细胞瘤。靶点：IDH1、IDH2 批准日期：2024年8月6日企业：Servier Pharmaceuticals 1.25.Yorvipath（palopegteriparatide）适应症：甲状旁腺功能亢进批准日期：2024年8月9日企业：ascendis Pharma. 1.26.Nemluvio（nemolizumab-ilto）适应症：结节性痒疹靶点:IL-31 批准日期：2024年8月12日企业：Galderma Pharma. 1.27. Livdelzi（seladelpar）适应症：原发性胆汁性胆管炎靶点：PPAR-δ 批准日期：2024年8月14日企业：Gilead Sciences 1.28.Niktimvo（axatilimab-csfr）适应症：慢性移植物抗宿主病靶点CSF-1R 批准日期：2024年8月14日企业：Incyte/Syndax制药 1.29.Lazcluze（lazertinib）适应症：非小细胞肺癌靶点：EGFRm 批准日期：2024年8月19日企业：强生 1.30.Ebglyss（lebrikizumab-lbkz）适应症：中度至重度特应性皮炎靶点：IL-13 批准日期：2024年9月13日企业：lilly 1.31.Miplyffa（arimoclomol）适应症：C型尼曼-匹克病靶点：HSP 批准日期：2024年9月20日企业：Zevra Therapeutics 1.32.Aqneursa （levacetylleucine）适应症：儿童和成人C型尼曼匹克病批准日期：2024年9月24日企业：IntraBio. 1.33.Cobenfy（xanomeline and trospium chloride）适应症：成人精神分裂症靶点：M1-和M4-选择性毒蕈碱受体批准日期：2024年9月26日企业：百时美施贵宝 1.34.Flyrcado（flurpiridaz F 18）适应症：评估心脏血流阻塞（心肌缺血）和心脏病发作（心肌梗塞）批准日期：2024年9月27日企业：GE HealthCare 1.35.Tevimbra（Tislelizumab）适应症：不可切除或转移性食管鳞状细胞癌靶点：PD-1 批准日期：2024年10月4日企业：百济神州 02 2024年FDA批准的突出药物 Voranigo（vorasidenib）这种双重IDH1/IDH2抑制剂处理导致癌细胞代谢变化的突变。它被批准用于2级星形细胞瘤或少突胶质细胞瘤，这是一种生长缓慢的脑肿瘤，具有显著的风险。这是一个突破，因为它直接针对驱动肿瘤生长的突变，提供了一种更有效的治疗选择，可以延缓疾病进展，减少对辐射等侵入性治疗的依赖。 Niktimvo（Axatilimab）是一种CSF-1R单克隆抗体，通过限制巨噬细胞活性来治疗cGVHD，巨噬细胞在免疫应答中起着至关重要的作用。这种疗法对患有cGVHD的患者至关重要，这是干细胞移植后的一种严重并发症，通常对现有治疗无效。它提供了一种更有针对性的策略来改善患者的生活质量。 Cobenfy作为Xanomeline和Trospium Chloride这种联合治疗方法，通过调节毒蕈碱受体，为治疗精神分裂症带来了新的途径。通过平衡大脑中的神经递质活动，它解决了这种疾病的阳性和阴性症状，这使得它对那些用其他药物都没有成功的患者特别有价值。它的双重机制提供了更全面的症状管理，改善了那些受这种具有挑战性的精神健康状况影响的结果。 Rezdiffra（resmetirom）是一款甲状腺激素受体（THR）-β口服选择性激动剂，THR-β在肝脏中高度表达，能够调节脂代谢，降低LDL-C、甘油三酯和致动脉粥样硬化性脂蛋白。此外，THR-β还能通过促进脂肪酸的分解和刺激线粒体的生物发生来减少脂肪毒性并改善肝功能，从而减少肝脏脂肪。Rezdiffra用于治疗患有中重度肝纤维化（F2至F3期）的非肝硬化非酒精性脂肪性肝炎（NASH）患者，成为FDA批准的首款NASH疗法，具有里程碑意义。 Anktiva是一款IL-15超级激动剂。IL-15通过影响自然杀伤（NK）细胞和免疫T细胞的发育、维持和功能，在免疫系统中发挥着至关重要的作用。Anktiva由与IL-15受体α/IgG1 Fc融合蛋白结合的IL-15突变体（IL-15N72D）组成。它与βγ T细胞受体结合，直接特异性刺激CD8阳性T细胞和NK细胞，同时避免刺激调节性T细胞（Treg）。与天然、非复合IL-15相比，Anktiva在患者体内具有更优的药代动力学特性，且能在淋巴组织中存在更长时间，表现出增强的抗肿瘤活性。Anktiva在2019年获FDA授予突破性疗法认定，用于与BCG联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。参考资料 [1]Novel Drug Approvals for 2024 | FDA [2]百济神州官网 BiG近期会议 10月26日，第三届生物计算大会保留栏目-第二届吐槽大会即将再度来袭！本届吐槽大会将围绕投融资、行业心态、年轻人，及AI等热门话题展开策划，通过移幕换景，大咖带新秀，让更多80-00后的行业亲历者来到聚光灯下，邀与会嘉宾一同探讨AI+Biomed的融合之道！共建Biomedical创新生态圈！如何加入BiG会员？

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药物(靶点)	适应症	全球最高研发状态

特丁胺培哚普利 ( ACE )	高血压更多	批准上市
培门冬酶 ( ASN )	超敏反应更多	批准上市
艾伏尼布 ( IDH1 )	IDH1突变急性髓性白血病更多	批准上市
Vorasidenib ( IDH1 x IDH2 )	IDH 突变型少突胶质细胞瘤更多	批准上市
Calaspargase Pegol-MKNL(Shire Plc) ( ASN )	急性淋巴细胞白血病更多	批准上市