主要研究目的：评估空腹和餐后状态下单次口服受试制剂泊那替尼片（规格：15 mg，持证商：成都硕德药业有限公司）与参比制剂泊那替尼片（Iclusig®，规格：15 mg，持证商：大塚製薬株式会社）在健康参与者体内的药代动力学参数，评价空腹和餐后状态下口服两种制剂的生物等效性。次要研究目的：评估泊那替尼片（规格：15 mg）与参比制剂泊那替尼片（Iclusig®，规格：15 mg）在健康参与者中的安全性。

开始日期2025-03-25

申办/合作机构

成都硕德药业有限公司

CTR20250810

/ Active, not recruitingN/A

评估受试制剂泊那替尼片与参比制剂泊那替尼片（ICLUSIG®）作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究

研究空腹状态下单次口服受试制剂泊那替尼片与参比制剂泊那替尼片（ICLUSIG®）在健康成年受试者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性和安全性。

开始日期2025-03-20

申办/合作机构

齐鲁制药有限公司

NCT06860269

/ Not yet recruiting临床2/3期IIT

A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia

Adult acute lymphoblastic leukemia (ALL) includes Ph-positive (Phpos) ALL, Ph-negative (Phneg) B-cell precursor (BCP) ALL and T-ALL/lymphoblastic lymphoma (LL), accounting for approximately 25, 50 and 25% of all cases, respectively. In younger adults, the results associated with standard therapy have markedly improved in these 3 groups, due to chemotherapy intensification in the BCP and T groups and addition of TKIs in the Phpos group, respectively. This led to reevaluate the role of allogeneic hematopoietic stem cell transplantation (HSCT) in first remission, which is generally now indicated only in higher-risk patients, mostly defined as those with persistent high levels of minimal residual disease (MRD). Nevertheless, event-free survival (EFS) remains at 60-70% at 3 years, meaning there is still room for further improvements.
Fortunately, new immunotherapies have been approved to treat relapsed/refractory (R/R) BCP-ALL patients, including the anti-CD19 bispecific T-cell engager blinatumomab (BLINA, Blincyto®, Amgen). 4 BLINA is also approved for the frontline treatment of patients with persistent high measurable residual disease (MRD) levels after initial therapy (IG/TR MRD ≥0.1% (≥1.10-3
)). BLINA has been also evaluated frontline in combination with TKI in the Phpos group leading to promising outcome improvements. Toxicities associated with these combined treatments seem to be limited and manageable. In the Phpos ALL subset, the third-generation tyrosine kinase inhibitor ponatinib (PONA, Iclusig®, Incyte) has also been evaluated frontline with promising results when compared to 1st or even 2nd generation TKI. In the T-ALL/LL subset, anti-CD38 antibodies, approved to treat patients with multiple myeloma, are potential drugs of interest. The anti-CD38 antibody isatuximab (ISA, Sarclisa®, Immunogen, Sanofi-Aventis) is currently approved to treat myeloma patients in 2nd line. In vitro and in vivo preclinical studies suggest that CD38 is a relevant target in T-ALL and that isatuximab may be useful to eradicate residual disease in this subgroup of patients. Incorporation/combination of these new agents into frontline adult ALL therapy could allow reducing relapse incidence and prolonging survival in these patients, challenging the indication for HSCT in first complete remission (CR).
The present GRAALL-2024 study is a prospective multicenter multi-country 3-cohort randomized clinical trial.
The 3 cohorts are :
GRAALL-2024/B : Phneg BCP-ALL GRAAPH-2024 : Phpos ALL GRAALL-2024/T : T-ALL/LL
Eligible patients will be allocated to one on the 3 study cohorts during a common treatment prephase. The primary objective of the study is to improve the outcome of younger adults with ALL through optimal frontline incorporation of new antibody-based therapies, including BLINA in Phneg/pos BCP-ALL patients and ISA in T-ALL/LL patients, and to refine indication for allogeneic HSCT in first remission in Phneg/pos BCP-ALL patients.

开始日期2025-03-15

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

100 项与盐酸普纳替尼相关的临床结果

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100 项与盐酸普纳替尼相关的转化医学

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100 项与盐酸普纳替尼相关的专利（医药）

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2,032

项与盐酸普纳替尼相关的文献（医药）

2025-12-31·Virulence

Ponatinib and other clinically approved inhibitors of Src and Rho-A kinases abrogate dengue virus serotype 2- induced endothelial permeability

Article

作者: Awasthi, Mansi ; Modak, Ayan ; Sobha, Archana ; Sreekumar, Easwaran ; Mishra, Srishti Rajkumar

Severe dengue often presents as shock syndrome with enhanced vascular permeability and plasma leakage into tissue spaces. In vitro studies have documented the role of Src family kinases (SFKs) and RhoA-kinases (ROCK) in dengue virus serotype 2 (DENV2)-induced endothelial permeability. Here, we show that the FDA-approved SFK inhibitors Bosutinib, Vandetanib and Ponatinib, as well as the ROCK inhibitors, Netarsudil and Ripasudil significantly inhibit DENV2-induced endothelial permeability. In cultured telomerase immortalized human microvascular endothelial cells (HMEC-1), treatment with these inhibitors reduced the phosphorylation of VE-Cadherin, Src and myosin light chain 2 (MLC2) proteins that were upregulated during DENV2 infection. It also prevented the loss of VE-Cadherin from the inter-endothelial cell junctions induced by viral infection. In in-vivo studies using DENV2-infected AG129 IFN receptor-α/β/γ deficient mice, ponatinib, when administered 24 h post-infection onwards, demonstrated significant benefits in improving body weight, clinical outcomes, and survival rates. While all virus-infected, untreated mice died by day-10 post-infection, 80% of the ponatinib-treated mice survived, and approximately 60% were still alive at the end of the 15-day observation period. The treatment also significantly reduced disease severity factors such as vascular leakage, thrombocytopenia; mRNA transcript levels of proinflammatory cytokines such as IL-1β and TNF-α; and restored liver function. Comparable effects were observed even when ponatinib treatment was initiated after symptom onset. The results highlight ponatinib as an effective therapeutic option in severe dengue; and also a similar potential for other FDA- approved SFK and ROCK inhibitors.

2025-06-01·Toxicology reports

Gossypol enhances ponatinib's cytotoxicity against human hepatocellular carcinoma cells by involving cell cycle arrest, p-AKT/LC3II/p62, and Bcl2/caspase-3 pathways

Article

作者: Elkattan, Hadeel H ; El-Lakkany, Naglaa M ; Elsisi, Alaa E

Despite significant breakthroughs in frontline cancer research and chemotherapy for hepatocellular carcinoma (HCC), many of the suggested drugs have high toxic side effects and resistance, limiting their clinical utility. Exploring potential therapeutic targets or novel combinations with fewer side effects is therefore crucial in combating this dreadful disease. The current study aims to use a novel combination of ponatinib and gossypol against the HepG2 cell line. Cell survival, FGF19/FGFR4, apoptotic and autophagic cell death, and synergistic drug interactions were assessed in response to increasing concentrations of ponatinib and/or gossypol treatment. Research revealed that ponatinib (1.25-40 μM) and gossypol (2.5-80 μM) reduced the viability of HepG2 cells in a way that was dependent on both time and dose. Ponatinib's anti-proliferation effectiveness was improved synergistically by gossypol and was associated with a rise in apoptotic cell death, cell cycle blockage during the G0/G1 phase, and suppression of the FGF19/FGFR4 axis. Furthermore, the ponatinib/gossypol combination lowered Bcl-2 and p-Akt while increasing active caspase-3, Beclin-1, p62, and LC3II. This combination, however, had no harm on normal hepatocytes. Overall, gossypol enhanced ponatinib's anticancer effects in HCC cells. Notably, this new combination appears to be potential adjuvant targeted chemotherapy, a discovery that warrants more clinical investigation, in the management of patients with HCC.

2025-06-01·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Treatment of Older Patients With ALL

Review

作者: Haddad, Fadi G. ; Jabbour, Elias ; Kantarjian, Hagop

Older patients with ALL often have high-risk disease characterized by adverse-risk cytogenetic and molecular abnormalities, as well as Philadelphia chromosome (Ph)-positive and Ph-like phenotypes. They often have comorbidities resulting in poor tolerance to chemotherapy and are at risk of developing therapy-related myeloid neoplasms (t-MNs). In Ph-negative ALL, the duration and intensity of chemotherapy was reduced, and outcomes improved with the addition of inotuzumab ozogamicin (InO) and blinatumomab into the frontline setting. However, t-MNs are still being observed, prompting the development of chemotherapy-free regimens with InO and blinatumomab as well as chimeric antigen receptor (CAR) T-cell therapies in high-risk disease. In Ph-positive ALL, chemotherapy and allogeneic hematopoietic stem-cell transplantation (HSCT) were historically considered a standard of care. However, the introduction of blinatumomab and newer-generation BCR::ABL1 tyrosine kinase inhibitors (TKIs) into the frontline setting significantly improved outcomes. The combination of blinatumomab and ponatinib induced high rates of complete molecular responses and excellent survival, without reliance on HSCT. A subset of patients with elevated WBC count at diagnosis are at particular risk of CNS and systemic relapse and may require additional strategies such as incorporating one to two cycles of high-dose methotrexate/cytarabine into consolidation, and potentially CAR T cells. In T-cell ALL, adding venetoclax into the frontline setting has improved outcomes. In early T-cell precursor ALL, HSCT is still needed. To further improve outcomes in older patients, novel agents such as subcutaneous blinatumomab, CAR T cells, newer-generation TKIs, and menin inhibitors should be investigated in the frontline setting.

242

项与盐酸普纳替尼相关的新闻（医药）

2025-05-18

·药明康德

有望2-3个月给药一次的哮喘疗法；疾病控制率超90%的ADC…… | 一周盘点

本期看点1. 抗体偶联药物（ADC）CX-2051在晚期结直肠癌（CRC）中取得了积极的1期临床试验结果，总缓解率（ORR）为28%，疾病控制率（DCR）达94%。2. IL-4Rα靶向单抗APG808在治疗哮喘的1b期临床试验中表现亮眼，该疗法在12周内对一种与哮喘恶化相关的2型炎症生物标志物具有强效且持续的抑制作用，有望支持其实现每两个月或更长时间一次的给药方案。3. FDA批准了Lantern Pharma公司的新型“合成致死”小分子药物LP-184的IND申请。CX-2051：公布1期临床试验的中期数据CytomX Therapeutics公布了其ADC疗法CX-2051在晚期结直肠癌（CRC）中的积极1期中期数据。CX-2051是一种条件激活型ADC，其使用的细胞毒性有效载荷是喜树碱的衍生物。喜树碱是一种拓扑异构酶-1抑制剂，这类药物已在ADC领域针对多个靶点显示出强大的临床抗癌活性。CX-2051已在包括结直肠癌在内的多个临床前模型中显示出强大的临床前活性和耐受性。截至2025年4月7日的数据，ORR为28%（5/18），其中10 mg/kg剂量组的ORR达到43%（3/7），显著高于目前三线及三线以上结直肠癌治疗药物的缓解率（通常仅有个位数的百分比）。DCR为94%（17/18），中位无进展生存期为5.8个月。截至数据截止时，18名患者中有10名仍在接受治疗。安全性方面，CX-2051的耐受性良好，未出现剂量限制性毒性（DLT），大多数治疗相关不良事件为1级或2级。APG808：公布1b期临床试验的中期数据Apogee Therapeutics公司公布了其候选单抗APG808用于治疗轻度至中度哮喘患者的1b期临床试验的积极中期数据。APG808是一种新型、皮下注射、半衰期延长的IL-4Rα靶向单抗，具有用于治疗哮喘、慢性阻塞性肺病（COPD）及其他炎症与免疫学适应症的潜力。IL-4Rα是一个已在八种2型过敏性疾病中得到临床验证的靶点。在1期临床试验中，APG808的药代动力学（PK）特征有望支持每2-3个月一次的维持治疗给药方案。此次公布的结果显示，多剂量给药APG808可使FeNO（一种与哮喘恶化相关的2型炎症生物标志物）较基线大幅下降53%，并在12周时仍维持约50%的抑制水平，显示出对哮喘的持续控制能力。APG808的优化配方和潜在“best-in-class”的PK特征，结合在12周内对FeNO的强效且持续的抑制作用，有望支持其实现每两个月或更长时间一次的给药方案，相较于目前每两周一次的标准治疗具有优势。此外，APG808整体耐受性良好，安全性特征与已有的抗IL-4Rα疗法一致。Soquelitinib：公布1期临床试验中队列1-3的数据Corvus Pharmaceuticals公司公布了其小分子白细胞介素-2诱导的T细胞激酶（ITK）抑制剂soquelitinib用于治疗中度至重度特应性皮炎的1期临床试验数据。ITK是一种主要表达于T细胞中的酶，在T细胞和自然杀伤（NK）细胞的免疫功能中起重要作用。通过抑制ITK，soquelitinib有望抑制自身免疫和炎症反应。此次公布的结果显示，所有3个队列中，soquelitinib治疗组在具有临床意义的终点湿疹面积和严重度指数较基线减少75%（EASI 75）和研究者总体评估（IGA）评分为0/1（皮肤症状清除或几乎清除）上，均显示出相较于安慰剂的显著疗效。与队列1和队列2（100 mg每天两次和200 mg每天一次，每日总剂量200 mg）相比，队列3（200 mg每天两次，每日总剂量400 mg）的缓解更早且更深。安全性方面，soquelitinib的耐受性良好，在所有队列中均未观察到DLT，也未出现具有临床意义的实验室指标异常。此外，所有队列中均未发生中断给药的情况。▲治疗第28天达到终点IGA 0/1、EASI 75的患者占比（图片来源：参考资料[1]）ELVN-001：公布1期临床试验的新数据Enliven Therapeutics公司公布其小分子激酶抑制剂ELVN-001治疗慢性粒细胞白血病（CML）患者的1期临床试验的新数据。ELVN-001是一种强效、高选择性、潜在“best-in-class”的小分子激酶抑制剂，专门针对CML患者的致癌驱动因子BCR-ABL融合蛋白。ELVN-001还具有针对耐药性最强的BCR-ABL1耐药突变体T315I和其他已知耐药突变体的活性。截至2025年1月21日的数据，在36例可评估的患者中，44%（16/36）在24周时达到主要分子学缓解（MMR），其中最后一线治疗时对酪氨酸激酶抑制剂（TKI）耐药的患者中有40%（10/25）达到了MMR，曾接受asciminib或ponatinib治疗的患者中也有36%（9/25）达到MMR，包括1例携带已知asciminib耐药突变的患者。所有达到或维持MMR的患者在数据截止时仍保持缓解。在该临床试验中所纳入的患者群体此前接受过大量治疗的情况下，ELVN-001与已获批的针对BCR-ABL融合蛋白的TKI在1期试验中所观察到的MMR相比，结果依然更好。安全性方面，ELVN-001在所有剂量组中仍表现出良好的耐受性，与其选择性激酶谱一致。LP-184：IND申请获得FDA许可Lantern Pharma公司宣布，FDA已批准其抗癌新药LP-184的IND申请。LP-184将与免疫检查点抑制剂联用，针对携带KEAP1和/或STK11突变和PD-L1低表达的非小细胞肺癌（NSCLC）患者开展1b/2期临床试验。LP-184是一种新型“合成致死”小分子药物，其作用机制是在前列腺素还原酶1（PTGR1）的激活下诱导DNA双链断裂。PTGR1在KEAP1突变型肿瘤中显著过表达。临床前研究表明，LP-184对NSCLC细胞系的杀伤力与PTGR1的表达水平呈正相关。该公司专有的RADR平台驱动的计算机分析和临床前研究表明，LP-184对DNA损伤修复（DDR）缺陷型癌症特别有效，包括携带KEAP1和STK11突变的NSCLC。此外，PTGR1会在肿瘤细胞内将LP-184由前药转化为具有生物活性的细胞毒性物质，而正常组织由于PTGR1表达水平低，基本不受影响。这使得LP-184有望在具有强效抗肿瘤活性的同时降低全身毒性。值得注意的是，LP-184的作用机制不受TP53突变状态影响。该突变是导致当前多种疗法产生耐药性的常见共突变因素。参考资料（可上下滑动查看）[1] Corvus Pharmaceuticals Announces Data from Cohorts 1-3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis. Retrieved May 16, 2025, from https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo[2] MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS). Retrieved May 16, 2025, from https://www.businesswire.com/news/home/20250511855391/en/MaaT-Pharma-Announces-Promising-Final-Data-Readout-for-Phase-1b-Evaluating-MaaT033-in-Amyotrophic-Lateral-Sclerosis-ALS[3] Cantargia announces successful Phase 1 results: PK/PD data of subcutaneously administered CAN10 confirms every 4-week dosing choice in Phase 2. Retrieved May 16, 2025, from https://cantargia.com/en/press-releases/cantargia-announces-successful-phase-1-results-pk-pd-data-of-subcutaneously-administered-can10-confirms-every-4-week-dosing-choice-in-phase-2[4] Apogee Therapeutics Announces Positive Interim Results from the Phase 1b Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody, in Patients with Mild-to-Moderate Asthma. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078912/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Results-from-the-Phase-1b-Trial-of-APG808-its-Novel-Half-life-Extended-IL-4R%CE%B1-Antibody-in-Patients-with-Mild-to-Moderate-Asthma.html[5] CytomX Announces Positive Interim Data From Phase 1 Dose Escalation Study of EpCAM Antibody Drug Conjugate (CX-2051) Candidate in Patients with Advanced Colorectal Cancer (CRC). Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078935/37704/en/CytomX-Announces-Positive-Interim-Data-From-Phase-1-Dose-Escalation-Study-of-EpCAM-Antibody-Drug-Conjugate-CX-2051-Candidate-in-Patients-with-Advanced-Colorectal-Cancer-CRC.html[6] MavriX Bio Announces FDA Clearance of IND Application to Initiate First-in-Human Study of Gene Therapy for Angelman Syndrome. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/mavrix-bio-announces-fda-clearance-of-ind-application-to-initiate-first-in-human-study-of-gene-therapy-for-angelman-syndrome-302451763.html[7] Ensoma Announces FDA Clearance of IND Application for First In Vivo HSC-Directed Gene Insertion Therapy. Retrieved May 16, 2025, from https://ensoma.com/press-release/ensoma-announces-fda-clearance-of-ind-application-for-first-in-vivo-hsc-directed-gene-insertion-therapy/[8] Faron Pharmaceuticals presents promising Phase 1/2 data from BEXMAB Study at MDS 2025 plenary session. Retrieved May 16, 2025, from https://faron.com/releases-and-publications/faron-pharmaceuticals-presents-promising-phase-1-2-data-from-bexmab-study-at-mds-2025-plenary-session/[9] Lantern Pharma Secures FDA Clearance for Planned Phase 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need. Retrieved May 16, 2025, from https://ir.lanternpharma.com/news-events/press-releases/detail/179/lantern-pharma-secures-fda-clearance-for-planned-phase-1b2[10] Innovo Therapeutics Announces Positive Phase 1 Results for INV-101, a Novel Immuno-Metabolic Modulator for Autoimmune Diseases. Retrieved May 16, 2025, from https://www.businesswire.com/news/home/20250512131551/en/Innovo-Therapeutics-Announces-Positive-Phase-1-Results-for-INV-101-a-Novel-Immuno-Metabolic-Modulator-for-Autoimmune-Diseases[11] Capsida Receives FDA IND Clearance for Its First-in-Class, IV-administered Gene Therapy for STXBP1 Developmental and Epileptic Encephalopathy. Retrieved May 16, 2025, from https://capsida.com/capsida-receives-fda-ind-clearance-for-its-first-in-class-iv-administered-gene-therapy-for-stxbp1-developmental-and-epileptic-encephalopathy/[12] AAVantgarde presents positive clinical data from its AAVB-081 program for Usher 1B and preclinical data from its AAVB-039 program for Stargardt at the ARVO 2025 annual meeting. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078987/0/en/AAVantgarde-presents-positive-clinical-data-from-its-AAVB-081-program-for-Usher-1B-and-preclinical-data-from-its-AAVB-039-program-for-Stargardt-at-the-ARVO-2025-annual-meeting.html[13] Artiva Biotherapeutics Announces Longer-term Phase 1/2 Data Demonstrating Prolonged Durability for AlloNK® in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/13/3080625/0/en/Artiva-Biotherapeutics-Announces-Longer-term-Phase-1-2-Data-Demonstrating-Prolonged-Durability-for-AlloNK-in-Combination-with-Rituximab-in-Patients-with-B-cell-Non-Hodgkin-Lymphoma.html[14] Sernova Biotherapeutics Provides Positive Interim Data from Ongoing Phase 1/2 Clinical Trial of Cell Pouch Bio-hybrid Organ in Patients Living with Type 1 Diabetes. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/14/3080975/0/en/Sernova-Biotherapeutics-Provides-Positive-Interim-Data-from-Ongoing-Phase-1-2-Clinical-Trial-of-Cell-Pouch-Bio-hybrid-Organ-in-Patients-Living-with-Type-1-Diabetes.html[15] Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML and Oral Presentation at the EHA 2025 Congress. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-updated-positive-data-from-phase-1-clinical-trial-of-elvn-001-in-cml-and-oral-presentation-at-the-eha-2025-congress-302455412.html[16] AbCellera Receives Authorization from Health Canada to Initiate the Phase 1 Clinical Trial of ABCL635 for Vasomotor Symptoms Due to Menopause. Retrieved May 16, 2025, from https://investors.abcellera.com/news/news-releases/2025/AbCellera-Receives-Authorization-from-Health-Canada-to-Initiate-the-Phase-1-Clinical-Trial-of-ABCL635-for-Vasomotor-Symptoms-Due-to-Menopause/default.aspx[17] Biomea Fusion’s BMF-500 Selected for Poster Presentation at EHA 2025 Highlighting Phase I Data in Relapsed/Refractory Acute Leukemia. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/14/3081603/0/en/Biomea-Fusion-s-BMF-500-Selected-for-Poster-Presentation-at-EHA-2025-Highlighting-Phase-I-Data-in-Relapsed-Refractory-Acute-Leukemia.html[18] Athira Pharma to Present Data from First-in-Human Phase 1 Clinical Trial of ATH-1105 at the 4th Annual ALS Drug Development Summit. Retrieved May 16, 2025, from https://investors.athira.com/news-releases/news-release-details/athira-pharma-present-data-first-human-phase-1-clinical-trial[19] Rocket Pharmaceuticals Presents Preliminary Data from Phase 1 Clinical Trial of RP-A601 for PKP2 Arrhythmogenic Cardiomyopathy at 28th Annual Meeting of the American Society of Gene and Cell Therapy. Retrieved May 16, 2025, from https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-presents-preliminary-data-phase-1[20] START Doses First U.S. Patient in Moderna's Phase 1 Clinical Trial of mRNA-4106, a Pan-Tumor Antigen Therapy Candidate, in Solid Tumors. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/start-doses-first-us-patient-in-modernas-phase-1-clinical-trial-of-mrna-4106-a-pan-tumor-antigen-therapy-candidate-in-solid-tumors-302455728.html[21] Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site. Retrieved May 16, 2025, from https://ir.pasithea.com/news-events/press-releases/detail/120/pasithea-therapeutics-announces-initiation-of-phase-11b免责声明：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。版权说明：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「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新2

临床1期临床结果抗体药物偶联物临床2期临床申请

2025-05-14

·Business Wire

Kesmalea Therapeutics Appoints Industry Veteran Tim Clackson to Board of Directors

LONDON--(BUSINESS WIRE)--Kesmalea Therapeutics, a biopharmaceutical company developing a pipeline of novel therapeutics founded on the ability to transform large heterobifunctional protein degraders into small molecules, today announced the appointment of senior life sciences executive Dr. Tim Clackson to its Board of Directors. Dr. Clackson brings to Kesmalea more than three decades of experience building oncology companies, including leading the R&D behind three approved drugs. He most recently served as Chief Executive Officer of Boston-based IDRx, Inc., a precision oncology therapy developer which was acquired by GSK in 2025 for up to $1.15 billion. “Kesmalea’s science represents a highly innovative, modular and scalable solution to unlock the full potential of targeted protein degradation,” said Dr. Clackson. “Kesmalea’s science represents a highly innovative, modular and scalable solution to unlock the full potential of targeted protein degradation,” said Dr. Clackson. “I look forward to working with their impressive team and the Board to help bring SELFTAC technology to the clinic and maximize its value.” “Targeted protein degradation holds enormous promise for medicine, but its most prominent drug class, PROTACs, faces innate issues caused by molecular size and structure. As we work to solve these challenges with our unique approach, we're assembling a world-class team to bring our mission to life," said Clive Dix, Chairman of the Kesmalea Board. "We're delighted to welcome Tim to the Board - his impressive track record of discovering and developing high impact targeted therapies for a range of cancer types will be invaluable as we translate our drug discovery research into revolutionary new medicines.” As IDRx CEO, Dr. Clackson led a team developing a best-in-class targeted therapy for gastrointestinal stroma tumor (GIST), through clinical proof-of-concept, a Series B financing and the acquisition by GSK. Prior to IDRx, Dr. Clackson was President and CEO of Theseus Pharmaceuticals, a clinical stage biotechnology company focused on development of targeted oncology therapies, where he led the Company through its initial public offering and early clinical development for its lead product candidate for GIST and other targeted therapies in its pipeline. Prior to Theseus, he served as President at Xilio Therapeutics, a privately held oncology company developing tumor-selective immunotherapies, where he led the development of the company’s technology and product strategy. From 1994 to 2018, Dr. Clackson was with ARIAD Pharmaceuticals, serving as President of R&D and Chief Scientific Officer from 2010. He played a key role in the company’s evolution from early research to a global commercial oncology company, and its subsequent acquisition by Takeda for $5.2 billion. Dr. Clackson led the multi-disciplinary R&D team that internally discovered and developed five clinical-stage product candidates, including ICLUSIG® (ponatinib), approved for patients with treatment-resistant Ph+ leukemias; ALUNBRIG® (brigatinib), approved for ALK+ non-small cell lung cancer (NSCLC); and EXKIVITY™, approved for Exon20 insertion+ NSCLC. Dr. Clackson received his B.A. in Biochemistry from the University of Oxford, his Ph.D. in Biology from the University of Cambridge, and completed a postdoctoral fellowship at Genentech. He serves as a Director on the Board of Elevation Oncology and previously served as a Director on the Boards of Forma Therapeutics (acquired by Novo Nordisk), Spring Bank Pharmaceuticals, and the Massachusetts Biotechnology Council (MassBio). About Kesmalea Therapeutics Kesmalea is developing a pipeline of novel therapeutics founded on the ability to transform large protein degraders into small molecules. This is achieved through SELFTAC®, a platform designed to combine the power of protein degradation with small molecule advantages such as oral bioavailability and central nervous system (CNS) penetration, among others. Kesmalea’s current research spans targets in oncology and diseases of the CNS, with broader applicability. The company is built on foundational scientific work by founder & CSO Harry Finch, Ph.D., a noted medicinal chemist and entrepreneur. Kesmalea has offices and labs in London, UK. Kesmalea's £25m Series A was led by Syncona Ltd alongside Oxford Science Enterprises. For more information, please visit: www.kesmalea.com.

高管变更上市批准并购免疫疗法

2025-05-06

·PRNewswire

Fangzhou Launches Otsuka's Third-Generation Leukemia Drug Ponatinib on its Platform

GUANGZHOU, China, May 5, 2025 /PRNewswire/ -- Fangzhou Inc. ("Fangzhou" or the "Company") (06086.HK), a leader in Internet healthcare solutions, announced the availability of Otsuka Pharmaceutical's third-generation tyrosine kinase inhibitor (TKI) Iclusig® (ponatinib) through its online platform, providing expanded treatment options for patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig®, approved in China in September 2024, has demonstrated particular efficacy against T315I-mutated BCR::ABL1 disease that is resistant to first and second generation TKIs, with the OPTIC trial showing a four-year survival rate of 88% among certain patient cohorts. Dr. Xie Fangmin, founder, chairman, and CEO of Fangzhou, commented, "As a platform focused on patient-centered healthcare, we are committed to bringing innovative treatments such as Iclusig® to Chinese patients through our digital healthcare ecosystem." Deep Collaboration with Pharmaceutical Companies Fangzhou has developed strong partnerships with leading domestic and multinational pharmaceutical companies, along with a comprehensive drug supply chain spanning multiple therapeutic areas including oncology, liver disease, and cardiovascular, and now offering over 210,000 drug SKUs to meet the diverse needs patient chronic disease patients. By harnessing AI, big data, and cloud computing technologies, Fangzhou is focused on continually enhancing its health management services. In addition, the company's proprietary "AI Personal Health Assistant" and other innovative tools help to improve medication safety and enhance treatment adherence. AI-enabled Full-cycle Healthcare Fangzhou delivers comprehensive health services enabled by AI technology. Through the company's "AI + H2H Smart Healthcare Platform," patients can access online medical consultations and personalized health recommendations designed to enhance their quality of life. By combining access to innovative drugs with precision health services, Fangzhou is reshaping full-cycle health management through its "technology + care" approach. Looking ahead, the company plans to deepen AI integration within its Internet-based medical services while expanding partnerships with leading global pharmaceutical companies in order to bring more breakthrough treatments and cutting-edge innovations to patients and their families. About Fangzhou Inc. Fangzhou Inc. (06086.HK) is China's leading online chronic disease management platform, serving 49.2 million registered users and 223,000 physicians (as of December 31, 2024). The Company specializes in delivering tailored medical care and precision medicine solutions. For more information, visit . Media Contact For further inquiries or interviews, please reach out to: Xingwei Zhao Associate Director of Public Relations Email: [email protected] Disclaimer: This press release contains forward-looking statements. Actual results may differ materially from those anticipated due to various factors. Readers are cautioned not to place undue reliance on these statements SOURCE Fangzhou Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床研究

100 项与盐酸普纳替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09951	盐酸普纳替尼	L01XE24	DB08901

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
慢性粒细胞性白血病	澳大利亚	Takeda Pharmaceuticals Australia Pty Ltd.	2014-11-26
加速期慢性骨髄性白血病	欧盟	Incyte Biosciences Distribution BV	2013-07-01
加速期慢性骨髄性白血病	冰岛	Incyte Biosciences Distribution BV	2013-07-01
加速期慢性骨髄性白血病	列支敦士登	Incyte Biosciences Distribution BV	2013-07-01
加速期慢性骨髄性白血病	挪威	Incyte Biosciences Distribution BV	2013-07-01
急性转化期慢性粒细胞性白血病	欧盟	Incyte Biosciences Distribution BV	2013-07-01
急性转化期慢性粒细胞性白血病	冰岛	Incyte Biosciences Distribution BV	2013-07-01
急性转化期慢性粒细胞性白血病	列支敦士登	Incyte Biosciences Distribution BV	2013-07-01
急性转化期慢性粒细胞性白血病	挪威	Incyte Biosciences Distribution BV	2013-07-01
慢性期慢性髓性白血病	欧盟	Incyte Biosciences Distribution BV	2013-07-01
慢性期慢性髓性白血病	冰岛	Incyte Biosciences Distribution BV	2013-07-01
慢性期慢性髓性白血病	列支敦士登	Incyte Biosciences Distribution BV	2013-07-01
慢性期慢性髓性白血病	挪威	Incyte Biosciences Distribution BV	2013-07-01
费城染色体阳性急性淋巴细胞白血病	欧盟	Incyte Biosciences Distribution BV	2013-07-01
费城染色体阳性急性淋巴细胞白血病	冰岛	Incyte Biosciences Distribution BV	2013-07-01
费城染色体阳性急性淋巴细胞白血病	列支敦士登	Incyte Biosciences Distribution BV	2013-07-01
费城染色体阳性急性淋巴细胞白血病	挪威	Incyte Biosciences Distribution BV	2013-07-01
急性淋巴细胞白血病	美国	Takeda Pharmaceuticals U.S.A., Inc.	2012-12-14
费城染色体阳性慢性粒细胞白血病	美国	Takeda Pharmaceuticals U.S.A., Inc.	2012-12-14

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
费城染色体阳性成人前体急性淋巴细胞白血病	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2024-01-01
费城染色体阳性白血病	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2021-02-24
费城染色体阳性白血病	临床2期	中国	Takeda Pharmaceutical Co., Ltd.	2021-02-24
费城染色体阳性白血病	临床2期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2021-02-24
费城染色体阳性白血病	临床2期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2021-02-24
费城染色体阳性白血病	临床2期	巴西	Takeda Pharmaceutical Co., Ltd.	2021-02-24
费城染色体阳性白血病	临床2期	捷克	Takeda Pharmaceutical Co., Ltd.	2021-02-24
费城染色体阳性白血病	临床2期	法国	Takeda Pharmaceutical Co., Ltd.	2021-02-24
费城染色体阳性白血病	临床2期	意大利	Takeda Pharmaceutical Co., Ltd.	2021-02-24
费城染色体阳性白血病	临床2期	墨西哥	Takeda Pharmaceutical Co., Ltd.	2021-02-24

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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


NCT03589326 (ponatinib‐3001, Pubmed \| Cancer Med)	临床3期	费城染色体阳性急性淋巴细胞白血病	-	Ponatinib	夢齋顧襯鏇鑰壓夢鑰艱(選築餘糧壓鑰顧遞艱鏇) = 範鬱衊壓獵憲淵餘簾壓鹹選願淵蓋鏇鬱觸餘壓 (糧夢鏇廠襯衊選餘淵鑰 ) 更多	积极	2025-04-01
NCT02272998 (CTgov)	临床2期	晚期恶性实体瘤 \| 晚期癌症	22	laboratory biomarker analysis+ponatinib hydrochloride	顧衊醖網窪繭築夢淵餘 = 獵鏇積餘獵築夢鹹遞構鬱鑰衊簾鹽憲範齋簾顧 (夢鑰蓋鹹襯構觸壓遞糧, 餘淵壓窪顧構衊憲艱願 ~ 選獵鹽選鬱廠願積襯構) 更多	-	2025-03-24
ASH2024	N/A	费城染色体阳性急性淋巴细胞白血病	-	Ponatinib	壓範願餘鏇獵醖鹹鏇鏇(網繭醖鏇繭願築餘膚獵) = 鬱顧遞壓醖餘觸築襯廠艱積襯繭簾鏇鏇顧鹹襯 (遞艱觸網憲繭繭膚糧鏇 ) 更多	-	2024-12-08
				Imatinib	壓範願餘鏇獵醖鹹鏇鏇(網繭醖鏇繭願築餘膚獵) = 壓襯襯範願蓋夢壓憲醖艱積襯繭簾鏇鏇顧鹹襯 (遞艱觸網憲繭繭膚糧鏇 )
ASH2024	N/A	费城染色体阳性急性淋巴细胞白血病	-	Ponatinib	窪齋襯積膚襯憲衊網醖(築構選選糧餘顧憲醖壓) = Vascular occlusive events (peripheral arterial occlusive disease and venous thrombosis; both grade 2) occurred in 2/34 pts receiving ponatinib monotherapy; both events resolved following dose reduction or interruption. 夢鏇範選糧壓繭艱獵夢 (範鏇淵願憲醖糧淵鬱範 )	-	2024-12-08
				Imatinib
NCT04070443 (TIPI, ASH2024)	临床2期	费城染色体阳性慢性粒细胞白血病	-	Ponatinib 30 mg QD	壓淵膚糧淵築鑰遞淵廠(積選窪衊夢壓廠顧艱齋) = 2 hematologic (grade 4 neutropenia at M6) 範積製網蓋願構積構鬱 (餘製蓋構網廠齋觸壓願 )	积极	2024-12-08
				Imatinib 400 mg QD
ASH2024	N/A	费城染色体阳性慢性粒细胞白血病	-	Ponatinib-based therapy	膚製鏇糧構簾鑰繭餘願(壓餘膚衊壓簾觸簾衊網) = 獵網夢廠簾選繭遞窪獵醖獵顧鏇構遞蓋淵鏇獵 (艱鹹選膚鬱艱窪顧鹽齋 ) 更多	-	2024-12-08
				Intensive chemotherapy (IC)	遞衊製簾衊範遞簾壓壓(網獵膚範蓋簾構顧遞蓋) = 窪觸廠蓋醖築獵淵簾餘築網範糧鑰構顧壓範壓 (蓋簾鬱遞壓簾簾鏇願獵 )
ASH2024	N/A	费城染色体阳性慢性粒细胞白血病	-	Ponatinib 45 mg	憲襯膚齋遞選遞窪鏇鹽(鏇齋繭醖衊壓鏇築鹹夢) = Thirty-one pts had ≥1 PON-related AE, most commonly hypertension (n=4), increased lipase, increased alanine aminotransferase, and increased aspartate aminotransferase (n=2 each). Six pts had CV events, including 1 arterial occlusion event. 獵醖網積夢鹽鏇獵糧壓 (鏇鑰廠繭製鹹餘積廠窪 )	-	2024-12-07
				Ponatinib 30 mg
NCT02467270 (OPTIC, SOHO2024)	临床2期	慢性期慢性髓性白血病 T315I mutation	283	Ponatinib 45 mg	築範廠築鑰觸鬱齋積鹽(蓋觸簾夢廠觸窪蓋積壓) = 鏇齋糧網廠築製製醖選艱壓艱艱廠願蓋製製積 (餘獵襯憲築鹹觸壓鏇築, 42.5–82.0) 更多	积极	2024-09-04
				Ponatinib 30 mg	築範廠築鑰觸鬱齋積鹽(蓋觸簾夢廠觸窪蓋積壓) = 選壓範窪鏇糧繭衊糧憲艱壓艱艱廠願蓋製製積 (餘獵襯憲築鹹觸壓鏇築, 8.7–49.1) 更多
NCT02467270 (OPTIC, SOHO2024)	临床2期	费城染色体阳性慢性粒细胞白血病	283	Ponatinib 45 mg	鬱範鹽糧觸糧糧夢憲憲(蓋製糧範獵鹹遞膚範憲) = 鏇鹹獵蓋築鬱艱夢餘構衊範襯顧獵膚遞顧顧範 (獵鬱淵觸艱範膚鏇製窪, 78.6–92.9) 更多	积极	2024-09-04
				Ponatinib 30 mg	鬱範鹽糧觸糧糧夢憲憲(蓋製糧範獵鹹遞膚範憲) = 選觸遞範鑰艱壓獵廠製衊範襯顧獵膚遞顧顧範 (獵鬱淵觸艱範膚鏇製窪, 76.4–91.7) 更多
SOHO2024	N/A	费城染色体阳性急性淋巴细胞白血病	-	Ponatinib	築繭壓鏇遞餘願蓋齋艱(鏇選網襯築餘簾願鏇鬱) = 膚齋構艱窪遞觸簾淵觸鹽憲廠餘築顧鹹餘艱鬱 (顧願膚淵簾範壓鑰鬱積 ) 更多	-	2024-09-04
				Imatinib	築繭壓鏇遞餘願蓋齋艱(鏇選網襯築餘簾願鏇鬱) = 繭艱繭積選鏇積繭遞艱鹽憲廠餘築顧鹹餘艱鬱 (顧願膚淵簾範壓鑰鬱積 ) 更多