Safety and Efficacy of Ropeginterferon Alfa-2b in Combination With Ruxolitinib in Patients With Myelofibrosis Demonstrating Suboptimal Response to Ruxolitinib Monotherapy

In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.

开始日期2025-03-01

申办/合作机构

香港大学

NCT06290765

/ Not yet recruiting临床4期

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)

This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.

开始日期2025-01-01

申办/合作机构

药华医药股份有限公司

NCT06468033

/ Not yet recruiting临床3期

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus

This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk.
Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.

开始日期2024-12-01

申办/合作机构

药华医药股份有限公司

100 项与罗培干扰素α-2b 相关的临床结果

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100 项与罗培干扰素α-2b 相关的专利（医药）

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项与罗培干扰素α-2b 相关的文献（医药）

2025-08-01·INTERNATIONAL JOURNAL OF CANCER

Hematologic and molecular responses to ropeginterferon alfa‐2b therapy of polycythemia vera: 48‐week results from a prospective study

Article

作者: Sohn, Sang Kyun ; Bae, Sung Hwa ; Oh, Suk Joong ; Shin, Ho‐Jin ; Choi, Eun‐Ji ; Park, Joon Seong ; Yang, Deok‐Hwan ; Lee, Gyeong‐Won ; Park, Yong ; Yoon, Seug Yun ; Bang, Soo‐Mee ; Choi, Chul Won ; Cheong, June‐Won ; Lee, Sung‐Eun ; Yoon, Sung‐Soo ; Park, Young Hoon

Abstract:

To prevent thrombosis in patients with polycythemia vera (PV), achieving a complete hematologic response (CHR) is highly recommended in practice. In addition, a reduced JAK2 V617F mutation burden is expected to have a disease‐modifying effect, and its molecular response (MR) is currently of significant interest. This study aimed to assess the association between CHR and MR in patients with PV following treatment with ropeginterferon alfa‐2b. This phase 2, single‐arm, open‐label, investigator‐initiated trial was conducted at 16 sites in South Korea. Ninety‐nine patients were treated with ropeginterferon alfa‐2b subcutaneously every 2 weeks, at doses of 250 μg (week 1), 350 μg (week 3), and 500 μg (week 5), until week 48. CHRs were 27% (25/94), 46% (40/87), 56% (47/84), and 63% (51/81) at 12, 24, 36, and 48 weeks, respectively. The MR rates were 32% (28/88), 36% (29/81), 49% (38/77), and 57% (42/74) at 12, 24, 36, and 48 weeks, respectively. The Phi Coefficient for the association between CHR and MR was 0.6146 (p < .0001) at 48 weeks. In the subgroup analysis, patients with hydroxyurea resistance or intolerance, and those who were hydroxyurea‐naïve, had similar results in terms of the CHR. In conclusion, CHR and MR were observed to be associated in patients with PV treated with ropeginterferon.

2025-06-01·Hepatology International

Sequential combination with ropeginterferon alfa-2b and anti-PD-1 treatment as adjuvant therapy in HBV-related HCC: a phase 1 dose escalation trial

Article

作者: Liu, Chun-Jen ; Chen, Pei-Jer ; Ho, Ming-Chih ; Qin, Albert ; Tsai, Chan-Yen

Abstract:

Background/purpose:

Post-operative recurrence is a major clinical challenge with hepatocellular carcinoma (HCC). While currently unapproved, anti-programmed cell death 1 (PD-1) and anti-vascular endothelial growth factor combination adjuvant therapy showed promise. We initiated a phase I trial using sequential treatment with ropeginterferon alfa-2b (ropeg), a novel interferon-based antiviral and antitumor agent, followed by anti-PD-1 therapeutic antibody nivolumab as an adjuvant therapy for hepatitis B virus (HBV)-related HCC.

Methods:

Patients who underwent surgical resection of HBV-related HCC with curative intent received sequential therapy with six doses of ropeg every two weeks at 450 μg, followed by three doses of nivolumab escalating from 0.3 to 0.75 mg/kg every two weeks. Safety, HBV surface antigen (HBsAg) loss or decrease, anti-HBV surface (HBs) antibodies, cancer recurrence, and survival were evaluated.

Results:

Fifteen eligible patients were enrolled. Most adverse events (AEs) were mild or moderate and no severe or serious AEs were observed. Alanine transaminase flares, including one grade 3 event as dose-limiting toxicity, were noted in five cases and the final recommended dose for anti-PD1 was determined at 0.75 mg/kg. Interestingly, all five cases had HBsAg clearance or reduction. All patients in the study were alive without cancer recurrence during a median follow-up of 1024 days with six patients surviving > 4 years and three for > 5 years.

Conclusions:

This phase I trial supports the safety and clinical efficacy of sequential treatment with ropeg and nivolumab in post-resection HBV-related HCC. This regimen holds promise for further adjuvant therapy trials in HCC, both HBV-related and other types.

Graphic abstract:

2025-06-01·Pharmacology Research & Perspectives

Population Pharmacokinetics‐Pharmacodynamics and Exposure‐Response of Ropeginterferon Alfa‐2b in Chinese and Japanese Patients With Polycythemia Vera

Article

作者: Wu, Lei ; Suo, Shanshan ; Komatsu, Norio ; Sato, Toshiaki ; Liao, Jason ; Li, Yaning ; Shen, Weihong ; Shimoda, Kazuya ; Chen, Haoqi ; Su, Xia ; Zhang, Lei ; Wu, Daoxiang ; Fu, Rongfeng ; Jin, Jie ; Kirito, Keita ; Gao, Yucheng ; Qin, Albert ; Wang, Wei ; Zhang, Jingjing

ABSTRACT:

Ropeginterferon alfa‐2b (ropeg) represents a new‐generation interferon‐based therapy approved for polycythaemia vera (PV) treatment. This study aimed to elucidate its population pharmacokinetics‐pharmacodynamics (PopPK‐PD) and exposure‐response (E‐R) relationships. A PopPK model was developed using pooled data from four clinical studies, including two Phase I studies in healthy volunteers (n = 48) and two Phase II studies in Chinese or Japanese patients with PV (n = 78). Sequential modeling was used to analyze pharmacokinetics‐pharmacodynamics (PK‐PD) regarding hematological parameters, including hematocrit, platelet, and white blood cell counts. Hematological changes were simulated using fast‐ and slow‐dose titration regimens. Individual exposure values were used to analyze the E‐R relationships regarding complete hematologic response (CHR), driver mutation, JAK2V617F allele burden, and safety. In this study, we developed a target‐mediated drug disposition model. Sigmoid indirect effects elucidated the PK‐PD in terms of hematological changes. Simulations showed that the fast‐titration regimen significantly accelerated hematocrit reduction. Logistic regression models showed that the probability of achieving CHR increased with exposure at Week 24 but not at Week 52. In contrast, JAK2V617F allele reductions correlated with exposure at both Weeks 24 and 52. Exposure‐safety analysis revealed a manageable risk of adverse events associated with transaminase increases. This study established a robust framework for ropeg PK‐PD, providing insights into its E‐R relationships and disease‐modifying action.Trial Registration: A17‐102, A19‐201, and A20‐202 are registered at ClinicalTrials.gov. The registration numbers are as follows: A17‐102, NCT03546465; A19‐201, NCT04182100; and A20‐202, NCT05485948. A17‐101 is registered at www.chinadrugtrials.org.cn. The registration number is CTR20190451

项与罗培干扰素α-2b 相关的新闻（医药）

2025-06-03

·Firstwordpharma

ASCO25: PharmaEssentia’s Besremi hits mark in late-stage thrombocythaemia study

PharmaEssentia’s Besremi (ropeginterferon alfa-2b) showed superior efficacy and safety compared with Takeda’s platelet-reducing drug Agrylin/Xagrid (anagrelide) as second-line therapy for essential thrombocythaemia (ET) in a Phase III study. The detailed results fom the SURPASS-ET trial which top-lined in January were presented at the American Society of Clinical Oncology (ASCO) annual meeting on Monday.The study enrolled 174 patients who were randomised to receive either Besremi or Agrylin/Xagrid, the primary endpoint being response rate as per Modified ELN response criteria at months 9 and 12.Results showed the trial’s main efficacy goal was met, with a primary response rate of 42.9% in patients receiving Besremi versus 6.0% in Agrylin/Xagrid recipients. Notably, Besremi demonstrated improvements on four key measures compared with the control: normalised blood counts (56.0% vs 6.0%), splenomegaly improvement/stabilisation (87.9% vs 54.2%), symptom control (71.4% vs 33.7%), and fewer haemorrhagic/thrombotic events (84.6% vs 51.8%). Additionally, a key secondary goal was achieved — a larger reduction in JAK2V617F allelic burden from baseline to 12 months with Besremi (33.7% to 25.3%) than with Agrylin/Xagrid (39.7% to 37.3%).Meanwhile, ET-related thrombotic and cardiovascular events were lower with Besremi (1.1% and 0%, respectively) versus Agrylin/Xagrid (8.8% and 7.5%, respectively). The PharmaEssentia drug also led to fewer adverse event (AE)-related discontinuations (5.5% vs 18.8%) and treatment-related serious AEs (2.2% vs 10.0%) than the comparator.“This marks the first registrational Phase III trial of a long-acting interferon in ET, demonstrating not only well-tolerated blood count control but also a measurable reduction in JAK2 mutation allele burden,” remarked co-principal investigator Ruben Mesa in an earlier company press release.Besremi was approved by the FDA in 2021 to treat adults with polycythemia vera.

临床结果上市批准临床3期ASCO会议

2025-05-20

·Business Wire

PharmaEssentia to Present Phase 3 SURPASS-ET Data in Oral Session at 2025 ASCO Annual Meeting

BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced it will present results from the Phase 3 SURPASS-ET clinical trial in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3 in Chicago. SURPASS-ET (NCT04285086) is evaluating ropeginterferon alfa-2b-njft as a second-line treatment for patients with essential thrombocythemia (ET). Earlier this year, PharmaEssentia announced positive topline Phase 3 results, with ropeginterferon alfa-2b-njft demonstrating a significantly higher durable clinical response rate compared to anagrelide (42.9% vs. 6.0%; p=0.0001), along with a favorable safety profile and a greater reduction in JAK2 V617F allelic burden over 12 months. Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). BESREMi® has been recognized by the National Comprehensive Cancer Network® (NCCN®) as a preferred first-line cytoreductive therapy for adults with symptomatic, low-risk PV and the only preferred therapeutic option for both high-risk and low-risk (symptomatic) patients, regardless of treatment history. “Current options for patients with ET are limited. Standard therapies like hydroxyurea have notable drawbacks and do not target the underlying biology of the disease, while anagrelide has been associated with toxicity concerns and limited efficacy,” said Ruben Mesa, M.D., co-principal investigator, presenting author, and President of Atrium Health Levine Cancer Institute, the largest cancer program in the Carolinas which includes the Comprehensive Cancer Center at Wake Forest Baptist. “This marks the first registrational Phase 3 trial of a long-acting interferon in ET, demonstrating not only well-tolerated blood count control but also a measurable reduction in JAK2 mutation allele burden. These findings support further investigation of ropeginterferon as a second-line option for patients with ET who are seeking additional treatment approaches.” “The ASCO meeting is an important opportunity to share detailed findings of our positive data from the SURPASS-ET study with the medical community,” said Albert Qin, M.D., Ph.D., Chief Medical Officer of PharmaEssentia USA. “These data highlight a significant advance in the treatment of essential thrombocythemia and reinforce our commitment to delivering innovative, non-chemotherapy options for patients living with myeloproliferative neoplasms.“ Presentation Details Title: Ropeginterferon alfa-2b versus anagrelide for the treatment of essential thrombocythemia: Topline results of the phase 3 SURPASS-ET trial Abstract Number: 6500 Presenter: Dr. Ruben Mesa Session: Hematologic Malignancies — Leukemia, Myelodysplastic Syndromes, and Allotransplant Date: Monday, June 2, 2025 Time: 3:00 p.m. - 6:00 p.m. CDT About Essential Thrombocythemia Essential thrombocythemia is a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm. Essential thrombocythemia is most often caused by genetic mutations that cause the bone marrow to produce too many platelets, which can obstruct blood flow and cause a stroke, heart attack or pulmonary embolism. About BESREMi® (ropeginterferon alfa-2b-njft) in polycythemia vera (PV) BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. BESREMi has orphan drug designation for the treatment of polycythemia vera (PV) in adults in the United States. BESREMi has been approved in more than 40 countries, with approval from the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023. It was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see full Prescribing Information, including Boxed Warning. About PharmaEssentia PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website, LinkedIn or X (formerly Twitter).

上市批准临床3期临床结果孤儿药ASCO会议

2025-05-16

·ioncology

2025 EHA大会摘要公布！30项中国研究入选口头报告，于“时尚之都”米兰奏响中国最强音

编者按第30届欧洲血液学会年会（EHA 2025）将于6月12日至15日在意大利米兰盛大召开。作为全球血液学领域的顶尖学术盛会之一，本届大会将全面聚焦血液学及其各亚专科的最新进展，深入探讨循证诊疗新方法，发布临床与转化研究的重磅成果，呈现创新技术、精准诊断工具与风险评估策略的最新突破。日前，大会官网正式公布了本次年会的入选摘要（不含LBA）。《肿瘤瞭望-血液时讯》第一时间汇总整理了中国学者入选的口头报告名单（如有遗漏，欢迎留言补充），让我们一同见证东方智慧在“时尚之都”米兰的精彩绽放。全体大会摘要（Plenary Abstract Session）01摘要号：S102英文标题：BETTER SAFETY AND EFFICACY WITH ROPEGINTERFERON ALFA-2B OVER ANAGRELIDE AS SECOND-LINE TREATMENT OF ESSENTIAL THROMBOCYTHEMIA IN THE TOPLINE RESULTS OF THE RANDOMIZED PHASE 3 SURPASS-ET TRIAL中文标题：随机Ⅲ期SURPASS-ET试验的初步结果显示，罗培干扰素α-2b相较阿那格雷二线治疗原发性血小板增多症的安全性和疗效更佳类型：口头报告专场名称：全体大会摘要汇报者及单位：Harry Gill，中国香港大学李嘉诚医学院口头报告（Oral Presentations）急性髓系白血病——生物学与转化研究Acute myeloid leukemia - Biology & translational research01摘要号：S134英文标题：DE NOVO DESIGN OF A CHROMATIN READER ZMYND8-TARGETING PEPTIDE PROTAC FOR ACUTE MYELOID LEUKEMIA THERAPY中文标题：靶向染色质识别蛋白ZMYND8的肽类PROTAC的重新设计：用于急性髓系白血病的治疗类型：口头报告专场名称：AML发病机制中的染色质和基因调控(Chromatin and gene regulation in AML pathogenesis)汇报者及单位：Hui Feng，西安交通大学第一附属医院02摘要号：S125英文标题：CELL-INTRINSIC INFLAMMATION SHAPES CELL-STATE HETEROGENEITY AND DRIVES THERAPEUTIC RESISTANCE IN HUMAN ACUTE MYELOID LEUKEMIA中文标题：细胞内在炎症塑造人类急性髓系白血病细胞状态异质性并驱动治疗耐药性类型：口头报告专场名称：AML免疫治疗的新进展（Novel advances in AML immunotherapy）汇报者及单位：Lina Liu，浙江大学医学院附属第一医院骨髓移植中心急性髓系白血病——临床Acute myeloid leukemia - Clinical01摘要号：S143英文标题：LONG-TERM FOLLOW-UP OF PREDOMINANTLY ASIAN PATIENTS WITH RELAPSED/REFRACTORY FLT3-MUTATED ACUTE MYELOID LEUKEMIA TREATED WITH GILTERITINIB VERSUS SALVAGE CHEMOTHERAPY IN THE PHASE 3 COMMODORE TRIAL中文标题：Ⅲ期COMMODRE试验中接受吉瑞替尼与挽救化疗治疗的复发/难治性FLT3突变急性髓系白血病患者（以亚洲患者为主）的长期随访类型：口头报告专场名称：AML的新疗法与FLT3抑制剂（Novel therapies and FLT3 inhibition for AML）汇报者及单位：王建祥，中国医学科学院血液病医院（中国医学科学院血液学研究所）侵袭性非霍奇金淋巴瘤——临床Aggressive Non-Hodgkin lymphoma - Clinical01摘要号：S246英文标题：A PIVOTAL STUDY OF SHR2554, AN ORAL INHIBITOR AGAINST ENHANCER OF ZESTE HOMOLOG 2 (EZH2), IN RELAPSED OR REFRACTORY (R/R) PERIPHERAL T-CELL LYMPHOMA (PTCL)中文标题：SHR2554[一种口服的增强子同源物2（EZH2）抑制剂）]用于复发或难治性（R/R）外周T细胞淋巴瘤（PTCL）的治疗：一项关键研究类型：口头报告专场名称：侵袭性非霍奇金淋巴瘤——临床（前瞻性）[Aggressive Non-Hodgkin lymphoma - Clinical (Prospective)]汇报者及单位：宋玉琴，北京大学肿瘤医院出血性疾病（先天性和获得性）Bleeding disorders (congenital and acquired)01摘要号：S315英文标题：BLASTS- AND MODIFIED EASIX-GUIDED RISK STRATIFICATION FOR CAR-T-ASSOCIATED COAGULOPATHY AND OUTCOMES中文标题：BLASTS和改良EASIX指导的CAR-T相关凝血病及预后的风险分层类型：口头报告专场名称：出血性疾病（先天性和获得性）[Bleeding disorders (congenital and acquired)]汇报者及单位：Yingying Li，华中科技大学同济医学院附属协和医院骨髓衰竭综合征（包括PNH）——临床Bone marrow failure syndromes incl.PNH-Clinical01摘要号：S184英文标题：EFFICACY AND SAFETY OF CYCLOSPORINE PLUS LUSPATERCEPT VERSUS CYCLOSPORINE IN NEWLY DIAGNOSED NON-TRANSFUSION-DEPENDENT NON-SEVERE APLASTIC ANEMIA: A PROSPECTIVE RANDOMIZED TRIAL中文标题：环孢素联合罗特西普 vs. 环孢素治疗新诊断非输血依赖型非重型再生障碍性贫血的疗效和安全性：一项前瞻性随机试验类型：口头报告专场名称：骨髓衰竭综合征(Bone marrow failure syndromes)汇报者及单位：Zhuxin Zhang，中国医学科学院北京协和医院慢性髓系白血病——生物学及转化研究Chronic myeloid leukemia-Biology & translational research01摘要号：S162英文标题：INTEGRATING GENOMIC AND TRANSCRIPTOMIC INSIGHTS FOR PREDICTING RESPONSES AND OUTCOMES IN PATIENTS WITH CML RECEIVING 3RD-GENERATION TKI THERAPY中文标题：整合基因组与转录组见解以预测接受第三代TKI治疗的CML患者的反应和预后类型：口头报告专场名称：CML治疗反应与耐药的生物学(Biology of CML treatment response and resistance)汇报者及单位：张小帅，北京大学人民医院基因治疗、细胞免疫治疗和疫苗接种——生物学和转化研究Gene therapy,cellular immunotherapy and vaccination-Biology & translational research01摘要号：S277英文标题：TYPE I INTERFERON IMPAIRS CAR-T CELL FUNCTION BY DISRUPTING IMMUNE SYNAPSE ASSEMBLY中文标题：I型干扰素通过破坏免疫突触组装削弱CAR-T细胞功能类型：口头报告专场名称：基因治疗、细胞免疫治疗和疫苗接种——生物学和转化研究（Gene therapy, cellular immunotherapy and vaccination - Biology & translational research）汇报者及单位：Meijuan Huang，华中科技大学同济医学院附属同济医院基因治疗、细胞免疫治疗和疫苗接种——临床Gene therapy,cellular immunotherapy and vaccination-Clinical01摘要号：S283英文标题：CTD402: A UNIVERSAL ANTI-CD7 CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY FOR PATIENTS WITH RELAPSED OR REFRACTORY (R/R) T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA (T-ALL/LBL)中文标题：CTD402：一种针对复发或难治性（R/R）T细胞急性淋巴细胞白血病/淋巴母细胞淋巴瘤（T-ALL/LBL）患者的通用抗CD7嵌合抗原受体T细胞疗法类型：口头报告专场名称：基因治疗、细胞免疫治疗和疫苗接种——临床（Gene therapy, cellular immunotherapy and vaccination - Clinical）汇报者及单位：Jiangtao Ren，Bioheng Therapeutics Co., Ltd,, Nanjing, China造血、干细胞和微环境Hematopoiesis,stem cells and microenvironment01摘要号：S272英文标题：ENHANCE THE THERAPEUTIC EFFICACY OF HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS IN PREVENTION OF ACUTE GRAFT-VERSUS-HOST DISEASE THROUGH CRISPLD2 MODULATION中文标题：通过调控CRISPLD2增强人脐带间充质干细胞在预防急性移植物抗宿主病中的治疗效果类型：口头报告专场名称：造血干细胞及其微环境(Hematopoietic stem cells and their niche)汇报者及单位：Xu Qing，陆军军医大学第二附属医院（新桥医院）02摘要号：S273英文标题：TGF-ß1-TRIGGERED MALADAPTIVE BONE MARROW ENDOTHELIUM IMPEDES HEMATOPOIETIC RECOVERY中文标题：TGF-β1诱导的骨髓内皮功能失调阻碍造血恢复类型：口头报告专场名称：造血干细胞及其微环境(Hematopoietic stem cells and their niche)汇报者及单位：Zhong-Shi Lyu，北京大学人民医院淋巴瘤生物学与转化研究Lymphoma biology & translational research01摘要号：S251英文标题：MULTI-OMICS DISSECTION OF EBV-DRIVEN HETEROGENEITY, METABOLIC REMODELING, AND TUMOR CELLULAR LANDSCAPE IN ENKTL PROGRESSION中文标题：EB病毒驱动的ENKTL进展中的异质性、代谢重塑及肿瘤细胞图谱的多组学解析类型：口头报告专场名称：淋巴瘤生物学与转化研究(Lymphoma biology & translational research)汇报者及单位：梁金花，南京医科大学第一附属医院（江苏省人民医院）02摘要号：S252英文标题：PTPN2 INHIBITION DISRUPTS MITOCHONDRIAL RENEWAL AND BLOCKS TFRC-MEDIATED PINK1-PRKN-DEPENDENT MITOPHAGY TO EXERT ANTI-TUMOR ACTIVITIES IN ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA中文标题：PTPN2抑制通过破坏线粒体更新并阻断TFRC介导的PINK1-PRKN依赖性线粒体自噬，在ALK阳性间变性大细胞淋巴瘤中发挥抗肿瘤作用类型：口头报告专场名称：淋巴瘤生物学与转化研究(Lymphoma biology & translational research)汇报者及单位：梁金花，南京医科大学第一附属医院（江苏省人民医院）骨髓增生异常综合征——生物学与转化研究Myelodysplastic syndromes-Biology & translational research01摘要号：S170英文标题：SINGLE-CELL ATLAS OF PEDIATRIC NRAS-MUTANT MYELOID NEOPLASMS REVEALS MYELOID LINEAGE BIAS AND IDENTIFIES POTENTIAL THERAPEUTIC TARGETS中文标题：儿童NRAS突变髓系肿瘤的单细胞图谱揭示髓系谱系偏倚并识别潜在治疗靶点类型：口头报告专场名称：MDS cellular and molecular therapeutic targeting汇报者及单位：Suyu Zong，中国医学科学院血液病医院（中国医学科学院血液学研究所）骨髓瘤及其他单克隆免疫球蛋白病——生物学与转化研究Myeloma and other monoclonal gammopathies -Biology & translational research01摘要号：S188英文标题：ENHANCER EXTRACHROMOSOMAL CIRCULAR DNA ANKRD28 DRIVES DRUG RESISTANCE VIA POU2F2-MEDIATED TRANSCRIPTIONAL REWIRING IN MULTIPLE MYELOMA中文标题：增强子染色体外环状DNA ANKRD28通过POU2F2介导的转录重编程驱动多发性骨髓瘤的药物耐药类型：口头报告专场名称：骨髓瘤及其他单克隆免疫球蛋白病——生物学与转化研究（Myeloma and other monoclonal gammopathies - Biology & translational research）汇报者及单位：Binzhen Chen，上海交通大学医学院附属仁济医院骨髓增生性肿瘤——临床Myeloproliferative neoplasms-Clinical01摘要号：S222英文标题：ROPEGINTERFERON ALFA-2B FOR PRE-FIBROTIC PRIMARY MYELOFIBROSIS AND DIPSS LOW/INTERMEDIATE-RISK MYELOFIBROSIS中文标题：罗培干扰素α-2b治疗纤维化前原发性骨髓纤维化及DIPSS低/中风险骨髓纤维化类型：口头报告专场名称：Innovative treatment approaches in MPN汇报者及单位：Harry Gill，中国香港大学李嘉诚医学院血液学中的新技术、新方法及数字分析工具Novel technologies,techniques and digital analytical tools in hematology01摘要号：S332英文标题：STEM CELL AGING CLOCK: A DEEP LEARNING DRIVEN FRAMEWORK FOR PREDICTING STEM CELL AGE中文标题：干细胞衰老时钟：基于深度学习的干细胞年龄预测框架类型：口头报告专场名称：计算机与人工智能辅助血液学的新进展（New developments in computational and AI-assisted hematology）汇报者及单位：Guanlin Wang，复旦大学代谢与整合生物学研究院血小板疾病Platelet disorders01摘要号：S313英文标题：BARICITINIB CORRECTS AP2-NAK MEDIATED C-MPL ENDOCYTIC DYSREGULATION TO RESTORE MEGAKARYOCYTES TPO-RA SENSITIVITY IN IMMUNE THROMBOCYTOPENIA中文标题：巴瑞替尼纠正AP2-NAK介导的c-MPL内吞调控异常，恢复免疫性血小板减少症中巨核细胞对TPO-RA的敏感性类型：口头报告专场名称：血小板疾病（Platelet disorders）汇报者及单位：安倬玉，北京大学人民医院02摘要号：S318英文标题：TARGETED SUPPRESSION OF EFFECTOR T CELLS BY GPIBα CAAR-TREG CELLS IN REFRACTORY/RELAPSED IMMUNE THROMBOCYTOPENIA中文标题：GPIBα CAAR-Treg细胞对难治/复发性免疫性血小板减少症效应T细胞的靶向抑制类型：口头报告专场名称：出血性疾病（先天性与获得性）[Bleeding disorders (congenital and acquired)]汇报者及单位：Jinhui Shu，华中科技大学同济医学院附属协和医院干细胞移植——临床Stem cell transplantation-Clinical01摘要号：S261英文标题：AUTONOMOUS AI-DRIVEN INTENSIFIED PROPHYLAXIS OF SEVERE ACUTE GRAFT-VERSUS-HOST DISEASE IN HAPLOIDENTICAL TRANSPLANTS: A SINGLE-CENTRE, PROOF-OF-CONCEPT, PHASE 2 TRIAL中文标题：自主人工智能驱动的加强预防严重急性移植物抗宿主病在半相合移植中的应用：一项单中心概念验证Ⅱ期试验类型：口头报告专场名称：干细胞移植——专场2(Stem cell transplantation - Session 2)汇报者及单位：Yigeng Cao，中国医学科学院血液病医院（中国医学科学院血液学研究所）02摘要号：S262英文标题：ANTI-CD25 ANTIBODY AS AN ALTERNATIVE TO METHOTREXATE FOR GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS RESULTED IN BETTER OUTCOMES IN PATIENT OF CHIMERIC ANTIGEN RECEPTOR-T CELL THERAPY BRIDGING TO TRANSPLANT中文标题：抗CD25抗体作为替代甲氨蝶呤的移植物抗宿主病预防方案，在嵌合抗原受体T细胞治疗桥接移植患者中取得了更好的疗效类型：口头报告专场名称：干细胞移植——专场2（Stem cell transplantation - Session 2）汇报者及单位：李智慧，北京高博博仁医院03摘要号：S263英文标题：PHARMACOKINETIC-GUIDED ATG DOSING OPTIMIZES OUTCOMES IN MYELOABLATIVE HAPLO-CORD HCT中文标题：基于药代动力学指导的ATG给药优化改善了清髓性半相合脐带血干细胞移植的治疗效果类型：口头报告专场名称：干细胞移植——专场2（Stem cell transplantation - Session 2）汇报者及单位：Qingya cui,苏州大学附属第一医院04摘要号：S256英文标题：TARGETED DOSING OF ANTI-THYMOCYTE GLOBULIN VERSUS FIXED DOSING STRATEGY IN PATIENTS UNDERGOING UNMANIPULATED HAPLOIDENTICAL HAEMATOPOIETIC STEM-CELL TRANSPLANTATION: A RANDOMIZED, MULTICENTER, PHASE 3 CLINICAL TRIAL中文标题：抗胸腺细胞球蛋白的目标给药与固定给药策略在接受未处理半相合造血干细胞移植患者中的比较：一项随机、多中心、Ⅲ期临床试验类型：口头报告专场名称：干细胞移植——专场1（Stem cell transplantation - Session 1）汇报者及单位：刘代红，解放军总医院第五医学中心05摘要号：S258英文标题：WHO IS THE BEST ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT DONOR FOR SEVERE APLASTIC ANEMIA? A MULTICENTER RETROSPECTIVE EXPERIENCE FROM CHINA中文标题：重型再生障碍性贫血的最佳异基因造血干细胞移植供者是谁？来自中国的多中心回顾性研究经验类型：口头报告专场名称：干细胞移植——专场1（Stem cell transplantation - Session 1）汇报者及单位：Xiao-Di Ma，北京大学人民医院06摘要号：S259英文标题：COMPARABLE SURVIVAL OUTCOMES IN HLA-MATCHED AND HAPLOIDENTICAL HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR SEVERE APLASTIC ANEMIA PATIENTS AGED 40-50: A CBMTR REGISTRY-BASED PSM ANALYSIS OVER THE LAST DECADE中文标题：接受HLA匹配与半相合造血干细胞移植40-50岁重型再生障碍性贫血患者的生存结局相当：过去十年基于CBMTR登记的PSM分析类型：口头报告专场名称：干细胞移植——专场1（Stem cell transplantation - Session 1）汇报者及单位：许兰平，北京大学人民医院干细胞移植——实验Stem cell transplantation-Experimental01摘要号：S255英文标题：JAK/ROCK INHIBITION WITH ROVADICITINIB SUPPRESSES MURINE AND HUMAN ACUTE GRAFT-VERSUS-HOST DISEASE: THE RESULTS OF PRECLINICAL AND PHASE 1B STUDY中文标题：JAK/ROCK抑制剂罗伐昔替尼抑制小鼠及人类急性移植物抗宿主病：临床前及Ⅰb期研究结果类型：口头报告专场名称：干细胞移植——专场1（Stem cell transplantation - Session 1）汇报者及单位：赵妍敏，浙江大学医学院附属第一医院骨髓移植中心地中海贫血Thalassemias01摘要号：S290英文标题：EFFICACY AND SAFETY OF BRL-101 IN TDT AND SCD中文标题：BRL-101 在输血依赖型地中海贫血（TDT）和镰状细胞病（SCD）中的疗效与安全性类型：口头报告专场名称：地中海贫血和红细胞生成（Thalassemia and erythopoiesis）汇报者及单位：Tan Qian，Shanghai tech immunology department, Shanghai, China02摘要号：S291英文标题：TREATMENT OF PATIENTS WITH SEVERE TRANSFUSION-DEPENDENT ß-THALASSEMIA WITH CS-101, AN AUTOLOGOUS, EX VIVO EDITED, CD34+ HEMATOPOIETIC STEM CELL PRODUCT USING INNOVATIVE TRANSFORMER BASE EDITOR (TBE)中文标题：采用创新型Transformer基础编辑器（TBE）对自体CD34+造血干细胞进行体外编辑制备的CS-101，用于治疗重型输血依赖型β-地中海贫血患者类型：口头报告专场名称：地中海贫血和红细胞生成（Thalassemia and erythopoiesis）汇报者及单位：陈佳，上海科技大学生命科学与技术学院基因编辑中心03摘要号：S292英文标题：FIRST-IN-HUMAN STUDY OF AUTOLOGOUS HBA2-EDITED CD34+ HEMATOPOIETIC STEM AND PROGENITOR CELLS IN ALPHA-THALASSEMIA WITH CONSTANT SPRING MUTATION中文标题：首次人体研究：自体HBA2基因编辑的CD34+造血干/祖细胞用于Constant Spring突变型α-地中海贫血治疗类型：口头报告专场名称：地中海贫血和红细胞生成（Thalassemia and erythopoiesis）汇报者及单位：Hui Xu，Reforgene Medicine, Guangzhou, China（来源：《肿瘤瞭望–血液时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

蛋白降解靶向嵌合体临床结果

100 项与罗培干扰素α-2b 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11027	罗培干扰素α-2b	L03AB15	DB15119

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适应症	国家/地区	公司	日期
真性红细胞增多症	欧盟	Aop Orphan Pharmaceuticals GmbH	2019-02-15
真性红细胞增多症	冰岛	Aop Orphan Pharmaceuticals GmbH	2019-02-15
真性红细胞增多症	列支敦士登	Aop Orphan Pharmaceuticals GmbH	2019-02-15
真性红细胞增多症	挪威	Aop Orphan Pharmaceuticals GmbH	2019-02-15

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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
原发性骨髓纤维化	临床3期	-	药华医药股份有限公司	2024-12-01
原发性血小板增多症	临床3期	美国	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	中国	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	日本	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	加拿大	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	中国香港	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	新加坡	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	中国台湾	药华医药股份有限公司	2020-08-25
慢性期慢性髓性白血病	临床3期	法国	Aop Orphan Pharmaceuticals GmbH	2017-05-04
慢性期慢性髓性白血病	临床3期	德国	Aop Orphan Pharmaceuticals GmbH	2017-05-04

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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


NCT04285086 (SURPASS-ET, ASCO2025)	临床3期	原发性血小板增多症二线	174	Ropeginterferon alfa-2b	範蓋蓋艱壓憲艱願鏇廠(鹽壓蓋願壓觸鹹壓餘構) = 膚觸鬱糧選糧簾鹹簾築壓艱鏇憲鹽壓淵範衊壓 (選醖廠鹽夢夢鹽鏇鹹廠 ) 更多	积极	2025-05-30
NCT04285086 (SURPASS-ET, ASCO2025)	临床3期	原发性血小板增多症二线	174	Anagrelide	範蓋蓋艱壓憲艱願鏇廠(鹽壓蓋願壓觸鹹壓餘構) = 膚膚糧觸積獵鬱醖獵鑰壓艱鏇憲鹽壓淵範衊壓 (選醖廠鹽夢夢鹽鏇鹹廠 ) 更多	积极	2025-05-30
NCT04285086 (EXCEED-ET, Biospace) 人工标引	临床3期	原发性血小板增多症二线	174	P1101 (Ropeginterferon alfa-2b-njft)	窪窪網觸獵壓願糧鹹繭(鏇鏇選築窪膚襯範網衊) = 願齋膚鹹膚顧夢夢鏇遞衊網窪鹹選範壓製選淵 (鹽繭簾窪鏇簾遞鬱構鹹 ) 达到更多	积极	2025-01-06
NCT04285086 (EXCEED-ET, Biospace) 人工标引	临床3期	原发性血小板增多症二线	174	Anagrelide	窪窪網觸獵壓願糧鹹繭(鏇鏇選築窪膚襯範網衊) = 鹹選積鹹願網餘觸簾顧衊網窪鹹選範壓製選淵 (鹽繭簾窪鏇簾遞鬱構鹹 ) 达到更多	积极	2025-01-06
EHA2024 人工标引	临床2期	真性红细胞增多症 JAK2V617F VAF \| IFNL4	114	Ropeginterferon alfa-2b (Ropeg)	顧艱夢蓋構鬱範艱願膚(製遞餘選鬱選簾構遞鏇) = 鏇繭膚憲鏇繭蓋選繭遞願膚醖構窪範襯醖簾獵 (鹹築鬱艱網簾鹹憲膚艱 )	积极	2024-05-14
EHA2024 人工标引	临床2期	真性红细胞增多症 JAK2V617F VAF \| IFNL4	114	Ropeginterferon alfa-2b (Ropeg)py, STD)	顧艱夢蓋構鬱範艱願膚(製遞餘選鬱選簾構遞鏇) = 獵獵鹹憲衊衊觸壓鹽餘願膚醖構窪範襯醖簾獵 (鹹築鬱艱網簾鹹憲膚艱 )	积极	2024-05-14
EUCTR2012-005259-18-CZ \| EUCTR2014-001357-17-PL (PROUD-PV, EHA2024) 人工标引	临床3期	真性红细胞增多症 JAK2V617F allele burden	169	ropeginterferon alfa-2b	觸壓蓋淵膚遞網網繭鹽(糧鹽壓獵憲窪遞製窪製) = 繭艱夢壓鹽蓋獵願繭積積積選窪鏇範醖襯積糧 (鏇簾壓鹽醖積積鏇顧蓋 ) 更多	积极	2024-05-14
	临床3期	真性红细胞增多症 JAK2V617F allele burden	169	HU/BAT	觸壓蓋淵膚遞網網繭鹽(糧鹽壓獵憲窪遞製窪製) = 構艱製遞網鹹鹹構餘顧積積選窪鏇範醖襯積糧 (鏇簾壓鹽醖積積鏇顧蓋 ) 更多	积极	2024-05-14
EHA2024	临床3期	真性红细胞增多症	34	Ropeginterferon alfa-2b	鹹遞積艱範願構網壓顧(衊簾窪膚蓋蓋糧構簾壓) = One patient developed autoimmune thyroiditis without the need to suspend treatment 艱窪衊構繭壓淵選觸蓋 (觸獵鹹選廠願願憲齋餘 ) 更多	积极	2024-05-14
PROUD-PV/CONTINUATION (EHA2024)	临床3期	二线 JAK2 mutated	12	Ropeginterferon alfa-2b	網淵鹹顧壓鑰鏇鹽簾積(鹹構願獵蓋淵餘遞憲憲) = One withdrew therapy due to intolerance (flushing and eczema, grade 1) after 9 months of treatment 製遞選醖糧製選遞願壓 (遞襯遞醖範觸範餘鏇鹹 )	积极	2024-05-14
EHA2024	临床2期	真性红细胞增多症 JAK2 V617F allele burden	27	Ropeginterferon alfa-2b	艱醖繭構餘簾膚醖願鹹(顧顧艱鏇鬱積鑰積糧艱) = Although most patients (25/27 [92.6%]) experienced adverse events (AEs), ropeginterferon alfa-2b was generally well tolerated. The most common AEs were WBC count decreased (7/27 [25.9%]) and urine beta-2 microglobulin increased (6/27 [22.2%]) 製網網廠衊繭積鏇築膚 (膚構膚鹽簾醖鏇淵鹽鹽 ) 更多	积极	2024-05-14
PROUD-PV/CONTINUATION-PV (ASH2023)	N/A	真性红细胞增多症	-	Ropeginterferon alfa-2b	蓋顧鑰鬱鏇選蓋蓋簾艱(簾醖鏇糧醖淵憲艱積選) = 壓膚夢簾範窪鏇夢壓鑰獵壓衊廠遞鏇齋觸壓壓 (遞簾糧選繭鹹夢淵淵繭 )	-	2023-12-11
P1101MF (ASH2023)	临床2期	原发性骨髓纤维化	-	Ropeginterferon alfa 2b	壓醖醖簾夢夢積製繭積(範廠遞餘夢觸齋繭願廠) = 範獵餘築膚遞鑰鹽蓋廠憲鹽鹽壓蓋積餘網廠構 (衊獵衊鑰醖衊鏇遞遞範 ) 更多	-	2023-12-11
ASH2023	N/A	真性红细胞增多症	99	P1101	廠壓艱淵蓋淵顧簾淵構(獵獵廠廠觸遞鬱淵鬱餘) = 觸範廠獵鏇顧壓憲簾窪願鬱鹹膚衊製構製蓋餘 (鏇餘獵顧積夢顧顧糧繭 ) 更多	-	2023-12-11