To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.

开始日期2026-11-27

申办/合作机构

药华医药股份有限公司

NCT07269470

/ Not yet recruiting临床2期IIT

Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

The goal of this clinical research study is to find out if treatment with a combination of dasatinib plus ropeginterferon can help to control CML-CP. The safety of this combination will also be studied.

开始日期2026-11-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT07468916

/ Not yet recruiting临床2期IIT

Ropeginterferon Alfa-2b for MDS/MPN Overlap Syndromes, Including CMML and MDS/MPN-RS-T

This phase II trial tests the safety, best dose, and effectiveness of ropeginterferon alfa-2b for the treatment of patients with myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes and chronic myelomonocytic leukemia. Ropeginterferon alfa-2b is a form of interferon. Interferons are a type of signaling protein normally produced by the body as part of the immune response. Interferons interfere with the division of cancer cells and can slow cancer cell growth. Ropeginterferon alfa-2b is a long-acting form of a type of interferon called interferon alfa-2b. In the body, ropeginterferon alfa-2b causes the production of proteins that modulate the immune system and have anticancer effects.

开始日期2026-09-29

申办/合作机构

Jonsson Comprehensive Cancer Center

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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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225

项与罗培干扰素α-2b 相关的文献（医药）

2026-06-09·Blood Advances

Ropeginterferon alfa-2b for prefibrotic myelofibrosis and lower-risk myelofibrosis requiring cytoreduction

Article

作者: Li, Vivian ; Wu, Tony K. Y. ; Lee, Carmen Y. Y. ; Gill, Harinder ; Zhang, Qi ; Yim, Rita ; Chin, Lynn ; Kwong, Yok-Lam ; Lee, Paul ; Au, Lester ; Leung, Garret M. K. ; Chan, Po-Yan

Abstract:

There is currently no consensus on the optimal treatment of early myelofibrosis (MF). Ropeginterferon alfa-2b (ropeg) is a next-generation monopegylated interferon alfa-2b developed specifically to treat myeloproliferative neoplasms. We conducted a phase 2 study in patients with prefibrotic primary MF (pre-PMF) and Dynamic International Prognostic Scoring System low-/intermediate-1–risk fibrotic PMF or secondary MF (SMF) who required cytoreduction. Ongoing treatment with hydroxyurea was substituted with ropeg (week 0, 250 μg; week 2, 350 μg; week 4 onward, 500 μg every 2 weeks). The primary end points were safety and clinicohematologic complete response (CHCR). Seventy-one patients (40 men and 31 women) with a median age of 60 years (range, 31-86) were enrolled and followed up for a median of 119 weeks (range, 10-131). At weeks 24, 48, and 104, CHCR was achieved in 63.8% (pre-PMF, 74%; fibrotic PMF, 20%; fibrotic SMF, 42.9%), 63.5% (pre-PMF, 69.6%; fibrotic PMF, 25%; SMF, 53.9%), and 70% of patients (pre-PMF, 78.4%; fibrotic PMF, 33.3%; SMF, 50%), respectively. Thrombo-hemorrhagic events were not observed after stopping hydroxyurea. At weeks 24, 48, and 104, reduction in JAK2V617F variant allele frequency (VAF) was observed in 53.1%, 70%, and 67.6% of patients, and reduction in CALR mutant VAF was observed in 52.6%, 42.9%, and 40% of patients, respectively. In 50 evaluable cases at week 104, 13 patients (26%) had reduced bone marrow reticulin fibrosis. There were 3 treatment discontinuations (4.2%) due to adverse events. In conclusion, ropeg was safe and induced CHCR associated with significant molecular responses in patients with early MF. This trial was registered at www.clinicaltrials.gov as NCT04988815.

2026-06-07·Leukemia & Lymphoma

Long-term outcomes of ropeginterferon alfa-2b-njft in polycythemia vera: a review of safety, efficacy, and potential disease modification

Review

作者: Reeves, Brandi ; Abu-Zeinah, Ghaith

Polycythemia vera (PV) is a chronic myeloproliferative neoplasm characterized by erythrocytosis, thrombotic risk, and possible progression to aggressive myeloid neoplasms. Optimal management should achieve durable hematologic response, tolerability, and potential for long-term disease modification. Interferon alpha (IFN-α) is unique among current PV treatments for its disease-modifying potential; however, long-term tolerability concerns remain. Ropeginterferon alfa-2b-njft (ropeg), a novel monopegylated IFN-α, is the only IFN-α approved in the US for PV treatment. Phase III data from PROUD-PV (NCT01949805; EudraCT, 2012-005259-18) and its phase IIIb extension, CONTINUATION-PV (NCT02218047; EudraCT, 2014-001357-17), demonstrate that ropeg, compared with hydroxyurea, achieves hematologic response more slowly but provides greater, more durable responses after ∼18 months, underscoring the importance of long-term adherence. Early adverse events can challenge adherence, emphasizing the need for proactive symptom management. This review offers evidence- and experience-based perspectives on long-term ropeg treatment and adverse event management to support adherence and maximize therapeutic benefit in PV.

2026-06-01·LEUKEMIA

A paradigm shift in the treatment of patients with polycythemia vera. The initial early use of recombinant interferon-alpha

Review

作者: Hasselbalch, Hans Carl ; Silver, Richard T

During the past 35 years, single-arm studies documented the efficacy and safety of recombinant interferon alpha (rIFNα) for treating polycythemia vera (PV). In some patients, 2-5 years of disease-modifying treatment resulted in symptom relief, regression of splenomegaly, normalization of abnormal blood counts and marrow morphology, and sustained JAK2V617F molecular remission. The PROUD-CONTI study showed the superiority of rIFNα compared to hydroxyurea (HU), which led to the European Medicines Agency approval in 2019 of ropeginterferon alpha-2b ("ropegIFN") for ELN-defined high-risk PV patients. In 2021, the Food and Drug Administration (USA) gave unrestricted approval, except for pregnant PV patients. The Low-PV randomized trial established the superiority of ropegIFN compared to phlebotomy-only (PHLEB-O) in ELN-defined low-risk patients. Nevertheless, worldwide, HU remains the cytoreductive drug most often used; maintenance PHLEB-O is still endorsed as maintenance therapy by some hematologists. The National Comprehensive Cancer Network (NCCN, USA) approved ropegIFN as a II-A recommendation for ELN-defined low and high-risk disease; the ELN suggested criteria for using rIFNα in low-risk patients if certain issues developed after PHLEB-O, including more symptoms, progressive splenomegaly, significant leukocytosis, thrombocytosis, or inadequate hematocrit control. These issues are important because even low-risk patients are at increased thrombotic risk, estimated at 2 to 3 times that of the general population. Moreover, as PV progresses, the development of myelofibrosis is the leading cause of morbidity, perhaps abetted by PHLEB-O. Here, we review recent progress in the treatment of PV with rIFNα and discuss our rationales and perspectives for, and the endorsement of the initial treatment with rIFNα of both low and high-risk PV patients, unless a contraindication exists to its use.

110

项与罗培干扰素α-2b 相关的新闻（医药）

2026-06-26

·BioSpace

PharmaEssentia Announces FDA Approval and U.S. Launch of BESREMi Pen™ (ropeginterferon alfa-2b-njft) for Polycythemia Vera

New pre-filled pen device enhances patient experience by simplifying self-administration 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 the U.S. Food and Drug Administration (FDA) approval and launch of the BESREMi Pen™ (ropeginterferon alfa-2b-njft) device for adult patients with polycythemia vera (PV). The device offers a more convenient self-administration option than the currently available pre-filled syringe. The BESREMi Pen™ is expected to become commercially available in the U.S. in the coming weeks. “The U.S. approval of the BESREMi Pen™ is a significant milestone both for our company, as well as the patients we serve,” said Samuel Lin, Head of Global Operations, PharmaEssentia. “With this new device, we’re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care.” “I’m very excited to see the FDA approval of the BESREMi Pen™ as a new option for patients,” said Dr. John Mascarenhas, Director of the Center of Excellence for Blood Cancers and Myeloid Disorders at Mount Sinai in New York City. “Treatment consistency is critical for managing PV, and this device has the potential to make a meaningful positive impact on patients’ lives by simplifying self-administration and supporting better adherence.” 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) . About Polycythemia Vera (PV) Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2. About BESREMi® (ropeginterferon alfa-2b-njft) Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA. BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications. INDICATION BESREMi® is indicated for the treatment of adults with polycythemia vera. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DISORDERS Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy. CONTRAINDICATIONS Existence of or history of severe depression, suicidal ideation, or suicide attempt Hypersensitivity to interferons or any inactive ingredients Moderate or severe hepatic impairment History or presence of active serious or untreated autoimmune disease History of transplantation and receiving immunosuppressant agents WARNINGS AND PRECAUTIONS Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Depression and Suicide: Monitor closely for symptoms and need for treatment. Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed. Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently. Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment. Hypersensitivity Reactions: Stop treatment and immediately manage reaction. Pancreatitis: Consider discontinuation if confirmed pancreatitis Colitis: Discontinue if signs or symptoms of colitis Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders. Hyperlipidemia: Monitor serum triglycerides before BESREMi® treatment and intermittently during therapy and manage when elevated. Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops. Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations. Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity. Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination. Please see full Prescribing Information , including Boxed Warning. Contacts Media Muriel Huang Director, Investor Relations and Corporate Communication muriel_huang@pharmaessentia.com

上市批准孤儿药

2026-06-24

·生物工艺与技术

生物制药生产中的大肠杆菌

大肠杆菌在重组DNA技术的发现中肩负了巨大的工作量。随着重组蛋白胰岛素在大肠杆菌中生产并用于治疗糖尿病，生物制药行业进入了一个新的时代。继胰岛素之后，许多由大肠杆菌生产的生物制药已获得美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）的批准，用于治疗各种人类疾病。尽管大肠杆菌存在一些缺点，如缺乏翻译后修饰和毒性，但它仍然是一个重要的宿主，具有许多优势，如在重组蛋白生产中是一个广为人知的细菌、生产成本低、生产系统简单且产量高。本研究考察了在大肠杆菌中生产并获得批准的生物制药，涵盖了肽类、激素、酶类、融合蛋白、抗体片段、疫苗和其他药物。这些生物制药的批准主题、生产时间、生产公司及其在该领域的应用和发展也进行了讨论。简介 20世纪70年代，随着重组DNA技术的引入，发现大肠杆菌能够强效且经济地生产重组蛋白。此之前，猪牛的胰腺是治疗糖尿病所需胰岛素的来源。然而，1980年代初，美国食品药品监督管理局（FDA）批准了由大肠杆菌生产的首个重组胰岛素，开启了糖尿病治疗的下一阶段，并为生产更多的重组药物提供了途径。这一成就表明，尽管胰岛素是一个需要氧化蛋白折叠的异二聚体，但它可以在大肠杆菌中合成。从那时起，改进后的重组药物，如单克隆抗体，开始使用包括大肠杆菌、酵母、丝状真菌、昆虫细胞和哺乳动物细胞在内的多种表达宿主进行生产。与其他重组微生物相比，大肠杆菌仍然是其最具吸引力的宿主之一。该细菌的基因学已被充分研究，且多种克隆技术和表达系统使其能够有效生产多种蛋白质。图1展示了一种在大肠杆菌中生产重组生物制药的通用方法。图1. 在大肠杆菌中生产生物药的一般方法。大肠杆菌因其快速生长、低廉的营养需求、易于扩展规模以及能够生产高产、高质量的药物而在大规模生产中受到青睐。然而，大肠杆菌的应用也存在一些限制。例如，某些复杂蛋白的生产可能受限于无法进行特定的翻译后修饰，从而限制了蛋白的成熟和二硫键的形成。人们普遍认为，适当的糖基化和折叠对于复杂蛋白（如单克隆抗体）尤为重要。目前，欧洲药品管理局（EMA）和美国FDA已批准多种由大肠杆菌生产的重组治疗药物用于多种临床用途。本综述讨论了由大肠杆菌生产的关键生物制药，涵盖激素、酶类、肽类、疫苗、融合蛋白、抗体片段和其他生物制药类别。大肠杆菌在生物制药生产中的应用激素激素是生物制药生产中的一个重要类别，大肠杆菌在该领域的发展中发挥了重要作用。人类胰岛素（Humulin）是首个由大肠杆菌生产的重组生物制药，用于治疗糖尿病，由Eli Lilly公司生产，并于1982年获得美国FDA批准。随后，Lantus，一种长效胰岛素甘精分子，由Sanofi-Aventis公司在大肠杆菌中生产，并于2000年在美国和欧盟获得批准。胰岛素甘精是通过重组方式生产的人类胰岛素类似物，能够与胰岛素受体结合。近年来，许多胰岛素类似物通过重组方式在大肠杆菌中生产。其中，Lyumjev（胰岛素Lispro），一种快速起效的胰岛素类似物，由Eli Lilly公司在大肠杆菌中生产，并于2020年获得FDA和EMA批准，用于治疗1岁及以上糖尿病患者。生长激素是可以在大肠杆菌中生产的最早的生物制药之一。生长激素Somatropin（Humatrope）由Eli Lilly公司在大肠杆菌中重组生产，用于治疗儿童生长激素缺乏症（GHD），并于1987年获得FDA批准。Sogroya（Somapacitan-beco），一种长效生长激素，由Novo Nordisk公司使用重组DNA技术在大肠杆菌中生产。通过改造Somapacitan分子，使其能够可逆地与血液中的白蛋白结合，从而减缓Somapacitan的排出，延长其作用时间。它于2020年获得FDA批准，2021年获得EMA批准，用于2.5岁及以上的成人和儿童患者。在一项临床研究中，Somapacitan每周使用一次对成人GHD患者有效且耐受良好。在另一项III期研究中，每周使用Somapacitan与每日生长激素相比，在儿童GHD患者中显示出相似的疗效和安全性。Skytrofa（Lonapegsomatropin-tcgd），一种长效生长激素，由Ascendis Pharma公司使用重组DNA技术在大肠杆菌中生产。2021年，FDA批准其用于治疗1岁及以上患有生长激素分泌不足的儿童患者。重组干扰素α-2b（Intron A）用于治疗生殖器疣、癌症和肝炎，由Merck Sharp & Dohme公司生产，并于1986年获得FDA批准。随后，干扰素分子的改良变体（干扰素α-2a、α-2b、α-1a、α-1b）被开发用于治疗各种疾病（如肾癌、肾细胞癌、非霍奇金淋巴瘤、皮肤T细胞淋巴瘤、慢性髓性白血病、黑色素瘤）。Besremi（ropeginterferon alfa-2b-njft）由PharmaEssentia公司使用重组DNA技术在大肠杆菌中生产，并于2021年获得FDA批准，用于治疗成人多血症（PV）（一种以血细胞增多为特征的罕见血液疾病）。在多血症患者接受3年治疗后，ropeginterferon alfa-2b被证明有效且安全，且对标准治疗反应更好。也有研究评估了ropeginterferon alfa-2b在妊娠期多血症患者中的疗效和安全性，但这些研究强调了需要更多的案例研究。 Forsteo（teriparatide），一种人类副甲状腺激素类似物，由Eli Lilly公司在大肠杆菌中生产，并于2003年获得EMA批准用于治疗骨质疏松症。随后，许多类似Forsteo的生物仿制药（如Movymia、Terrosa和Sondelbay）在大肠杆菌中生产。其中，Sondelbay（teriparatide），一种人类副甲状腺激素片段，由Accord Healthcare公司使用重组DNA技术在大肠杆菌中生产，并于2022年获得EMA批准，用于治疗骨质疏松症。Natpara（副甲状腺激素）由NPS Pharmaceuticals公司在大肠杆菌中重组生产，并于2015年获得FDA批准，用于治疗副甲状腺功能减退症（低钙血症）。重组副甲状腺激素疗法的临床研究持续了5年和12个月，结果表明该疗法能改善副甲状腺功能减退症患者的生化参数，并确认了治疗的疗效和安全性。此外，Natpar，一种重组人类副甲状腺激素，由Takeda Pharmaceuticals公司在大肠杆菌中生产，并于2017年获得EMA批准用于治疗副甲状腺功能减退症。最近的研究旨在调查在大肠杆菌中生产新的激素类似物和改性。超快速起效的胰岛素类似物，如VIAject/Linjeta、Biodel胰岛素（BIOD-531）、BioChaperone Lispro和LY900014，正在进行临床研究。这些制剂在作用速度和血糖控制方面优于传统胰岛素，如Humalog、NovoLog和Fiasp。另一种策略是将胰岛素类似物与重组人透明质酸酶结合。研究发现，胰岛素-透明质酸酶组合能在健康志愿者和1型糖尿病患者中引起更快的起效和更低的餐后高血糖。公司还在进行针对2型糖尿病的新型胰岛素的测试。例如，Eli Lilly正在测试LY3209590，这是一种设计的胰岛素，结合了抗体Fc结构域，具有长效基础型特性，并与甘精胰岛素进行了比较。酶类酶在多种生物过程中发挥重要作用，是另一类可以在大肠杆菌中生产的治疗蛋白。Pegloticase（重组人尿酸氧化酶，Krystexxa）于2010年在美国获得批准，用于治疗成人慢性痛风，由Savient Pharmaceuticals公司在大肠杆菌中重组生产。最近的一项研究表明，在无法控制的痛风患者中，将Pegloticase与甲氨蝶呤（MTX）联合使用可引发更高的治疗反应和更低的免疫原性。 Voraxaze（葡萄糖氨酸酶），一种羧肽酶，由BTG International公司生产，用于减少肾功能受损患者体内的甲氨蝶呤（MTX）。葡萄糖氨酸酶将MTX转化为谷氨酸和2,4-二氨基-N（10）-甲基叶酸。在大肠杆菌中重组生产的葡萄糖氨酸酶于2012年获得FDA批准，2022年获得EMA批准。 Calaspargase pegol（Asparlas），一种天冬氨酸酶，由Servier Pharmaceuticals公司在大肠杆菌中生产，用于治疗1个月至21岁急性淋巴细胞白血病（ALL）患者。使用重组DNA技术生产的Calaspargase pegol于2018年获得FDA批准。在一项ALL患者研究中，Calaspargase pegol的天冬氨酸酶活性比天然来源于大肠杆菌的Pegaspargase更为持久。 Pegvaliase-pqpz（Palynziq）由Biomarin公司在大肠杆菌中生产。这种酶可以减少血液中的苯丙氨酸含量，并于2018年获得FDA批准，用于治疗成人苯丙酮尿症患者。在一项研究中，介绍了使用Pegvaliase治疗苯丙酮尿症患者的病例经验。此外，最近还进行了一项临床试验，研究了使用Pegvaliase治疗过程中的治疗中断和剂量调整。 Revcovi（Elapegademase-lvlr）由Leadiant Biosciences公司在大肠杆菌中重组生产。该酶于2018年获得FDA批准，用于治疗腺苷脱氨酶重症联合免疫缺陷症（ADA-SCID）患者，包括成人和儿童。临床研究显示，Elapegademase治疗ADA-SCID患者的疗效和安全性，且使用Revcovi能够有效治疗ADA-SCID。近年来，使用大肠杆菌生产的酶类在临床前研究中得到了评估，旨在开发新的酶候选药物用于各种临床应用，以增强现有治疗的效果并最小化副作用。肽类肽类是生物制药中的一个基础类别，涵盖了广泛的治疗药物，并在临床应用中具有重要作用。本节重点讨论可以在大肠杆菌中生产的肽类。Natrecor（nesiritide），一种重组人类利尿肽，由Johnson & Johnson/Scios公司在大肠杆菌中生产。2001年，FDA批准其用于治疗急性失代偿性心力衰竭患者。 FDA于2005年批准Increlex（mecasermin），一种由重组DNA技术在大肠杆菌中生产的类胰岛素生长因子-1（IGF-1），用于治疗严重原发性IGF-1缺乏症或生长激素基因缺失的儿童生长失败。临床研究表明，mecasermin有效促进这些患者的线性生长。 Fortical（降钙素），一种用于治疗骨质疏松症和其他骨骼疾病的激素，也是在大肠杆菌中生产的。该肽由Unigene Laboratories公司生产，并于2005年获得FDA批准。研究表明，它能够有效减少骨吸收并增加骨矿物质密度，尤其在骨质疏松症患者中。 Gattex（teduglutide），由NPS Pharmaceuticals公司生产，于2012年获得FDA批准，用于治疗短肠综合症。研究表明，teduglutide治疗能显著改善短肠综合症患者的肠道吸收能力，并减少对外源性营养支持的需求。 Voxzogo（Vosoritide），一种利尿肽，由Biomarin Pharma在大肠杆菌中生产。2021年，FDA和EMA批准其用于治疗儿童患者的软骨发育不全。在一项针对5岁及以上（<18岁）软骨发育不全儿童的III期研究中，发现52周的Vosoritide治疗是一个重要的治疗选择。随后，Vosoritide治疗被报告为安全并能促进软骨发育不全儿童的持续生长。 Oxervate（cenegermin），一种神经生长因子，由Dompé U.S.公司使用重组DNA技术在大肠杆菌中生产。它于2017年获得EMA批准，2018年获得FDA批准，用于治疗神经营养性角膜炎（一种眼部疾病）。一项研究报告称，Cenegermin治疗能有效改善角膜上皮、角膜感觉和视力，但需要更全面的研究。然而，另一项研究报告指出，使用Cenegermin进行局部治疗时，如果与包带型隐形眼镜一起使用，可能会在镜片和眼表面造成药物沉淀。另一种在大肠杆菌中生产的肽类是Idefirix（imlifidase）。该药物用于预防身体排斥移植肾脏，由Hansa Biopharma公司在大肠杆菌中使用重组DNA技术生产，并于2020年获得EMA批准。研究表明，Imlifidase治疗可能是使肾脏移植受者去敏感化的有效且有前景的方法，但仍需要更多的临床数据以了解其使用和应用。近年来，在大肠杆菌中生产的生物制药肽类有助于生产那些可能难以化学合成的长肽或复杂肽。通过在大肠杆菌中生产的肽类生物制药包括了用于靶向各种疾病（如心血管病、代谢病、感染、癌症和自身免疫性疾病）的创新临床前方法。疫苗疫苗的开发和生产是生物制药领域的一个关键前沿，旨在保护公共健康并预防各种传染性疾病。在这一背景下，大肠杆菌被用作生产疫苗的多功能且宝贵的工具。Hecolin（Innovax）是首个基于病毒样颗粒的乙型肝炎病毒疫苗，由大肠杆菌生产，并于2011年获得中国食品药品监督管理局（CFDA）许可。在中国，针对16至65岁成人的III期研究报告显示，Hecolin有效预防了乙型肝炎病毒感染。人乳头瘤病毒（HPV）L1 VLPs疫苗（Cecolin；Innovax）也是由大肠杆菌生产，并在中国批准上市。在一项III期研究中，该HPV疫苗对生殖器损伤和持续性感染有效。 Strangvac疫苗，含有马链球菌CCE、mEq84和IdeE抗原，是由Intervacc公司使用重组DNA技术在大肠杆菌中生产的，用于防治马链球菌引起的马脖腺炎，并于2021年获得EMA批准。一项研究报告称，Strangvac疫苗接种是安全的，且能有效保护马匹免受由马链球菌引起的脖腺炎。 Prevnar 13疫苗用于预防13种肺炎链球菌血清型引起的肺炎，由Wyeth Pharmaceuticals公司使用棒状分枝杆菌生产，并于2010年获得FDA批准。此外，辉瑞公司于2016年宣布，Prevnar 13是唯一获得批准用于所有年龄段人群的肺炎球菌疫苗。随后，肺炎球菌结合疫苗（蛋白质多糖）也在大肠杆菌中重组生产，并显示其在与Prevnar 13疫苗相比时，能够用于预防肺炎球菌感染。此外，还进行了一项研究，旨在提高在大肠杆菌中生产的肺炎球菌生物结合疫苗的产量并减少内毒素的形成。 Trumenba（B组脑膜炎球菌疫苗），也称为MenB-FHbp，由Wyeth Pharmaceuticals（辉瑞子公司）在大肠杆菌中生产。Trumenba包含两种重组的Neisseria meningitidis B群的因子H结合蛋白（FHbp）变体。2014年，FDA批准其用于10至25岁人群预防由B群脑膜炎球菌引起的疾病，2017年EMA批准该疫苗用于预防该病。一项最新的III期研究表明，MenB-FHbp在青少年和年轻成人中应用良好，耐受性好，安全性高，并能增加保护性抗体反应。2018年至2020年间进行的接种研究报告称，Trumenba接种后没有出现死亡或免疫后的不良事件。另一种脑膜炎球菌疫苗，Bexsero（含有B群脑膜炎球菌的片段），也称为4CMenB，由GlaxoSmithKline公司在大肠杆菌中生产。Bexsero于2015年获得FDA批准，适用于10至25岁患者，2013年获得EMA批准，适用于2个月及以上人群。在美国进行的一项研究显示，Bexsero疫苗没有引发新的安全问题，且所有的副作用大多为轻微的。根据9年的数据报告，4CMenB的使用在不同年龄组中并未引起显著的安全问题。然而，接种后婴儿可能会出现短暂的发热。一项最近的研究报告称，使用4CMenB能有效预防5岁以下儿童的侵袭性脑膜炎球菌病。在大肠杆菌中生产的间日疟原虫抗原已被证明能够增强小鼠的细胞免疫和体液免疫反应，并可能成为针对基于间日疟原虫的疟疾的潜在疫苗候选者。此外，首批动物疫苗之一，p45猫白血病病毒包膜抗原（Leucogen；Virbac），是由Hansa Biopharma使用重组DNA技术在大肠杆菌中生产，并于2009年获得EMA批准。Letifend（LETI Pharma），一种来自利什曼原虫的蛋白质Q疫苗，用于治疗犬类利什曼病，也是使用重组DNA技术在大肠杆菌中生产，并于2016年获得EMA批准。大肠杆菌继续被用于生产各种疫苗抗原。例如，1998年，FDA批准了一种包含重组生产的由博莱氏螺旋体产生的外表面脂蛋白OspA的莱姆病疫苗。然而，由于担心严重的副作用，该疫苗在2002年被撤回市场。一个改进版本VLA15，仍然在大肠杆菌中生产，目前正在进行III期临床试验。融合蛋白和抗体片段在大肠杆菌中生产融合蛋白和抗体片段已成为开发生物制药的关键策略，并为各种治疗应用提供了特定的解决方案。Ranibizumab分子（Lucentis）由Genentech/Roche公司在大肠杆菌中生产，用于治疗年龄相关性黄斑变性（AMD），并于2006年在美国获得批准。Ranibizumab是一种单克隆抗体片段，针对所有血管内皮生长因子A（VEGF-A）同种型。该结合物可防止与细胞表面受体如VEGFR1和VEGFR2的二聚化，从而减少血管生成、内皮细胞增生和血管泄漏。Ranibizumab是治疗糖尿病性黄斑水肿的重要选择，并能改善增殖性糖尿病视网膜病变。随后，Byooviz，一种与Lucentis类似的生物相似药，在大肠杆菌中生产，并于2021年获得FDA和EMA批准，用于治疗AMD、视网膜静脉闭塞后黄斑水肿和近视性脉络膜新生血管。Susvimo（ranibizumab），一种VEGF抑制剂，由Genentech公司在大肠杆菌中生产，并于2021年获得FDA批准，用于治疗AMD。曲妥珠单抗（Herceptin）单克隆抗体由Genentech/Roche公司在中国仓鼠卵巢细胞中生产，并于1998年获得FDA批准用于临床治疗。然而，已有研究表明该分子也可以在大肠杆菌中生产。人类表皮生长因子受体2（HER2）蛋白位于细胞表面，在调节细胞生长和通信中起着至关重要的作用。约四分之一的乳腺癌患者发现该受体表达过高。曲妥珠单抗（抗HER2）针对HER2受体，已报告其可以减缓由于HER2信号传导引起的癌症发展。赛妥珠单抗（Cimzia）单克隆抗体片段由UCB Pharma公司在大肠杆菌中生产，用于治疗克罗恩病和类风湿性关节炎（RA）。它也是一种肿瘤坏死因子（TNF）抑制剂。该Fab（抗原结合片段）分子以可溶性形式生产，并于2008年获得FDA批准。罗米普利司汀（Nplate）融合蛋白由Amgen公司在大肠杆菌中生产，用于治疗免疫性血小板减少性紫癜。这种蛋白在细胞质中以包涵体的形式生产，并于2008年获得FDA批准，2009年获得EMA批准。莫昔单抗帕苏多毒素（Lumoxiti）融合蛋白由AstraZeneca公司生产，并于2018年获得FDA批准。该重组蛋白特异性结合B细胞表面的CD22受体，并在大肠杆菌中生产，用于治疗毛细胞白血病。 Caplacizumab（Cablivi）抗体由Ablynx/Sanofi公司生产，用于治疗获得性血栓性血小板减少性紫癜，并于2019年获得FDA批准。该单克隆抗体在大肠杆菌中以可溶性形式生产，靶向冯·维尔兰德因子。EMA也于2018年批准其用于12岁以上儿童和成人。 Brolucizumab（Beovu）是一种由诺华公司生产的单克隆单链可变片段，用于治疗AMD。该分子结合VEGF受体，并通过重组DNA技术在大肠杆菌中生产，于2019年获得FDA批准。另一个单克隆抗体片段是Bentracimab（PB2452）。Bentracimab能逆转抗血栓药物替卡格雷（Brilinta）的作用。在健康志愿者的研究中，Bentracimab显示出有效性和安全性。目前，Bentracimab的III期临床试验——替卡格雷快速持续逆转干预试验正在进行中。此外，2023年达成协议，宣布SFJ Pharmaceuticals将负责Bentracimab的持续临床研究。在大肠杆菌中生产的融合蛋白和抗体片段也用于癌症治疗。Tebentafusp（Kimmtrak）融合蛋白由Immunocore公司在大肠杆菌中生产，用于治疗转移性葡萄膜黑色素瘤，并于2022年获得FDA和EMA批准。Oportuzumab monatox（Vicineum）融合蛋白由Sesen Bio公司在大肠杆菌中生产，用于治疗膀胱癌，并已开发至III期研究。通过重组DNA技术生产的这种可溶性形式的蛋白靶向上皮细胞黏附分子抗原，该抗原在大多数实体肿瘤中高表达。然而，2022年7月18日，公司宣布决定停止在美国进一步开发Vicineum。近年来，Genentech和Sutro Biopharma已在临床研究中探索了大肠杆菌生产的去糖基化抗体。Genentech在II期和III期研究中探索了抗MET抗体onartuzumab（OA-5D5，RG3638），用于治疗多种晚期实体瘤；然而，由于缺乏显著的临床效果，III期试验被停止。此外，Genentech的全长IgG4双特异性抗体BIT7201A（RG7990）也在I期研究中测试，用于哮喘治疗，并显示出良好的耐受性。Sutro Biopharma的三种单克隆抗体药物偶联物和一种双特异性单克隆抗体药物偶联物目前都处于I期临床试验阶段。STRO-001正在评估用于治疗多发性骨髓瘤和B细胞恶性肿瘤；STRO-002用于治疗过度表达FolRα的铂耐药性卵巢癌和其他实体瘤；ispectamab debotansine（CC-99712，BMS-986352）用于治疗多发性骨髓瘤；M1231用于非小细胞肺癌和食道癌。这些都在I期临床试验中。其他生物制药大肠杆菌生产的生物制药的范围不仅限于疫苗、抗体、酶、融合蛋白、抗体片段和激素，还包括具有独特应用的各种治疗药物。本节重点介绍了在大肠杆菌中生产的其他生物制药。Filgrastim分子（Neupogen）是由安进公司在大肠杆菌中生产的重组人粒细胞集落刺激因子，用于治疗中性粒细胞减少症，并于1991年在美国获得批准。2002年，同一公司开发了Filgrastim分子的聚乙二醇化形式（Neulasta），用于治疗癌症相关感染。随后，许多Neulasta（聚filgrastim）生物相似药被生产出来。Stimufend（聚filgrastim-fpgk）是由Fresenius Kabi公司生产的，用于治疗中性粒细胞减少症，并于2022年获得FDA批准。 Beromun（tasonermin）是一种肿瘤坏死因子（TNF-α），由Boehringer Ingelheim公司在大肠杆菌中重组生产，用于治疗软组织肉瘤，并于1999年获得EMA批准。 Anakinra分子（Kineret）是一种白介素-1受体拮抗剂，由瑞典孤儿生物技术公司Biovitrum在大肠杆菌中重组生产，用于治疗类风湿性关节炎，并于2001年在美国获得批准。 Meterleptin（Myalept）是一种类脂素，由Aegerion Pharmaceuticals公司在大肠杆菌中重组生产。2014年，FDA批准其用于治疗获得性或先天性广泛性脂肪营养不良患者的类脂素缺乏症。虽然脂肪营养不良是一种罕见疾病，且治疗选择有限，Meterleptin的研究较少，但一项研究表明，它显著改善了接受Meterleptin治疗者的生活质量。 Tagraxofusp-erzs（Elzonris）是一种细胞因子，由Stemline Therapeutics公司使用重组DNA技术在大肠杆菌中生产。2018年，FDA批准其用于治疗儿童和成人的爆发性浆细胞状树突状细胞肿瘤，并于2021年获得EMA批准。结论大肠杆菌具有诸多优势，如良好的遗传结构知识、克隆技术应用简便、生产快速、对营养培养基要求简单以及易于大规模生产。然而，它在生产复杂蛋白质时存在一些局限性（如缺乏后期翻译修饰和二硫键形成的限制）。尽管如此，大肠杆菌仍然是生产生物制药的一个有吸引力的宿主。本文回顾了FDA和EMA批准的大肠杆菌生产的生物制药，包括激素、酶、疫苗、融合蛋白和抗体片段。本文按时间顺序讨论了从胰岛素开始，到目前为止，在大肠杆菌中生产并获得批准的生物制药，并介绍了这些生物制药用于治疗的疾病。此外，还提到了相关领域中一些正在进行的治疗研究。因此，大肠杆菌仍然是许多已经生产并将来会生产的生物制药的重要宿主，用于治疗各种疾病。未来，随着生物技术的研究和发展，可以消除大肠杆菌重组蛋白生产中的局限性，提高其效果。因此，来自大肠杆菌的生物制药可能在治疗疾病和制药行业中占据重要地位。原文：İ.İncir, Ö.Kaplan, Escherichia coli in the production of biopharmaceuticals. Biotechnology and Applied Biochemistry, 2024.

2026-06-11

·BioSpace

PharmaEssentia Expands North American Commercial Footprint with Acquisition of Canadian Partner FORUS Therapeutics

Acquisition deepens PharmaEssentia's presence in the Canadian hematology-oncology MPN market to accelerate BESREMi ® (ropeginterferon alfa-2b) commercialization BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical company headquartered in Taiwan, today announced the acquisition of FORUS Therapeutics Inc. ("FORUS"), a Canadian specialty pharmaceutical company, in a transaction valued at US$36.5 million. The acquisition represents an important component of PharmaEssentia's North American commercial strategy and marks a significant milestone in the company's global expansion. PharmaEssentia entered into a commercial licensing agreement with FORUS for BESREMi ® in Canada in 2024. FORUS has deep roots in the Canadian hematology and oncology space, with an experienced team and established regulatory, medical, commercial, and market-access infrastructure. FORUS submitted a New Drug Submission to Health Canada for ropeginterferon alfa-2b for polycythemia vera (PV) in July 2025, with regulatory approval expected in Q3 2026. A submission for the additional indication of essential thrombocythemia (ET) is being prepared, further expanding the market opportunity. By acquiring 100% of FORUS, PharmaEssentia will fully integrate Canadian regulatory and medical affairs, marketing, and commercial channel resources — consolidating competitive advantages for BESREMi ® and future products in the market. This opportunity also allows PharmaEssentia to explore potential important market synergies and opportunities in Canada with FORUS’s other partner, Karyopharm and its lead asset, XPOVIO. "This acquisition is the culmination of a strong and proven partnership with the FORUS team," said Dr. Ko-Chung Lin, Founder and Chief Executive Officer of PharmaEssentia. "By bringing their regulatory expertise, market relationships, and medical/commercial capabilities fully in-house, we are best positioned to accelerate BESREMi ® 's availability to patients with MPN across Canada, and to build a durable North American platform for our growing portfolio." The FORUS team brings more than 25 years of hematology and oncology commercialization experience, with backgrounds at Celgene, Roche, Pfizer, and other leading global pharmaceutical companies. Collectively, the team has launched more than 10 products, generating over C$2 billion in cumulative sales. FORUS CEO Kevin Leshuk spent 13 years at Celgene, where he established the Canadian subsidiary and built a leading hematology-oncology team, successfully launching multiple critical oncology therapies. "Joining PharmaEssentia marks an exciting new chapter and opportunity for the FORUS team," said Kevin Leshuk, CEO of FORUS Therapeutics. "Our respective organizations share a deep commitment to the hematology community and to bringing ropeginterferon alfa-2b to the Canadian patients who need it. This acquisition now provides the local team the opportunity to build upon the existing experience with XPOVIO and leverage combined capabilities, infrastructure, and expertise as we build a leading MPN and hematology-oncology franchise in Canada." PharmaEssentia remains committed to advancing innovation, building strategic international partnerships, and expanding access to transformative therapies for patients worldwide. 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 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) . About BESREMi ® (ropeginterferon alfa-2b-njft) Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi ® for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA. BESREMi ® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications. INDICATION BESREMi ® is indicated for the treatment of adults with polycythemia vera. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DISORDERS Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy. CONTRAINDICATIONS Existence of or history of severe depression, suicidal ideation, or suicide attempt Hypersensitivity to interferons or any inactive ingredients Moderate or severe hepatic impairment History or presence of active serious or untreated autoimmune disease History of transplantation and receiving immunosuppressant agents WARNINGS AND PRECAUTIONS Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Depression and Suicide: Monitor closely for symptoms and need for treatment. Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed. Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently. Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment. Hypersensitivity Reactions: Stop treatment and immediately manage reaction. Pancreatitis: Consider discontinuation if confirmed pancreatitis Colitis: Discontinue if signs or symptoms of colitis Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders. Hyperlipidemia: Monitor serum triglycerides before BESREMi ® treatment and intermittently during therapy and manage when elevated. Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops. Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations. Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity. Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination. Please see full Prescribing Information , including Boxed Warning. Contacts Media Muriel Huang Director, Investor Relations and Corporate Communication muriel_huang@pharmaessentia.com

上市批准引进/卖出并购孤儿药

100 项与罗培干扰素α-2b 相关的药物交易

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外链

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

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
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

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
原发性骨髓纤维化	临床3期	日本	药华医药股份有限公司	2025-07-18
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	韩国	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

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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


ASCO2026	N/A	真性红细胞增多症	18	Ropeginterferon alfa-2b with HIDAT	餘觸廠獵顧築鹽製網願(網糧艱製鑰遞壓醖齋鏇) = 餘顧鬱築廠遞製齋選顧壓淵鹽觸簾夢淵築繭膚 (鏇鬱淵遞獵獵遞鹽齋構 ) 更多	积极	2026-05-29
				Ropeginterferon alfa-2b with low-dose regimens	餘觸廠獵顧築鹽製網願(網糧艱製鑰遞壓醖齋鏇) = 衊網鹽觸醖糧遞遞鹽鑰壓淵鹽觸簾夢淵築繭膚 (鏇鬱淵遞獵獵遞鹽齋構 ) 更多
NCT06506084 (EHA2026)	N/A	真性红细胞增多症	262	ROPEGINTERFERON ALFA-2B (HU-intolerant patients)	範糧願蓋構廠憲鹹鹽鬱(齋餘鏇鏇獵鏇鏇願淵糧) = 鹽鏇夢鏇鑰鹹膚蓋膚製鹹衊壓鹽鬱醖積觸膚積 (鏇觸範鹹壓鑰齋糧淵網 ) 更多	积极	2026-05-12
				ROPEGINTERFERON ALFA-2B (with a history of skin cancer)	範糧願蓋構廠憲鹹鹽鬱(齋餘鏇鏇獵鏇鏇願淵糧) = 壓壓遞夢糧鹽製糧願積鹹衊壓鹽鬱醖積觸膚積 (鏇觸範鹹壓鑰齋糧淵網 ) 更多
NCT04285086 (SURPASS-ET, EHA2026)	临床3期	原发性血小板增多症	174	P1101	繭糧憲鹽選餘觸製觸簾(膚構醖鏇醖積鑰夢艱鑰) = 遞鹽鏇夢襯鑰膚構製蓋餘鏇窪艱壓襯鏇範襯鏇 (製齋衊衊顧顧淵繭製顧, 66.4 ~ 84.4) 更多	积极	2026-05-12
				Anagrelide	繭糧憲鹽選餘觸製觸簾(膚構醖鏇醖積鑰夢艱鑰) = 艱觸壓鑰淵願壓齋鹽衊餘鏇窪艱壓襯鏇範襯鏇 (製齋衊衊顧顧淵繭製顧, 30.6 ~ 55.0) 更多
EHA2026	N/A	真性红细胞增多症 JAK2V617F	15	Ropeginterferone alfa-2b (JAK2V617F positive + Polycythemia Vera + HU-intolerant)	鬱繭築餘糧憲製襯膚鹽(醖觸繭構網壓獵膚範鏇) = 襯淵夢憲艱構齋艱艱艱膚襯構鏇蓋繭簾壓遞製 (鬱構窪願蓋鹹築糧製鹹 ) 更多	积极	2026-05-12
SURPASS-ET (EHA2026)	临床3期	原发性血小板增多症	137	Ropeginterferon alfa-2b (SURPASS-ET study)	壓觸憲鑰範醖顧壓餘衊(餘夢遞齋鹹積鏇積艱壓) = 襯觸鹹壓餘窪選願糧構壓範鑰鏇艱衊顧願鏇築 (壓糧網艱襯觸鹹網鬱艱 ) 更多	积极	2026-05-12
				Anagrelide (SURPASS-ET study)	衊膚遞窪願醖製鏇糧鹽(選憲築獵築繭遞選鑰廠) = 簾醖夢廠鹽鹹積觸壓壓築蓋齋積淵窪構艱襯艱 (製顧餘糧壓膚蓋窪醖淵 ) 更多
EHA2026	N/A	真性红细胞增多症	99	Ropeginterferon alfa-2b	糧築願壓蓋憲網糧鏇糧(網製襯範膚構醖簾遞夢) = 醖繭築夢顧艱襯範糧鹹窪糧蓋選觸醖網鑰壓廠 (構夢窪蓋壓夢繭壓醖築 ) 更多	积极	2026-05-12
NCT06514807 (ROP-ET, EHA2026)	临床3期	原发性血小板增多症	132	Ropeginterferon alfa-2b	製網簾鏇襯淵顧壓壓壓(衊衊積選獵鑰範鹹醖築) = 鏇顧糧憲遞艱糧簾網淵鹹襯鬱範繭築選範衊糧 (淵夢糧築憲廠獵餘壓願 ) 更多	积极	2026-05-12
				Ropeginterferon alfa-2b (high‐risk)	廠遞製範願鹽遞積廠鏇(獵範選觸艱襯鬱獵願觸) = 壓繭鏇醖鏇鹹蓋夢築鹹顧齋構範簾繭鹽憲壓窪 (網鹹廠餘齋憲顧壓壓選, 42.3 ~ 69.7)
EHA2026	N/A	骨髓增生性疾病	206	ropeginterferon alfa-2b	鹹窪憲築獵製餘簾遞觸(獵範蓋膚繭糧製網積鹹) = Adverse event-related discontinuations included hepatic dysfunction, neuropathy, migraine, ocular symptoms, and vascular events, each occurring in ≤ 2 patients. 夢選膚顧鹹鑰餘蓋簾襯 (繭夢鬱鑰鏇遞選簾遞構 ) 更多	积极	2026-05-12
				ropeginterferon alfa-2b (switch cohort)
NCT06002490 (A23-301, Company_Website) 人工标引	临床3期	真性红细胞增多症	-	BESREMi	鹹淵憲夢範窪範憲糧鏇(醖獵簾構築齋廠糧糧衊) = 範夢壓醖鹹壓艱襯遞構製築願觸觸廠鏇構構醖 (製製鑰襯壓糧廠範廠築 )	积极	2026-03-02
NCT05482971 (EXCEED-ET, Company_Website) 人工标引	临床2期	原发性血小板增多症	91	Ropeginterferon alfa-2b-njft (Treatment-naïve patients)	繭鏇鑰齋獵齋築糧繭廠(構遞築構廠夢淵醖構範) = 鬱壓鏇夢遞憲壓窪築獵繭襯糧糧糧齋蓋糧簾鑰 (顧廠窪窪鹹繭鏇構襯廠 ) 更多	积极	2026-01-12
				Ropeginterferon alfa-2b-njft (Hydroxyurea-experienced patients)	繭鏇鑰齋獵齋築糧繭廠(構遞築構廠夢淵醖構範) = 糧蓋艱構鬱鑰鏇築遞簾繭襯糧糧糧齋蓋糧簾鑰 (顧廠窪窪鹹繭鏇構襯廠 ) 更多