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2024-10-01

申办/合作机构

药华医药股份有限公司

NCT06290765 / Not yet recruiting临床4期

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

This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks).

开始日期2024-07-01

申办/合作机构

药华医药股份有限公司

NCT06514807 / Recruiting临床3期

A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients Who Are Intolerant or Refractory to or Not Eligible for Other Cytoreductive Treatments

The primary objective of this study is to assess the efficacy of ropeginterferon alfa-2b in patients with ET who need cytoreductive treatment but are intolerant or refractory to, and/or ineligible for cytoreductive treatments approved and available for the treatment of ET (i.e., HU, ANA, BUS, and PB, when they are available and approved for ET treatment).
Ropeginterferon alfa-2b is currently the only interferon authorised as a cytoreductive treatment of a myeloproliferative neoplasm (MPN), and the long-term treatment data from its comprehensive clinical development program show its efficacy in the induction of haematologic remission, resolution of disease-associated symptoms, disease-modifying effect, as well as its favourable safety profile (Gisslinger et al., 2020; Kiladjian et al. 2022).
Available clinical data and experience show that ropeginterferon alfa-2b normalises various haematological parameters, including platelets. In addition, suppression of the malignant clone causing ET may be achieved, at least after long-term treatment, which is expected to possibly defer the onset of, or avoid long-term sequelae of ET.

开始日期2023-12-04

申办/合作机构

Aop Orphan Pharmaceuticals GmbH

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 相关的转化医学

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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）

2024-03-01·Clinical lymphoma, myeloma & leukemia

SOHO State of the Art Update and Next Questions: Novel Therapies for Polycythemia Vera

Review

作者: Chifotides, Helen T ; Masarova, Lucia

In the recent years, landmark advancements in the treatment of polycythemia vera (PV) have been achieved. We witnessed the regulatory approval of ropeginterferon and the advanced clinical development of other novel agents that may affect the underlying pathophysiological mechanisms of the disease. Agents with the potential of disease modification may soon overtake preceding treatment options that were based on the patient's age and history of thrombosis. Recent studies using ropeginterferon in low-risk PV patients earlier in the disease course challenge the current treatment paradigm and shift the focus on modifying the course of the disease. Hepcidin mimetics offer an excellent alternative to phlebotomy, providing better quality of life, and may lead to improved outcomes in PV by tight hematocrit control. Novel agents, such as histone deacetylase inhibitors, hold promise to complement the therapeutic landscape of PV and might be particularly promising in rationale combinations. Ruxolitinib is well established as an approved second-line treatment for PV. In the frontline setting, the precise role of ruxolitinib, which also represents an appealing agent in combination regimens, will be determined in ongoing research studies. Longer follow-up is necessary to assess whether novel agents/regimens elicit fewer thromboembolic/ hemorrhagic events and halt disease progression to myelofibrosis and acute myeloid leukemia. We aspire that disease-modifying approaches in PV are on the horizon, and that we will be empowered to ultimately change the natural course of the disease and profoundly impact the lives of PV patients in the near future.

2024-02-01·Annals of hematology

Ropeginterferon phase 2 randomized study in low-risk polycythemia vera: 5-year drug survival and efficacy outcomes

Article

作者: Vianelli, Nicola ; Rossi, Elena ; Benevolo, Giulia ; Bonifacio, Massimiliano ; Carioli, Greta ; Pane, Fabrizio ; Fenili, Francesca ; Lunghi, Francesca ; Mora, Barbara ; Rambaldi, Alessandro ; Gesullo, Francesca ; Carobbio, Alessandra ; Cattaneo, Daniele ; Musolino, Caterina ; Cacciola, Emma ; Loscocco, Giuseppe Gaetano ; Carli, Giuseppe ; Scaffidi, Luigi ; Cascavilla, Nicola ; Bucelli, Cristina ; Iurlo, Alessandra ; Betti, Silvia ; De Stefano, Valerio ; Rumi, Elisa ; Vannucchi, Alessandro Maria ; Ghirardi, Arianna ; Ricco, Alessandra ; Barbui, Tiziano ; Caramella, Marianna ; Palandri, Francesca ; Bellini, Marta ; Finazzi, Maria Chiara ; Siragusa, Sergio ; Ciceri, Fabio ; Rapezzi, Davide ; Ramundo, Francesco ; Guglielmelli, Paola ; Alvarez-Larran, Alberto ; Tognoni, Gianni ; Patriarca, Andrea ; Calabresi, Laura

In patients with low-risk polycythemia vera, exposure to low-dose Ropeginterferon alfa-2b (Ropeg) 100 µg every 2 weeks for 2 years was more effective than the standard treatment of therapeutic phlebotomy in maintaining target hematocrit (HCT) (< 45%) with a reduction in the need for phlebotomy without disease progression. In the present paper, we analyzed drug survival, defined as a surrogate measure of the efficacy, safety, adherence, and tolerability of Ropeg in patients followed up to 5 years. During the first 2 years, Ropeg and phlebotomy-only (Phl-O) were discontinued in 33% and 70% of patients, respectively, for lack of response (12 in the Ropeg arm vs. 34 in the Phl-O arm) or adverse events (6 vs. 0) and withdrawal of consent in (3 vs. 10). Thirty-six Ropeg responders continued the drug for up to 3 years, and the probability of drug survival after a median of 3.15 years was 59%. Notably, the primary composite endpoint was maintained in 97%, 94%, and 94% of patients still on drug at 3, 4, and 5 years, respectively, and 60% of cases were phlebotomy-free. Twenty-three of 63 Phl-O patients (37%) failed the primary endpoint and were crossed over to Ropeg; among the risk factors for this failure, the need for more than three bloodletting procedures in the first 6 months emerged as the most important determinant. In conclusion, to improve the effectiveness of Ropeg, we suggest increasing the dose and using it earlier driven by high phlebotomy need in the first 6 months post-diagnosis.

2024-02-01·Advances in therapy

Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities

Article

作者: Qin, Albert ; Liu, Wang-Da ; Tsai, Chan-Yen ; Sheng, Wang-Huei ; Hou, Hsin-An ; Li, Ko-Jen

INTRODUCTION:

Ropeginterferon alfa-2b represents a new-generation PEGylated interferon. It is approved for the treatment of polycythemia vera and shows promising anti-SARS-CoV-2 activities.

OBJECTIVE:

This clinical study aims to evaluate the efficacy and safety of ropeginterferon alfa-2b in patients with coronavirus disease 2019 (COVID-19) and comorbidities.

METHODS:

The randomized controlled study is designed to enroll adult patients with COVID-19 infection and comorbidities. Patients are non-responders to anti-SARS-CoV-2 drugs or not suitable to receive them. Comorbidities include hematologic cancer, solid tumor, and well-controlled autoimmune disease. Non-responders to anti-SARS-CoV-2 drugs are defined as having received treatment but have a Ct value < 30 at 14 days after symptom onset. Patients are randomized in a 1:1 ratio to receive ropeginterferon alfa-2b at 250 μg plus standard of care (SOC) or SOC alone. SARS-CoV-2 antigen test will be conducted at day 15 and day 29 visits to determine whether to administer additional ropeginterferon alfa-2b doses. Patients who are positive on the antigen test on days 15 and 29 will receive the second and third doses of ropeginterferon alfa-2b at 350 μg and 500 μg, respectively. Patients with a negative antigen test but a Ct value < 30 by reverse transcription polymerase chain reaction (RT-PCR) at days 15 and 29 are also administered the second (350 μg) and third (500 μg) doses. Patients at high risk of COVID-19 rebound/relapse, e.g., immunocompromised patients, will be given additional ropeginterferon alfa-2b doses even if the Ct is ≥ 30. Approximately 60 patients will be enrolled.

PLANNED OUTCOMES:

The primary outcome is to compare the time from randomization to the achievement of Ct value ≥ 30 by RT-PCR between ropeginterferon alfa-2b and control groups. Our previous studies have shown safety and promising anti-SARS-CoV-2 activities in patients with moderate or severe COVID-19. This study will provide valuable data in patients with COVID-19 and comorbidities, for whom safe and effective treatment is urgently needed.

TRIAL REGISTRATION NUMBER:

This trial is registered at ClinicalTrials.gov (Identifier NCT05808322).

项与罗培干扰素α-2b 相关的新闻（医药）

2024-07-22

·GlobeNewswire-Health Care

Aligos Therapeutics Announces Clinical Collaboration with Xiamen Amoytop Biotech Co., Ltd.

Amoytop to sponsor a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in CHB patients SOUTH SAN FRANCISCO, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has entered into a clinical trial collaboration agreement with Xiamen Amoytop Biotech Co., Ltd. (“Amoytop”). Under the terms of the agreement, Amoytop will sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. The clinical study is expected to begin after approval by the National Medical Products Administration in China. “We are pleased to build on our existing relationship with Amoytop, as they have proven to be a valuable partner,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We look forward to initiating this exploratory study to evaluate the combination of ALG-000184 with PEGBING®, one of the approved drugs for CHB patients in China, to assess the potential benefits of a combinatory approach.” ALG-000184 is a potent best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for CHB. It is designed to exploit the dual role of CAMs by disrupting hepatitis B cccDNA levels and its derived transcripts by reducing expression of viral markers such as DNA, RNA, and the relevant antigens (HBsAg, HBeAg, HBcrAg). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear pharmacokinetics (PK) and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg x ≤96 weeks ± entecavir (ETV), ALG-000184 monotherapy has demonstrated best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough to date. PEGBING®, independently developed by Amoytop, is the world's first 40kD pegylated interferon α-2b injection. With dual effects of inhibiting viral replication and enhancing immunity, PEGBING® is mainly used in the clinical treatment of viral hepatitis and is the first-line drug for the antiviral treatment of chronic hepatitis B, which plays an important role in improving the clinical cure rate of hepatitis B and reducing the risk of liver cancer. “We are pleased to deepen our cooperation in the field of liver disease treatment and look forward to working together to provide a new treatment solution for patients in need,” said Sun Li, Chairman and Chief Executive Officer at Amoytop. “Amoytop is committed to further optimizing the chronic hepatitis B combination treatment pathway and hopes that the cooperation will lead to better clinical value drugs and drug combinations.” The Phase 1b study will be a randomized, double blinded, active controlled study to evaluate the safety, pharmacokinetics, and antiviral activity of oral once daily doses of 300 mg ALG-000184 + PEGBING® + entecavir (ETV) compared with 300 mg ALG-000184 + ETV or PEGBING® + ETV in treatment naïve or currently-not-treated HBeAg-positive and nucleos(t)ide analog (NA) suppressed HBeAg-negative subjects with CHB for 48 weeks. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. For more information, please visit www.aligos.com or follow us on LinkedIn or X. About Xiamen Amoytop Biotech Co., Ltd. Xiamen Amoytop Biotech Co., Ltd. is an innovative biopharmaceutical company and a listed company on the Science and Technology Innovation Board (SSE STAR Market) in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. Focusing on the R&D of immune-related cytokine medicines, Amoytop is committed to becoming a leader in solving cytokine medicine-based systemic immune problems, providing better solutions for major diseases (such as viral hepatitis, malignant tumors) and immunotherapy. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including, without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Aligos Therapeutics Investor Contact Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media Contact Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Xiamen Amoytop Biotech Co., Ltd. Investor Contact Liu Peiyu联系电话：86592-6889118邮箱：ir@amoytop.com Media Contact Wu Xueyan联系电话：86592-6889127邮箱：wxy@amoytop.com

临床1期引进/卖出临床2期

2024-07-08

·GBIHealth

糖尿病相关疼痛将缓解！第一三共创新药物美洛加巴林在中国获批上市

药械追踪 No.1 / 德琪医药XPO1抑制剂希维奥获批DLBCL新适应证 2024年7月8日，德琪医药（6996.HK）宣布，希维奥（塞利尼索片）获中国国家药品监督管理局（NMPA）批准新适应证，作为单药治疗接受过至少两线系统性治疗的复发或难治性（R/R）弥漫大B细胞淋巴瘤（DLBCL）成人患者。希维奥是全球首个全新机制的口服选择性核输出蛋白（XPO1）抑制剂，最早由Karyopharm Therapeutics Inc.（NSDQ：KPTI）开发。基于与Karyopharm达成的合作协议，德琪医药拥有塞利尼索在多个国家及地区的独家开发和商业化授权。目前，希维奥已获得中国大陆、中国台湾、中国香港、中国澳门、韩国、新加坡及澳大利亚的新药上市批准。 ->点击阅读原文，解锁完整双语新闻 No.2 / 东诚药业心肌灌注显像剂锝[⁹⁹ᵐTc]替曲膦注射液获批 2024年7月8日，烟台东诚药业集团股份有限公司（东诚药业，002675.SZ）宣布，旗下核药锝[⁹⁹ᵐTc]替曲膦注射液获得中国国家药品监督管理局（NMPA）批准上市。锝[⁹⁹ᵐTc]替曲膦注射液是一种 SPECT 心肌灌注显像剂，是目前欧美、日本心肌灌注显像主要使用的核药产品之一。该产品由 GE HEALTHCARE 开发，后授权东诚药业全资子公司南京江原安迪科正电子研究发展有限公司（以下简称“安迪科”）在中国大陆生产、经销。在患有或疑似冠状动脉疾病的成人中两次注射液给药条件下，该产品可用于药物负荷和静息状态下的心肌灌注显像，以反映心肌血流灌注变化。 ->点击阅读原文，解锁完整双语新闻 No.3 / 嘉晨西海自复制RNA肿瘤治疗产品在美获批临试 2024年7月8日，嘉晨西海宣布，旗下自复制RNA肿瘤治疗产品JCXH-211-IV（静脉注射）获得美国FDA批准开展I/II期临床试验。 JCXH-211-IV是全球首个静脉注射自复制RNA肿瘤治疗产品，基于嘉晨西海新型自复制RNA平台技术开发，通过静脉注射srRNA-IL12突破了传统IL-12产品局部给药的限制。JCXH-211-IV具有双重抗肿瘤机制，分别来自于srRNA的固有免疫激活能力，以及表达IL-12所提供的抗肿瘤免疫调节效力。此前，嘉晨西海旗下同机制产品JCXH-211-IT（肿瘤内注射）已在临床I期试验中表现出良好的安全性、耐受性和显著的抗肿瘤生物活性。本次JCXH-211-IV进入I/II期临床，有望进一步拓展srRNA-IL12的临床使用场景。 ->点击阅读原文，解锁完整双语新闻 No.4 / 第一三共美洛加巴林在中国获批上市 2024年7月5日，第一三共宣布，旗下自主研发的创新药物德力静（苯磺酸美洛加巴林片，TARLIGE）获国家药监局批准，用于治疗成人糖尿病性周围神经病理性疼痛（DPNP）。此次获批基于DS5565-A-A315临床研究结果，这是一项随机、双盲、安慰剂对照中国Ⅲ期临床试验。该试验共纳入393例受试者，旨在评估苯磺酸美洛加巴林治疗DPNP患者的疗效和安全性。研究结果显示，与安慰剂组相比，15mg美洛加巴林每日两次给药组在第14周的疼痛评分具有统计学意义的显著改善（P=0.0301），且明显改善了患者对疼痛的整体印象、睡眠、患者生活质量等。 ->点击阅读原文，解锁完整双语新闻 No.5 / 药华医药超长效干扰素获NMPA批准上市近日，药华医药旗下罗培干扰素a-2b获国家药监局批准上市，用于治疗成人真性红细胞增多症（PV）患者。该药是公司自主研发的创新型超长效干扰素，此前已在欧盟、美国、日本、韩国、中国台湾地区、中国澳门地区等38个国家和地区获批。罗培干扰素a-2b（商品名：Besremi）是一种新型的超长效单聚乙二醇脯氨酸干扰素，含有被一个40kDa聚乙二醇（PEG）基团共价修饰的额外N端脯氨酸。该产品最大用药剂量可到每次500ug，最大耐受剂量高，单支的有效成分是其他长效干扰素的几十倍，且不良反应低。该产品目前2~4周注射1次，大大提高了PV患者便捷性。 ->点击阅读原文，解锁完整双语新闻 No.6 / 诺和诺德A型血友病长效疗法在中国获批上市近日，国家药监局正式批准了诺易特（注射用培妥罗凝血素α）在中国的上市申请，是中国首个且目前唯一获批上市的长效重组凝血因子Ⅷ，用于12岁及以上的儿童和成人血友病A患者按需治疗及控制出血事件、围手术期管理及常规预防治疗以防止或减少出血事件的发生。诺易特是重组人凝血因子证与40kDa聚乙二醇（PEG）分子组成的共价偶联物。经过创新的结构修饰，诺易特可延长凝血因子四半衰期至1.6倍，从而减少年注射次数，开启血友病A长效重组凝血因子替代治疗的新时代。诺易特作为中国首个且目前唯一获批上市的长效重组凝血因子Ⅷ，目前已经在美国、加拿大、意大利、日本等50个国家获批34个国家及地区上市。 ->点击阅读原文，解锁完整双语新闻 No.7 / 罗氏阿来替尼术后辅助治疗适应证在华获批近日，罗氏宣布，阿来替尼新适应证获国家药监局批准，用于间变性淋巴瘤激酶（ALK）阳性的ⅠB期至ⅢA期非小细胞肺癌（NSCLC）患者术后辅助治疗。阿来替尼是新一代间变性淋巴瘤激酶（ALK）抑制剂，2018年8月获批用于治疗ALK阳性的局部晚期或转移性非小细胞肺癌，商品名为安圣莎。对于ALK阳性早期NSCLC患者，术后两年以内是复发的高峰期且复发多为远处转移。既往标准的辅助治疗方案为辅助化疗，但获益并不理想，仍有近一半的早期NSCLC患者在术后发生疾病复发。此次获批早期肺癌辅助治疗适应证的获批，标志着阿来替尼成为了目前国内首个同时覆盖早期和晚期的ALK-TKI。 ->点击阅读原文，解锁完整双语新闻 No.8/ Medigene旗下NY-ESO-1/LAGE1a双靶向TCR疗法在华获专利保护德国生物技术公司Medigene （FSE:MDG1）近日宣布，其针对NY-ESO-1（纽约食管鳞状细胞癌1）和LAGE 1a（L抗原家族成员-1a）的T细胞受体（TCR）获得中国国家知识产权局授予的专利。根据新闻稿，该专利有效地涵盖了该公司领先候选药物MDG1015的核心成分，这是一种靶向NY-ESO-1和LAGE1a首创的第三代TCR-T疗法，通过共刺激开关蛋白PD1-41BB进行保护和增强。该产品此前在美国、欧盟、日本、韩国和澳大利亚也获得了类似的专利。Medigene计划在2024年第三季度在美国提交该分子的第一个临床试验申请，适应证初步包括胃癌、卵巢癌、黏液样/圆细胞脂肉瘤和滑膜肉瘤。该分子的临床前数据已经在2023年的AACR和ESMO年会上发表。 ->点击阅读原文，解锁完整双语新闻企业动态 No.1 / 英国点名多家跨国药企违反行业行为准则近日，多家跨国药企因违反英国《处方药执业机构守则》而受到指责，该规范是英国制药工业协会（ABPI）制定的专业行为准则机构，由处方药行为准则管理局（PMCPA）管理。PMCPA点名诺华（NYSE: NVS）、辉瑞（NYSE:PFE）、大冢（TYO:4578）和诺和诺德（NYSE: NVO）在不同程度上违反ABPI行为准则。诺和诺德曾在2023年主动宣称，其未能报告2020年至2022年间向卫生专业人员和医疗保健组织支付的780万英镑（1000万美元）款项，随后面临公开谴责。该公司指出，这些付款都与合法活动有关，但出于人为原因而被错误分类。 ABPI强调的不法行为还包括：诺华未能及时更新与诺欣妥（沙库比曲/缬沙坦）处方信息相关的文件；以及辉瑞通过社交媒体平台X（前身为推特）推广了一种未经许可的疫苗。 ->点击阅读原文，解锁完整双语新闻 No.2 / 鑫泽源完成超亿元B轮融资，深耕微创医疗器械供应链近日，微创医疗器械供应链平台企业杭州鑫泽源医疗科技有限公司（以下简称“鑫泽源”）宣布完成超亿元B轮融资。本轮由启明创投领投，天堂硅谷跟投，点石资本担任独家财务顾问。新一轮融资将主要用于上游核心技术研发、生产基地建设等，打造全球一流的微创医疗器械供应链平台。鑫泽源成立于2015年，总部位于杭州。公司深耕微创供应链领域，陪伴国内下游企业成长，已形成内窥镜及镜下耗材为核心的全链路供应平台。公司覆盖超30000种微创医疗零部件、超3600种组件，具备从“概念设计”到“批量生产上市”的全流程服务能力。目前，鑫泽源已获得迈瑞医疗等400余家器械客户认可，远销全球20余个国家和地区。 ->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

上市批准申请上市临床1期

2024-07-08

·医药观澜

9款新药在中国获批！3款癌症新药，来自罗氏、德琪医药、药华医药

▎药明康德内容团队编辑上周，也就是2024年下半年的第一周（7月1日~7月7日），中国国家药监局（NMPA）批准了9款新药或新适应症。这些新药来自信立泰、海思科、第一三共、阿斯利康、德琪医药、亿腾医药、罗氏、药华医药、诺和诺德等公司，它们的获批将为非小细胞肺癌、2型糖尿病、带状疱疹后神经痛、糖尿病性周围神经病理性疼痛、血友病A、大B细胞淋巴瘤等患者带来新的治疗选择。信立泰：苯甲酸福格列汀片适应症：2型糖尿病 7月4日，NMPA官网宣布批准信立泰1类创新药苯甲酸福格列汀片上市，适用于改善成人2型糖尿病患者的血糖控制。苯甲酸福格列汀片是一款DPP-4抑制剂，具有口服吸收迅速、半衰期长、作用持久等特点。研究结果显示，无论是单药治疗还是联合二甲双胍治疗2型糖尿病患者，在给药24周后，福格列汀对比安慰剂都能显著地降低HbA1c，具有明显的降糖效果。海思科：苯磺酸克利加巴林胶囊适应症：带状疱疹后神经痛 7月5日消息，海思科神经痛新药苯磺酸克利加巴林胶囊新适应症上市申请已获得批准，用于治疗带状疱疹后神经痛。克利加巴林是一款电压敏感型钙离子通道调节剂，其首个适应症已于今年5月在中国获批，用于治疗成人糖尿病性周围神经病理性疼痛（DPNP）。根据海思科新闻稿介绍，中国带状疱疹后神经痛患者的3期双盲试验已完成。3期临床结果表明，克利加巴林胶囊40mg/日、80mg/日均在统计意义上显著优于安慰剂，研究达到主要疗效终点。第一三共：苯磺酸美洛加巴林片适应症：成人糖尿病性周围神经病理性疼痛 7月5日消息，第一三共（Daiichi Sankyo）苯磺酸美洛加巴林片获批上市，用于治疗成人糖尿病性周围神经病理性疼痛。美洛加巴林片为第三代钙离子通道调节剂类药物，其作用位点是钙离子通道的α2δ亚基，与钙离子通道α2δ亚基亲和力高，但与α2δ-1亚基（更多与镇痛作用相关）解离慢，与α2δ-2亚基（更多与中枢不良反应相关）解离快，可更好地平衡疗效和安全性，在临床前研究中的镇痛作用更强且更持久。据第一三共新闻稿介绍，在一项纳入393例受试者的中国3期临床试验中，与安慰剂组相比，15mg美洛加巴林每日两次给药组在第14周的疼痛评分具有统计学意义的显著改善，且明显改善了患者对疼痛的整体印象、睡眠、患者生活质量等。阿斯利康：布地奈德福莫特罗吸入气雾剂 (III) 7月5日消息，阿斯利康（AstraZeneca）布地奈德福莫特罗吸入气雾剂 (III)上市申请已获得批准。公开资料显示，这是一款吸入糖皮质激素/长效β2受体激动剂联合疗法，此前已于2021年在中国获批，用于成人和12岁以上青少年轻度哮喘患者的抗炎缓解治疗。在全球范围内，布地奈德福莫特罗吸入粉雾剂已经在多个国家和地区获批用于治疗哮喘或慢性阻塞性肺疾病。德琪医药：塞利尼索片适应症：弥漫性大B细胞淋巴瘤 7月5日消息，德琪医药引进的口服XPO1抑制剂塞利尼索新适应症上市申请已获得批准，用于既往接受至少2线系统性治疗后，复发性或难治性弥漫性大B细胞淋巴瘤（DLBCL），包括由滤泡性淋巴瘤转化的DLBCL成人患者。这是继复发/难治性多发性骨髓瘤之后，塞利尼索在中国获批的第二项适应症。根据德琪医药新闻稿介绍，中国注册性临床试验SEARCH研究的试验数据显示，60例接受治疗的中国受试者的总体缓解率（ORR）达到试验预设的主要终点。亿腾医药：二十碳五烯酸乙酯软胶囊适应症：降低心血管事件风险 7月5日消息，亿腾医药引进的心血管创新药二十碳五烯酸乙酯软胶囊新适应症上市申请已获得批准，用于降低心血管事件风险（CRR）。根据亿腾医药新闻稿介绍，作为研究用药的大型心血管结局试验REDUCE-IT表明，对他汀治疗后仍存在高甘油三酯血症的确诊心血管疾病或心血管疾病高危患者，二十碳五烯酸乙酯（IPE）能显著降低主要不良心血管事件相对风险达25%，心肌梗死、卒中和心血管死亡的相对风险分别降低31%、28%和20%。罗氏：盐酸阿来替尼胶囊适应症：早期非小细胞肺癌 7月5日消息，罗氏（Roche）盐酸阿来替尼胶囊新适应症上市申请已获得批准，用于ALK阳性的IB期至IIIA期非小细胞肺癌患者术后辅助治疗。罗氏新闻稿表示，此次早期肺癌辅助治疗适应症的获批，标志着阿来替尼成为了同时覆盖早期和晚期的ALK酪氨酸激酶抑制剂（ALK-TKI）。作为本次适应症在华获批的主要依据，ALINA研究结果显示，与以铂为基础的化疗组相比，使用阿来替尼口服辅助治疗2年，可以使患者疾病复发或死亡风险降低76%，使患者中枢神经系统复发或死亡风险降低78%。研究没有观察到新的非预期安全信号。药华生物：罗培干扰素α-2b注射液适应症：真性红细胞增多症 7月5日，药华医药宣布其自主研发的罗培干扰素（商品名：百斯锐明）正式获得NMPA批准，用于治疗真性红细胞增多症（PV）。真性红细胞增多症是造血干细胞恶性肿瘤，已被列入中国《第二批罕见病目录》。罗培干扰素是单一异构体超长效干扰素，可2~4周注射1次。经多项临床研究显示，该产品可快速有效的控制血细胞的过度增殖、并显著降低致病基因的突变负荷，从而有效降低血栓栓塞并发症及其所导致的死亡风险。药华医药新闻稿指出，罗培干扰素是全球首个获批用于真性红细胞增多症的干扰素。该产品最早于2019年在欧洲上市、2021年在美国上市。诺和诺德：注射用培妥罗凝血素α 适应症：血友病A 7月5日，NMPA官网公示，（Novo Nordisk）注射用培妥罗凝血素α（商品名：诺益特）在华获批，用于12岁及以上成人和儿童血友病A患者按需治疗及控制出血事件、围手术期管理、常规预防治疗以防止或减少出血事件的发生。诺和诺德新闻稿指出，这是中国获批的首个长效重组凝血因子VIII（FVIII），开启了血友病长效治疗的新时代。血友病A是由于缺乏凝血因子VIII而导致的一种遗传性出血性疾病，以反复出血及其相关并发症为主要临床表现，严重者可危及生命。目前血友病A的主要治疗手段是定期输注凝血因子VIII，但频繁输注给患者生活带来极大不便。注射用培图罗凝血素α（N8-GP）经创结构修饰后可将半衰期延长1.6倍，以长效治疗帮助血友病患者减少输液次数，减轻治疗负担。与此同时，上周同期也有多款重磅新药在美国或欧盟获批上市或获批新适应症：礼来公司（Eli Lilly and Company）宣布其Kisunla（donanemab）获得美国FDA批准，用于治疗出现早期症状的阿尔茨海默病（AD）成年人。这些患者包括有轻度认知障碍（MCI）患者以及处于轻度痴呆阶段的AD患者，患者确认存在淀粉样蛋白病理。根据新闻稿，每月一次的Kisunla是首个有证据表明在淀粉样斑块清除后可停止治疗的淀粉样斑块靶向疗法，因此预计该疗法可以降低治疗成本并减少输液次数。罗氏宣布双特异性抗体Vabysmo（faricimab）6.0mg单剂量预填充注射器（PFS）获FDA批准，用于治疗新生血管性或湿性年龄相关性黄斑变性（nAMD）、糖尿病黄斑水肿（DME）和视网膜静脉阻塞（RVO）引起的黄斑水肿。根据新闻稿，Vabysmo PFS是获FDA批准用于治疗可能导致失明视网膜疾病的首个预填充双特异性抗体注射器。再生元（Regeneron）与赛诺菲（Sanofi）的重磅疗法Dupixent（dupilumab）获得欧洲药品管理局批准，作为一种附加维持治疗药物，用于治疗以血液嗜酸性粒细胞升高为特征、且未得到控制的慢性阻塞性肺病（COPD）成人患者。新闻稿指出，Dupixent是欧盟十多年来被批准用于治疗COPD的首款新疗法，这也是Dupixent在全球首次获监管机构批准治疗COPD。阿斯利康的表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）Tagrisso（osimertinib，奥希替尼）联合培美曲塞和铂类化疗在欧盟获得批准，用于一线治疗肿瘤存在外显子19缺失或外显子21（L858R）突变的晚期表皮生长因子受体突变（EGFRm）非小细胞肺癌成年患者。期待这些新药的获批能够造福更多病患，为遭受疾病困扰的患者群体提供更多更好的治疗选择。参考资料： [1]中国国家药监局官网.Retrieved July 8，2024, From https://www.nmpa.gov.cn/zwfw/zwfwpjfbzs/index.html [2]各公司官网及公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期上市批准临床结果

100 项与罗培干扰素α-2b 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11027	-	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	-	药华医药股份有限公司	2024-10-01
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	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
慢性丙型肝炎	临床3期	中国	诺思格（北京）医药科技股份有限公司	2019-05-22

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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


Phase 2 extension study (EHA2024)	临床2期	真性红细胞增多症 JAK2 V617F allele burden	27	Ropeginterferon alfa-2b	壓鹽簾選齋鑰夢膚鑰衊(獵淵範繭製遞齋廠衊選) = 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%]) 鬱鏇網獵壓襯壓網鹹鏇 (鏇願膚壓製膚艱膚範網 ) 更多	积极	2024-05-14
phase 3 trials (EHA2024)	临床3期	真性红细胞增多症	34	Ropeginterferon alfa-2b	淵範廠壓願衊遞艱範壓(艱顧糧膚淵繭築餘積範) = One patient developed autoimmune thyroiditis without the need to suspend treatment 壓窪齋憲醖繭糧鏇網鏇 (齋繭糧鏇窪鏇鏇築鑰遞 ) 更多	积极	2024-05-14
ASH2023	临床2期	原发性骨髓纤维化	-	Ropeginterferon alfa 2b	積鬱餘醖鏇衊製窪糧觸(齋襯顧餘構選積艱鏇糧) = 願齋製餘蓋範醖簾壓鑰選醖窪醖鹽糧鹹鹽廠壓 (壓壓廠膚鹽膚築築廠遞 ) 更多	-	2023-12-11
PROUD-PV/CONTINUATION-PV (ASH2023)	N/A	真性红细胞增多症	-	Ropeginterferon alfa-2b	衊衊壓獵壓獵壓築構鹹(膚鹹鏇壓淵鹽選願鑰鑰) = 醖蓋鹽艱範顧選鑰衊觸願網齋齋積蓋膚窪網壓 (醖襯鑰窪網齋壓製選窪 )	-	2023-12-11
ASH2023	N/A	真性红细胞增多症	99	P1101	膚繭艱顧壓築糧夢獵齋(範鏇願蓋製蓋遞艱鑰憲) = 鏇齋憲鑰淵築獵窪鬱艱膚顧蓋衊鹽積範廠憲壓 (範獵鏇繭齋壓衊鏇鬱鏇 ) 更多	-	2023-12-11
CTR20211664 \| NCT05485948 (Pubmed) 人工标引	临床2期	真性红细胞增多症	49	ropeginterferon alfa-2b	壓繭夢夢築構鹹淵觸鑰(窪糧觸鏇窪鹹選網窪獵) = 夢選鹹選襯廠齋鬱窪製窪構衊顧憲遞齋襯夢顧 (選鑰糧鏇網繭憲鑰鹹淵 ) 更多	积极	2023-06-21
EHA2023	N/A	真性红细胞增多症	99	Hydroxyurea-naive patients	網鹽衊繭蓋選製壓簾遞(膚繭醖鏇製襯鬱簾鬱網) = 廠鬱糧獵餘膚鬱糧簾淵製築網襯齋鑰繭蓋鑰艱 (鑰簾鑰蓋齋膚淵顧製製 )	-	2023-06-08
EHA2023	N/A	真性红细胞增多症	99	ROPEGINTERFERON ALFA-2B (Resistance/Intolerance patients)	網鹽衊繭蓋選製壓簾遞(膚繭醖鏇製襯鬱簾鬱網) = 襯鹽選獵衊糧構構鬱膚製築網襯齋鑰繭蓋鑰艱 (鑰簾鑰蓋齋膚淵顧製製 )	-	2023-06-08
EHA2023	N/A	骨髓增生性疾病	21	ROPEGINTERFERON ALPHA-2B	鏇選膚繭襯蓋艱淵淵鬱(遞鑰觸壓艱壓觸觸獵壓) = 顧膚獵夢鹹選齋鹹夢憲顧築網範鏇範範壓醖構 (網壓範鏇艱顧築襯衊艱 ) 更多	-	2023-06-08
Pubmed	临床2期	真性红细胞增多症	-	Ropeginterferon α-2b 250 μg	壓鹽遞壓艱憲艱窪網憲(鹽餘鹹積憲憲願夢選鏇) = 淵範築醖鹹壓鹹觸醖夢憲顧糧壓範鹹願壓淵繭 (簾願觸網壓築繭顧窪鹹 ) 更多	-	2023-05-02
NCT04182100 (Pubmed \| Int J Hematol) 人工标引	临床2期	真性红细胞增多症	29	ropeginterferon alfa-2b	選醖獵選網簾繭築構齋(壓積網簾構簾淵獵築構) = 獵鏇醖夢積顧簾憲遞築壓壓積糧壓憲醖積顧鑰 (顧鬱糧艱鹹襯鏇鏇遞廠 )	积极	2022-08-01