Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy

Patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round are randomly assigned to either the control or experimental arm. Patients in the control arm continue pegfilgrastim injection on day 1 while patients in the experimental arm will receive pegfilgrastim injection on day 3 to see if changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy could reduce the incidence of neutropenia

开始日期2023-11-07

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

KCT0008416 / Not yet recruitingN/AIIT

Reduce neutropenia by changing the date of eflapegrastim administration in breast cancer patients who have experienced neutropenia after chemotherapy

开始日期2023-05-01

申办/合作机构-

NCT04570423 / Recruiting临床2期

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy

The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.

开始日期2021-05-20

申办/合作机构

Spectrum Pharmaceuticals, Inc.

100 项与 Eflapegrastim 相关的临床结果

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100 项与 Eflapegrastim 相关的转化医学

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100 项与 Eflapegrastim 相关的专利（医药）

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212

项与 Eflapegrastim 相关的文献（医药）

2025-12-01·Journal of Clinical Immunology

A large cohort from an immunology reference center and an algorithm for the follow-up of chronic neutropenia

Article

作者: Ergenoğlu, Damla Nur ; Cagdas, Deniz ; Maslak, Ibrahim Cemal ; Çiçek, Begüm ; Bildik, Hacer Neslihan ; Esenboga, Saliha ; Tezcan, Ilhan ; Sinanoğlu, Nidanur ; Caka, Canan

Chronic neutropenia causes involve nutritional deficiencies and inborn errors of immunity(IEI), such as severe congenital neutropenia. To classify common chronic neutropenia causes in a pediatric immunology unit. We enrolled 109 chronic neutropenia patients admitted to a pediatric immunology department between 2002-2022. We recorded clinical/laboratory features and genetic characteristics. The male/female ratio was 63/46. Fifty-eight patients had parental consanguinity(57.4%). 26.6% (n = 29) patients had at least one individual in their family with neutropenia. Common symtpoms at presentation were upper respiratory tract infections(URTI)(31.1%), oral aphthae(23.6%), skin infections(23.6%), pneumonia(20.8%), and recurrent abscesses(12.3%). Common infections during follow-up were URTI(56.8%), pneumonia(33%), skin infections(25.6%), gastroenteritis(18.3%), and recurrent abscesses(14,6%). Common long-term complications were dental problems(n = 51), osteoporosis(n = 22), growth retardation(n = 14), malignancy(n = 16)[myelodysplastic syndrome(n = 10), large granulocytic leukemia(n = 1), acute lymphoblastic leukemia(n = 1), Hodgkin lymphoma(n = 1), EBV-related lymphoma(n = 1), leiomyosarcoma(n = 1), and thyroid neoplasm(n = 1)]. We performed a genetic study in 86 patients, and 69(71%) got a genetic diagnosis. Common gene defects were HAX-1(n = 26), ELA-2 (ELANE)(n = 10), AP3B1(n = 4), and ADA-2(n = 4) gene defects. The IEI ratio(70.6%) was high. GCSF treatment(93.4%), immunoglobulin replacement therapy(18.7%), and HSCT(15.9%) were the treatment options. The mortality rate was 12.9%(n = 14). The most common long term complications were dental problems that is three times more common in patients with known genetic mutations. We prepared an algorithm for chronic neutropenia depending on the present cohort. An important rate of inborn errors of immunity, especially combined immunodeficiency(11.9%) was presented in addition to congenital phagocytic cell defects. Early diagnosis will allow us tailor the disease-specific treatment options sooner, preventing irreversible consequences.

2024-10-01·Transfusion and Apheresis Science

Analysis of apheresis outcomes in a cohort of Chilean patients treated with autologous stem cell transplantation: A single center real-world experience

Article

作者: Vergara, M ; Ocqueteau, M ; Palacios, F ; Garcia, M J ; Campbell, M J ; Jara, V ; Salinas, J ; Sarmiento, M ; Sandoval, V ; Gutierrez, C ; Rojas, P ; Flores, Y ; Vidal, M

Adequate stem cell harvesting is required for autologous hematopoietic transplantation. In deficient mobilizer patients, the collection of stem cells can be challenging because of the impossibility of achieving satisfactory CD34 cell counts with GCSF + - chemotherapy. Plerixafor is a potent and expensive drug that promotes the release of stem cells from the medullary niche to the peripheral blood and allows satisfactory harvests. We performed a retrospective analysis of 370 patients with myeloma and lymphoma harvested at our institution. 99 % of patients achieved satisfactory apheresis using Plerixafor in 45 %. Satisfactory harvests were obtained in patients mobilized with GCSF or plerixafor. In patients who used plerixafor, it was necessary to perform fewer apheresis procedures (P = 0.05). In multivariate analysis, the only factor that predicted the need for plerixafor was the presence of less than 30,000 CD34 / ul on the day of apheresis (OR 0.3. p < 0.001). Since we adopted the plerixafor protocol guided by CD34 counts, the number of patients with harvest failure has decreased. In conclusion, the rational and standardized use of plerixafor favors satisfactory harvest in patients who require autologous transplantation in South-American patients.

2024-10-01·Transplant Infectious Disease

Use of letermovir for cytomegalovirus primary prophylaxis in lung transplant recipients

Article

作者: Arunachalam, Ambalavanan ; Miner, Brad ; Kleiboeker, Hanna L. ; Wang, Jacob ; Paplaczyk, Krista ; Betensley, Alan D. ; Wright, Jennifer ; Subramani, Mrinalini Venkata ; Borkowski, Nicole ; Myers, Catherine N. ; Prom, Alyson ; Tomic, Rade

AbstractBackgroundCytomegalovirus (CMV) is a driver of negative outcomes after lung transplant (LTX) and primary prophylaxis (PPX) with valganciclovir (VGC) is standard‐of‐care. VGC is associated with myelosuppression, prompting interest in letermovir (LTV).MethodsAdults receiving LTX between April 1, 2015, and July 30, 2022, at our institution were evaluated. Patients were excluded if low CMV risk (D‐/R‐), survived <90 days post‐LTX, or transferred care before PPX withdrawal. Primary outcomes were leukopenia (white blood cell count [WBC] ≤ 3.0 × 109/L), severe leukopenia (WBC ≤ 2.0 × 109/L), and neutropenia (absolute neutrophil count ≤ 1500 cells/µL) requiring granulocyte‐colony stimulating factor (GCSF) on PPX. Secondary outcomes included breakthrough CMV infection and post‐PPX CMV infection.Results204 patients met inclusion criteria: 175 patients on VGC and 29 patients on LTV (after VGC conversion). Most patients received bilateral LTX (62.7%) with non‐lymphocyte‐depleting induction (96.6%) and moderate‐risk serostatus (D+/R+, 48.5%). Patients transitioned from VGC to LTV after a mean of 178 days (SD 80.8 days) post‐transplant. Patients on VGC experienced significantly more leukopenia (82.3% vs. 58.6%, p = 0.008), severe leukopenia (57.1% vs. 31.0%, p = 0.016), and neutropenia requiring GCSF (70.9% vs. 51.7%, p = 0.048). Breakthrough (5.7% vs. 3.4%, p = 0.955) and post‐PPX (24.6% vs. 37.9%, p = 0.199) infections were similar. A subgroup analysis of patients with high‐risk serostatus showed similar trends, though did not reach statistical significance.ConclusionsIn this single‐center study, the incidence of leukopenia and neutropenia requiring GCSF were reduced with LTV compared to VGC. Breakthrough and post‐PPX infections were not significantly different. This evidence suggests that LTV has comparable efficacy with reduced myelosuppression compared to VGC in LTX recipients, and may be an appropriate alternative for PPX.

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项与 Eflapegrastim 相关的新闻（医药）

2024-11-11

·EndPoints

Assertio denies activist investor's claims of fraud in open letter

Assertio Holdings responded to activist investor Alexander Parker after Parker’s firm accused Assertio of fraud. The Buxton Helmsley Group on Friday released an open letter to Assertio’s stockholders, accusing the Chicago area company of fraud related to its acquisition last year of Spectrum Pharmaceuticals’ Rolvedon and offering hush money to whistleblowers regarding Rolvedon, which is used to prevent infections in cancer patients undergoing treatment. In response to Parker’s statement, Assertio CEO Brendan O’Grady said Monday that Parker has wasted management and the board’s resources “with the same repeated and baseless allegations,” adding that they were investigated by the company and not found to be true. O’Grady also said that Parker tried to get money and a board position from Assertio, and then contacted Assertio’s legal team and proposed the company “pay his legal fees in exchange for dropping his activist activities.” But that offer never came on paper, according to O’Grady, who said that Parker’s statement was then released Friday. “At the same time, he stated he moved from activist investor to a short seller of our stock,” O’Grady said in the statement. “We are reviewing all legal options, including referring Mr. Parker to the appropriate regulatory and enforcement authorities.” Assertio’s stock $ASRT was up about 14% on Monday, trading just under $1.00. In Parker’s letter on Friday, he argued that Buxton Helmsley Group had made “extensive attempts” to convince Assertio’s leader to address his concerns. “The board of directors and management team have continued to opt for a ‘head in the sand’ approach to avoid admitting colossal due diligence failures as part of the Spectrum acquisition, at the expense of Assertio’s stockholders and to the detriment of cancer patients,” he wrote in the letter . The company has also said it spoke with a former Spectrum employee who has raised allegations about how the company operates its clinical trials. In July, Parker called for the ousting of four board members and threatened a proxy battle if changes his firm suggested weren’t made.

并购

2024-06-27

·E药经理人

全球首个HER3 ADC上市卡壳！礼来、艾伯维曾陷类似窘境，什么拦住了默沙东的FIC？

生产方面的缺陷为何到了FDA审查环节才被发现？撰文| Kathy 编辑| 润屿顿河就差临门一脚！凭着优异临床数据拿到优先审批资格，翘首以盼半年，默沙东和第一三共等来的却是一纸延迟批准的CRL（完整回复函）。本该摘下全球首个HER3成药光环的默沙东与第一三共，却在PDUFA（FDA对新药申请的目标批准日期）当日，遭遇反转。 6月26日，默沙东和第一三共宣布，其HER3 ADC药物Patritumab Deruxtecan基于第三方生产原因，被FDA延迟批准用于既往至少接受过两种系统治疗的EGFR突变型局部晚期或转移性非小细胞肺癌。 FDA的完整回复函中提到，延迟审批的原因来自于第三方制造设施检查相关的调查结果。作为全球首款申报上市的HER3 ADC，Patritumab Deruxtecan既承载着“全球首个HER3成药”的希望，更担着“默沙东的第一个ADC”的“重任”。不幸之中的万幸是，CRL表示，Patritumab Deruxtecan疗效和安全性数据并未存在问题。但隐藏于这番“侥幸”之下的，是越来越多好不容易迈过“十年十亿美元”研发难关的创新药，筑起千里之堤后，倏然“卡在”了生产方面的缺陷——一个或许最不该成为掣肘的环节上。打破成药黑洞只差最后一脚 73亿美元，这大概就是10个月前默沙东打包第一三共三款在研ADC产品权益时，HER3-DXd一条管线的价值，可想这含金量。具体而言，根据双方协议，双方达成合作时，默沙东一次性支付给第一三共7.5亿美元（约合54亿元）预付款用于HER3 ADC产品。待合作12个月后，继续支付7.5亿美元。预付款合计15亿美元。 HER3的竞争虽不及HER2激烈，但靶点被发现三十余年来，始终未能成药，谁能拔得头筹？备受瞩目。原本一路领跑的默沙东与第一三共，突然卡在终点线前，不禁让人惋惜。 Patritumab Deruxtecan原本是全球研发进展最快的HER3靶点药物。去年12月时，FDA受理了该药的BLA并给予优先审评，用于治疗EGFR突变的局部晚期或转移性非小细胞肺癌（NSCLC）且在接受第三代酪氨酸激酶抑制剂（TKI）和铂类药物治疗期间或之后出现疾病进展的患者。 Patritumab Deruxtecan递交的BLA是基于HERTHENA-Lung01关键性II期试验的主要结果和IASLC 2023世界肺癌大会（#WCLC23）上公布的数据结果，这些结果同时发表在《临床肿瘤学杂志》上。 HERTHENA-Lung01研究结果显示：在EGFR TKI和铂类化疗后疾病进展的225例EGFR突变局部晚期或转移性NSCLC患者中，Patritumab Deruxtecan治疗的客观缓解率（ORR）为29.8%（95%CI：23.9-36.2），包括1例完全缓解和66例部分缓解。中位缓解持续时间为6.4个月（95%CI：4.9-7.8）。细看FDA这次发出的CRL显示，被延期的原因主要是由于第三方制造设施检查相关的调查结果。让人稍感安慰的是，FDA表示疗效和安全性数据并未存在问题。这也意味着，待解决制造问题后，HER3 DXD ADC依然有希望成为照进黑洞的第一缕光，在ADC领域砸下重金的默沙东，依然还有拿下第一名的机会。然而，也极有可能的是，Patritumab Deruxtecan的第一名宝座会被摘得竞争对手弯道超车而抢占。双抗与ADC是近年来靶向HER3治疗中最有希望成药的两大赛道。就在上月，Merus公司的HER2/HER3双抗Zenocutuzumab上市申请已获FDA受理，并被授予了优先审评资格。此前有分析指出，若一切顺利，Zenocutuzumab有可能在今年11月获批。默沙东/第一三共与Merus，分别代表了ADC与双抗，双方正在首个HER3成药的审批上“暗暗较劲”，而在他们身后，处在研发阶段的企业也在奋力冲刺、虎视眈眈。百利天恒与BMS潜在总交易额高达84亿美元的项目BL-B01D1，同样是HER3靶点ADC，为EGFR×HER3双抗ADC。值得注意的是，Patritumab Deruxtecan与BL-B01D1是唯二处于临床III期的HER3 ADC。也难怪BMS此前不惜砸下重金。从研发进展来看，百利天恒已经在国内启动三项Ⅲ期临床与多项II期临床，同时BL-B01D1的Ⅰ/Ⅱ期探索性临床正在对十余个潜在适应证进行验证。此外，BL-B01D1正在开展全球多中心I期临床研究（BL-B01D1-LUNG101），根据此前披露，BMS及百利天恒将陆续启动在肺癌、乳腺癌领域的全球注册临床。就像Patritumab Deruxtecan此前曾多次遭遇临床研究失败一样，正处在II期阶段的另一款研发进展较为靠前的宜联生物HER3 ADC在上周被FDA叫停。 BioNTech在上周披露了一份SEC公告文件，其中显示FDA已部分暂停了其合作伙伴宜联生物的HER3 ADC BNT326/YL202的多中心、开放标签、首次人体I期临床（NCT05653752）。具体来看，由于试验过程中已有三位患者因药物副作用死亡，FDA表示了担忧，即在较高剂量下，可能会使人类受试者面临不合理和重大的疾病或伤害风险。究竟谁能打破HER3靶点被发现超过30年，却至今未有成药的尴尬现实？推荐阅读 * 曾10年蝉联榜首，今400亿美元围猎ADC，默沙东能重回全球药企TOP1吗？ * 全球TOP10药物大变！K药最"短命"，罗氏砍8大项目，AZ 、辉瑞停GLP-1，默沙东研发费用300亿…… 生产缺陷“害惨”了谁被延迟批准的FIC，Patritumab Deruxtecan不是第一个。上一个与其经历类似的选手Zolbetuximab，花费了近4个月的时间重新向FDA递交BLA，PDUFA也因此推迟了10个月。与HER3的相似，成名于2016年ASCO的Zolbetuximab是全球进展最快的Claudin 18.2靶点药物，一举一动同样全球瞩目。 2023年7月时，FDA基于安斯泰来提交的Zolbetuximab的优异的临床数据，授予其用于一线治疗不可切除、局部晚期或转移性、HER2阴性、胃或胃食管交界处 (GEJ) 患者的优先审批资格，PDUFA日期为2024年1月12日。同样在万众期待之下，安斯泰来收到的也是一封延迟审批CRL。在CRL信函中，FDA指出了Zolbetuximab第三方生产工厂未解决的缺陷，因此不能在原定的PDUFA日期前批准该药上市。历史总是惊人的相似，和Patritumab Deruxtecan目前的境况一样，FDA也未对Zolbetuximab的临床数据提出任何疑问，也没有要求安斯泰来开展额外的临床试验。虽然因生产缺陷暂时折戟FDA，Zolbetuximab今年3月在日本获批上市，成为全球首款且目前唯一获批的靶向CLDN18.2阳性、不可切除、晚期或复发性胃癌患者的治疗方案。在今年5月，安斯泰来重新向FDA递交了Zolbetuximab的BLA。根据处方药用户费用法案（PDUFA），FDA将新审批日期设定为今年的11月9日。一个第三方生产工厂的缺陷，让一款FIC药物上市后独占市场的时间减少至少十个月。安斯泰来与默沙东、第一三共的遭遇并非个案。包括艾伯维、礼来、诺和诺德、再生元在内的全球巨头，抑或是Biotech公司，都倒在了生产核查环节。来自生产方面的缺陷，在FDA发出CRL并延迟审批/拒绝其NDA/BLA申请的比例越来越高，甚至有企业连续四次都无法通过FDA的检查。 FDA签发CRL中所涉及的缺陷，一般分为7大类，即一般缺陷、药效、安全性、临床药理学、非临床研究、生产制造、标签。虽然药效、安全性仍然是FDA“说不”的最主要原因，但与生产制造相关问题的比例近年来明显攀升。公开数据统计，仅2023年，FDA共发出36封CRL（包含小分子及大分子药物），存在生产方面缺陷的CRL达到18封，占比已经高达50%。与药物安全性、有效性出现缺陷相比，生产方面相关的问题或许不是致命性的，但却同样会让一款药物的上市计划被搁置，轻则股价波动、重则商业化停滞、失去市场先机。艾伯维就在近日因为第三方生产商的问题第二次被FDA拒绝，股票在当日早盘交易中小幅下跌。 6月25日，艾伯维收到FDA就ABBV-951（foslevodopa / foscarbidopa）用于晚期帕金森病运动症状波动（motor fluctuations）的新药上市申请（NDA）发出的完整回复函（CRL）。时隔一年多再次被FDA拒绝批准的原因主要在于第三方生产商。 FDA列出了在对第三方合同生产组织检查中观察到的结果，不涉及ABBV-951及设备，也未提及ABBV-951（包括该组合的皮下注射泵装置）安全性、有效性、标签相关的任何问题，且没有要求艾伯维补充额外的疗效和安全性试验。不过艾伯维依然没有放弃，表示会继续与FDA保持积极合作，尽早为帕金森病患者提供该创新疗法。 MNC或许还能快速应对，对于抗风险能力较弱的Biotech公司来说，可能带来“灭顶之灾”。 Spectrum Pharmaceuticals就曾在收到FDA关于其Rolontis用于治疗接受骨髓抑制性癌症药物的患者的中性粒细胞减少证申请的CRL后，股价应声下跌了近30%，CRL信中提到因生产制造方面的缺陷，有必要对韩国的Hanmi Bioplant公司进行重新检查。比Spectrum处境更糟糕的ImmunityBio，其膀胱癌治疗药物Anktiva因第三方合同制造商存在缺陷而收到CRL，市值蒸发60%。一封CRL还带来了更严重的“后遗症”，此后ImmunityBio宣布裁员以简化运营，专注于当前的业务战略并降低成本。或许越来越多生产制造缺陷带来的CRL与警告信，正在给药物研发公司敲个警钟：在递交上市申请前，不论是自有工厂生产或委托第三方生产，都要进行风险评估与系统检查，对产品设计、生产工艺、设施等等全流程进行更严格的核查。生产方面的缺陷到了FDA审查才被发现，是否太晚了？回复“逆商”，了解电子期刊详情精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

抗体药物偶联物优先审批临床2期引进/卖出申请上市

2024-04-24

·PRNewswire

Hanmi Enters into Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate BH3120 in Combination with KEYTRUDA® (pembrolizumab)

Hanmi Pharmaceutical announces Clinical Trial Collaboration with MSD to evaluate 'BH3120' in combination with KEYTRUDA in phase 1 clinical trial in patients with progressive or metastatic solid tumors SEOUL, South Korea, April 23, 2024 /PRNewswire/ -- Hanmi Pharmaceutical (KOSPI: 128940, CEO: Jae-Hyun Park), a leading biopharma company in Korea that focuses on research areas such as oncology, obesity/metabolism, and rare diseases, announced it has entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA). Upon the execution of the agreement, Hanmi Pharmaceutical will conduct a phase 1 clinical trial to evaluate the safety and efficacy of its immuno-oncology drug, 'BH3120', in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with progressive or metastatic solid tumors. Hanmi Pharmaceutical will sponsor the clinical trial, and MSD will supply KEYTRUDA. 'BH3120' is a next-generation immunotherapy drug that applies 'Pentambody', a bispecific antibody platform technology, currently under joint development by Hanmi Pharmaceutical and its Chinese subsidiary, BJHM (Beijing Hanmi Pharmaceutical). Pentambody is a technology that combines one antibody to two different targets simultaneously, facilitating both immuno-oncology therapy and targeted therapy. More specifically, BH3120 is an lgG-like bivalent bispecific antibody targeting PD-L1 and 4-1BB with biased binding affinities towards PD-L1. This design aims to induce strong anti-tumor activities, particularly in PD-L1 overexpressed tumor tissues within the tumor microenvironment (TME), while minimizing undue immune activation in normal tissues. Most of the existing antibody candidates targeting 4-1BB have limitations in terms of safety. However, BH3120 has been shown through various non-clinical studies to exhibit a clear decoupling of immune activity between TME and normal tissue, confirming its potential as an effective and safe anticancer agent. Dr. Kim Dong-wan, the director of the Seoul National University Hospital Clinical Trials Center (Hemato-Oncology Department), is the Principal Investigator of the phase 1 clinical trial of BH3120 in Korea and the US. He said, "Through the collaboration with MSD, we expect BH3120 in combination with KEYTRUDA could improve outcomes for patients with relapsed or refractory disease." A Hanmi representative stated, "BH3120 is our first global clinical research project using the next-generation bispecific antibody platform technology 'Pentambody' in the field of immuno-oncology therapy, potentially changing the paradigm of anticancer treatment," and added, "We are dedicated to surpassing the constraints of current therapies and innovatively boosting therapeutic efficacy through our next-generation immune-oncology therapy." KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Contact info: Official Websites: [email protected], +08-2-410-0467 Introducing Hanmi Pharmaceutical Established in 1973, Hanmi Pharmaceutical is an R&D-centric pharmaceutical company that strives to create global first-in-class drugs through industry-leading R&D investments. Hanmi Pharmaceutical has strategically established more than 30 pipelines covering metabolic diseases(diabetes, obesity), inflammation-fibrosis(MASH) treatment, anticancer drugs, and rare disease treatments, among which 'Rolontis', a neutropenia treatment, has received marketing authorization from the FDA in 2022. The company retains solid partnerships with leading global pharmaceutical companies based on proprietary technologies such as 'LAPSCOVERY', a platform technology that prolongs the duration of action of biologics, and 'PENTAMBODY', a bispecific antibody platform technology. Hanmi Pharmaceutical is enhancing the synergy of various R&D activities, such as AI new drug development and immuno-anticancer drug development, through the 'Open Innovation' strategy that opens the door to excellent external R&D capabilities. For more information, please refer to our website About BH3120 BH3120 is a heterodimeric bispecific antibody (PENTAMBODY) designed to target 4-1BB and PD-L1 simultaneously to stimulate anti-tumor immune response either by inhibition of an immune checkpoint mechanism and by activation of a co-stimulatory signal in tumor microenvironment (TME) focused manner. Non-clinical observations with BH3120, either as a monotherapy or in combination settings, consistently explain strong anti-tumor T cell activities in a tumor tissue-specific manner with clear dose dependency, while systemic immune response is minimally modulated. These properties support further evaluation of the immune-modulating bispecific antibody, and BH3120 will be studied as a therapeutic candidate with multiple types of solid tumors. SOURCE Hanmi Pharmaceutical

临床1期免疫疗法引进/卖出上市批准

100 项与 Eflapegrastim 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11188	Eflapegrastim	-	DB15001

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
化疗引起的发热性中性粒细胞减少症	美国	Spectrum Pharmaceuticals, Inc.	2022-09-09
中性粒细胞减少	韩国	Hanmi Pharmaceutical Co., Ltd.	2021-03-18

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
早期乳腺癌	临床3期	匈牙利	Spectrum Pharmaceuticals, Inc.	2017-05-10
早期乳腺癌	临床3期	印度	Spectrum Pharmaceuticals, Inc.	2017-05-10
早期乳腺癌	临床3期	加拿大	Spectrum Pharmaceuticals, Inc.	2017-05-10
早期乳腺癌	临床3期	韩国	Spectrum Pharmaceuticals, Inc.	2017-05-10
早期乳腺癌	临床3期	波兰	Spectrum Pharmaceuticals, Inc.	2017-05-10
早期乳腺癌	临床3期	美国	Spectrum Pharmaceuticals, Inc.	2017-05-10
化疗引起的发热性中性粒细胞减少症	临床3期	加拿大	Spectrum Pharmaceuticals, Inc.	2016-01-19
化疗引起的发热性中性粒细胞减少症	临床3期	韩国	Spectrum Pharmaceuticals, Inc.	2016-01-19
乳腺癌	临床3期	以色列	Spectrum Pharmaceuticals, Inc.	2013-03-25
乳腺癌	临床3期	澳大利亚	Spectrum Pharmaceuticals, Inc.	2013-03-25

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临床结果

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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


NCT01037543 (Pubmed \| Drugs R D)	临床1期	-	84	Eflapegrastim	(選膚願鬱製壓觸願膚襯) = There were no significant adverse events attributable to eflapegrastim or pegfilgrastim in both Japanese and Caucasian subjects. 遞襯觸襯齋廠遞鏇築糧 (鑰淵膚淵夢餘遞鹹範壓 )	积极	2022-01-06
NCT01724866 (Pubmed)	临床2期	乳腺癌辅助	148	Rolontis 45 μg/kg	(鹽範網鬱築鏇繭襯範衊) = 夢鑰糧遞鹽憲蓋鹽顧顧蓋蓋齋鑰鏇糧築觸製築 (鑰醖網築膚繭襯鹽蓋艱, -0.56, ~ 0.06)	积极	2018-05-01
NCT01724866 (Pubmed)	临床2期	乳腺癌辅助	148	Rolontis 135 μg/kg	(鹽範網鬱築鏇繭襯範衊) = 廠繭窪選餘鹽鏇膚糧網蓋蓋齋鑰鏇糧築觸製築 (鑰醖網築膚繭襯鹽蓋艱, -0.28 ~ 0.64)	积极	2018-05-01