Iparomlimab

据国家药品监督管理局（NMPA）最新药品通知件送达信息，齐鲁制药艾帕洛利单抗注射液（受理号：CXSS2300077，注册分类：1类）和乐普生物注射用维贝柯妥塔单抗（受理号：CXSS2400102，注册分类：1类，适应症：既往经至少二线系统化疗和PD-1/PD-L1抑制剂治疗失败的复发/转移性鼻咽癌）在列。 一般来说，出现在通知件中通常意味着两种可能：一是该药物的上市申请可能被不予批准，二是企业可能主动撤回了申请。然而，目前尚无法确定具体是哪种情况。不过，不管何种原因均表明两家药企相应新药无法如期上市。 1、齐鲁PD-1单抗 公开信息显示, 艾帕洛利单抗注射液(研发代码:QL1604)为齐鲁制药研发的全球首个PD-1/CTLA-4双功能组合抗体。该药物由靶向PD-1的艾帕洛利单抗和靶向CTLA-4的托沃瑞利单抗组成，具有同时阻断PD-1和CTLA-4两条免疫检查点通路的协同作用机制。 2023年12月，齐鲁制药在2023年ESMO大会中公布其单药治疗DNA错配修复缺陷（dMMR）或高度微卫星不稳定（MSI-H）实体瘤的II期临床研究结果。 2020年6月至2023年1月，共纳入120例dMMR/MSI-H实体瘤患者，其中结直肠癌80例（66.7%），胃癌18例（15.0%），其它实体瘤22例（18.3%）；97.5%患者入组时疾病分期IV期，中位治疗线数为2.0（范围：0–6）。 有效性方面，截至2023年7月20日，中位随访时间13.6个月，11例患者完全缓解（CR），44例部分缓解（PR），ORR为45.8%（95%CI: 36.7%–55.2%），疾病控制率（DCR）为77.5%（95%CI: 69.0%–84.6%）。结直肠癌患者ORR和DCR分别为42.5%（95%CI: 31.5%–54.1%）和77.5%（95%CI: 31.5%–54.1%）。中位缓解持续时间（DoR）尚未达到，6个月和12个月DoR率分别为100%和97.4%；中位无进展生存期（PFS）和中位总生存期（OS）未达到。 在安全性方面，治疗期间发生不良事件（TEAEs）的发生率为97.5%。最常见的治疗相关不良事件发生率为25.8%，3级以上TRAEs发生率为5.0%；无治疗药物相关性死亡事件发生。 2024年9月30日，艾帕洛利托沃瑞利单抗注射液曾获得NMPA附条件批准上市，用于治疗既往接受含铂化疗失败的复发或转移性宫颈癌患者。 此次艾帕洛利单抗注射液出现在NMPA的通知件待领取信息中，可能与后续的补充申请或其他适应症的审批有关。不过，目前无法确定具体原因是否与药物的审批状态有关，这个还需等待齐鲁的官方回应。 2、乐普EGFR ADC 注射用维贝柯妥塔单抗（研发代码：MRG003）为乐普生物的靶向表皮生长因子受体（EGFR）的ADC，其由EGFR靶向单克隆抗体与强效的微管抑制有效载荷一甲基澳瑞他汀E分子通过缬氨酸－瓜氨酸链接体偶联而成。以高亲和力特异性地结合肿瘤细胞表面的EGFR，通过内吞及溶酶体蛋白酶裂解后释放强效的有效载荷，从而导致肿瘤细胞死亡。 其在研适应症为二线或以上NPC（鼻咽癌）或HNSCC（头颈部鳞状细胞癌）。其鼻咽癌适应症2024年向CDE递交上市申请（受理号：CXSS2400102），并获优先审评资格。 对于收到药品通知件送达信息，今天乐普生物最新公告进行了回应，出现通知件原因为CDE要求补充相关资料，所以企业撤回申请，并于今天重新递交上市申请。 对于之前投资者最担心的，上市未获批准是否是临床数据不佳、CMC问题等，乐普生物也针对大众关心的内容在2025年3月4日上午主动召开了沟通会，详细阐述。根据会议上内容，针对MRG003的相关内容以及乐普生物后续新药计划与近期成果，大致可总结为以下几点： MRG003此次未获批准，并非临床试验数据问题，不影响上市，主要为此次申报材料的错误导致，内部已对团队做出了惩罚。 MRG003此次重新提交上市申请，对产品整体进度影响大致为1-3个月（从2025年底到2026年初），但整体进度上，不影响2026年的医保谈判。 2025年下半年，针对MRG003联合PD-1的相关疗法，会有初期临床数据解读。多抗平台目前已筛选出全新抗体，有望在2025年上半年提交IND。 乐普生物业绩正增长，2025年将是收获大年。 总结而言，此次MRG003的上市申请提交对产品整体上市与上市进度的影响不大，对关键节点时间（医保谈判）的影响并不大，且由于采用eCTD格式递交注册文件，在审批进度上也可能存在加速，更关键的是对公司后续新药产品的相关审批有着积极影响。 本文综合整理自药讯随说、博药速递、一度医药等。 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！ 请注明：姓名+研究方向！ 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

SAN FRANCISCO and SUZHOU, China, March 2, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the first patient has been dosed in its registrational study evaluating IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy versus pembrolizumab (Keytruda®) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. This is IBI363's first pivotal study and a significant milestone for China's innovative immuno-oncology (IO) therapy in addressing the global challenge of treating "cold tumors." This is a randomized, multicenter, pivotal study designed to evaluate the efficacy and safety of IBI363 monotherapy versus pembrolizumab monotherapy in patients with unresectable, locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. The primary endpoint is progression-free survival (PFS), as assessed by an Independent Radiology Review Committee (IRRC) based on RECIST v1.1 criteria. IBI363 has demonstrated outstanding efficacy signals in immunotherapy (IO)-naïve melanoma patients across two earlier clinical trials (Phase 1a/1b study NCT05460767 and Phase 2 study NCT06081920), which enrolled a total of 26 patients with advanced acral or mucosal melanoma: The overall objective response rate (ORR) was 61.5%, and the disease control rate (DCR) was 84.6%—significantly higher than current domestic immunotherapy standards. Prolonged follow-up revealed sustained tumor responses and long-term benefits, suggesting the potential superiority of IBI363 over existing standard therapies. These preliminary data were presented at SITC 2024[1], and updated follow-up results will be shared at international conferences in 2025. IBI363 has also demonstrated a manageable safety profile. To date, IBI363 monotherapy or combination therapy has been administered to hundreds of patients with advanced solid tumors globally. The overall safety profile remains consistent with known toxicities of PD-1/PD-L1 and IL-2 therapies, with common treatment-related adverse events (TRAEs) including arthralgia, anemia, thyroid dysfunction, and rash—all of which are manageable with routine clinical care. Professor Jun Guo, Principal Investigator of the Study and Director of Peking University Cancer Hospital, stated: "Melanoma has a high mortality rate in China, and its incidence is rising annually. IO-naïve melanoma patients currently have a median PFS of only around three months, reflecting a significant unmet clinical need. Moreover, non-cutaneous subtypes like mucosal melanoma—which are more prevalent in China—are particularly resistant to immunotherapy with limited clinical benefits. IBI363 has shown the potential to convert 'cold tumors' into 'hot tumors' by the dual activation of PD-1 and IL-2 pathways. Encouraging efficacy observed in Phase 1a/1b and 2 studies suggest its potential as a next-generation IO therapy for melanoma. Along with my fellow investigators, I hope this trial will lead to more effective treatment options for patients with acral and mucosal melanoma." Dr. Hui Zhou, Senior Vice President of Innovent, stated, "As Innovent's first-in-class next-generation IO therapy, IBI363 simultaneously and selectively inhibits the PD-1/PD-L1 pathway and activates the IL-2 pathway. In previous studies, IBI363 has demonstrated outstanding efficacy and safety in melanoma and multiple cancer types. This pivotal trial, through a head-to-head comparison with pembrolizumab, aims to validate IBI363's potential as a superior treatment option for melanoma patients over the current standard-of-care. We are also accelerating the global development of IBI363 across multiple tumor types, with the goal of extending the benefits of China's innovation to patients worldwide." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein)) IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. It is a PD-1/IL-2 bispecific antibody fusion protein designed to enhance efficiency while minimizing toxicity. The IL-2 arm of IBI363 has been engineered to optimize therapeutic effects with reduced side effects, while the PD-1 binding arm enables PD-1 blockade and selective IL-2 delivery. By simultaneously inhibiting the PD-1/PD-L1 pathway and activating the IL-2 pathway, IBI363 facilitates more precise and efficient targeting and activation of tumor specific T cells. Preclinical studies have shown that IBI363 exhibits strong anti-tumor activity across multiple tumor-bearing pharmacological models, including those resistant to PD-1 inhibitors and metastatic models. Additionally, it has demonstrated a favorable safety profile in preclinical models. Clinical trials of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies. The first pivotal study of IBI363 has been initiated, for the treatment of IO-naive mucosal or acral melanoma. Furthermore, IBI363 has received two fast track designations (FTD) from the U.S. FDA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. About Melanoma Melanoma is a malignant tumor that develops from melanocytes. Although melanoma accounts for only 3% of all types of skin cancer, it has the highest motality rate of all types and is the most likely to metastasize. In China, the incidence and mortality rate of melanoma continue to rise. Melanoma is classified into three main subtypes: cutaneous, acral and mucosal. The characteristics of melanoma in Chinese patients differs greatly from those seen in European and American Caucasian populations in terms of pathogenesis, biological behavior, histological morphology, treatment response and prognosis[4]. For advanced cutaneous and acral melanomas, patients with the BRAF V600 mutation typically receive BRAF inhibitor combined with MEK inhibitors as the preferred molecular targeted therapy. For those without the BRAF V600 mutation, chemotherapy combined with anti-angiogenic drugs can be is a first-line treatment option. Notably, immunotherapy has not yet been approved as the first-line treatment indication for advanced melanoma in China. For second-line treatment, therapies not previously used in first-line settings are recommended. Patients who have not received PD-1 monoclonal antibody in the first-line setting may be treated with PD-1 inhibitors as a second-line option. For advanced mucosal melanoma, chemotherapy or PD-1 monoclonal antibody combined with anti-angiogenic drugs can be considered first-line treatment. For those with BRAF V600 mutation, BRAF inhibitor ±MEK inhibitor can be selected. Currently, posterior treatment options for melanoma are very limited. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 14 products in the market. It has 4 new drug applications under regulatory review, 2 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: 1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). 2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. Reference： SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED