This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data

开始日期2024-06-20

申办/合作机构

北京大学人民医院

NCT06464991 / Recruiting临床3期

A Phase III Randomized, Controlled Study of Equecabtagene Autoleucel Injection in Subjects With Lenalidomide-Refractory R/R Multiple Myeloma

This is a multicenter, randomized, controlled, open-label, phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy.

开始日期2024-03-27

申办/合作机构

南京驯鹿生物技术股份有限公司初创企业

NCT05698303 / Not yet recruiting临床1期

A Phase Ib Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

It is a dose expansion, open-label, phase Ib study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of CT103A in patients with relapsed/refractory multiple myeloma.

开始日期2023-05-08

申办/合作机构

南京驯鹿生物技术股份有限公司初创企业

100 项与伊基奥仑赛相关的临床结果

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100 项与伊基奥仑赛相关的转化医学

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100 项与伊基奥仑赛相关的专利（医药）

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项与伊基奥仑赛相关的文献（医药）

2023-11-01·Molecular diagnosis & therapy

Equecabtagene Autoleucel: First Approval.

Review

作者: Keam, Susan J

Equecabtagene autoleucel (Fucaso^®), an autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy that uses lentivirus as a gene vector to transfect autologous T cells, is being developed by IASO Biotechnology and Innovent Biologics, Inc. for the treatment of multiple myeloma (MM) and autoimmune diseases of the nervous system, including neuromyelitis optica spectrum disorder (NMOSD). Equecabtagene autoleucel was granted conditional approval in China in June 2023 for the treatment of adults with relapsed or refractory MM (RRMM) who have progressed after ≥ 3 lines of therapy (≥ 1 proteasome inhibitor and an immunomodulator). This article summarizes the milestones in the development of equecabtagene autoleucel leading to this first approval in patients with RRMM who have progressed after multiple lines of therapy.

2023-08-10·Current drug delivery

Integrated animal experiments and network pharmacology for investigating therapeutic effect of celastrol-loaded liposomes on NAFLD.

Article

作者: Xiong, Yang ; Luo, Ningchao ; Xu, Shujun ; Ma, Ninghui ; Shi, Jingbin ; Huang, Jingyi

BACKGROUND:

The prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) is closely related to the increase of the incidence rate of obesity.

AIMS:

To find out the targets of celastrol on NAFLD with the treatment of celastrol-loaded liposomes (Cel-Lips).

METHODS:

Gene Expression Omnibus (GEO) data were used to compare the expression of differential genes in NAFLD patients with normal individuals. Celastrol was loaded into liposomes to improve its solubility, as well as, achieving a passive targeting effect on the liver to improve the availability, which also could delay the release rate of celastrol to prolong the action time and thus reduce the frequency of administration. Due to rarely reported molecular mechanisms of celastrol, with the help of network pharmacological analysis, the targets of celastrol acting on NAFLD were predictively analyzed.

RESULTS:

An association between NAFLD and lipid metabolism was detected in GEO data. Cel-Lips significantly alleviated NAFLD in vivo. Through network pharmacology, it was found that most of the action pathways of celastrol were related to lipid metabolism.

CONCLUSION:

Celastrol has the potential to treat NAFLD, and its possible targets have been identified through network pharmacological screening, which provides a certain basis for the follow-up researches.

2023-06-15·International journal of biological macromolecules

A cellulose-based material as a fluorescent sensor for Cr(VI) detection and investigation of antimicrobial properties of its encapsulated form in two different MOFs.

Article

作者: Kayhan, Elif Yemeniciler ; Kocer, Mustafa Baris ; Yildirim, Ayse ; Uysal, Ahmet ; Yilmaz, Mustafa

It is crucial to detect toxic chromium ions quickly, reliably, sensitively and at low concentrations. In recent years, fluorescence-based methods have been developed for the rapid detection and determination of toxic ions such as chromium. In present work, we focused on the development of a cellulose-based fluorescent probe (Cel-Nap) for the determination of Cr(VI). The fluorescent probe bearing the 1,8-naphthalimide group displayed a low LOD of 1.07 μM for Cr(VI) in the working range of 0.33 × 10^-5-3.22 × 10^-5 M. The fluorescence and antibacterial properties of UiO-66-Cel-Nap and ZIF-8-Cel-Nap materials prepared by encapsulating Cel-Nap with 2 different MOF types (UiO-66 and ZIF-8) were investigated. While it was found that ZIF-8-based materials had better antimicrobial properties compared to those of UiO-66, it was determined that materials containing Ag⁺ were more effective against microbial than those containing AgNPs. It was found that the most effective material was ZIF-8-Cel-Nap-Ag⁺ and it had a significant antibacterial effect against E. coli at a MIC value of 0.0024 mg/mL.

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项与伊基奥仑赛相关的新闻（医药）

2024-07-01

·美通社

驯鹿生物在2024 EAN年会口头报告伊基奥仑赛注射液治疗中枢神经系统免疫性疾病的临床数据和单细胞多组学分析成果

中国南京、上海和美国加州圣荷西2024年7月1日 /美通社/ -- 驯鹿生物，一家致力于细胞创新药物研发、生产和销售的生物制药公司，在2024年欧洲神经病学协会（EAN）年会上口头报告了全人源靶向 BCMA嵌合抗原受体自体T细胞注射液伊基奥仑赛注射液治疗中枢神经系统免疫性疾病的临床数据和单细胞多组学分析成果。报告标题：中枢神经系统自身免疫性疾病的BCMA CAR-T细胞治疗和单细胞分析报告类型：口头报告报告时间： 2024年7月1日上午 8:30 - 9:45（欧洲东部夏令时间）报告地点：芬兰赫尔辛基摘要编号： A-24-12777 汇报人：华中科技大学同济医学院附属同济医院秦川教授本次汇报内容基于一项研究者发起的评估输注伊基奥仑赛注射液治疗复发/难治性抗体介导的神经系统特发性炎症性疾病的安全性和有效性的探索性临床研究（NCT04561557）结果，该研究正在华中科技大学同济医学院附属同济医院开展，研究者为同济医院神经内科王伟教授团队。该研究入组了12例水通道蛋白4（AQP4）抗体阳性的复发/难治性视神经脊髓炎谱系疾病（NMOSD）受试者，入组的受试者为至少使用一种免疫抑制剂治疗一年以上、但症状控制欠佳的患者。研究结果显示，伊基奥仑赛注射液在NMOSD中展现出良好耐受性和安全性、持久的致病性抗体清除作用以及潜在的临床疗效。具有趋化特性的CAR-T细胞可以穿透血脑屏障进入中枢，直接杀伤中枢神经系统的异常浆细胞，减少鞘内自身抗体的分泌以及免疫细胞的异常激活，从而纠正NMOSD患者中枢神经系统免疫紊乱状态，有利于患者的中枢免疫重建。华中科技大学同济医学院附属同济医院和驯鹿生物作为全球最先使用BCMA CAR-T治疗免疫病的研究团队之一，其突破性的研究成果验证了创新细胞治疗用于复发难治的免疫病的临床价值，使其应用前景在国际范围内越来越受认可和重视。目前， BCMA CAR-T疗法已被国际视神经脊髓炎研究小组（NEMOS）评价为极具潜力的治疗策略之一，并纳入最新的治疗修订建议(J Neurol 2024) 。约翰霍普金斯大学免疫学系Maximilian F. Konig教授在Nat Rev Rheumatol杂志撰写年度细胞治疗进展（Year in review，Immunotherapies in 2023: The rise of precision cellular therapies）中指出， CAR-T疗法的应用，为免疫病的创新细胞治疗带来了划时代意义的进展。本项临床研究的主要研究者，华中科技大学同济医学院附属同济医院王伟教授表示："该研究是全球首个CAR-T疗法在AQP4介导的复发/难治性NMOSD疾病领域的临床试验，不仅证明了伊基奥仑赛注射液在NMOSD中令人鼓舞的有效性和可控的安全性，还阐明了CAR-T治疗中枢神经系统免疫性疾病的细胞动力学特征和免疫学特征，为抗体介导的自身免疫性疾病提供了一种新的治疗思路，也为后续CAR-T细胞治疗免疫病的产品迭代改良提供重要的科学依据。除NMOSD外，伊基奥仑赛注射液在治疗其他抗体介导的自身免疫性疾病包括重症肌无力和免疫介导性坏死性肌病中均展现出非常好的临床疗效，甚至逆转了疾病的征象，并在国际权威学术期刊发表了多篇相关研究论文。自免疾病患者群体庞大，反复发作，难以治愈，患者需要长期甚至终身用药，存在巨大的未被满足的临床需求，我们将与驯鹿生物团队持续探索伊基奥仑赛注射液在更多难治性自身免疫性疾病中的应用，改变自免疾病的治疗格局。" 关于驯鹿生物驯鹿生物是一家致力于细胞创新药物研发、生产和销售的生物制药公司。公司以开发血液肿瘤细胞类药物和抗体药物为创新基石，向自身免疫疾病拓展，拥有完整的从早期发现、临床开发、注册申报到商业化生产的全流程能力。公司现有10余个处于不同研发阶段的创新药物品种，其中伊基奥仑赛注射液（全人源BCMA CAR-T产品）已获国家药监局（NMPA）批准上市，并已获得美国FDA批准注册临床，用于治疗复发\/难治多发性骨髓瘤。驯鹿生物凭借其强大的管理团队、创新的产品线、自有的GMP生产和超强的临床开发能力，旨在提供变革性、可治愈的创新型疗法，为中国乃至全球患者带来治愈的希望。了解更多信息，请访问公司官网： www.iasobio.com 或领英账号： www.linkedin.com\/company\/iasobiotherapeutics。

细胞疗法免疫疗法

2024-07-01

·PRNewswire

IASO Bio Presented Clinical Data and Single-cell Analysis of Equecabtagene Autoleucel for the Treatment of Central Nervous System Autoimmunity in Oral Presentation at EAN Congress 2024

SHANGHAI, NANJING, CHINA, and SAN JOSE, Calif., July 1, 2024 /PRNewswire/ -- IASO biotechnology ("IASO Bio"), a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, presented the clinical data and single-cell analysis of the fully human anti-BCMA CAR T cell therapy (Equecabtagene Autoleucel, Eque-cel) for the treatment of central nervous system autoimmunity in an oral presentation at the 2024 European Academy of Neurology (EAN) Annual Meeting. Presentation Title: Single-cell analysis of anti-BCMA CAR T cell therapy in patients with central nervous system autoimmunity Presentation Type: Oral report Session Date and Time: 1 July 2024, 8:30 - 9:45 (EEST) Location: Helsinki, Finland Publication Number: A-24-12777 Presenter: Professor Chuan Qin, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology This report is based on an investigator-initiated study to evaluate the safety and efficacy of Eque-cel for the treatment of relapsed/refractory antibody-mediated idiopathic inflammatory disorders of the nervous system (NCT04561557). It was conducted by Professor Wei Wang's team at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. The study enrolled 12 subjects with aquaporin-4 (AQP4) antibody-positive relapsed/refractory neuromyelitis optica spectrum disorder (NMOSD), all of whom had been treated with at least one immunosuppressant for over a year but had poor symptom control. The study results preliminarily demonstrated the good tolerability and safety, durable pathogenic antibody clearance, and potential clinical efficacy of Eque-cel in NMOSD. And CAR-T cells with chemotactic properties can cross the blood-brain barrier and enter the central nervous system to directly kill abnormal plasma cells in the central nervous system. The action facilitates the restoration of central immunity as it reduces the secretion of autoantibodies within sheaths and the abnormal activation of immune cells. As a result, the immune disorder in the central nervous system of the NMOSD patients can be rectified and its immune system can be reset. As one of the pioneering research teams that first use BCMA CAR-T therapy for the treatment of immune diseases in the world, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology and IASO Bio have achieved breakthrough research results that validate the clinical value of innovative cell therapy for relapsed and refractory immune diseases, making its application prospects increasingly recognized and valued internationally. Currently, BCMA CAR-T therapy has been rated as one of the most promising treatment strategies by the International Neuromyelitis Optica Study Group (NEMOS) and incorporated into the latest revised treatment recommendations (J Neurol 2024). In addition, Professor Maximilian F. Konig from department of immunology, Johns Hopkins University, stated in Year in review, Immunotherapies in 2023: The rise of precision cellular therapies, published in Nat Rev Rheumatol, that the application of CAR-T therapy has brought groundbreaking advancements in innovative cellular therapies for immune diseases. Professor Wei Wang from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, the principal investigator of this study, stated: "This study was the world's first clinical trial of CAR-T therapy in the field of AQP4-mediated relapsed/refractory NMOSD. It not only demonstrated the encouraging efficacy and controllable safety of Eque-cel in NMOSD but also elucidated the cellular dynamics and immunological characteristics of CAR-T therapy for central nervous system autoimmune diseases. This provides a new therapeutic approach for antibody-mediated autoimmune diseases and also provides scientific insights into refining CAR-T cell therapies for autoimmune diseases. In addition to NMOSD, Eque-cel has shown an excellent clinical efficacy in the treatment of other antibody-mediated autoimmune diseases, including myasthenia gravis and immune-mediated necrotizing myopathy, even with early signs of reversing the disease. We have published several related research papers in leading international academic journals. There is a large patient population with autoimmune diseases, which are prone to relapses, difficult to cure, and require long-term or even lifelong medication, with a huge unmet clinical demand. We will continue to explore the application of Eque-cel in more refractory autoimmune diseases with IASO Bio team, aiming to transform the treatment landscape of autoimmune diseases." About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RRMM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . SOURCE IASO Bio

免疫疗法细胞疗法上市批准临床研究临床结果

2024-06-29

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第24期/总第145期

全球药物批准/研发动态 01 全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）全球（不含中国）共有13个新药获批上市。其中，NDA批准2个，BLA批准3个，疫苗批准1个，新适应症批准7个，新剂型批准1个。与上个统计周期相比，本次增加8个批准新药。 6月17日，默沙东宣布FDA已批准CAPVAXIVE™（肺炎球菌21价结合疫苗）用于预防成人侵袭性肺炎球菌疾病和肺炎球菌肺炎。与其他肺炎球菌疫苗相比，CAPVAXIVE包括八种独特的血清型，即15A、15C、16F、23A、23B、24F、31和35B。这些血清型约占50岁及以上成年人IPD病例的27%，约占65岁及以上成年人的30%。CAPVAXIVE以单剂量给药。 6月20日，Sarepta宣布，FDA批准扩大ELEVIDYS的适应症，用于治疗4岁及以上DMD突变的杜氏肌营养不良症（DMD）患者，并加速批准ELEVIDYS用于非卧床杜氏患者。ELEVIDYS是一种基于腺相关病毒的单剂量基因转移疗法，用于静脉输注，通过递送编码骨骼肌中ELEVIDYS微抗肌萎缩蛋白的靶向生产的转基因，解决杜氏肌营养不良症的潜在遗传原因-DMD基因的突变或变化导致抗肌萎缩蛋白的缺乏。全球（不含中国）新药批准情况（部分） 02 全球新药申报进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）全球（不含中国）共有5个新药申报上市。其中，NDA申报进展2个，BLA申报进展3个。与上次统计周期相比，本次增加3个NDA/BLA申报。 6月17日，强生宣布向FDA提交sBLA，此sBLA为Amivantamab和重组人透明质酸酶的固定组合皮下给药用于目前所有批准或提交的Amivantamab静脉脉注射剂型的NSCLC相关适应症。数据显示，皮下注射Amivantamab能显著缩短给药时间，输注相关反应减少五倍，同时延长总生存期、无进展生存期和反应持续时间。 NDA/BLA申报根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）全球（不含中国）共有1个药物获监管机构特殊资格认定。其中，细胞疗法1个。与上次统计周期相比，本次减少6个获监管机构特殊资格认定的药物。 6月18日，Neurona Therapeutics宣布FDA已授予NRTX-1001 "RMAT加速计划"，用于治疗耐药性颞叶中叶癫痫（MTLE）。NRTX-1001细胞疗法与目前的手术方案不同，目前的手术方案会破坏脑组织，并可能导致包括神经认知障碍在内的严重不良反应，而NRTX-1001细胞疗法已显示出控制癫痫发作的潜力，且不会产生此类不良反应。如果这些研究结果得到证实，NRTX-1001将满足耐药性癫痫患者尚未得到满足的重大医疗需求。 NRTX-1001是一种候选再生细胞疗法，源自人类多能干细胞。目前，NRTX-1001正在两项开放标签多中心I/II期试验中进行安全性和有效性研究，这两项试验分别针对耐药单侧颞叶间叶癫痫和耐药双侧颞叶间叶癫痫，未来还计划研究新皮质局灶性癫痫和其他适应症。NRTX-1001细胞疗法正在进行的I/II期临床试验取得了积极的最新数据，显示出良好的安全性和显著降低耐药性癫痫发作频率的潜力。特殊资格认定情况 03 全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）全球（不含中国）新药临床研发状态更新共计58条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及皮肤病等共计14个领域。其中，血液和淋巴疾病临床进展更新居各领域之首，为12条：血液和淋巴疾病领域涉及化学药7条，生物药1条，细胞疗法4条。 6月17日，科济药业宣布宣布，赛恺泽®的更新成果已在EHA年会上进行报告。结果显示，在既往经过至少3线治疗的R/R MM患者中，总体缓解率（ORR）为92.2%。中位随访时间为20.3个月时，DOR、PFS和OS尚未成熟，所有患者12个月和18个月的PFS率分别为76.3%和61.9%。所有患者12个月和30个月的OS率分别为90.2%和79.4%。在达到CR/sCR的患者中，12个月和30个月的OS率分别为95.9%和87.7%。全球新药研发进展详情（部分） 04 全球医药交易事件本次统计周期（2024.06.15-06.21）全球（含中国）医药交易时间共计46起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态 01 国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有7个新药获NMPA批准上市。其中，NDA批准3个，新适应症批准2个，新剂型批准2个。与上次统计周期相比，本次增加4个NMPA批准新药。 6月18日，康哲药业宣布亚甲蓝肠溶缓释片（莱芙兰®）的新药上市许可申请已于6月11日获得NMPA批准。产品用于在接受结肠镜检查筛查或监测的成人患者中增强结直肠病变的可视化，成为中国首个口服亚甲蓝肠溶缓释片。莱芙兰®采用多基质（MMX）的专利技术，将活性物质直接输送至结肠并局部控制释放，可增加结直肠病变和健康粘膜之间的对比度，显著提高非息肉样结直肠病变检出率，提高危险病变如非息肉样腺瘤的检测率。 6月19日，迪哲医药宣布高选择性JAK1抑制剂高瑞哲®正式获得NMPA批准，单药适用于既往至少接受过一线系统性治疗的复发或难治的外周T细胞淋巴瘤（r/r PTCL）成人患者。研究结果显示，高瑞哲®单药治疗r/r PTCL：深度缓解：经IRC确认的ORR达44.3%，完全缓解率达23.9%；全面获益：在不同亚型PTCL中均观察到肿瘤缓解，满足了既往药物无法覆盖的治疗需求；更长生存：中位缓解持续时间长达20.7个月。中国新药批准情况（部分） 02 国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有32个新药获临床默示许可，涉及50个受理号。其中，化学药15个，治疗用生物制品17个。与上个统计周期相比，本次增加28个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分） 03 国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有4个新药申报上市，涉及7个受理号。其中，化药1个，治疗用生物制品3个。与上个统计周期相比，本次增加4个新药申报上市受理号。国内新药申报上市情况（部分）根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有35个新药申报临床，涉及45个受理号。其中，化学药18个，治疗用生物制品16个，预防用生物制品1个。与上个统计周期相比，本次减少4个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内共有1个药物获NMPA特殊资格认定。其中，化学药1个。与上个统计周期相比，本次获监管机构特殊资格认定的药物数量与上个统计周期相同。 6月17日，CDE官网公示，礼邦医药的AP306胶囊拟纳入突破性治疗品种，拟开发的适应症为慢性肾脏病高磷血症。AP306是一种口服磷酸盐转运蛋白NaPi-IIb、PiT-1、PiT-2泛抑制剂，能阻断肠道磷酸盐主动转运，有望克服低磷饮食和磷结合剂治疗高磷血症的局限性，目前已完成针对慢性肾脏病高磷血症的II期临床研究。研究数据显示：在主要疗效终点，即从基线到治疗结束时血清磷平均值的变化方面，达到了统计学意义的下降，其中AP306组为-2.51mg/dL，其血清磷下降幅度明显高于碳酸司维拉姆组（-1.08 mg/dL）。AP306组最常见的不良事件为胃肠道反应，主要是腹泻。所有腹泻事件严重程度均为1/2级且大多数在2周内自行缓解。AP306组未报告严重不良事件。 NMPA药物特殊资格认定相关进展情况 04 国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.06.15-06.21）国内新药临床研发状态更新共计10条，涉及肿瘤、血液和淋巴疾病、内分泌系统疾病、呼吸系统疾病和感染疾病共计5个领域。其中，化学药3个，生物药5个，细胞疗法1个，疫苗1个。 6月17日，驯鹿生物在2024年EHA年会上展示了伊基奥仑赛注射液用于治疗不适合移植的高危新诊断多发性骨髓瘤患者的临床数据。伊基奥仑赛注射液回输后中位随访时间7.46个月，12个月PFS率为84.4%，100%受试者均达到MRD阴性，其中71.4%受试者持续维持MRD阴性超过12个月；客观缓解率为100%，其中93.8%达到严格意义的完全缓解。国内新药研发进展情况（部分） 05 国内新药研发领域政策法规动态关于公开征求《晚期胃癌新药临床试验设计指导原则（征求意见稿）》意见的通知晚期胃癌是抗肿瘤新药研发的热点领域，伴随新药研发进展，免疫检查点抑制剂、抗体偶联药物等新药的使用，对临床试验设计和终点选择带来了挑战,现有指导原则尚不能涵盖。为给业界人员在临床研发路径和临床研究设计方面提供参考，提高临床研发效率，药品审评中心组织撰写了《晚期胃癌新药临床试验设计指导原则》，现形成征求意见稿。我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议，并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻海思科的破茧成蝶之旅国内的药企中，海思科是特别的存在，特别坚韧，也特别耐得住寂寞。如果纵观其整个发展历程，还会发现海思科在谋篇布局上费尽了心机。在仿制药时代，选择了肠外营养领域并做到了龙头位置；进入创新药时代后，又瞄准了麻醉药这一高壁垒作为先锋，继而投入PROTAC这类超前沿领域，不仅胆大而且心细。如今海思科创新药已进入全新阶段，十余年煞费心血之后终于迎来破茧成蝶。全面进军麻醉领域可以说，环泊酚救了此前摇摇欲坠的海思科。更多资讯，请阅读原文诺泰生物为何能在国内CXO中一枝独秀？国内CXO行业不得不面对一个残酷的事实，那就是无法阻挡的衰退。可以说，从疫情结束之后，这种衰退就无法避免。进入2024年之后，我们看到了地缘政治对一个行业的影响有多么巨大，尽管大洋彼岸的制裁还没落地，尽管落地的可能性也要打个问号，但不影响资本市场对中国整个CXO行业的绞杀。在这种氛围中，诺泰生物在资本市场的表现却一路高涨，丝毫未受地缘政治的影响，这是为何？踩中了风口在时代洪流当中，个人努力固然十分重要，但也要考虑历史进程。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“0628创新药周报”，即可下载。

上市批准疫苗突破性疗法申请上市

100 项与伊基奥仑赛相关的药物交易

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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
多发性骨髓瘤	中国	南京驯鹿生物医药有限公司	2023-06-30
多发性骨髓瘤	中国	Innovent Biologics, Inc.	2023-06-30

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性多发性骨髓瘤	临床3期	中国	南京驯鹿生物技术股份有限公司初创企业	2024-03-27
桥本脑炎	临床1期	中国	南京驯鹿生物技术股份有限公司初创企业	2020-09-22
特发性炎症性肌病	临床1期	中国	南京驯鹿生物技术股份有限公司初创企业	2020-09-22
多发性硬化症	临床1期	中国	南京驯鹿生物技术股份有限公司初创企业	2020-09-22
重症肌无力	临床1期	中国	南京驯鹿生物技术股份有限公司初创企业	2020-09-22
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床1期	中国	南京驯鹿生物技术股份有限公司初创企业	2020-09-22
视神经脊髓炎	临床1期	中国	南京驯鹿生物技术股份有限公司初创企业	2020-09-22
POEMS综合征	临床1期	中国	南京驯鹿生物技术股份有限公司初创企业	2020-09-22
慢性炎症性脱髓鞘性多发性神经病	临床1期	中国	南京驯鹿生物技术股份有限公司初创企业	2020-09-22
水通道蛋白4抗体阳性视神经脊髓炎谱系疾病	临床申请批准	中国	南京驯鹿生物医药有限公司	2022-08-19

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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


NCT05181501 (FUMANBA-2, EHA2024) 人工标引	临床1期	多发性骨髓瘤一线	16	EQUE-CEL	齋夢壓醖壓選餘膚繭餘(夢鏇醖鏇糧顧構憲繭簾) = 膚餘膚淵壓築醖壓範選艱選窪鑰構構遞膚選蓋 (淵壓窪襯築積顧獵鹹觸 ) 更多	积极	2024-05-14
NCT04561557 (Pubmed) 人工标引	早期临床1期	重症肌无力	2	CT103A	遞觸膚鏇餘獵餘簾範鹹(夢糧顧淵鏇構簾觸製願) = 艱襯觸齋醖遞膚醖築範淵積繭鑰鬱膚繭廠鏇鹽 (艱窪選選艱製繭鏇繭鹽 )	积极	2024-02-26
NCT04561557 (Pubmed \| Proc Natl Acad Sci U S A) 人工标引	早期临床1期	免疫介导的坏死性肌病	1	Equecabtagene Autoleucel	糧艱網築選簾築鹹願獵(廠醖觸鏇積鏇範壓繭齋) = The patient developed only grade 1 cytokine release syndrome (CRS), but had no immune effector cell-associated neurotoxicity syndrome (ICANS). Only transient hemocytopenia was observed. 構淵鏇鑰顧醖齋積獵齋 (遞構襯製鹽鏇蓋窪糧衊 ) 更多	积极	2024-01-30
ASH2023	临床1期	复发性多发性骨髓瘤	18	CT103A	願鹹膚鏇夢製壓淵憲積(鏇鏇艱簾艱網遞網遞廠) = The recovery of B cells and globulin were observed in 5 and 15 patients, respectively. But for the seven alive patients with sCR, only two of them had B cell recovered. 選鏇廠窪淵膚艱網壓窪 (獵鹽鹹艱蓋廠製願糧範 ) 更多	积极	2023-12-11
FUMANBA-1 (IMS2023)	临床1/2期	复发性多发性骨髓瘤 BCMA	105	Eque-cel	構糧鏇選夢襯範願鹹齋(築鹽鏇積繭憲積淵餘壓) = 簾觸醖繭齋鏇網鬱願鏇繭憲壓顧簾淵範鹽糧簾 (遞顧夢窪艱襯憲網繭範, 80.07 ~ 96.92) 更多	积极	2023-09-26
NCT05066646 (FUMANBA-1, ASCO2023) 人工标引	临床1/2期	复发性多发性骨髓瘤末线	103	CT103A	鬱淵構範範範鑰淵廠網(醖顧窪窪網淵鏇簾蓋鑰) = 觸築獵範憲膚簾鹹餘憲繭淵鹹艱積壓構鹹鑰鹹 (願廠壓遞鑰夢齋艱齋艱 ) 更多	积极	2023-05-26
NCT04561557 (PRNewswire) 人工标引	临床1期	视神经脊髓炎 AQP4 Antibody Positive	12	Equecabtagene Autoleucel	鏇鏇憲鏇築餘鏇獵範醖(鬱鏇遞獵繭簾構糧鏇淵) = 觸積蓋淵選夢鬱顧鹽糧顧構鹽鏇製淵膚窪鬱膚 (窪網範積範獵膚顧鏇構 ) 更多	积极	2022-11-18
NCT05066646 (FUMANBA-1, ASH2022) 人工标引	临床1/2期	复发性多发性骨髓瘤	103	Equecabtagene Autoleucel (the median time to first response was 16 days)	餘築夢衊齋鹽遞築夢醖(糧鹽網蓋鏇願衊壓醖壓) = 13 of 98 subjects (13.3%) 襯鹹鑰衊網膚蓋願憲製 (鏇廠蓋構憲獵築壓餘鏇 ) 更多	积极	2022-11-15
NCT05066646 (FUMANBA-1, ASH2022) 人工标引	临床1/2期	复发性多发性骨髓瘤	103	Equecabtagene Autoleucel (subjects who have completed 3-month follow-up)		积极	2022-11-15
NCT05066646 \| ChiCTR1800018137 (FUMANBA-1, EHA2022) 人工标引	临床1/2期	复发性多发性骨髓瘤末线	79	Equecabtagene Autoleucel 1.0×10^6 CAR+ T cells/kg+cyclophosphamide 500 mg/m^2+fludarabine 30 mg/m^2	艱繭願夢鹽餘製膚觸齋(鹹齋獵構範繭齋鬱簾衊) = 網鑰壓獵艱衊襯顧襯遞願範積築鹽窪衊選壓鬱 (鹽壓醖淵鑰鑰範積廠鏇 ) 更多	积极	2022-05-12
EHA2021	临床1期	复发性多发性骨髓瘤	35	CT103A	衊遞遞艱膚夢鹽範網衊(醖鹽鬱構淵繭壓範鏇鑰) = 齋艱鬱鏇觸觸壓鏇鹽齋壓積憲鑰觸蓋鬱淵獵鹽 (獵繭襯網獵簾網壓蓋積 ) 更多	-	2021-06-09