An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates

The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.

开始日期2025-05-01

申办/合作机构

迈威（上海）生物科技股份有限公司

NCT06926998

/ Not yet recruiting临床1/2期

An Open-Label, Multicenter Phase Ib/ll Clinical Study Evaluating the Safety and Efficacy of 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors

To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.

开始日期2025-04-15

申办/合作机构

迈威（上海）生物科技股份有限公司

NCT06947226

/ Not yet recruiting临床1/2期

A Phase Ib/ll Clinical Study of Safety and Efficacy of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.

开始日期2025-04-01

申办/合作机构

迈威（上海）生物科技股份有限公司

100 项与迈威（上海）生物科技股份有限公司相关的临床结果

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0 项与迈威（上海）生物科技股份有限公司相关的专利（医药）

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项与迈威（上海）生物科技股份有限公司相关的文献（医药）

2025-04-21·Cancer Research

Abstract 5466: 7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers

作者: Tan, Xiaoding ; Zhou, Wei ; Guo, Cuicui ; Fang, Peng ; Wang, Rui ; Gui, Xun ; Wu, Hai

AbstractBackground:Cadherin 17 (CDH17), a member of the 7D-cadherin superfamily, is critically involved in intercellular adhesion, tissue integrity, and intestinal peptide transport. It is predominantly expressed on the basolateral membrane of intestinal and pancreatic ductal epithelial cells, with minimal expression in non-gastrointestinal (GI) tissues. Overexpression of CDH17 is strongly associated with tumor progression and metastasis in colorectal, gastric, and pancreatic cancers, making it an attractive target for therapeutic intervention. Here, we report the development of 7MW4911, a novel ADC designed to selectively target CDH17-positive tumors while sparing normal tissues.Methods:CDH17 expression as a therapeutic target was validated using comprehensive omics analyses. An anti-CDH17 specific mAb Mab0727 was generated using Mabwell’s integrated novel antibody discovery system. The ADC 7MW4911 was constructed by conjugating Mab0727 to the proprietary payload MF-6 via a cleavable linker, achieving a drug-to-antibody ratio (DAR) of 4 using site-specific inter-chain disulfide bond conjugation technology. Binding affinity, internalization, and cytotoxicity of 7MW4911 were evaluated in CDH17-positive GI cancer cell lines. Efficacy was further assessed in cell line-derived xenograft (CDX) and patient-derived xenograft (PDX) models. Pharmacokinetics and safety were studied in cynomolgus monkeys.Results:Immunohistochemistry (IHC) analysis confirmed CDH17 as a highly specific target, with expression observed in 100% (110/110) of colorectal, 77% (110/142) of gastric, and 55% (58/105) of pancreatic cancer samples. 7MW4911 demonstrated strong binding, efficient internalization, and potent cytotoxicity in CDH17-positive cell lines. In vivo, 7MW4911 showed substantial tumor growth inhibition (TGI), with TGI ranging from 29-97% in nine colorectal CDX models, 56-95% in three gastric models, and 81% in one pancreatic model. In PDX models, TGI ranged from 71-99% across nine colorectal and one gastric model. Importantly, 7MW4911 outperformed MMAE-based ADCs in multidrug-resistant CDX and PDX models. Pharmacokinetic studies in cynomolgus monkeys demonstrated a favorable safety profile, with a maximum tolerated dose exceeding 20 mg/kg and minimal off-target toxicity.Conclusions7MW4911 demonstrated exceptional preclinical efficacy, including robust activity against multidrug-resistant cancers, along with a strong safety profile. These findings highlight its potential as a transformative therapeutic candidate for CDH17-positive GI cancers, addressing significant unmet needs in oncology.Citation Format:Rui Wang, Peng Fang, Wei Zhou, Cuicui Guo, Xiaoding Tan, Hai Wu, Xun Gui. 7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 5466.

2025-04-21·Cancer Research

Abstract 2866: An innovative T cell engager platform with optimized CD3 affinity and formats for targeting hematologic and solid tumors

作者: Guo, Cuicui ; Han, Zhen ; Yun, Fenglin ; Li, Ao ; Gui, Xun ; Wu, Hai ; Pang, Yu

AbstractBackground:T-cell engagers (TCEs) are a promising class of immunotherapies that bridge T cells to tumor cells, triggering T-cell activation and subsequent tumor cell cytotoxicity. While TCEs demonstrated substantial efficacy in hematologic malignancies, their clinical benefit in solid tumors remains less established. The development of effective TCEs is hindered by challenges related to the complex interplay between CD3 affinity, TCE format, tumor-associated antigen (TAA) density, and specificity. To address these challenges, we have developed an innovative TCE platform designed to optimize CD3 affinity and TCE format to better match TAA expression profile and improve therapeutic efficacy.Methods:Humanized CD3 and TAA-targeting antibodies were generated by Mabwell’s integrated novel antibody discovery system. CD3 activity was assessed through T-cell binding and activation assays, while TAA binding potency was measured using tumor cell binding assays. Various bispecific and trispecific TCE formats were evaluated and optimized for developability, stability, and functional activity. Tumor-directed cytotoxicity (TDCC) assays were used to assess the efficacy of TCEs in vitro, while cytokine release syndrome (CRS) potential was also evaluated.Results:CD3 parental antibodies with varying T-cell binding and activation potencies, including cross-reactivity with monkey CD3, were generated. TAAs were identified and prioritized using a bioinformatics analysis system, leading to the selection of tumor-specific targets such as LILRB4, CLL-1, CLDN6, MUC16, MSLN, CDH17, GUCY2C, SEZ6, DLL3, and ENPP3. Several optimized 1+1, 1+2, and 2+2 TCE formats were developed, demonstrating excellent developability and potent in vitro tumor cell killing. Importantly, these TCEs exhibited minimal cytokine release syndrome (CRS) potential. Our platform also integrates comprehensive indication analysis, target validation, and TCE format optimization, facilitating the identification of multiple TAAs across a broad range of cancer types.Conclusion:Our innovative TCE platform offers a flexible and powerful approach for designing TCEs with enhanced efficacy and minimal CRS. This platform holds significant promise for developing novel T-cell engagers with robust therapeutic activity and favorable safety profiles for both hematologic and solid tumor indications.Citation Format:Cuicui Guo, Yu Pang, Zhen Han, Fenglin Yun, Ao Li, Hai Wu, Xun Gui. An innovative T cell engager platform with optimized CD3 affinity and formats for targeting hematologic and solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 2866.

2025-04-21·Cancer Research

Abstract 830: Combined a B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiates the antitumor activity in B7-H3-positive cancers

作者: Yu, Dongan ; You, Meng ; Yao, Yueqin ; Yin, Long ; Zhou, Wei ; Zhang, Yiyan ; Yang, Yueyue ; Cen, Xiaowei ; Fang, Peng ; Tan, Xiaoding ; Wu, Hai ; Li, Xueying ; Sun, Xiaowei ; Mei, Fei

AbstractIntroduction:B7-H3, an attractive target for antibody drug conjugate, is overexpressed in multiple tumors. Overexpression of B7-H3 in tumor cells frequently correlates with fewer tumor-infiltrating lymphocytes, faster cancer progression, and poor clinical outcome in several malignancies. Preliminary evidence revealed PARP inhibitors (PARPi) and B7-H3-directed antibody-drug conjugate (ADC) as two practical approaches to overcome chemoresistance in solid cancers. Thus, synthetic lethality exploitation by an anti-B7-H3 ADC plus PARPi might be a promising strategy in solid tumor models. Here, we investigated the activity of 7MW3711, a B7-H3-directed ADC bearing a novel isomerase I inhibitor (TOP1i) payload, alone and in combination with PARPi, in preclinical models to evaluate the potential for future clinical application.Method:7MW3711 was evaluated in vitro and vivo efficacy with or without PARPi (Olaparib or AZD5305). In vitro, human cancer cell lines were treated with 7MW3711 and two PARPi to determine the effect on anti-proliferative effects, double-stranded DNA breaks, and cell-cycle arrest. In vivo, mice bearing ovarian and SCLC tumor xenografts were treated with the combination of 7MW3711 and PARPi.Results:Evaluation of the drug resistance ability in cell lines expressing P-gp revealed 7MW3711 exhibited > 3-fold more potent than DS7300 (B7-H3-directed DXd ADC), indicating that 7MW3711 has a lower efflux efficiency in drug-resistant strains. 7MW3711 combined use of PARPi synergistically potentiated the inhibitory effects of 7MW3711 on the growth of B7-H3-positive cancer cells, inducing DNA damage and apoptosis. The highest level of double-stranded DNA breaks was observed in cells treated with combination which can be determined in the upregulation of γ-H2AX protein. Combination increased both G2/M phase-arrested cells and S-phase cells, reduced G1-phase, indicating that most proliferating cells were arrested. Combining 7MW3711 with olaparib or AZD5305 produced significant antitumor effects and survival benefit above that achieved with monotherapy in various B7-H3-positive solid tumor xenografts. Collectively, our results demonstrate the synergistic antitumor activity of combining 7MW3711 with PARPi, suggesting that DNA damage-repair inhibitors in combination with B7-H3-targeted ADCs is a promising approach for treating B7-H3-positive malignancies.Conclusion:These data provide evidence for the potential utility of 7MW3711 combination with PARPi for treatment of B7-H3-expressing tumors and support the rationale for further clinical studies.Citation Format:Xiaowei Cen, Peng Fang, Yueyue Yang, Dongan Yu, Yueqin Yao, Fei Mei, Xueying Li, Meng You, Yiyan Zhang, Long Yin, Xiaowei Sun, Xiaoding Tan, Wei Zhou, Hai Wu. Combined a B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiates the antitumor activity in B7-H3-positive cancers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 830.

2,616

项与迈威（上海）生物科技股份有限公司相关的新闻（医药）

2025-05-02

·医药笔记

礼来2025Q1：替尔泊肽大卖62亿美元

▎Armstrong2025年5月1日，礼来发布一季度财报，营业收入127亿美元，同比增长45%，核心产品销售额75亿美元，同比增长119%。礼来2025年580-610亿美元的收入指引不变，强调小分子GLP-1的成功具有重要意义。不过诺和诺德在减重药物市场上积极应对，允许多家远程医疗服务商大幅降价。同时，市场对于特朗普政府可能实施的药品关税影响业绩也存在担忧。礼来在公布亮眼的一季报数据后，股价却大跌12%，目前市值为7500亿美元。美国市场上，礼来GLP-1市场份额已经超过诺和诺德，并保持增长趋势。替尔泊肽降糖版一季度销售额38.42亿美元，同比增长113%。替尔泊肽减重版一季度销售额23.12亿美元，为去年一季度的4倍多，替尔泊肽两者合计61.54亿美元。信达生物信迪利单抗一季度销售额1.375亿美元，合10亿元人民币，同比增长19%。总结礼来核心产品销售额一路高涨，尤其是替尔泊肽在降糖市场快速替代司美格鲁肽，减重市场快速放量，预计今年将达到300亿美元销售额，占总营收的一半左右。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

财报抗体药物偶联物医药出海

2025-05-01

·医药笔记

Madrigal：首款MASH新药，上市首年大卖3.17亿美元

▎Armstrong2025年5月1日，Madrigal Pharmaceuticals发布一季度财报，MASH新药Rezdiffra销售额1.373亿美元。Rezdiffra从去年上市以来，季度销售额一路高涨，上市满一年实现3.174亿美元销售额。使用Rezdiffra的患者人数不断攀升，2025年一季度超过17000例，相比于31.5万例适用人群仅有5%的渗透率，意味着仍有很大的上涨空间。Rezdiffra对于处方医生的渗透率一路高升，体现了临床上巨大的未满足临床需求。Rezdiffra目前获批的是F2-F3阶段的MASH，对于F4阶段的临床试验正在进行中。目前的数据显示，Rezdiffra对于F4阶段的MASH同样有治疗潜力。总结昨天，司美格鲁肽治疗MASH的三期临床数据发表在新英格兰医学期刊上。FGF21在F4阶段也获得突破性的疗效数据，THR-β激动剂、GLP-1受体激动剂、FGF21的临床进展，未来将为广大MASH患者带来更多治疗选择。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

财报临床3期抗体药物偶联物

2025-04-30

·生物制药进展杂评

生物类似药达成3亿美元出海授权合作，复宏汉霖走出了新的路径

4月29日，复宏汉霖（2696.HK）宣布与全球仿制药和生物类似药领域领导者山德士（Sandoz，SIX:SDZ/OTCQX:SDZNY）达成授权合作协议，授予后者对公司自主研发的伊匹木单抗生物类似药HLX13（抗CTLA-4单抗）在美国、欧洲42个国家和地区、日本、加拿大及澳大利亚的独家商业化权益。HLX13是本公司自主研发的伊匹木单抗生物类似药，拟用于黑色素瘤、肾细胞癌、结直肠癌、肝细胞癌、非小细胞肺癌、恶性胸膜间皮瘤及食管鳞状细胞癌的治疗。2023年12月，HLX13在中国健康男性受试者中开展的1期临床研究完成首例受试者给药。根据IQVIA MIDASTM的数据（IQVIA是全球医药健康产业专业信息和战略咨询服务提供商），2024年度，伊匹木单抗于全球范围内的销售额为28.73亿美元。交易金额：首付款3100万美元，也还不错，总计可以获得3.01亿美元的潜在收入。这给生物类药物，带来了新的契机~生物类似药出海，尽管东南亚，中亚东欧会相对容易依一些，但是美国也还是有机会进入，总体上占比交易价值也很可观。之前曾经整理过出海的产品，已经看出生物类似药企业已经开始积极拓展海外的市场，但是还是走的“农村包围城市的”策略，这次的交易，算是开了一个很积极的信号，未来类的的交易必然会越来越多~在此之前汉曲优已经实现了中美欧三地上市，但是生物类似药授权合作到欧美市场应该还是第一例。汉曲优®（曲妥珠单抗生物类似药）：中美欧三地突破，覆盖50+国家核心进展美国市场：2024年12月首次实现商业化供货，成为首款在中、美、欧三大主流市场获批的国产单抗生物类似药。加拿大市场：2024年8月获批，商品名Adheroza，覆盖乳腺癌和胃癌治疗。欧盟市场：2020年7月获批，商品名Zercepac®，进入英国、德国、法国等核心市场。合作模式国际授权：与Intas（美国子公司Accord）、Abbott、Eurofarma等企业合作，覆盖生产、分销及终端销售。本地化生产：通过美国FDA、欧盟EMA及中国NMPA三地GMP认证，确保全球供应链稳定。关于国内上市产品出海主要地区分布：一带一路，中东欧成为主要地区，美国市场不再是唯一选择。出海生物药中，国内“过剩的”生物类似药物、PD1/PDL1成为出海主力；迈威生物出海数量居首位（3次交易）；市场开始扩大到一带一路地区。创新药、双抗/ADC/小核酸类新分子结构产品以美国市场为主；欢迎阅读盘点 2024国内企业license-out特点，MNC在关注什么？可以看一下出海产品和特点的总览

生物类似药引进/卖出临床1期抗体药物偶联物临床3期

100 项与迈威（上海）生物科技股份有限公司相关的药物交易

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100 项与迈威（上海）生物科技股份有限公司相关的转化医学

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