A Prospective, Controlled Phase II Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib Monotherapy as First - Line Treatment for Locally Advanced or Recurrent Metastatic Non - Squamous NSCLC With EGFR Mutations and High PD-L1 Expression.

A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.

开始日期2025-06-30

申办/合作机构

上海市胸科医院

[+1]

NCT07015749

/ Recruiting临床1期IIT

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Asthma - a Randomized, Double-Blind, Placebo-Controlled Study

This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 multiple doses in participants with asthma. The study plans to enroll participants with asthma on stable inhaled treatment, FeNO≥25ppb at screening and randomization, elevated peripheral blood eosinophils and Pre-BD FEV1 ≤ 80% of the prediction. The safety, tolerability, PK, immunogenicity and changes in PD and clinical characteristics of multiple doses of IBI3002 in asthma subjects will be evaluated.
The entire study includes the screening period (4 weeks before dosing), the treatment period (12 weeks), and the safety follow-up period (8 weeks).
The study plans to enroll 9 to 27 participants with asthma, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants will remain blind within the cohort.
Cohort 1: 150mg SC(IBI3002: placebo =2 :1); Cohort 2: 300mg SC(IBI3002: placebo =2 :1); Cohort 3: 600mg SC(IBI3002: placebo =2 :1);
The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.

开始日期2025-06-20

申办/合作机构

苏州大学附属第一医院

[+1]

NCT07015762

/ Not yet recruiting临床1期IIT

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis - a Randomized, Double-Blind, Placebo-Controlled Study

This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of IBI3002 in participants with moderate to severe atopic dermatitis (AD). The study plans to enroll patients with moderate to severe AD who have a poor response to topical treatment or who are not suitable for topical treatments. It aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, PD characteristics, and changes in clinical characteristics of these participants receiving multiple doses of IBI3002.
The entire study includes the screening period (4 weeks before dosing), the dosing period (12 weeks), and the safety follow-up period (8 weeks).
The study plans to enroll 9 to 27 participants with moderate to severe AD, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants remain blind within the same cohort.
Cohort 1: 150mg SC (IBI3002: placebo=2 :1); Cohort 2: 300mg SC (IBI3002: placebo=2 :1); Cohort 3: 600mg SC( IBI3002: placebo=2 :1);
The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.

开始日期2025-06-15

申办/合作机构

苏州大学附属第一医院

[+1]

100 项与信达生物制药相关的临床结果

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0 项与信达生物制药相关的专利（医药）

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项与信达生物制药相关的文献（医药）

2025-05-01·Med

IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial

Article

作者: Tang, Yaling ; Zhang, Guonan ; Huang, Yi ; Ma, Xinyan ; Li, Huayi ; Zhao, Weidong ; Qian, Jianhua ; Xu, Qin ; Zhang, Jieqing ; Zheng, Hong ; Wang, Danbo ; Gao, Qinglei ; Zhou, Hui ; Tang, Ying ; Peng, Zikun ; Qiu, Hui ; Ji, Jianghai ; Yin, Kang ; Liu, Jihong ; Cai, Chujun ; An, Ruifang ; Shen, Yiyang ; Wang, Li ; Zhang, Hongfei ; Wang, Shuyan ; Xie, Han ; Wang, Xia ; Li, Guiling ; Chang, Baoping ; Yuan, Jianlin ; Ma, Cailing ; Sun, Li ; He, Aiqin ; Jiao, Xiaofei ; Zhu, Lijing ; Xu, Yu ; Wang, Ya ; Zhu, Jianqing ; Lou, Ge ; Wang, Jing ; Xia, Bairong ; Ma, Ding ; Duan, Wei ; Lu, Liqin ; Wang, Ke ; Li, Li ; Zhu, Hong ; Cheng, Yan ; Yu, Guohua ; Huang, Jianli ; Huang, Bowen ; Chen, Youguo ; Zhang, Youzhong

BACKGROUND:

It remains unclear whether adding CTLA-4 blockade to PD-1/PD-L1 blockade improves clinical outcomes in cervical cancer (CC).

METHODS:

In this randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov: NCT04590599), patients with recurrent/metastatic CC (R/M CC) who experienced disease progression after or during platinum-based chemotherapy were enrolled from 37 centers across China and randomly assigned (1:1), stratified by PD-L1 expression and prior treatment lines, to receive either IBI310 plus sintilimab or placebo plus sintilimab intravenously every 3 weeks for 12 weeks, followed by sintilimab alone. The primary endpoint was the objective response rate (ORR). Pivotal secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

FINDINGS:

205 patients were randomized to receive IBI310-sintilimab (n = 103) or placebo-sintilimab (n = 102). The ORR difference between the IBI310-sintilimab arm (32.3%, 95% confidence interval [CI]: 23.3%-42.5%) and the placebo-sintilimab arm (23.5%, 95% CI: 15.5%-33.1%) was not significant (p = 0.17). IBI310-sintilimab and placebo-sintilimab exhibited median PFS values of 3.6 (95% CI: 2.7-6.3) and 4.2 months (95% CI: 2.8-6.2), respectively (hazard ratio [HR] = 0.91, 95% CI: 0.65-1.27; p = 0.58). The median OSs were 13.9 months (95% CI: 11.5-25.6) in the IBI310-sintilimab arm and 17.2 months (95% CI: 13.7-25.9) in the placebo-sintilimab arm (HR = 1.12, 95% CI: 0.79-1.58; p = 0.54). Adding IBI310 to sintilimab increased the incidence of grade ≥3 treatment-related adverse events (55% versus 19%).

CONCLUSIONS:

Compared to single-agent PD-1/PD-L1 blockade, dual blockade of CTLA-4 and PD-1/PD-L1 did not significantly improve clinical outcomes in R/M CC.

FUNDING:

This work was funded by Innovent Biologics (Suzhou).

2025-02-01·Ophthalmology Retina

Efficacy and Safety of Efdamrofusp Alfa versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration

Article

作者: Li, Jinying ; Wen, Ying ; Lu, Shujie ; Yu, Songping ; He, Tao ; Li, Haoyu ; Wang, Xian ; Xu, Yihua ; Wei, Wenbin ; Dai, Hong ; Tong, Jianping ; Zhang, Wenfang ; Jia, Huixun ; Wang, Wei ; Wu, Miaoqin ; Zhang, Jinglin ; Zheng, Qinxiang ; Pei, Cheng ; Li, Mingxin ; Liu, Qinghuai ; Deng, Junjie ; Mao, Junfeng ; Cui, Ling ; Ye, Jian ; Gong, Yuanyuan ; Hao, Jilong ; Guan, Huaijin ; Liu, Xiaoling ; Tao, Liming ; Yan, Ming ; Bi, Yanlong ; Qian, Lei ; Shu, Xiangwen ; Ding, Lin ; Sun, Xiaodong ; Peng, Hui ; Fan, Ke ; Li, Chaopeng ; Xu, Xiangzhong ; Song, Yanping ; Wu, Zhifeng ; Sun, Junran ; Zhao, MingWei ; Wang, Hong ; Zhu, Dan ; Liu, Wei ; Wang, Feng ; Lu, Peirong

PURPOSE:

To evaluate efficacy and safety of efdamrofusp alfa compared with aflibercept in neovascular age-related macular degeneration (nAMD).

DESIGN:

Randomized, double-masked, multicenter, active-controlled, noninferiority phase II study.

PARTICIPANTS:

A total of 231 treatment-naive and previously treated participants with active choroidal neovascularization secondary to nAMD were enrolled.

METHODS:

Eligible participants were randomized (1:1:1) to 2 mg efdamrofusp alfa, 4 mg efdamrofusp alfa, or 2 mg aflibercept groups. Participants in all groups received 3 initial monthly loading doses, followed by treatment every 8 weeks, with assessment every 4 weeks up to week 52.

MAIN OUTCOME MEASURES:

The primary end point was the mean best-corrected visual acuity (BCVA) change from baseline to week 36. The prespecified noninferiority margin was set as -5 letters (80% confidence interval [CI]).

RESULTS:

Each treatment group included 77 participants. The mean BCVA changes from baseline to week 36 for 2 mg efdamrofusp alfa, 4 mg efdamrofusp alfa and aflibercept groups were +10.6, +11.4, and +12.0 letters, respectively; least squares mean difference were -1.4 (80% CI: -3.5 to 0.7) between 2 mg efdamrofusp alfa and aflibercept, and -0.6 (80% CI: -2.7 to 1.6) between 4 mg efdamrofusp alfa and aflibercept. Mean central retinal thickness changes were consistent across groups. Adverse event rate was comparable among the groups.

CONCLUSIONS:

Efdamrofusp alfa demonstrated noninferiority to aflibercept in BCVA improvement, accompanied by a similar safety profile.

FINANCIAL DISCLOSURE(S):

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

2025-02-01·Med

A tumor cornification and immune-infiltration-based scheme for anti-PD-1 plus chemotherapy response in advanced squamous cell lung carcinoma

Article

作者: Sun, Jiya ; Wang, Lei ; Hu, Congli ; Wu, Fengying ; Cheng, Lei ; Li, Xuefei ; Wu, Lin ; Zhou, Caicun ; Jiang, Minlin ; Fan, Yun ; Gao, Guanghui ; Liu, Lianke ; Wu, Chunyan ; Zhou, Hui ; Li, Fei ; Peng, Bo ; Wang, Zhehai

BACKGROUND:

Anti-PD-1 immunotherapy plus chemotherapy (combo) exhibits significantly prolonged survival for squamous cell lung cancer (LUSC). An exploration of predictive biomarkers is still needed.

METHODS:

High-throughput RNA sequencing (RNA-seq) of 349 LUSC samples from the randomized, multi-center, phase 3 trial ORIENT-12 (ClinicalTrials.gov: NCT03629925) was conducted for biomarker discovery, followed by flow cytometry and multiplex immunohistochemistry (mIHC) in additional clinical cohorts, and in vitro experiments were performed for verification.

RESULTS:

A high abundance of activated CD8⁺ T and CD56^bright natural killer (NK) cells benefited patients' outcomes (progression-free survival [PFS]; overall survival [OS]) with combo treatment. Tumor cornification level remarkably affected the infiltration of the two crucial immune cells. Thus, a novel scheme of LUSC immune infiltration and cornification characterization-based classification (LICC) was established for combo efficacy prediction. Patients who received combo treatment achieved significant PFS improvements in LICC1 (hazard ratio [HR] = 0.43, 95% confidence interval [CI]: 0.25-0.75, p = 0.0029) and LICC2 (HR = 0.32, 95% CI: 0.17-0.58, p = 0.0002) subtypes but not in the LICC3 subtype (HR = 0.86, 95% CI: 0.60-1.23, p = 0.4053). Via single-cell RNA-seq analysis, the tumor cornification signal was mainly mapped to SPRR3⁺ tumor cells, whose relationships with activated CD8⁺ T or CD56^bright NK cells were verified using flow cytometry and mIHC. Our data suggest that SPRR3⁺ tumor cells might evade immune surveillance via the CD24-SIGLEC10 (M2 macrophage) axis to maintain a suppressive tumor microenvironment.

CONCLUSIONS:

Tumor cornification greatly impacts immune infiltration, and the LICC scheme may guide clinical medication of anti-PD-1+chemo treatment in patients with LUSC.

FUNDING:

The study was funded by the National Key R&D Program of China, the National Natural Science Foundation of China, Shanghia Multidisplinary Cooperation Building Project for Diagnosis and Treatment of Major Disease, and Innovent Biologics, Inc.

8,348

项与信达生物制药相关的新闻（医药）

2025-07-02

·药渡

禾元生物IPO过会！系科创板第五套标准重启后首家

7月1日，上交所官网显示，武汉禾元生物科技股份有限公司（简称“禾元生物”）科创板IPO成功通过上交所上市审核委员会审议。这也是重启科创板第五套上市标准后，首家按此标准成功过会的IPO企业。“稻米造血”6月18日，证监会宣布在科创板设置成长层，并重启未盈利企业适用科创板第五套标准上市。一周后，上交所即公告禾元生物于7月1日上会。回溯禾元生物科创板IPO整体历程，公司IPO于2022年12月29日获得受理；2023年1月19日，公司收到首轮问询函，2023年7月至2024年12月，禾元生物进行了两轮审核问询回复。禾元生物成立于2006年，是一家创新型生物医药企业。招股书显示，公司核心在研产品HY1001（重组人白蛋白注射液）是一款1类新药，主要用于补充或提高血液中的血清白蛋白水平，有望在临床上替代血浆来源的人血清白蛋白。据介绍，人血清白蛋白，作为人体血浆中含量最丰富的蛋白质，堪称人体内的“万能搬运工”，在烧伤、肝硬化、肾病等多种疾病的治疗中不可或缺。传统的人血清白蛋白主要从人类血浆中提取，国际上一直试图采用生物技术研发重组人白蛋白，但在表达量和纯度等关键技术指标上一直没有大的突破。禾元生物自主研发的水稻胚乳细胞生物反应器技术，提高了重组人白蛋白的表达量和纯度，降低了生产成本，提升了临床用药安全性。据公司介绍，历经近19年的研发，已实现每公斤水稻中的重组人白蛋白表达量从最初的2.75克提升到最高30克。2024年9月，HY1001的药品上市许可申请（NDA）获得受理，药品上市审评进展顺利，已完成了大部分的审评程序。公司预计HY1001将于近期获批上市并实现快速放量销售，获批适应症预计为“肝硬化低白蛋白血症”，预计为国内首个获批上市的重组人白蛋白药品。核心产品获批上市后，禾元生物收入预计将有较大提升，亏损也有望缩窄。从现场问询的问题来看，上交所上市委主要围绕禾元生物相关技术平台的先进性和数据可靠性、HY1001药品市场空间、公司预计2027年实现盈利是否审慎等方面的问题展开问询。根据上会结果，禾元生物无进一步需落实事项。业内人士表示，本次禾元生物成功过会，是落实证监会《关于在科创板设置科创成长层增强制度包容性适应性的意见》，重启未盈利企业适用科创板第五套标准上市，增强对优质科技型企业的制度包容性适应性又一典型案例，充分彰显了尊重科技创新规律，更好支持优质科技型企业发展的政策导向。科创板第五套标准已迎来20家上市公司据上证报记者梳理，目前，科创板第五套标准已上市的20家企业均为创新型生物医药企业。其中，19家为创新药研发企业，1家为高端医疗器械研发企业，有力地支持了中国生物医药行业的研发创新。初步统计，2018年至2025年第一季度，已上市科创板第五套标准企业向市场推出17款1类新药，合计约占同期国产创新药获批总数的12%。2024年，20家企业合计营业收入超过140亿元，较2023年增长超40%；有16家企业营收过1亿元，其中4家营收超10亿元。2025年第一季度，上述20家公司延续增长趋势，合计实现营业收入37.80亿元，同比增长29.27%。截至2025年6月，20家科创板第五套上市标准企业中，19家已实现核心产品上市，另1家已递交上市申请。研发突破方面，20家企业2024年平均研发投入5亿元，高于A股3.64亿元的平均水平。2024年，科创板第五套上市标准企业新增6款1类新药，6款产品的7项适应症被纳入突破性治疗品种。以迪哲医药为例，公司舒沃替尼是肺癌领域首个获中、美两国双突破性治疗认定的国产创新药。业内人士认为，《关于在科创板设置科创成长层增强制度包容性适应性的意见》推出了一揽子更具包容性、适应性的制度改革，在重启科创板第五套上市标准案例落地后，其他改革措施也有望逐步落地实施，将进一步发挥科创板“试验田”作用，更好促进科技创新和产业创新深度融合，更大力度支持高水平科技自立自强、发展新质生产力。作者：荆淮侨何昕怡来源：上海证券报*声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！全球首款！信达生物「玛仕度肽」获批上市9款重磅疗法上市！2025上半年获批肺癌新药全盘点恒瑞JAK1抑制剂「艾玛昔替尼」新适应症获批，剑指重度斑秃

IPO

2025-07-02

·E药经理人

再燃“DS时刻”！全球首个EGFR/HER3双抗ADC达主要终点，来自中国成都百利天恒！

7月3日，百利天恒发布公告，公司自主研发的全球首创(First-in-class)、新概念(New concept)且唯一进入III期临床阶段的 EGFRXHER3 双抗 ADC(iza-bren)在鼻咽癌的III期临床试验(研究方案编号:BL-BO1D1-303)中，期中分析达到主要终点。适应症为：既往经PD-1/PD-L1单抗治疗且经至少两线化疗(至少一线含铂)治疗失败的复发性或转移性鼻癌。据悉，iza-bren 正在中国和美国进行 40 余项针对多种肿瘤类型的临床试验。截至目前，iza-bren 已有5项适应症被国家药品监督管理局药品审评中心纳入突破性治疗品种名单。Iza-bren由EGFR×HER3双特异性抗体通过基于四肽的稳定可裂解连接子与新型拓扑异构酶I抑制剂有效载荷（Ed-04）偶联而成。其抗体部分具有双重靶向能力，能够同时识别并结合肿瘤细胞表面过表达的EGFR和HER3受体。2023年底，百利天恒与BMS达成合作，BMS 以84亿美元总交易金额引进百利天恒HER3/EGFR双抗ADC产品iza-bren（BL-B01D1），成为中国首个授权合作的双抗ADC，创造了当时国产ADC新药预付款新纪录，还刷新了全球ADC领域最大BD交易额。推荐阅读百利天恒朱义：“内生式”创新是成为跨国药企的前提一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐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

抗体药物偶联物引进/卖出细胞疗法免疫疗法临床3期

2025-07-02

·医药笔记

百利天恒：EGFR/HER3 ADC鼻咽癌三期临床成功

▎Armstrong2025年7月2日，百利天恒发布公告，EGFR/HER3 ADC新药iza-bren治疗晚期鼻咽癌的三期临床试验在期中分析达到主要终点，标志着全球首款双靶点ADC完成三期临床POC，即将申报上市。BL-B01D1已经拿下5项突破性治疗药物认证，覆盖鼻咽癌、EGFR突变NSCLC、EGFR野生型NSCLC、食管癌、小细胞肺癌。总结BL-B01D1为全球首款EGFR/HER3 ADC，也是百利天恒的核心管线。今年4月百时美施贵宝已经在美国启动三阴乳腺癌的2/3期临床，标在海外也推进到关键注册临床阶段。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。

临床3期抗体药物偶联物申请上市引进/卖出基因疗法

100 项与信达生物制药相关的药物交易

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100 项与信达生物制药相关的转化医学

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2025年07月04日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

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