Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient/Microsatellite Instability-High (dMMR/MSI-H) Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study

This is a randomized, non-comparative, open-label, two-arm phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab plus induction chemotherapy versus adebrelimab plus SHR-8086 in patients with dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.

开始日期2026-01-30

申办/合作机构-

NCT07229625

/ Recruiting临床3期

A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)

This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.

开始日期2026-01-21

申办/合作机构

苏州盛迪亚生物医药有限公司

ChiCTR2600117863

/ Not yet recruiting临床2期IIT

Multicenter, open-access Phase II clinical study of SHR-4849 injection combined with other anti-tumor drugs in patients with malignant solid tumors

开始日期2026-01-20

申办/合作机构

山东省肿瘤医院

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100 项与伊匹木单抗生物类似药(基石药业) 相关的临床结果

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100 项与伊匹木单抗生物类似药(基石药业) 相关的转化医学

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100 项与伊匹木单抗生物类似药(基石药业) 相关的专利（医药）

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项与伊匹木单抗生物类似药(基石药业) 相关的文献（医药）

2024-06-01·Cancer

Dual CTLA‐4 and PD‐1 checkpoint blockade using CS1002 and CS1003 (nofazinlimab) in patients with advanced solid tumors: A first‐in‐human, dose‐escalation, and dose‐expansion study

Article

作者: Kotasek, Dusan ; Ma, Yiding ; Aghmesheh, Morteza ; Chan, Stephen L. ; Cosman, Rasha ; Zielinski, Robert ; Mant, Andrew ; Moore, Maggie ; Bishnoi, Sarwan ; Li, Peiqi ; Tse, Archie N. ; Pan, Zhaoxuan ; Prawira, Amy ; Yau, Thomas ; Su, Rila ; Li, Fei ; Eek, Richard

Abstract:

Background:

This study investigated the safety and efficacy of an anti–CTLA‐4 monoclonal antibody (CS1002) as monotherapy and in combination with an anti–PD‐1 monoclonal antibody (CS1003) in patients with advanced/metastatic solid tumors.

Methods:

The phase 1 study involved phase 1a monotherapy dose‐escalation (part 1) and phase 1b combination therapy dose escalation (part 2) and expansion (part 3). Various dosing schedules of CS1002 (0.3, 1, or 3 mg/kg every 3 weeks, or 3 mg/kg every 9 weeks) were evaluated with 200 mg CS1003 every 3 weeks in part 3.

Results:

Parts 1, 2, and 3 included a total of 13, 18, and 61 patients, respectively. No dose‐limiting toxicities or maximum tolerated doses were observed. Treatment‐related adverse events (TRAEs) were reported in 30.8%, 83.3%, and 75.0% of patients in parts 1, 2, and 3, respectively. Grade ≥3 TRAEs were experienced by 15.4%, 50.0%, and 18.3% of patients in each part. Of 61 patients evaluable for efficacy, 23 (37.7%) achieved objective responses in multiple tumor types. Higher objective response rates were observed with conventional and high‐dose CS1002 regimens (1 mg/kg every 3 weeks or 3 mg/kg every 9 weeks) compared to low‐dose CS1002 (0.3 mg/kg every 3 weeks) in microsatellite instability‐high/mismatch repair‐deficient tumors, melanoma, and hepatocellular carcinoma (50.0% vs. 58.8%, 14.3% vs. 42.9%, and 0% vs. 16.7%).

Conclusion:

CS1002, as monotherapy, and in combination with CS1003, had a manageable safety profile across a broad dosing range. Promising antitumor activities were observed in patients with immune oncology (IO)‐naive and IO‐refractory tumors across CS1002 dose levels when combined with CS1003, supporting further evaluation of this treatment combination for solid tumors.

Plain Language Summary:

CS1002 is a human immunoglobulin (Ig) G1 monoclonal antibody that blocks the interaction of CTLA‐4 with its ligands and increases T‐cell activation/proliferation. CS1003, now named nofazinlimab, is a humanized, recombinant IgG4 monoclonal antibody that blocks the interaction between human PD‐1 and its ligands.In this original article, we determined the safety profile of CS1002 as monotherapy and in combination with CS1003. Furthermore, we explored the antitumor activity of the combination in anti–programmed cell death protein (ligand)‐1 (PD‐[L]1)‐naive microsatellite instability‐high/mismatch repair‐deficient (MSI‐H/dMMR) pan tumors, and anti–PD‐(L)1‐refractory melanoma and hepatocellular carcinoma (HCC).CS1002 in combination with CS1003 had manageable safety profile across a broad dosing range and showed promising antitumor activities across CS1002 dose levels when combined with CS1003. This supports further assessment of CS1002 in combination with CS1003 for the treatment of solid tumors.

2017-01-01·BMJ open4区 · 医学

Rococo study: a real-world evaluation of an over-the-counter medicine in acute cough (a multicentre, randomised, controlled study)

4区 · 医学

ArticleOA

作者: Edwards, V ; Wilson, R ; Brew, J ; Kilbourn, A ; Morice, A H ; Birring, S S

Objectives:

To investigate the efficacy and safety of CS1002, an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based demulcent.

Design:

A multicentre, randomised, parallel group, controlled, single-blinded study in participants with acute upper respiratory tract infection-associated cough.

Setting:

4 general practitioner (GP) surgeries and 14 pharmacies in the UK.

Participants:

Participants aged ≥18 years who self-referred to a GP or pharmacist with acute cough of <7 days' duration. Participant inclusion criterion was cough severity ≥60 mm on a 0–100 mm visual analogue scale (VAS). Exclusion criteria included current smokers or history of smoking within the past 12 months (including e-cigarettes). 163 participants were randomised to the study (mean participant age 38 years, 57% females).

Interventions:

Participants were randomised to CS1002 (Unicough) or simple linctus (SL), a widely used cough treatment, and treatment duration was 7 days or until resolution of cough.

Main outcome measures:

The primary analysis was intention-to-treat (157 participants) and comprised cough severity assessed using a VAS after 3 days' treatment (prespecified primary end point at day 4). Cough frequency, sleep disruption, health status (Leicester Cough Questionnaire (LCQ-acute)) and cough resolution were also assessed.

Results:

At day 4 (primary end point), the adjusted mean difference (95% CI) in cough severity VAS between CS1002 and SL was −5.9 mm (−14.4 to 2.7), p=0.18. At the end of the study (day 7) the mean difference in cough severity VAS was −4.2 mm (−12.2 to 3.9), p=0.31. CS1002 was associated with a greater reduction in cough sleep disruption (mean difference −11.6 mm (−20.6 to 2.7), p=0.01) and cough frequency (mean difference −8.1 mm (−16.2 to 0.1), p=0.05) compared with SL. There was greater improvement in LCQ-acute quality of life scores with CS1002 compared with SL: mean difference (95% CI) 1.2 (0.05 to 2.36), p=0.04 after 5 days' treatment. More participants prematurely stopped treatment due to cough improvement in the CS1002 group (24.4%) compared with SL (10.7%; p=0.02). Adverse events (AEs) were comparable between CS1002 (20.5%) and SL (27.6%) and largely related to the study indication. 6 participants (7%) in the CS1002 group reduced the dose of medication due to drowsiness/tiredness, which subsequently resolved. These events were not reported by participants as AEs.

Conclusions:

Although the primary end point was not achieved, CS1002 was associated with greater reductions in cough frequency, sleep disruption and improved health status compared with SL.

Trial registration number:

EudraCT number 2014-004255-31 .

Frontiers in Immunology

SHR-8068 combined with adebrelimab and bevacizumab in the treatment of refractory advanced colorectal cancer: study protocol for a single-arm, phase Ib/II study

Article

作者: Zhang, Pei ; Wang, Xin ; Wang, Jianfei ; Yang, Yu ; Li, Xiaofen ; Cao, Dan

Background:

The third-line treatment for refractory colorectal cancer (CRC) has limited efficacy. This study aimed to evaluate the safety and efficacy of SHR-8068 (an anti-CTLA-4 antibody), combined with adebrelimab (an anti-PD-L1 antibody), and bevacizumab in refractory non-microsatellite instability-high (MSI-H) or proficient mismatch repair (pMMR) CRC.

Method:

This study is a prospective, open-label, single-center phase Ib/II clinical trial. Patients with pathologically confirmed pMMR/non-MSI-H metastatic colorectal adenocarcinoma who have failed ≥2 lines prior standard systemic treatments will be enrolled (n=36). The Ib phase will evaluate two dosing regimens of SHR-8068 in combination therapy (n=9 each dosage): SHR-8068 (1 mg per kilogram, every six weeks, intravenously) or SHR-8068 (4 mg per kilogram, every twelve weeks, intravenously) combined with adebrelimab (1200 mg, every three weeks, intravenously) and bevacizumab (7.5 mg per kilogram, every three weeks, intravenously). The efficacy and adverse events (AEs) of these regimens will be assessed to determine the recommended phase II dose (RP2D) of SHR-8068. Those of RP2D group from the phase Ib will be included in the phase II. The study will go to include 18 additional patients according to the one-sample log-rank test design in the phase II. The primary endpoint of the Ib phase is safety, with secondary endpoints including the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and quality of life (QOL). The primary endpoint for phase II was PFS, with secondary endpoints including ORR, OS, DCR, safety, and QOL. Identifying biomarkers to predict the efficacy of this regimen is the exploratory study endpoint.

Discussion:

This proof-of-concept study would provide safety and efficacy signals of this novel combination treatment for the MSS CRCs in the late-line setting. And it may offer new insights on the clinical application of dual immunotherapy combined with anti-angiogenic therapy in the MSS CRC.

185

项与伊匹木单抗生物类似药(基石药业) 相关的新闻（医药）

2026-03-06

·新浪看点

港股公告精选｜徽商银行2025年净赚超169亿元威胜控股年度盈利同比增超4成

财联社3月6日讯（编辑冯轶）财联社为您带来今日港股重要公告1）业绩速递徽商银行(03698.HK)：2025年营收376.7亿元，同比增长约1.2%；净利润约人民币169.3亿元，同比增长约6.3%。威胜控股(03393.HK)：预计于2025年取得综合净利润约10亿-10.6亿元，同比增长约42%至50%。主要归功于销售收入增加以及推行有效的成本控制措施。奥克斯电气(02580.HK)：预计2025年收入约人民币300亿元，净利润22亿元，上一年同期为29.10亿元。主要由于原材料价格持续上升，渠道库存水平较高以及终端消费需求疲软。原生态牧业(01431.HK)：预计2025年净利润5.2亿元至人民币5.7亿元。主要受益于销量增加及奶牛饲料成本下降。多想云(06696.HK)：预计2025财年亏损金额约不少于2.7亿元人民币，上一年同期亏损1.86亿元。主要由于销售成本增加及管理费用增加。力鸿检验(01586.HK)：发盈警，预期年度股东应占利润将取得减幅约为45%至55%。大禹金融(01073.HK)：预计2025年税后净利润约3700万港元。青建国际(01240.HK)：预计2025年净利润不低于6000万港元。知行科技(01274.HK)：预计2025财年取得除税前亏损约4.15亿元人民币，同比增幅约为44%。主要由于定价策略和产品结构调整，SupervisionTM销售收入下降。摩比发展(00947.HK)：发盈警，预期年度综合亏损净额约9000万元至1亿元，同比减少。上美股份(02145.HK)：发盈喜，预期2025年度利润约11.4亿元至11.6亿元，同比增加约41.9%至44.4%。晶门半导体(02878.HK)：发盈警，预期2025年度股东应占综合溢利约350万美元至400万美元，同比减少约60%至65%。2）公司要闻越秀地产(00123.HK)：前2月累计合同销售71.06亿元，同比下降約44.6%。保利置业集团(00119.HK)：前2月累计合同销售60亿元，同比减少28.57%。中梁控股(02772.HK)：前2个月累计合约销售金额约为15亿元，同比下降35.06%。宝龙地产(01238.HK)：前2月累计合同销售9.01亿元，同比减少30.69%。龙源电力(00916.HK)：前2月累计完成发电量1353.57万兆瓦时，同比增长6.42%。其中风电同比增长3.04%，太阳能发电同比增长31.06%。江山控股(00295.HK)：前2月总发电量约为34820兆瓦时，同比减少27.69%。恒瑞医药(01276.HK)：阿得贝利单抗注射液、SHR-8068注射液获得药物临床试验批准通知书。2024年同类产品组合全球销售额合计约为32.71亿美元。石药集团(01093.HK)：高选择性PDE4B抑制剂(SYH2059吸入粉雾剂)在美国获临床试验批准。维立志博-B(09887.HK)：评价维利信™(PD-L1/4-1BB双特异性抗体奥帕替苏米单抗，LBL-024)用于治疗一线食管鳞状细胞癌的II期临床研究首例患者已成功入组。知行集团控股(01539.HK)：就于印尼提供高效能运算或人工智能图形处理单元服务与Multipolar订立谅解备忘录。致浩达控股(01707)：针对附属公司的清盘呈请聆讯押后至4月13日。派格生物医药-B(02565.HK)：派格生物新一代GLP-1(CR059)首次人体试验取得一个月临床观察结果。澜起科技(06809.HK)：稳定价格行动及稳定价格期结束。金辉集团(00137.HK)：附属拟2345.5万美元出售一艘船舶。3）回购动态顺丰控股(06936.HK)：斥资人民币742.44万元回购20.32万股A股，回购价36.48-36.62元。渣打集团(02888.HK)：斥资1506.54万英镑回购87.24万股股份，回购价16.895-17.585英镑。心动公司(02400.HK)：斥资778.27万港元回购11万股，回购价69.1港元至72.15港元。（财联社冯轶）发布于：上海

2026-03-06

·快资讯

恒瑞医药(01276)：阿得贝利单抗注射液、SHR-8068注射液获得药物临床试验批准通知书

智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称“公司”)子公司苏州盛迪亚生物医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局(以下简称“国家药监局”)核准签发关于阿得贝利单抗注射液、SHR-8068注射液的《药物临床试验批准通知书》，将于近期开展临床试验。阿得贝利单抗注射液是公司自主研发的人源化抗PD-L1单克隆抗体，能通过特异性结合PD-L1分子从而阻断导致肿瘤免疫耐受的PD-1/PD-L1通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。公司阿得贝利单抗注射液已于2023年获批上市，获批的适应症为与卡铂和依托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。国外有同类产品Atezolizumab(商品名：Tecentriq)、Avelumab(商品名：Bavencio)和Durvalumab(商品名：Imfinzi)于美国获批上市销售，其中Atezolizumab和Durvalumab已在中国获批上市。国内有多款同类产品获批上市。经查询，2024年Atezolizumab、Avelumab和Durvalumab全球销售额合计约为96.48亿美元。截至目前，阿得贝利单抗注射液相关项目累计研发投入约11.51亿元(未经审计)。SHR-8068注射液是公司引进的一款全人源抗CTLA-4单克隆抗体，可增强抗肿瘤免疫效应。目前全球共有两款同类产品获批上市，分别是伊匹木单抗和替西木单抗。经查询，2024年伊匹木单抗和替西木单抗全球销售额合计约为32.71亿美元。截至目前，SHR-8068注射液相关项目累计研发投入约3.17亿元(未经审计)。

上市批准

2026-03-06

·腾讯网

恒瑞医药子公司获得药物临床试验批准通知书

智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司子公司苏州盛迪亚生物医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局核准签发关于阿得贝利单抗注射液、SHR-8068注射液的《药物临床试验批准通知书》，将于近期开展临床试验。根据《中华人民共和国药品管理法》及有关规定，经审查，2025年12月11日受理的阿得贝利单抗注射液、SHR-8068注射液符合药品注册的有关要求，同意开展临床试验。具体为：阿得贝利单抗联合SHR-8068和放化疗作为局部进展期可切除直肠癌围术期治疗的随机、双盲、安慰剂对照、多中心II/III期临床研究。

临床2期申请上市

100 项与伊匹木单抗生物类似药(基石药业) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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
直肠腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-03-02
直肠癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-03-02
局部晚期直肠癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-03-01
晚期胆道癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-01-08
局部晚期非小细胞肺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-10-22
转移性非小细胞肺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-10-22
晚期肝细胞癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2024-10-28
转移性非鳞状非小细胞肺癌	临床3期	中国	上海盛迪医药有限公司	2024-03-01
晚期肾细胞癌	临床2期	中国	苏州盛迪亚生物医药有限公司	2026-01-06
肾细胞癌	临床2期	中国	苏州盛迪亚生物医药有限公司	2025-12-18

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临床结果

适应症

分期

评价

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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


NCT05444088 (ASCO2025) 人工标引	临床1/2期	晚期肝细胞癌二线 \| 一线 \| 三线	101	SHR-8068 (1 mg/kg Q6W)SHR-8068 (1 mg/kg Q6W) + Adebrelimab + Bevacizumab (Combo 1)	壓築艱觸壓顧醖製遞獵(壓窪網衊壓築繭膚鏇衊) = 齋衊鹹鏇繭憲選願餘鬱膚蓋網窪網簾廠鏇鹽襯 (襯艱艱齋顧顧鏇壓餘製, 13.8 ~ 50.2) 更多	积极	2025-05-30
				SHR-8068 (4 mg/kg priming)SHR-8068 (4 mg/kg priming) + Adebrelimab + Bevacizumab (Combo 2)	壓築艱觸壓顧醖製遞獵(壓窪網衊壓築繭膚鏇衊) = 範鬱廠餘鑰鬱製簾顧鑰膚蓋網窪網簾廠鏇鹽襯 (襯艱艱齋顧顧鏇壓餘製, 33.3 ~ 61.4) 更多
NCT03523819 (ESMO_IO 12021 \| ESMO_IO 22021) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	36	CS1002+CS1003 (MSI-H/dMMR tumors or MEL + arm A)	鏇鹹範積遞糧積襯鹹獵(夢範艱鬱鹽構鑰顧觸壓) = 5 (9.3%) pts had AEs leading to discontinuation of CS1002 and CS1003. 餘遞夢鏇鹽窪衊壓鑰窪 (醖鹽鹹廠壓窪鏇襯構構 ) 更多	积极	2021-12-09
				CS1002+CS1003 (MSI-H/dMMR tumors or MEL + arm B)
NCT03523819 (ESMO 12021 \| ESMO 22021) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	33	CS1003 200 mg+CS1002 0.3 mg/kg	鑰簾製鑰鑰鹽鏇築鏇醖(窪顧鏇鬱齋衊鏇繭獵遞) = Two (6.1%) pts experienced AEs leading to discontinuation of CS1002 and CS1003. 鏇顧鏇鬱壓範築夢鹽艱 (糧鏇繭製憲構願鬱壓繭 )	积极	2021-09-16
				CS1003 200 mg+CS1002 1 mg/kg