舒格利单抗(Sugemalimab) - 药物靶点：PDL1_在研适应症：转移性非小细胞肺癌，胃食管交界处腺癌，胃癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Cejemly、Recombinant human anti-PDL1 monoclonal antibody(CStone Pharmaceuticals Co. Ltd.)、重组抗PD-L1全人单克隆抗体(CStone Pharmaceuticals Co. Ltd.)

+ [11]

靶点

PDL1

作用方式

抑制剂

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)

治疗领域

肿瘤免疫系统疾病消化系统疾病+ [3]

在研适应症

转移性非小细胞肺癌胃食管交界处腺癌胃癌+ [16]

非在研适应症

腺癌霍奇金淋巴瘤局部晚期食管鳞状细胞癌+ [5]

原研机构

基石药业（苏州）有限公司

在研机构

基石药业SFL Pharmaceuticals Deutschland GmbH

辉瑞投资有限公司

+ [2]

非在研机构

EQRx International, Inc.药明生物技术有限公司

权益机构

Stein Holding Group

Istituto Gentili Srl

拜耳医药保健有限公司

+ [7]

最高研发阶段批准上市

首次获批日期

中国 (2021-12-20),

转移性非鳞状非小细胞肺癌非鳞状非小细胞肺癌鳞状非小细胞肺癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、孤儿药 (美国)、突破性疗法 (中国)、附条件批准 (中国)、创新许可和获取途径 (英国)、特殊审批 (中国)、优先审评 (中国)

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结构/序列

Sequence Code 616714836H

来源: *****

Sequence Code 616714851L

来源: *****

关联

22

项与舒格利单抗相关的临床试验

NCT05700448

/ Not yet recruiting临床3期

A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

开始日期2025-12-01

申办/合作机构

基石药业

NCT06987734

/ Recruiting临床2期IIT

Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients

This is a single arm, open-label exploratory study conducted in resectable stage II-IIIA NSCLC without EGFR/ALK mutations, aiming to investigate feasibility, safety and efficacy of Sugemalimab in perioperative contexts. Twenty-five resectable stage II-IIIA patients are planned to be enrolled. The proportion of patients with squamous cell carcinoma will not less than 40%.
Combined neoadjuvant chemotherapy and immunotherapy with fixed dose of Sugemalimab 1200 mg IV Q3W + Platinum-based chemo in resectable stage II-IIIA NSCLC adult patients followed by surgery. After completion of neoadjuvant therapy (3-4 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression in neoadjuvant therapy. Pathological response is planned to assessed after surgery. Following surgery, the patients with complete resection will receive an additional 1 year of Sugemalimab q3w. Treatment will commence as soon as clinically feasible post-surgery.
Informed consent will be obtained prior to tissue collection and genome sequencing for each participant. Primary tumour tissue will be obtained at diagnosis by biopsy such as percutaneous lung puncture biopsy, bronchoscopic biopsy or endobronchial ultrasound (EBUS) (based on clinical practice). Fresh tumour tissue was collected after surgical resection. Tissues collected were subjected to medically necessary pathology for diagnosis. Specimens were processed for multiplex immunofluorescence, single-cell sequencing and spatial transcriptomics, bulk RNAseq and WES to explore the changes in the immune microenvironment before and after suglizumab administration.

开始日期2025-06-19

申办/合作机构

上海市肺科医院

[+1]

CTR20233170

/ Recruiting临床1期

活菌MNC-168肠溶胶囊分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的安全性、耐受性、药代动力学特征及初步有效性的I期临床研究

主要目的：评价MNC-168分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的安全性和耐受性，确定其最大耐受剂量（MTD）和/或推荐的II期剂量(RP2D)。次要目的： 1) 评价MNC-168分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的药代动力学特征； 2) 评估MNC-168分别联用帕博利珠单抗、舒格利单抗的初步抗肿瘤疗效，为后续临床研究推荐合适的用药剂量。

开始日期2024-09-24

申办/合作机构

慕恩（广州）生物科技有限公司

100 项与舒格利单抗相关的临床结果

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100 项与舒格利单抗相关的转化医学

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100 项与舒格利单抗相关的专利（医药）

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44

项与舒格利单抗相关的文献（医药）

2025-07-01·LANCET ONCOLOGY

Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): 4-year outcomes from a double-blind, randomised, phase 3 trial

Article

作者: Dai, Hangjun ; Chen, Xueqin ; Li, Xingya ; Sun, Si ; Ma, Zhiyong ; Zhang, Xiaochun ; Cui, Jiuwei ; Wang, Ziping ; Yang, Jason ; Zhang, Yiping ; Ma, Rui ; Shu, Yongqian ; Zhao, Hui ; Wang, Bo ; Li, Lin ; Sun, Meili ; Shen, Hong ; Liu, Yunpeng ; Liang, Li ; Hu, Chunhong ; Yu, Yan ; Zhou, Caicun ; Wang, Mengzhao ; Zhuang, Wu ; Lu, You ; Zhou, Jianying ; Sun, Ping ; Chen, Jianhua ; Cao, Lejie ; Shi, Qingmei ; Liu, Jiwei ; Li, Jingzhang ; Li, Man ; Wang, Changli ; Wang, Qiang ; Yao, Wenxiu ; Wang, Jingru ; Yang, Hui ; Gu, Kangsheng ; Liu, Chunling ; Wu, Rong

BACKGROUND:

GEMSTONE-302 was a phase 3 trial in patients with treatment-naive metastatic squamous or non-squamous non-small-cell lung cancer (NSCLC), showed significant improvement in progression-free survival and overall survival with sugemalimab, a PD-L1 inhibitor, plus chemotherapy versus placebo plus chemotherapy. We report the 4-year outcomes from this study.

METHODS:

This randomised, double-blind, phase 3 trial was conducted across 35 hospitals and academic research centres in China. Eligible patients were aged 18-75 years; had treatment-naive, histologically or cytologically confirmed stage IV NSCLC, irrespective of PD-L1 expression levels; and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomised (2:1) by investigators using an interactive web response or voice response system via permuted blocks (block sizes of three or six, randomised within each stratum). Patients received histology-specific platinum-based chemotherapy combined with either sugemalimab (1200 mg; sugemalimab group) or placebo (placebo group) for up to four cycles, followed by for up to 35 cycles of maintenance therapy with sugemalimab alone for patients with squamous NSCLC and sugemalimab plus pemetrexed for patients with non-squamous NSCLC in the sugemalimab group, or placebo for patients with squamous NSCLC and placebo plus pemetrexed for patients with non-squamous NSCLC in the placebo group, administered intravenously. Treatment beyond 35 cycles was permitted at the investigator's discretion. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Here, we report post-hoc 4-year efficacy and safety outcomes from GEMSTONE-302. This study is registered with ClinicalTrials.gov (NCT03789604) and concluded on May 15, 2023, with all patients discontinued.

FINDINGS:

Between December 13, 2018, and May 15, 2020, 846 patients were assessed for eligibility. 479 patients were randomly assigned into the sugemalimab group (n=320) and placebo group (n=159). 254 (79%) patients were men and 66 (21%) were women in the sugemalimab group and 129 (81%) were men and 30 (19%) were women in the placebo group. All patients were Asian. As of the data cutoff on May 15, 2023, median follow-up durations were 43·5 months (IQR 41·2-46·9) in the sugemalimab group and 43·0 months (40·7-44·8) in the placebo group; median treatment durations were 7·2 months (4·2-18·8) with sugemalimab and 4·6 months (2·8-6·9) with placebo. Median progression-free survival was 9·0 months (95% CI 7·4-10·9) in the sugemalimab group versus 4·9 months (4·8-5·2) in the placebo group (hazard ratio [HR] 0·49 [95% CI 0·39-0·60]). Median overall survival was 25·2 months (20·1-30·2) in the sugemalimab group versus 16·9 months (12·8-20·7) in the placebo group (HR 0·68 [0·54-0·85]). The 4-year overall survival rates were 32·1% (95% CI 26·7-37·6) in the sugemalimab group versus 17·3% (11·1-24·7) in the placebo group. The most common grade 3-4 treatment related adverse events were decreased neutrophil count (105 [33%] with sugemalimab vs 52 [33%] with placebo), decreased white blood cell count (48 [15%] vs 27 [17%]), anaemia (44 [14%] vs 18 [11%]), and decreased platelet count (35 [11%] vs 15 [9%]). Treatment-related serious adverse events occurred in 82 (26%) patients with sugemalimab and 31 (20%) with placebo. No additional treatment-related deaths occurred since the previous overall survival interim analysis. No new safety signals were identified.

INTERPRETATION:

Sugemalimab with chemotherapy showed a superior long-term overall survival benefit compared with placebo with chemotherapy, as a first-line treatment for patients with NSCLC with no known sensitising EGFR, ALK, ROS1, or RET genomic alterations. These results underscore the efficacy of sugemalimab plus platinum-based chemotherapy as a standard first-line treatment option for both squamous and non-squamous metastatic NSCLC while maintaining a manageable safety profile.

FUNDING:

CStone Pharmaceuticals.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

2025-04-15·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer

Article

作者: Shi, Qingmei ; Shen, Zhenwei ; Liang, Xinjun ; Liao, Wangjun ; Pan, Hongming ; Zhang, Tao ; Sun, Meili ; Shen, Lin ; Gao, Yanrong ; Hou, Anji ; Li, Qi ; Deng, Yanhong ; Zhao, Yunbo ; Xiao, Li ; Wang, Jufeng ; Wang, Qi ; Chen, Yanhua ; Wan, Yiye ; Xie, Zhong ; Liu, Yunpeng ; Luo, Zhanxiong ; Zhang, Li ; Xie, Yanru ; Wang, Gang ; Zhu, Dan ; Yang, Xinhui ; Lu, Chuangxin ; Yang, Jason ; Hu, Changlu ; Lin, Xiaoyan ; Lin, Yan ; Sun, Yinping ; Luo, Jie ; Ji, Yanxia ; Yan, Dong ; Wang, Junye ; Wang, Zishu ; Mou, Yiping ; Li, Hongxia ; Yao, Sheng ; Zhang, Xiaotian ; Zhang, Yanqiao ; Fan, Qingxia ; Zhang, Ruixing ; Shi, Yongquan ; Sun, Sanyuan ; Xiong, Jianping ; Li, Jiayi ; Shu, Yongqian ; Fu, Ting ; Chen, Ping ; Yao, Juntao

Importance:

Gastric cancer, including gastroesophageal junction cancer, is one of the most commonly diagnosed cancers worldwide, with high mortality. Sugemalimab is a fully human anti–programmed death-ligand 1 (PD-L1) antibody. The combination of sugemalimab and chemotherapy showed promising antitumor activity and safety in a phase 1b study among patients with treatment-naive, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. This combination was further evaluated in the GEMSTONE-303 phase 3 trial.

Objective:

To evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 combined positive score (CPS) of 5 or greater.

Design, Setting, and Participants:

GEMSTONE 303 is a phase 3, randomized, double-blind, placebo-controlled study conducted at 54 sites in China that enrolled patients from April 9, 2019, through December 29, 2021, with follow-up to July 9, 2023. A total of 479 eligible patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS of 5 or greater who did not receive any prior systemic therapy were randomized.

Intervention:

Patients received sugemalimab (1200 mg intravenously) (n = 241) or placebo (n = 238) every 3 weeks for up to 24 months, plus CAPOX every 3 weeks for up to 6 cycles.

Main outcomes and Measures:

Primary outcomes were overall survival and investigator-assessed progression-free survival.

Results:

Baseline characteristics were well balanced between the 2 groups. Most patients were male (71.4% in sugemalimab group, 74.8% in placebo group). Median follow-up was 25.1 months in the sugemalimab group and 26.3 months in the placebo group. The sugemalimab group demonstrated significant improvements in overall survival (median, 15.6 months [95% CI, 13.3-17.8] vs 12.6 months [95% CI, 10.6-14.1]; hazard ratio, 0.75 [95% CI, 0.61-0.92]; P = .006) and progression-free survival (median, 7.6 months [95% CI, 6.4-7.9] vs 6.1 months [95% CI, 5.1-6.4]; hazard ratio, 0.66 [95% CI, 0.54-0.81]; P &lt; .001). Grade 3 or higher treatment-related adverse events occurred in 53.9% of patients in the sugemalimab group and 50.6% in the placebo group.

Conclusions and Relevance:

Sugemalimab plus chemotherapy significantly prolonged overall survival and progression-free survival with a manageable safety profile in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03802591

2025-03-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Comprehensive population pharmacokinetic modelling of sugemalimab, an anti‐programmed death‐ligand 1 (PD‐L1) human monoclonal antibody, in patients with solid tumours or lymphomas across multiple Phase I–III studies

Article

作者: Xu, Fengyan ; Wang, Kun ; Tse, Archie N. ; Sheng, Yucheng ; Pan, Chaohsuan

Aims:

The aim of this study was to develop a population pharmacokinetics model for sugemalimab, a monoclonal antibody that targets programmed death‐ligand 1 (PD‐L1), using data from Phase I–III trials and to assess clinical factors affecting sugemalimab exposure.

Methods:

A nonlinear mixed‐effect modelling approach was employed to analyse pooled data from nine studies involving 1628 subjects to characterize the PopPK of sugemalimab. This investigation examined the influence of various covariates on sugemalimab pharmacokinetics (PK), encompassing demographics, baseline hepatic and renal function‐related covariates, and others (including anti‐drug antibody [ADA], combination treatment, Eastern Cooperative Oncology Group [ECOG] performance score, tumour burden and tumour type). Estimation accuracy and predictive ability of the final model were evaluated using various methods. The influence of covariates on sugemalimab exposure was assessed by simulation from the final model.

Results:

A two‐compartment model with first‐order elimination and time‐varying clearance effectively described the PK of sugemalimab. Covariate analyses revealed significant relationships between sugemalimab clearance and body weight, albumin, gender, ADA, tumour burden and tumour type. The statistically significant covariates on central volume were body weight, albumin, gender and tumour type. No significant relationships were found in the final model for age, race, alanine aminotransferase, aspartate aminotransferase, creatinine, total bilirubin, alkaline phosphatase, combination treatment, creatinine clearance, ECOG, renal function or hepatic function. All significant covariates demonstrated less than a 20% effect on sugemalimab exposure.

Conclusions:

The PopPK model adequately described the pharmacokinetic profile of sugemalimab with no clinically meaningful impact observed on its exposure across all covariates. Dose adjustment does not appear to be necessary.

523

项与舒格利单抗相关的新闻（医药）

2025-07-08

·医药投资部落

销售分成50%！又一款国产创新药达成BD交易

2025年7月8日，港股上市的创新药企业基石药业对外宣布，与一家专注肿瘤领域、并在欧洲市场深耕百年的生物医药公司Istituto Gentili（“Gentili”）公司，就基石药业的舒格利单抗在西欧和英国的商业化，达成独家战略合作。根据双方的协议，基石药业将有望获得最高1.925亿美元总额的付款，包括首付款、注册与销售里程碑付款。尤为值得一提的是，基石药业将获得舒格利单抗在协定区域近50%的淨销售额，作为营业收入。在近年来的国产创新药对外BD交易中，基石药业的这笔首付款并不突出，但是高达50%的销售收入分成，是这笔交易的一个亮点。舒格利单抗(Sugemalimab)，是由基石药业研发的全人源抗 PD-L1单克隆抗体。作为一种全人源全长抗PD-L1单克隆抗体，舒格利单抗是一种最接近人体的天然G型免疫球蛋白4（IgG4）单抗药物，因此在患者体内产生免疫原性及相关毒性的风险更低，这使得舒格利单抗与同类药物相比体现出潜在的独特优势。2024年7月26日，欧盟委员会（EC）批准舒格利单抗（商品名：Cejemly®）联合含铂化疗用于无EGFR敏感突变, 或无ALK, ROS1, RET基因组肿瘤变异的转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。至此，舒格利单抗成为全球首个在欧洲上市的、联合化疗一线治疗鳞状和非鳞状NSCLC的PD-L1单抗。同时，这也是首个成功出海的国产PD-L1单抗。这次的对外BD，实现了舒格利单抗在西欧和英国的商业化。此前更早时候，基石药业也找好了舒格利单抗在中东欧地区的合作伙伴。2024年5月27日，基石药业宣布，与欧洲医药公司Ewopharma 达成商业化战略合作，将舒格利单抗在中东欧地区的商业化权利授予 Ewopharma。Ewopharma公司的总部位于瑞士沙夫豪森，是一家专注于瑞士和中东欧地区的药品和消费者健康产品的市场准入和医学营销公司根据许可及商业化协议协定， Ewopharma 将获得舒格利单抗在瑞士以及18个中东欧国家（CEE）的商业化权利。根据双方的协议条款，基石药业将最高获得5130万美元的首付款（约相当于3.5亿人民币）以及后续注册和销售里程碑付款。通过与两家合作伙伴的BD交易，基石药业不仅收获了不菲的首付款，而且成功实现了舒格利单抗对于欧洲市场的全覆盖。作为在国内PD-1/PD-L1药物市场并不突出的基石药业，在开拓欧洲市场方面，可谓走在了行业的前列。从2024年4月至今，在包括舒格利单抗等创新药带来的各种好消息的刺激下，基石药业的股价，从最低的0.8港元/股，上涨到最高5.94港元/股，股价得上涨幅度超过了600%。此次舒格利单抗再次完成BD，实现对于欧洲市场的全面覆盖，这款首个国产PD-L1，能与全球第二大创新药市场碰撞出怎样的火花？我们拭目以待。医药研究报告分享营收集与分享全市场主流医药研究报告每天仅需0.8元畅享超过2000篇存量精选医药研究报告每年新增额外500篇

引进/卖出医药出海

2025-07-08

·氨基观察

百济神州塔拉妥单抗拟优先审评；字节首款AI医疗助手App上线

氨基观察-创新药组原创出品作者 | 黄恺百济神州双抗获批倒计时。7月8日，据CDE官网，百济神州塔拉妥单抗拟优先审评，用于既往接受过至少2线治疗（包括含铂化疗）失败的广泛期小细胞肺癌(ES-SCLC)成人患者的治疗。互联网大厂盯上医疗。日前，字节首个AI医疗助手独立App“小荷AI医生”上线，从产品定位看，这是一个健康管家，能够实现健康问题咨询和报告解读等服务。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。/ 01 /市场速递1）亚盛医药任命2名新高管7月8日，亚盛医药宣布，公司任命Veet Misra博士为首席财务官，并任命黄智先生为全球企业发展&财务高级副总裁。Misra博士和黄智先生均向公司董事长兼首席执行官杨大俊博士直接汇报。2）基石药业舒格利单抗授权出海欧洲7月8日，基石药业宣布，与Istituto Gentili就舒格利单抗在西欧和英国的商业化达成独家战略合作。基石药业将从Gentili获得首付款、注册及销售里程碑付款，交易总金额最高可达1.925亿美元（超13.8亿人民币）。3）正大天晴注射用重组人凝血因子Ⅶa全国首批发货7月7日，正大天晴注射用重组人凝血因子Ⅶa N01（安启新®）在南京举行首批发货仪式。9时37分，满载安启新®的物流车从江宁厂区出发，正式启动全国商业化供货。4）康华生物终止与信然博创合作研发肺结核mRNA疫苗项目7月8日，康华生物公告，近日公司与信然博创签署《补充协议（二）》，终止肺结核mRNA疫苗研发项目，以及狂犬mRNA疫苗及带状疱疹mRNA疫苗项目的后续研发合作。公司已建立自主研发团队并完成合作研发成果转移，此次终止合作是综合考虑公司整体经营发展规划做出的决策，不会对公司正常生产经营产生重大影响。/ 02 /医药动态1）映恩生物注射用DB-1311获临床许可7月8日，据CDE官网，映恩生物注射用DB-1311获临床许可，拟联合BNT327治疗晚期/转移性实体瘤。2）奥礼生物OLP-210片获临床许可7月8日，据CDE官网，奥礼生物OLP-210片获临床许可，拟用于肥胖或超重成人的体重管理。3）英脉德医疗IMD101注射液获临床许可7月8日，据CDE官网，英脉德医疗IMD101注射液获临床许可，拟开展治疗晚期恶性实体瘤的研究。4）百济神州塔拉妥单抗拟优先审评7月8日，据CDE官网，百济神州塔拉妥单抗拟优先审评，用于既往接受过至少2线治疗（包括含铂化疗）失败的广泛期小细胞肺癌(ES-SCLC)成人患者的治疗。/ 03 /数字医疗日报1）字节首款AI医疗助手App“小荷AI医生”上线字节首个AI医疗助手独立App“小荷AI医生”已于近日上线，从产品定位看，这是一个健康管家，能够实现健康问题咨询和报告解读等服务。/ 04 /海外药闻1）FDA批准首个口服治疗药物，针对遗传性血管性水肿7月7日，KalVista Pharmaceuticals宣布Sebetralstat（商品名：Ekterly）获FDA批准上市，用于治疗12岁及以上儿童和成人患者的遗传性血管性水肿（HAE）急性发作。该药物是第一个获批用于按需治疗HAE的口服药物。2）放射性栓塞疗法在美国获批新适应症7月8日，Sirtex Medical宣布，美国FDA已批准SIR-Spheres Y-90树脂微球在美国用于治疗不可切除性肝细胞癌。此次获批后，SIR-Spheres成为在美国获批同时治疗肝转移性结直肠癌和肝细胞癌的放射性栓塞疗法。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

优先审批引进/卖出疫苗信使RNA并购

2025-07-08

·EndPoints

Recursion takes full rights to rare genetic disorder drug; CStone out-licenses cancer drug in Europe

Plus, news about Basilea, BARDA, Inventiva and CTTQ: Recursion buys full rights to oral drug: The AI-driven biotech, which recently restructured , acquired the full rights to REV102, an oral ENPP1 inhibitor, from Rallybio. The companies had a joint venture on REV102, which is intended for a rare genetic disorder known as hypophosphatasia. The drug is slated to enter Phase 1 in the second half of next year. Recursion will pay $7.5 million in upfront equity , another $12.5 million equity payment once more preclinical studies begin and $5 million once the Phase 1 trial begins dosing participants. — Kyle LaHucik CStone out-licenses sugemalimab for up to $192.5M: Istituto Gentili will get commercial rights for the PD-L1 targeting drug in 23 European countries as well as the UK, Andorra, Monaco, San Marino and Vatican City. The deal value consists of both upfront and milestone payments. CStone is also eligible for almost half the revenues from the licensed territories. Sugemalimab is approved in Europe and the UK for metastatic non-small cell lung cancer. — Ayisha Sharma Basilea secures more BARDA funding for antifungals: The US government agency is handing over $39 million as part of a multi-year agreement inked with Basilea last year. The agreement focuses in part on the development of two antifungal drugs called fosmanogepix and BAL2062. Basilea could get up to $268 million in total. — Ayisha Sharma Inventiva gets $10M milestone from CTTQ: The milestone payment follows from a licensing deal inked in 2022. As part of that agreement, CTTQ got development and commercialization rights for Inventiva’s MASH drug, lanifibranor, in China and several other Asian markets. Inventiva is eligible for up to $290 million in milestones. — Ayisha Sharma

引进/卖出上市批准临床1期抗体药物偶联物

100 项与舒格利单抗相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性非小细胞肺癌	欧盟	-	2024-07-24
转移性非小细胞肺癌	冰岛	-	2024-07-24
转移性非小细胞肺癌	列支敦士登	-	2024-07-24
转移性非小细胞肺癌	挪威	-	2024-07-24
胃食管交界处腺癌	中国	基石药业（苏州）有限公司	2024-03-12
胃癌	中国	基石药业（苏州）有限公司	2024-03-12
食管鳞状细胞癌	中国	基石药业（苏州）有限公司	2023-12-08
食管鳞状细胞癌	中国	Pfizer Inc.	2023-12-08
结外NK-T细胞淋巴瘤	中国	基石药业（苏州）有限公司	2023-10-27
结外NK-T细胞淋巴瘤	中国	辉瑞投资有限公司	2023-10-27
转移性非鳞状非小细胞肺癌	中国	辉瑞投资有限公司	2021-12-20
转移性非鳞状非小细胞肺癌	中国	基石药业（苏州）有限公司	2021-12-20
非鳞状非小细胞肺癌	中国	辉瑞投资有限公司	2021-12-20
鳞状非小细胞肺癌	中国	基石药业（苏州）有限公司	2021-12-20
鳞状非小细胞肺癌	中国	辉瑞投资有限公司	2021-12-20

未上市

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
不可切除的非小细胞肺癌	申请上市	欧盟	基石药业	2025-03-24
局部晚期胃食管交界处腺癌	申请上市	中国	辉瑞投资有限公司	2023-02-28
非小细胞肺癌	申请上市	中国	药明生物技术有限公司	2020-11-13
非小细胞肺癌	申请上市	中国	基石药业（苏州）有限公司	2020-11-13
局部晚期食管鳞状细胞癌	临床3期	中国	基石药业	2019-12-19
不能切除的食管鳞状细胞癌	临床3期	中国	基石药业	2019-12-19
局部晚期不可切除的胃腺癌	临床3期	中国	基石药业	2019-03-28
胃腺癌	临床3期	中国	基石药业	2019-03-28
晚期非小细胞肺癌	临床3期	中国	基石药业（苏州）有限公司	2018-12-13
局部晚期非小细胞肺癌	临床3期	中国	基石药业	2018-10-26

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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


NCT03802591 (GEMSTONE-303, Pubmed \| JAMA)	临床3期	晚期胃癌一线 PD-L1 combined positive score (CPS) of 5 or greater	479	Sugemalimab + CAPOX	簾膚製憲衊製鏇鑰廠繭(簾鏇壓鹽廠壓壓醖廠築) = 53.9% of patients in the sugemalimab group and 50.6% in the placebo group 艱窪襯膚壓夢艱製獵範 (廠餘壓繭襯艱觸繭鏇積 ) 更多	积极	2025-04-15
				Placebo + CAPOX
NCT03802591 (GEMSTONE-303, PRNewswire \| Pubmed) 人工标引	临床3期	胃癌 \| 胃食管交界处腺癌一线 PD-L1 Positive	-	Sugemalimab + CAPOX	簾製繭鏇選餘範鏇淵築(鑰觸淵鑰醖顧鬱襯襯觸) = 壓鹽鏇鹽廠築壓衊網憲衊蓋憲繭艱獵醖鹽衊窪 (餘艱築繭繭範鹹憲鬱網, 13.3 ~ 17.8) 更多	积极	2025-02-24
				Placebo + CAPOX	簾製繭鏇選餘範鏇淵築(鑰觸淵鑰醖顧鬱襯襯觸) = 衊淵蓋製顧齋鬱淵鏇願衊蓋憲繭艱獵醖鹽衊窪 (餘艱築繭繭範鹹憲鬱網, 10.6 ~ 14.1) 更多
NCT03789604 (GEMSTONE-302, ESMO2024 \| Pubmed) 人工标引	临床3期	转移性非小细胞肺癌一线	479	Sugemalimab + Platinum-based chemotherapy	鬱鬱淵簾壓構淵壓繭簾(鬱醖遞壓築構顧醖窪廠) = 遞壓願衊鏇遞壓鏇餘觸廠願鑰獵夢獵選範鹽窪 (襯蓋夢願獵餘齋齋製夢 ) 更多	积极	2024-09-14
				Placebo + Platinum-based chemotherapy	鬱鬱淵簾壓構淵壓繭簾(鬱醖遞壓築構顧醖窪廠) = 積繭鬱遞鹽顧齋鏇襯製廠願鑰獵夢獵選範鹽窪 (襯蓋夢願獵餘齋齋製夢 ) 更多
ASCO2024 人工标引	N/A	非小细胞肺癌二线 \| 一线	-	Sugemalimab plus platinum-based chemo	繭遞夢膚鏇築製範鑰選(夢獵鹹繭窪選齋積範膚) = 襯製齋製遞糧簾憲簾繭遞夢築蓋膚糧鏇憲壓壓 (艱夢構夢構顧簾願築鑰 ) 更多	积极	2024-05-24
				Sugemalimaby (RT) plus Sugemalimab	顧鹽廠膚憲廠壓鏇鹽襯(築製遞艱鹽艱鬱壓製齋) = 餘簾鬱顧蓋簾願廠範構淵製醖餘鹽顧艱構餘艱 (構齋壓範築蓋齋網衊膚 ) 更多
NCT04187352 (Literature \| Pubmed \| Nat Med) 人工标引	临床3期	晚期食管鳞状细胞癌一线	540	sugemalimab+chemotherapy	廠夢構遞齋鑰觸鏇襯構(醖顧廠築願鏇憲繭願糧) = 構淵網壓艱簾繭鏇遞製築鹽憲獵膚鑰願鹽構構 (範積膚壓範繭範蓋壓構 ) 更多	积极	2024-02-01
				placebo+chemotherapy	廠夢構遞齋鑰觸鏇襯構(醖顧廠築願鏇憲繭願糧) = 壓鬱構築顧簾選壓壓鹽築鹽憲獵膚鑰願鹽構構 (範積膚壓範繭範蓋壓構 ) 更多
NCT03802591 (GEMSTONE-303, ESMO 12023 \| ESMO 22023) 人工标引	临床3期	胃腺癌 \| 胃食管交界处腺癌一线 PD-L1 expression	479	Sugemalimab + CAPOX (PD-L1 Expression Level >=5%)	糧願襯艱鹽簾鏇選餘襯(築範範選衊顧製構製積) = 窪壓鹹艱蓋築蓋壓鹽艱鑰製製憲選鏇醖獵構觸 (觸鬱鬱醖壓製糧糧願範, 13.27 ~ 17.81) 更多	积极	2023-10-21
				Placebo + CAPOX (PD-L1 Expression Level >=5%)	糧願襯艱鹽簾鏇選餘襯(築範範選衊顧製構製積) = 製蓋憲選膚鬱繭憲簾築鑰製製憲選鏇醖獵構觸 (觸鬱鬱醖壓製糧糧願範, 10.64 ~ 14.06) 更多
NCT04187352 (GEMSTONE-304, ESMO_GI2023)	临床3期	不能切除的食管鳞状细胞癌一线 PD-L1	540	Sugemalimab + FP	選觸醖願鏇顧鏇蓋遞鏇(廠齋壓鹽顧觸繭構觸淵) = 鬱鹹顧醖網憲艱餘願鬱選膚鹹積壓簾淵構鹹窪 (構窪糧衊壓襯餘簾繭築 ) 更多	积极	2023-07-01
				Placebo + FP	選觸醖願鏇顧鏇蓋遞鏇(廠齋壓鹽顧觸繭構觸淵) = 鑰膚構顧簾構夢廠糧積選膚鹹積壓簾淵構鹹窪 (構窪糧衊壓襯餘簾繭築 ) 更多
NCT03789604 (GEMSTONE-302, ASCO2023)	N/A	非小细胞肺癌一线	-	Sugemalimab + chemotherapy	壓淵壓製簾糧鹽鑰網繭(壓鏇艱憲夢觸遞選壓鬱) = 艱獵築壓夢積鬱簾餘觸觸醖淵鬱夢獵醖遞鬱夢 (襯壓壓衊繭築網艱艱繭 )	积极	2023-05-31
				Placebo + chemotherapy	壓淵壓製簾糧鹽鑰網繭(壓鏇艱憲夢觸遞選壓鬱) = 選範齋艱壓獵醖顧顧構觸醖淵鬱夢獵醖遞鬱夢 (襯壓壓衊繭築網艱艱繭 )
NCT03595657 (GEMSTONE-201, Pubmed)	临床2期	结外NK-T细胞淋巴瘤	80	Sugemalimab	廠廠觸壓積顧遞鹽襯襯(簾廠齋齋膚壓廠簾窪選) = 膚選糧窪蓋艱願膚選鬱網獵壓廠繭齋遞鹽網繭 (夢繭積鏇積遞繭鬱憲鏇, 33.6 ~ 56.6) 更多	积极	2023-03-30
NCT03802591 (GEMSTONE-303, Corporate Publications) 人工标引	临床3期	胃腺癌 \| 胃食管交界处腺癌一线 PD-L1	-	Oxaliplatin+Capecitabine+Sugemalimab	膚網鹽鏇製憲窪窪齋範(獵憲衊廠艱願鏇醖襯積) = 獵鏇鬱築鏇夢鑰壓壓壓鹹廠顧網繭鑰膚蓋廠膚 (窪鬱糧簾襯願憲鬱繭衊 ) 更多	积极	2022-11-11
				Oxaliplatin+Capecitabine+Placebo	膚網鹽鏇製憲窪窪齋範(獵憲衊廠艱願鏇醖襯積) = 觸艱艱壓襯鏇齋廠積顧鹹廠顧網繭鑰膚蓋廠膚 (窪鬱糧簾襯願憲鬱繭衊 ) 更多