预约演示

更新于：2025-05-31

Sugemalimab

舒格利单抗

更新于：2025-05-31

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

辉瑞投资有限公司

基石药业SFL Pharmaceuticals Deutschland GmbH

+ [2]

非在研机构

药明生物技术有限公司EQRx International, Inc.

权益机构

Stein Holding Group

拜耳医药保健有限公司

上海药明生物技术有限公司

+ [6]

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

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

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结构/序列

Sequence Code 616714836H

来源: *****

Sequence Code 616714851L

来源: *****

关联

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2025-06-01

申办/合作机构

基石药业

NCT06987734

/ Not yet 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2025-05-31

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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项与舒格利单抗相关的文献（医药）

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.

2025-02-01·Translational Lung Cancer Research

Comparative outcomes of first-line PD-1/PD-L1 inhibitors plus chemotherapy for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis of randomized clinical trials

Article

作者: Liu, Zhefeng ; Patel, Akshay J ; Wang, Zhikuan ; Hu, Yi ; Han, Lu ; Zhu, Jun ; Tao, Haitao ; Huang, Ziwei

Background:

Head-to-head comparisons between the available first-line regimens with programmed cell death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors and chemotherapy for advanced squamous non-small cell lung cancer (NSCLC) are lacking. Therefore, we conducted a systematic review and network meta-analysis to identify the optimal first-line regimen with PD-1/PD-L1 inhibitors plus chemotherapy for advanced squamous NSCLC.

Methods:

A systematic review and network meta-analysis of randomized clinical trials (RCTs) were performed. PubMed, Embase, Web of Science, and the ClinicalTrials.gov databases and major annual conferences were searched. RCTs that compared PD-1/PD-L1 inhibitors plus chemotherapy with chemotherapy alone in patients with advanced squamous NSCLC were eligible for inclusion. Risk of bias was assessed using the Cochrane Risk of Bias Tool (version 2.0), and a funnel plot was used to assess the publication bias.

Results:

A total of nine RCTs comprising 3,210 patients were included. When combined with chemotherapy, PD-1 inhibitors were superior to PD-L1 inhibitors in terms of overall survival (OS) [PD-1: hazard ratio (HR) 0.70, 95% credible interval (CrI): 0.62 to 0.79; PD-L1: HR 0.82, 95% CrI: 0.71 to 0.94] and progression-free survival (PFS) (PD-1: HR 0.50, 95% CrI: 0.45 to 0.55; PD-L1: HR 0.63, 95% CrI: 0.55 to 0.72). Moreover, the PD-1 inhibitor camrelizumab was the most effective agent in combined therapy for prolonging OS (HR 0.56, 95% CrI: 0.44 to 0.71) and PFS (HR 0.32, 95% CrI: 0.25 to 0.42), followed by the PD-L1 inhibitor sugemalimab (OS: HR 0.61, 95% CrI: 0.43 to 0.86; PFS: HR 0.37, 95% CrI: 0.26 to 0.52). Moreover, the addition of camrelizumab or tislelizumab to chemotherapy was associated with the improved objective response rate (ORR) and a longer duration of response (DoR). Regarding safety, pembrolizumab and camrelizumab were associated with the lowest risk of developing grade 3-5 treatment-related adverse events (TRAEs). Most of the trials were at low risk for bias, and no obvious publication bias was observed in the outcomes.

Conclusions:

When combined with first-line chemotherapy, camrelizumab has the potential to be a preferred option in patients with advanced squamous NSCLC. This finding might serve as a guideline to aid in the selection of first-line immunotherapy plus chemotherapy strategies for advanced squamous NSCLC.

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项与舒格利单抗相关的新闻（医药）

2025-05-20

·Firstwordpharma

Pfizer strikes $6B deal with China's 3SBio for cancer bispecific

Pfizer signed a mega licensing deal worth over $6 billion with Chinese firm 3SBio, securing ex-China rights to the latter’s PD-1/VEGF-targeting bispecific antibody SSGJ-707 in oncology indications. The news sent 3SBio’s stock surging over 30% at the Hong Kong exchange on Tuesday.The deal announced Monday, grants Pfizer exclusive global development, manufacturing and commercialisation rights for SSGJ-707, excluding China, with an option to acquire commercialisation rights within China at a later date. Under the agreed terms, Pfizer will make an upfront payment of $1.25 billion — a new record for licensing pacts with Chinese biotechs. Additionally, 3SBio will be eligible for potential milestone payments reaching $4.8 billion, alongside tiered double-digit sales royalties. SSGJ-707, which targets two critical cancer pathways simultaneously — immune checkpoint inhibition via PD-1 and anti-angiogenesis via VEGF — demonstrated encouraging efficacy and safety data in early trials and is being investigated across several solid tumours. 3SBio plans to kick off the first Phase III study for the bispecific in China later this year.Pfizer noted that upon closing of the transaction, which is anticipated in the third quarter subject to regulatory and shareholder approvals, it will make an additional $100-million equity investment in 3SBio. The US drugmaker will set up manufacturing operations for SSGJ-707 at its facilities in North Carolina and Kansas.The deal comes amid emerging competition in the PD-(L)1)/VEGF bispecific landscape, with Akeso and Summit Therapeutics’ ivonescimab and BioNTech’s BNT327 already battling it out to end the reign of Merck & Co.’s Keytruda (pembrolizumab), which the latter expects to offset by developing LaNova Medicines’ LM-299. Read more on this: Spotlight On: Biopharma's next immuno-oncology goldrush is already under way.With this agreement, Pfizer joins other major biopharmas that’ve had a flurry of China partnering deals in recent times. For more, see: Vital Signs: Who's taking the biggest risks (and rewards) with Chinese assets? In the past, Pfizer partnered with CStone Pharmaceuticals, gaining rights to CStone's experimental PD-L1 antibody sugemalimab in China.

引进/卖出免疫疗法抗体药物偶联物

2025-05-14

·生物制品圈

三抗/双抗/ADC齐发：基石药业的「炫富式」亮相

5月6日-7日，基石药业携5款自主研发的重磅产品亮相2025年美国癌症研究协会（AACR）年会，以壁报形式公布了研发管线2.0多款创新产品的临床前研究结果，除两款值得重点关注的三抗和双抗产品CS2009（PD-1/VEGF/CTLA-4）和CS2011（EGFR/HER3）外，还有出自其自有ADC平台的三款创新ADC分子CS5007（EGFR/HER3双特异性ADC）、CS5005（ITGB4 ADC）和CS5006（SSTR2 ADC），其中不乏亮点数据，引发广泛关注。 01 CS2009三抗引领免疫治疗新突破CS2009是一款同时靶向PD-1/VEGFA/CTLA-4的创新型三特异性抗体，覆盖范围广阔，包括非小细胞肺癌、肝癌、胃癌、子宫内膜癌、卵巢癌、肾细胞癌及宫颈癌等，具备first/best in class潜力。具体来说，阻断PD-1可逆转T细胞耗竭，阻断CTLA-4可促进T细胞活化和增殖，而阻断VEGFA则可抑制肿瘤血管生成，从而改善肿瘤微环境（TME）。在抗肿瘤领域，抗PD-1与CTLA-4的双重阻断已在包括非小细胞肺癌在内的多种肿瘤类型中显示出协同效应，可显著提升患者的总生存期（OS）和无进展生存期（PFS）获益。本次披露数据显示，同时结合PD-1、CTLA-4靶点时，CS2009展现出了更高的亲和力，通过优先结合TME中的PD-1/CTLA-4双阳性T细胞，实现了疗效提升。AACR 2025 CS2011公布数据1而通过与VEGFA交联，PD-1和CTLA-4的双重阻断作用能够得到显著增强。尽管前有PD-1/VEGF双抗对比K药展现出了PFS优势，但OS数据却表现平平，而这种三靶点组合的差异化分子设计，则有望发挥更为深化的协同机制，同时在短期缩瘤与长期生存上展现出色疗效。据本次公布数据示，通过与VEGA二聚体交联，CS200使PD-1/CTLA-4双报告基因细胞上的检查点抑制活性提高了约150倍；而在PD-1报告基因细胞中，CS2009/VEGFA相较CS2009免疫检查点活性提高了约300倍。在激活原代T细胞活性的MLR实验中，与VEGFA二聚体交联也显著提高了该产品活性。也就是说，CS2009在VEGFA富集的TME中可以实现活性的显著提升，从而提高其治疗窗口。同时，该产品还可优先结合PD-1和CTLA-4双阳性的肿瘤浸润T细胞，并最大程度上弱化对外周T细胞中CTLA-4调节通路的干扰，在提升疗效的同时降低系统性毒性。AACR 2025 CS2009公布数据2在多数药企执着大热双抗的靶点组合时，基石药业早在2022年就已进入三抗研究阶段。公司表示，相较于潜在竞品（如PD-1/CTLA-4双抗、PD-1/VEGF双抗及抗PD-1/抗CTLA-4联合疗法），CS2009具有更强的抑瘤效力，且安全性突出。通过在同一分子结构中整合以上三种作用机制，有望超越现有PD-(L)1单抗、PD-(L)1/VEGF双抗及PD-(L)1/CTLA-4双抗，成为下一代肿瘤免疫骨架产品，与基石药业目前进展最快的ROR1ADC管线CS5001，共同构成了该司临床阶段核心资产。目前，其全球多中心1期临床研究正在澳大利亚进行，已于今年3月完成首例患者给药，后续将扩展至中国和美国。 02 CS2011双抗靶向精准治疗而本次公布数据另一款重磅产品CS2011则是更为成熟的靶点组合。这是一款EGFR/HER3双特异性抗体，两个靶点同属HER家族受体酪氨酸激酶并在多种肿瘤上高表达，也是晚期实体瘤临床治疗中经过充分验证的靶点。通过协同阻断这两个关键的肿瘤生长信号通路，可有效阻断两个靶点的下游信号传导，从而抑制EGFR/HER3阳性肿瘤细胞的生长。CS2011同样亮点不少。首先，该产品几乎可以阻断除HER2同源二聚体之外的所有HER家族相关信号通路，可有效克服肿瘤异质性。同时，其对EGFR和HER3靶点均有较强的结合力，且能够有效结合EGFR/HER3单独表达和共同表达的肿瘤细胞。AACR 2025 CS2011公布数据此外，针对主要潜在竞品，CS2011在体内和体外研究中均表现出更优的抗肿瘤活性。相较EGFR单抗、HER3单抗和EGFR/HER3竞品，CS2011能够：1.在不同EGFR/HER3表达水平的肿瘤细胞表面触发更高效的内吞2.对EGFR下游信号的抑制作用与EGFR单抗相当，对HER3信号通路的抑制作用优于同类EGFR/HER双抗竞品3.在不同EGFR和HER3表达水平的肿瘤细胞上均能高效抑制肿瘤增殖在体内CDX肿瘤模型中表现出优于EGFR单抗与HER3单抗的肿瘤抑制作用，并与两者联合治疗方案疗效相当当前，CS2011已于2025年3月注册专利，预计将很快递交IND。 03 多款FIC与潜在BIC正式发力的自有ADC平台基石药业多款重磅产品实现关键进展，离不开其搭建的新一代ADC平台的技术支持。以专有连接子为特色，该平台能够针对不同的靶点和有效载体进行优化。着眼此次公布的两款ADC管线CS5005和CS5006，我们也能看出其自有平台的正式开始发力，一举便至少造出两款First in Class 分子。其中，CS5005是一款靶向SSTR2的ADC。分子结构上，该产品搭载了其专有的高亲和力与高选择性的SSTR2全人源抗体，Linker为亲水性的β葡萄糖醛酸连接子，Payload为拓扑异构酶1抑制剂Exatecan，在体外及体内研究中均展现出令人鼓舞的抗肿瘤活性，可精准狙击SSTR2阳性肿瘤，如小细胞肺癌、神经内分泌癌、神经内分泌瘤等。而CS5006则是靶向全新ITGB4靶点的ADC，目前尚未有同靶点ADC进入临床。通过内部开发的机器学习生物信息学算法结合实验验证，该司发现ITGB4在非小细胞肺癌、结直肠癌、食管鳞状细胞癌和头颈部鳞状细胞癌等多瘤种中表达显著上调、而在正常组织中表达极低，接近于HER2的表达模式，且其高表达水平与肿瘤侵袭和转移相关，成为理想的治疗开发靶点。而临床前体外及体内研究也表明，CS5006在多种动物模型中均表现出强效抑瘤作用，不仅能触发快速、高水平的内化，且耐受性良好，展现出优异的治疗潜力。而双抗ADC CS5007则是基石药业在ADC领域创新linker技术的产物。CS5007的EGFR/HER3双抗抗体骨架是前文提及的CS2011，其设计和临床前数据能够解决肿瘤异质性，Linker搭载其专有的亲水性、稳定的β-葡萄糖苷连接子确保该分子拥有较强的内吞效率，而Payload仍是拓扑异构酶1抑制剂Exatecan。该产品可靶向几乎所有HER家族（除HER2同源二聚体外）受体的信号传导，潜在覆盖广泛瘤种并有效克服肿瘤异质性。其分子设计集精准的靶点结合、优化的连接子稳定性及经验证的有效载荷于一身，使其有望成为肿瘤精准靶向治疗中的Best in class候选药物。AACR 2025 CS5007公布数据目前全球范围内EGFR/HER3双抗ADC只有百利天恒的BL-B01D1处于临床阶段（映恩生物的DB-1418在临床前阶段)，得益于亮眼的临床数据，实现了高溢价出海。而在CS5007的临床前数据中，不仅基于CS2011抗体骨架展现出对EGFR+和/或HER3+的肿瘤细胞的高亲和力，而且还触发了这些细胞上的靶向受体的高速内化，高效且有选择性地释放毒素，导致强力且精准的细胞杀伤。这意味着其能够改善同类药物BL-B01D1治疗窗口不显著的问题。如此背景下，CS5007的商业前景不可谓不广阔。 04 管线2.0聚焦研发优势，加速走出寒冬从复杂三抗到精准双抗再到创新分子，基石药业的靶点立项体现出其前瞻性的布局思维和系统性的ADC管线设计，但同时伴随的，还有商业成绩上历经多年的经营亏损。直到2024年上半年，基石药业才首次实现盈利，但仍尚未实现扭亏为盈。2016年成立的基石药业，初时可以说是大放异彩。2018年斩获国内生物医药企业最高单笔B轮融资记录，一度备受资本热捧，2019年便实现上市，用时不到3年。具体来说，这要得益于其成立时采取的VIC模式，即风险投资（VC）、知识产权（IP）、合同制研发服务机构（CRO）三者相结合，通过引进国外先进研究成果建立自己的管线梯队，迅速开展临床，并推进产品上市。如此模式下，该司在2021年一年内便实现了4款产品（普拉提尼、阿伐替尼、艾伏替尼和舒格利单抗）获批上市，进展可谓迅猛。接下来便是不出意外的更大愿景——向biopharma转型。现实是，由于国内市场中PD-(L)1产品的疯狂内卷，加上其他三款进口药定价过高、无法进入医保，其商业化元年，便开局不利，2021年销售收入仅1.63亿元。而早已在全国100多个城市铺开的商业化团队，以及同年试运行、产能却无法得到充分利用的苏州工厂，又无可避免地成为运营开支的两大负担。当年财报显示，亏损高达19.2亿元。2022年，基石药业开始做出一系列重要调整。关停苏州工厂、加速进口药品的地产化、转让部分产品的商业化权益并同步精简销售团队。降本的同时，着力开源。一方面，积极布局海外市场，推进产品出海，充分发挥上市产品的商业价值，另一方面，开展全球管线合作，提升产品预期，进一步吸引投资。具体来说，其biopharma架构向基于成熟商业化模式的biotech架构调整，进一步聚焦自身研发优势，正式推出了管线2.0新战略——开展项目不再局限于国内市场，而是着眼全球权益，致力各靶点研发跻身世界前列。基石药业管线2.0新战略下，公司重点推进两项关键临床项目，即本次披露关键数据的三抗管线 CS2009以及当前进展最快的ROR1 ADC管线CS5001。后者开发进程位列全球第二，在多个血液瘤适应症中均展示出良好的潜在获益，在实体瘤领域也显示了出色的肿瘤抑制活性。当前其I期试验在美国、澳大利亚和中国同步进行中。如此操作下，次年亏损便大幅减少，至2024年上半年，基石药业已实现盈利佳绩，快步走出低谷。考虑到其两款临床阶段核心资产广阔的临床价值与出色的商业化潜力，其前景可谓稳步向好。结语基石药业在2025年AACR年会上展现的研发成果，标志着其在肿瘤免疫治疗与ADC领域的加速突破。通过差异化设计与技术创新，公司不仅验证了其技术平台的创新性与高效性，更在临床前数据中凸显出优于现有疗法的潜力。可以想见，市场或将迎来一个找准主线后奋起直追的主力选手。若后续临床试验能延续当前优势，公司或将借助差异化的技术路线，在全球创新药与ADC产品竞争中占据不可忽视的一席之地。引用1.AACR 2025 | 基石药业发布CS2009（PD-1/VEGF/CTLA-4）最新临床前研究结果https://www.cstonepharma.com/html/news/3793.html2.AACR 2025 | 基石药业发布CS2011（EGFR/HER3双特异性抗体）临床前研究结果https://www.cstonepharma.com/html/news/3794.html3.AACR 2025 | 基石药业发布CS5007（EGFR/HER3双特异性ADC）临床前研究结果https://www.cstonepharma.com/html/news/3797.html4.AACR 2025 | 基石药业发布CS5005（SSTR2 ADC）临床前研究结果https://www.cstonepharma.com/html/news/3796.html5.AACR 2025 | 基石药业发布CS5006（ITGB4 ADC）临床前研究结果https://www.cstonepharma.com/html/news/3798.html其他官网资料识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

AACR会议抗体药物偶联物临床结果

2025-04-24

·正大天晴药业集团

双适应症申报获受理！贝莫苏拜方案“头对头”优于替雷联合化疗、覆盖Ⅲ期肺癌巩固治疗

肺癌治疗领域再传捷报！4月23日，正大天晴1类创新药贝莫苏拜单抗注射液联合盐酸安罗替尼胶囊两项新适应症获得国家药品监督管理局药品审评中心（CDE）受理：针对晚期鳞状非小细胞肺癌（sq-NSCLC）患者的一线治疗、Ⅲ期非小细胞肺癌（NSCLC）患者的巩固治疗。至此，贝莫苏拜单抗联合安罗替尼已经申报上市5个适应症。此前，贝莫苏拜单抗联合化疗后序贯联合安罗替尼对比替雷利珠单抗注射液联合化疗一线治疗晚期sq-NSCLC的主要研究终点无进展生存期（PFS）达到方案预设的优效界值。头对头替雷利珠！一线治疗sq-NSCLC取得显著阳性TQB2450-Ⅲ-12（NCT05718167）是一项多中心、随机、双盲、平行对照的Ⅲ期临床研究，旨在评估贝莫苏拜单抗注射液联合化疗后序贯联合盐酸安罗替尼胶囊对比替雷利珠单抗注射液联合化疗一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）的有效性和安全性。本研究的期中分析结果显示，与替雷利珠单抗联合化疗组相比，贝莫苏拜单抗联合化疗后序贯联合安罗替尼可显著延长患者的中位无进展生存期（PFS），本研究安全性数据与已知风险相符，未发现新的安全性信号。经独立数据监查委员会（IDMC）判定，主要研究终点PFS达到方案预设的优效界值。基于以上试验结果，公司向CDE提交了贝莫苏拜单抗及安罗替尼新适应症的上市申请，并获得受理。值得关注的是，本研究是全球首个对比PD-1免疫联合化疗一线治疗sq-NSCLC取得阳性结果的Ⅲ期临床研究，详细研究数据将于2025年美国临床肿瘤学会（ASCO）上公布。NSCLC患者巩固治疗新方案获受理！上市进入倒计时针对局部晚期/不可切除的Ⅲ期NSCLC治疗手段有限，同步/序贯放化疗后使用免疫单药巩固治疗是标准治疗方案[1,2]。此次同步获CDE受理的上市申请还有贝莫苏拜单抗联合或不联合安罗替尼，用于同步/序贯放化疗后未进展的局部晚期/不可切除（Ⅲ期）NSCLC的巩固治疗。R-ALPS研究（NCT04325763）是一项随机、双盲、平行对照、多中心的Ⅲ期临床研究，旨在评估该疗法的有效性和安全性。研究显示，相较于对照组，贝莫苏拜联合或不联合安罗替尼治疗同步/序贯放化疗后未进展的Ⅲ期NSCLC患者可显著降低疾病进展风险，详细研究数据将于2025年ASCO公布。至此，贝莫苏拜单抗联合安罗替尼的“免疫+抗血管生成治疗”模式已经申报上市5个适应症，其中用于治疗广泛期小细胞肺癌、子宫内膜癌的适应症已获批上市，治疗肾细胞癌以及此次获受理的2个适应症的上市申请正在审评中。安罗替尼则已经申报上市12个适应症，其中7个适应症已获批上市。贝莫苏拜单抗+安罗替尼，持续推进肺癌治疗新高度2022年全球癌症数据统计显示，全球肺癌发病人数达248万，中国发病人数为106.1万，肺癌在全球和中国的发病率及死亡率居所有恶性肿瘤的第一位[3]。其中非小细胞肺癌（NSCLC）占全部肺癌的80%-85%[4]，鳞状非小细胞肺癌（sq-NSCLC）是NSCLC的主要亚型之一，约占全部NSCLC的30%[5]。虽然免疫联合化疗是多种肺癌的首选方案，但仍有部分患者无法达到肿瘤缓解或在短期内疾病进展，如何扩大免疫治疗响应人群，延长无进展生存期是目前亟待解决的问题[6]。研究发现，免疫治疗的响应与肿瘤微环境（TME）的免疫浸润状态有关，抗血管生成药物治疗不仅参与微环境中异常血管的重构、调节肿瘤免疫细胞浸润，还能逆转TME的免疫抑制状态[7]，二者联合在抗肿瘤治疗中具有协同增效的作用。贝莫苏拜单抗作为一种创新人源化抗PD-L1单克隆抗体，能够精准地作用于肿瘤细胞表面的PD-L1，从而阻止肿瘤细胞对免疫系统的抑制，重新激活免疫细胞。安罗替尼则是一种小分子多靶点酪氨酸激酶抑制剂，能有效抑制VEGFR 1-3、PDGFR α/β、FGFR 1-4、c-Kit等靶点，通过调控肿瘤微环境重编程，起到抑制肿瘤血管新生、抑制肿瘤生长、调控免疫微环境的作用。随着多项在研创新项目陆续进入收获期，贝莫苏拜单抗联合安罗替尼的“免疫联合抗血管生成治疗”模式必将持续推进肺癌治疗的新高度，为肺癌患者提供更丰富的治疗选择。参考文献：[1] Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377(20):1919-1929.[2] Qing Zhou,Ming Chen,et al.Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced, unresectable, stage III non-small-cell lung cancer in China (GEMSTONE-301): interim results of a randomised, double-blind, multicentre, phase 3 trial.The Lancet Oncology.2022;2(23).P209-219.[3] Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021.[4] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA: a cancer journal for clinicians, 2024, 74(3): 229-263.[5] Hirsh V. New developments in the treatment of advanced squamous cell lung cancer: focus on afatinib. Onco Targets Ther. 2017 May 11;10:2513-2526.[6] Remon J, Passiglia F, Ahn MJ, et al. Immune checkpoint inhibitors in thoracic malignancies: Review of the existing evidence by an IASLC expert panel and recommendations. J Thorac Oncol, 2020,15(6):914-947.[7] Liang H, Wang M. Prospect of immunotherapy combined with anti-angiogenic agents in patients with advanced non-small cell lung cancer.Cancer Manag Res,2019,11:7707-7719.▲ 上下滑动查看更多声明：1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。2.本公司不对任何药品和/或适应症作推荐。3.本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● 从“引领创新”到“投资创新” 中生引领（上海）私募投资基金揭牌成立● 应邀出席中国医学发展大会谢承润：用AI助力患者全周期健康管理，打造亚太多中心临床联盟● 中国工程院党组成员、副院长王辰院士一行到正大天晴调研● 《CSCO非小细胞肺癌诊疗指南（2025）》发布，正大天晴3款1类新药新增I级推荐

临床3期ASCO会议临床结果上市批准申请上市

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	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

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

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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, 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	膚餘觸範壓遞範衊壓醖(夢膚襯壓構觸鑰築獵廠) = 廠鹽膚鹽遞構顧襯艱襯鏇憲襯網餘窪遞糧遞淵 (襯醖積簾觸簾夢鬱衊顧, 13.3 ~ 17.8) 更多	积极	2025-02-24
				Placebo + CAPOX	膚餘觸範壓遞範衊壓醖(夢膚襯壓構觸鑰築獵廠) = 鏇壓糧壓壓簾夢選鹽繭鏇憲襯網餘窪遞糧遞淵 (襯醖積簾觸簾夢鬱衊顧, 10.6 ~ 14.1) 更多
NCT03789604 (GEMSTONE-302, ESMO2024) 人工标引	临床3期	转移性非小细胞肺癌一线	479	Sugemalimab + Platinum-based chemotherapy	選選顧餘衊窪窪遞獵艱(簾鏇壓網遞鹽艱鏇艱醖) = 簾蓋齋鹽鏇觸壓蓋鑰醖製夢衊製觸廠艱齋鹹夢 (構醖製願鬱鹽鏇鹽襯繭 ) 更多	积极	2024-09-14
				Placebo + Platinum-based chemotherapy	選選顧餘衊窪窪遞獵艱(簾鏇壓網遞鹽艱鏇艱醖) = 築窪齋鏇壓鬱顧餘願選製夢衊製觸廠艱齋鹹夢 (構醖製願鬱鹽鏇鹽襯繭 ) 更多
NCT03595657 (GEMSTONE-201, CTgov)	临床2期	结外NK-T细胞淋巴瘤	80	sugemalimab (CS1001)	構願壓繭壓襯糧窪廠醖 = 築糧鏇淵齋糧鑰遞衊製壓積夢顧遞鑰鬱衊鏇遞 (積淵廠鹹構醖窪獵選獵, 網繭艱廠願顧築鬱蓋廠 ~ 襯構遞膚獵夢艱壓壓觸) 更多	-	2024-06-18
ASCO2024 人工标引	N/A	非小细胞肺癌二线 \| 一线	-	Sugemalimab plus platinum-based chemo	鬱觸齋鹽築糧窪範獵餘(鏇選顧膚齋網觸遞齋醖) = 鹹鑰簾鏇鑰艱製鹹顧夢糧憲積構膚醖襯網醖鹽 (製鹽築餘鹹壓襯範鏇衊 ) 更多	积极	2024-05-24
				Sugemalimaby (RT) plus Sugemalimab	鑰餘鹽遞顧餘夢選夢鏇(觸製鹽網範淵廠醖構構) = 鏇鹹範艱顧範網憲鑰憲鑰夢築觸夢觸積築遞願 (蓋齋淵鏇繭齋鑰蓋衊遞 ) 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	憲觸醖鑰簾構選襯壓範(憲積糧膚餘廠觸遞鏇築) = 網鏇鹽繭膚網鬱鑰選構鬱窪齋選構簾膚淵選鬱 (繭鑰襯憲艱簾觸製範鏇 ) 更多	积极	2024-02-01
				placebo+chemotherapy	憲觸醖鑰簾構選襯壓範(憲積糧膚餘廠觸遞鏇築) = 獵膚襯願鑰範醖鬱願蓋鬱窪齋選構簾膚淵選鬱 (繭鑰襯憲艱簾觸製範鏇 ) 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%)	艱觸鬱衊觸構願膚窪鬱(淵餘網蓋艱簾鑰網觸繭) = 願鏇襯鏇積膚齋窪蓋艱憲醖構鹹鏇築築憲範齋 (構鏇鏇鬱鏇選憲壓鏇築, 13.27 ~ 17.81) 更多	积极	2023-10-21
				Placebo + CAPOX (PD-L1 Expression Level >=5%)	艱觸鬱衊觸構願膚窪鬱(淵餘網蓋艱簾鑰網觸繭) = 網窪鑰淵範鹽餘夢鏇觸憲醖構鹹鏇築築憲範齋 (構鏇鏇鬱鏇選憲壓鏇築, 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	蓋築願襯窪獵糧膚觸窪(窪願醖襯淵積簾壓膚願) = 餘鹹簾壓簾蓋鬱鹽醖選鏇簾遞憲顧構鹽觸築廠 (鑰醖壓膚衊獵觸範顧範 ) 更多	积极	2023-07-01
				Placebo + FP	蓋築願襯窪獵糧膚觸窪(窪願醖襯淵積簾壓膚願) = 醖膚餘糧選網壓願顧憲鏇簾遞憲顧構鹽觸築廠 (鑰醖壓膚衊獵觸範顧範 ) 更多
NCT03789604 (GEMSTONE-302, ASCO2023)	N/A	非小细胞肺癌一线	-	Sugemalimab + chemotherapy	衊窪鹹齋壓鏇構醖願願(顧獵網獵範廠獵壓蓋餘) = 窪簾醖積網夢鏇蓋網蓋簾鹽醖鬱衊範襯遞醖夢 (範繭願壓膚獵壓齋窪餘 )	积极	2023-05-31
				Placebo + chemotherapy	衊窪鹹齋壓鏇構醖願願(顧獵網獵範廠獵壓蓋餘) = 鹹淵鹽範製繭鏇鏇鏇鏇簾鹽醖鬱衊範襯遞醖夢 (範繭願壓膚獵壓齋窪餘 )
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	積鹽醖窪憲選構鹹觸齋(觸齋觸獵襯壓鹽憲鏇襯) = 糧顧鹽構廠鏇願製糧鏇積積淵顧遞鬱夢鏇夢餘 (餘齋衊壓衊築糧獵憲築 ) 更多	积极	2022-11-11
				Oxaliplatin+Capecitabine+Placebo	積鹽醖窪憲選構鹹觸齋(觸齋觸獵襯壓鹽憲鏇襯) = 鹹顧鏇齋艱襯餘膚餘壓積積淵顧遞鬱夢鏇夢餘 (餘齋衊壓衊築糧獵憲築 ) 更多
NCT03789604 (GEMSTONE-302, ASCO2022) 人工标引	临床3期	转移性非小细胞肺癌一线	479	chemotherapy + Sugemalimab	簾鹽艱醖糧齋網壓齋範(鏇鹹積淵鑰齋蓋壓築糧) = 鹽構餘獵壓廠醖醖繭遞鏇繭醖顧襯遞壓餘醖夢 (構憲膚鑰齋簾築鑰觸鑰 ) 更多	积极	2022-06-02
				chemotherapy + placebo	簾鹽艱醖糧齋網壓齋範(鏇鹹積淵鑰齋蓋壓築糧) = 憲鹹願窪窪憲鹽觸遞鬱鏇繭醖顧襯遞壓餘醖夢 (構憲膚鑰齋簾築鑰觸鑰 ) 更多