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

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

NCT06217757

/ Recruiting临床1/2期IIT

Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer

The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.

开始日期2024-04-18

申办/合作机构

四川大学

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）

2025-03-01·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.

2025-01-02·EXPERT OPINION ON BIOLOGICAL THERAPY

An evaluation of sugemalimab for the treatment of relapsed or refractory extranodal natural killer T-cell lymphoma

Review

作者: Yu, Jingwei ; Zhang, Huilai ; Li, Lanfang ; Qian, Zhengzi ; Qiu, Lihua ; Liu, Xia ; Wang, Xianhuo ; Feng, Yingfang ; Song, Zheng ; Zhou, Shiyong

INTRODUCTION:

Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) is a rare and aggressive subtype arising from natural killer or cytotoxic T-cells, predominantly affecting the nasal cavity and paranasal sinuses, lacking a standardized therapeutic approach. Sugemalimab, a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody (mAb), has been investigated in a Single-Arm, Multicenter, Phase II Study (GEMSTONE-201). The results demonstrated significant efficacy, favorable tolerability, and manageable adverse reactions of sugemalimab in R/R ENKTL. This study summarizes and compares the efficacy and safety profile of sugemalimab with several other PD-1/PD-L1 inhibitors in R/R ENKTL patients.

AREA COVERED:

We included a Phase II study (GEMSTONE-201) of sugemalimab in R/R ENKTL.

EXPERT OPINION:

The clinical trials have demonstrated superior efficacy of sugemalimab, evidenced by a complete response rate (CRR) of 35.9% and an overall response rate (ORR) of 44.9%. In comparison with other immune checkpoint inhibitors (ICIs), sugemalimab shows a notably higher CRR. Additionally, sugemalimab exhibits a manageable safety profile. Further evaluation of sugemalimab is required based on its efficacy and safety in real-world patient populations. Should sugemalimab be included in medical insurance in the future, it could potentially benefit a larger number of patients with R/R ENKTL.

502

项与舒格利单抗相关的新闻（医药）

2025-03-30

·E药经理人

中药第一妖股被“ST”，明星Biotech破产，CXO净利集体暴跌！年报季，谁绝地反击了？

本周，多家药企财报密集发布。截至今日，创新转型药企“三剑客”2024年成绩单已集齐，在“A+H”新布局及“自研+BD”研发长线策略下，三家头部大药企集体表现出了韧劲和应对变化的灵敏度。数家创新药企发布财报，以云顶新耀、基石药业为代表的Biotech，凭以自身不错的商业化成果助力自身渐回高峰；以康宁杰瑞为代表的公司，则以BD交易寻找到了新的盈利增长点。然而，无论是大药企，还是创新药企，财报深处仍旧透露了他们各自为更好适应变化、快速穿越周期的压力和焦虑。CXO，作为创新药行业的晴雨表，侧面印证了过去一年整个行业还在破局的艰难探索路上。泰格医药，归母净利润约4.05亿元，同比下降79.99%；昭衍新药，归母净利润下降81.34%；博腾股份，年度净亏损2.88亿元……但要相信创新力量本身。本周，两起大额BD交易再次印证了中国新药之于国际舞台的重要性：联邦制药GLP-1/GIP/GCG授权给诺和诺德，交易总额最高约20亿美元；恒瑞也以近20亿美元将Lpa小分子抑制剂授权给了默沙东。一起看看本周都有什么大事发生？年报季复宏汉霖：2024年实现营业收入约人民币57.244亿元，较去年同期增长约6.1%，净利润达8.205亿元，同比增长50.3%。这是继2023年首次取得全年盈利之后，公司连续第二年实现全年盈利。核心产品商业化销售的持续扩大，成为业绩盈利的重要驱动力，产品销售收入合计约人民币49.335亿元，同比增长8.3%。云顶新耀：全年总收入大幅增长461%，达7.067亿元，超额完成7亿元既定目标；实现高毛利率83%，运营费用占收入比重大幅减少562%，非国际财务准则亏损总额显著收窄25%，现金储备达人民币16亿元，首次实现了年度商业化层面盈利。全球首个对因治疗IgA肾病药物耐赋康年内实现3.534亿元收入，同比增长1581%。全球首个氟环素类抗菌药物依嘉，实现收入3.528亿元，同比增长256%。康宁杰瑞：全年收入飙升至6.4亿元，同比增长192%，并实现净利润1.66亿元，成功扭亏为盈。许可费收入表现尤为亮眼，成为推动收入增长的主要动力。百利天恒：实现营业总收入58.23亿元，同比增长936.31%；归母净利润37.08亿元，同比扭亏为盈；经营活动产生的现金流量净额为40.59亿元。君实生物：实现营业收入19.48亿元，同比上升29.67%；归母净利润自上年同期亏损22.83亿元变为亏损12.81亿元。核心产品特瑞普利单抗获批适应证及纳入国家医保目录适应证增加，使得该药物的国内市场销售额同比大幅增长。科伦博泰：实现营业收入19.33亿元，同比增长25.5%；毛利达12.74亿元，增幅67.8%。调整后年度亏损同比大幅收窄73.7%至1.18亿元，经营效率显著优化。华北制药：公司实现营业收入98.70亿元，同比下滑2.48%；实现归母净利润1.27亿元，同比增长2496.8%。药明生物：2024年实现收入186.754亿元，同比增长9.6%；全年纯利为39.45亿元，同比增长10.5%。公司新增151个综合项目，综合项目总数高达817个，其中超过一半新增项目来自美国客户。政策动态2025版《药典》发布：3月25日，国家药监局、国家卫健委发出《关于2025年版《中华人民共和国药典》的公告》，根据《中华人民共和国药品管理法》，2025年版《中华人民共和国药典》将自2025年10月1日起施行。据观察，新版中国药典中有19种中成药被剔除。全国药政工作会议在京召开：会议强调，在研究完善国家药品制度、实施基层药品联动服务行动、巩固完善国家基本药物制度、整体提升全国短缺药品应对处置质效、深化药品使用监测和临床综合评价结果拓展应用、健全激励药师药学服务机制、持续提升特殊人群及特定疾病药品应用管理实效等方面，聚焦协同发展，强化治理转型，加快构建药品供应保障高质量发展新格局。北京将新设100亿元规模医药并购基金：3月26日，北京市医保局局长马继业3月26日在博鳌亚洲论坛期间透露，北京市充分发挥市级200亿元医药健康投资基金的作用，2024年，投决金额和撬动社会资本近100亿元。今年将再新设100亿元规模的医药并购基金，构建全周期接续支持、市区协同的医药健康产业基金体系。26省联盟启动带量采购：3月28日，山西省药械集中招标采购中心发布《关于做好二十六省联盟药品集中带量采购品种数据填报工作的通知》。此前，一份《关于填报二十六省联盟药品集中带量采购品种采购需求量的通知》在业内流传，文件共涉及50个药品，覆盖妇科及激素类、造影剂等重点品种。大型制药卫材出售雷贝拉唑钠中国权益：3 月 28 日，日本卫材制药宣布，将其质子泵抑制剂波利特（通用名：雷贝拉唑钠肠溶片）在中国的权利转让给康桥资本集团控制的北京顶峰生物医药。随着集采政策的推进和市场竞争的加剧，该产品市场表现面临一定挑战。此次交易标志着卫材制药在优化全球资源配置、聚焦核心业务领域的战略调整中迈出了重要一步。强生被判罚16.4亿美元：据行业媒体报道，强生旗下子公司在推广HIV药物Prezista和Intelence时，存在非法行为，根据判决，需向美国政府支付3.6亿美元，以弥补其违反联邦《虚假申报法》的过错。此外，还需承担12.8亿美元的民事罚款。恒瑞医药Lpa小分子抑制剂授权给默沙东：3月25日，恒瑞医药宣布将Lpa小分子抑制剂HRS-5346的大中华区以外全球权益授权给默沙东。根据协议，默沙东将支付2亿美元预付款，17.7亿美元里程碑金额，以及一定比例的销售分成。联邦制药GLP-1/GIP/GCG授权给诺和诺德：3月24日，联邦制药宣布将GLP-1/GIP/GCG受体激动剂UBT251的大中华区外全球权益授权给诺和诺德，诺和诺德支付2亿美元预付款、18亿美元里程碑金额，以及一定比例的销售分成。UBT251为联邦制药自主研发的GLP-1/GIP/GCG受体激动剂，目前处于糖尿病、减重II期的临床试验阶段。阿斯利康呼吸领域首款生物制剂在华正式商业上市：阿斯利康宣布，其重度嗜酸粒细胞性哮喘（SEA）创新靶向生物制剂本瑞利珠单抗注射液（商品名：凡舒卓）在中国正式商业上市，用于成人和12岁及以上青少年重度嗜酸粒细胞性哮喘的维持治疗。本瑞利珠单抗是精准靶向嗜酸性粒细胞（EOS）的抗IL-5R创新生物制剂，也是阿斯利康在呼吸领域的首款生物制剂。罗氏制药与默克达成战略合作，推进中国肺癌精准治疗：3月26日，罗氏制药和默克共同宣布双方正式签订协议，就特泊替尼在中国大陆市场的商业化达成合作。特泊替尼是全球首个获批上市的MET抑制剂，于2023年12月在中国获批上市，通过靶向METex 14跳跃突变等特定靶点，用于非小细胞肺癌患者的精准治疗。赛诺菲血友病新药获FDA批准：赛诺菲和Alnylam联合开发的潜在重磅siRNA疗法Qfitlia（fitusiran）于近期获美国FDA批准，该疗法通过抑制肝脏中抗凝血酶的生产，有望成为一种革命性的预防手段。这是美国批准的第六款Alnylam发现的RNAi治疗药物，也是唯一一种降低抗凝血酶的治疗药物。生物科技基石药业向欧洲递交舒格利单抗治疗III期非小细胞肺癌的新适应证申请：3月24日，基石药业宣布已向欧洲药品管理局（EMA）提交舒格利单抗的新适应证申请，用于治疗同步或序贯放化疗（CRT）后未出现疾病进展的、不可切除的III期非小细胞肺癌（NSCLC）患者。这是继2024年该药物首次获EMA批准用于转移性鳞状和非鳞状NSCLC一线治疗后，基石药业在欧洲市场推进的第二项适应证。三叶草生物陷2.24亿美元纠纷：3月24日，三叶草生物发布公告，全资附属子公司三叶草生物制药（香港）有限公司收到全球疫苗免疫联盟（GAVI）的书面通知，称其单方面终止预购协议，并要求三叶草香港退还预付款项2.24亿美元。而三叶草生物方面表示，公司拒绝有关退款的要求，认为基于预购协议条款该等要求缺乏依据，并将全力以赴、严正有力地维护自身权益。全球首创阿尔茨海默病新药III期研究再次失败：3月25日，Cassava Sciences公司宣布其Simufilam治疗轻度至中度阿尔茨海默病（AD）的III期REFOCUS-ALZ研究未达到主要终点。此前，该研究因III期RETHINK-ALZ研究失败在2024年11月25日终止开展。资本市场上海莱士拟收购南岳生物：3月26日，上海莱士宣布拟以42亿元收购南岳生物100%股权，南岳生物是湖南省唯一拥有GMP证照的血液制品生产企业，其生产基地的设计产能达500吨、目前旗下在运营的单采血浆站共9家，2024年采浆量达278吨。本次收购旨在进一步拓展公司血浆资源和优质生产基地，与上海莱士现有优势资源形成协同与互补。香雪制药将被ST：近日，香雪制药发布公告，称收到中国证监会发出的《行政处罚事先告知书》，经查明，公司2019年年度报告存在虚假记载；未按规定披露关联方非经营性资金占用，2016年至2020年年度报告存在重大遗漏。香雪制药、公司实控人王永辉，时任董事和高管卢锋、陈炳华、黄滨、徐力、郝世明被警告及罚款15万元到1000万元不等，另外，王永辉被实施5年证券市场禁入措施。智飞生物斥资近6亿增资控股宸安生物：近日，智飞生物发布公告，称将以现金5.93亿元人民币对重庆宸安生物制药有限公司进行增资，取得后者51%的股权。早在2023年11月，智飞生物就与宸安生物原股东就智飞生物拟以现金形式收购宸安生物股权达成初步意向并签署了《股权收购意向性协议》，此次公告意味着该交易真正落地。基因检测公司23andMe申请破产：在多年努力寻找可持续的商业模式却未能成功后，23andMe于近日申请第11章破产保护，以便推动公司出售。在宣布破产的一份声明中，该公司称其首席执行官Anne Wojcicki已立即辞职，不过她将继续留在公司董事会。丽珠生物获10亿元增资：丽珠集团发布公告，称拟使用自有资金10亿元向珠海市丽珠生物医药科技有限公司增资。丽珠生物为公司与控股股东健康元药业集团股份有限公司共同投资的企业，本次交易构成关联交易。增资完成后，丽珠生物的注册资本将从10.95亿元增加至13.02亿元，公司持股比例将提升至66.54%。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 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 | 中国医药手册

财报

2025-03-27

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最具爆发力的Biotech

是时候重新展露成长锋芒了。过去两年半，基石药业在财务端度过颠簸期，已经解决生存问题。2024年财务业绩同比大幅改善，接近盈亏平衡；管线1.0商业化产品实现可持续盈利，舒格利单抗（PD-L1抑制剂）、普拉替尼（RET抑制剂）、阿伐替尼（KIT/PDGFRA抑制剂）将提供稳定现金流和足够安全垫。站在坚实的岸上，下一步即是在研发端向全球市场发起进攻。管线2.0无法低调，拥有全球权益，定位全球前三，而且全部开展全球多中心临床。基石管线2.0阵容不逊于任何头部Biotech，现有10个以上BIC/FIC分子，以两个大药为前锋。其中，CS5001（ROR1 ADC）潜在销售峰值数十亿美元，CS2009（PD-1/VEGF/CTLA-4三抗）有望成为迭代PD-(L)1单抗（百亿美元级）的新一代肿瘤免疫分子。基石药业管线2.0 两年半的蛰伏转型，沉淀出攻守兼备的商业版图——舒格利单抗在国内与海外闯出新的市场空间；普拉替尼、阿伐替尼通过本地化生产降低成本，在国内市场加速放量；FIC/BIC的2.0管线紧扣未来5-10年肿瘤治疗的主线IO+ADC，前景广阔。公司在策略上务实高效，不盲目自信，达到静待收获的最佳状态和身位，中小规模市值已呈现大型市值企业才有的管线布局思路、研发临床能力和国际化实践。从估值来看，基石药业主要计入基本面的企稳，对成长性几乎没有体现。随着MNC从中国BD的侧重点转向创新成色更高的临床前管线，其早研资产将迎来价值重估，而CEO杨建新及董事们不断自掏腰包增持，对公司未来的信心可见一斑。 01 两个硬核大单品我们直奔重点，先看两个大单品的磅礴实力。 CS5001 (ROR1 ADC)全球进度前二，单药治疗临床数据优于默沙东。靶点潜力：ROR1作为ADC的一种高潜力开发靶点，横跨血液瘤+实体瘤，市场广阔。MNC下重金押注，默沙东在2020年11月以27.5亿美元从VelosBio公司获得了处于I期临床阶段的zilovertamab vedotin（VLS-101）。 CS5001紧随其后，进度排全球第二。分子设计：CS5001具有独特的设计，使用肿瘤特异性激活的PBD前毒素载荷（Payload）和连接子(linker)。只在到达肿瘤并被肿瘤细胞内吞后，在溶酶体中其连接子被在肿瘤细胞中高表达的特异性酶切割，释放PBD前毒素，随后PBD前毒素在肿瘤细胞内被激活，进而精准杀死肿瘤细胞。这种连接子加前毒素的双控机制有效地减少与传统PBD载荷有关的毒性问题，而获得更大的安全窗口。CS5001还利用定向偶联技术获得精准的药物抗体比率（DAR），便于实现均质及大规模生产。潜在优效：在初步选定的II期推荐剂量（RP2D）水平（125 µg/kg），CS5001针对非霍奇金淋巴瘤（NHL）和霍奇金淋巴瘤（HL）的客观缓解率（ORR）分别达到70%和100%。这些结果证明CS5001具备快速上市的潜力，并可作为前线联合疗法的骨架产品。与默沙东同靶点竞品zilovertamab vedotin相比，CS5001安全性及疗效均展示出潜在的优效。进度及前景：CS5001全球多中心临床试验正在美国、澳大利亚和中国同步推进。其单药治疗侵袭性和惰性晚期淋巴瘤队列正在有序入组中，后续有望扩展为II期单臂注册研究。除了淋巴瘤之外，治疗多种实体瘤以及一线治疗DLBCL队列也在同步开展。CS5001是目前已知首个在实体瘤和淋巴瘤中均观察到临床疗效的ROR1 ADC，8个队列铺开适应症，覆盖前线、后线、单药、联用多个应用领域，剑指数十亿美元销售目标。 CS2009（PD-1/VEGF/CTLA-4）FIC三抗，临床前数据优于潜在竞品。组合潜力：完成明星组合的未竟任务，PD-(L)1 + VEGFA组合对比PD- (L)1单药，未实现OS获益，而PD-(L)1 + CTLA-4组合PFS与OS均得到显著延长。PD-1、VEGFA和CTLA-4三抗联用可能产生最大的生存获益，而且通过叠加CTLA-4抑制功能，潜在适应症市场空间较PD-1/VEGF双抗进一步扩大，有望真正地颠覆目前PD-(L)1联合化疗在多个肿瘤一线治疗的地位。分子设计：创新的分子设计预期能通过优先结合肿瘤微环境（TME）中的PD-1/CTLA-4双阳性T细胞提升疗效，同时避免作用于CTLA-4单阳性细胞以降低系统性毒性，此外还保留了完整的抗VEGFA臂以阻止肿瘤血管新生。潜在优效：临床前数据显示，CS2009的抗肿瘤活性优于潜在竞争对手，包括PD-1/CTLA-4或PD-1/VEGF双抗和抗PD-1/抗CTLA-4联合疗法，可覆盖广泛瘤种，包括非小细胞肺癌，卵巢癌，肝细胞癌，三阴性乳腺癌等。CS2009具备成为同类首创/同类最优的下一代肿瘤免疫骨架产品的潜力，并替代现有以PD-(L)1为基础的疗法。进度及前景：2025年3月，公司宣布CS2009全球多中心I期临床试验完成首例患者给药，未发生输注反应或其他不良事件。目前已有四款国产PD-(L)1/VEGF双抗出海，成为BD市场的爆款，其中康方生物、礼新医药分别达成50亿美元、33亿美元的交易总额，可以预见CS2009潜在价值巨大。 02 生存无忧，期待BD爆发力基石药业已达成稳定性与成长性的平衡，期待今后释放BD爆发力。坚如基石：管线1.0打好盈利基底管线1.0时代3个商业化药物舒格利单抗、普拉替尼、阿伐替尼将持续为管线2.0输血——一方面通过商业化合作锁定销售费用占比，另一方面基于本地化生产降低成本。目前商业化价值铺垫工作基本完成，未来持续的利润与现金流可期。舒格利单抗已经凭一己之力证明了基石临床开发的强势能力和商业化思路的正确性。其全球的商业化版图不断扩张——2024年舒格利单抗在两大国际市场获批一线治疗鳞状和非鳞状非小细胞肺癌全人群，今年又趁热打铁，将治疗III期非小细胞肺癌新适应症递交EMA，一经获批，舒格利单抗会是欧洲第二款治疗该适应症的PD-(L)1抗体，可贯穿中晚期非小细胞肺癌的治疗，再结合ESMO指南非小细胞肺癌双适应症一线治疗推荐，舒格利单抗的全球市场空间持续扩大。目前在欧美获批的国产大适应症创新药，仅有个位数，而以中国临床数据在欧洲获批上市的仅有舒格利单抗，力证基石药业临床开发的国际化水准。目前，舒格利单抗已在瑞士与中东欧、中东与非洲、拉美市场达成3项商业化合作，覆盖前述地区40个国家，预计还将拿下西欧、东南亚和加拿大等市场。舒格利单抗积累的经验，亦将助推管线2.0的国际化。锐如基石：ADC平台助力创新管线2.0打开天花板基石药业通过全自研管线CS2009显示的先进分子设计技术，将贯穿于整个管线2.0，这意味着后续还有与CS5001、CS2009同等或者更加重磅的分子。而要收获大额BD，还得有自己的技术平台。为推进ADC疗法的创新升级，基石药业开发了专有的ADC技术平台，一边进行自有知识产权连接子的开发，一边优化不同靶点和毒素，以提升ADC的系统稳定性与肿瘤选择性。β-葡糖醛酸连接子拥有高亲水性，可以改善ADC的循环稳定性。在肿瘤微环境中过度表达的β-葡糖醛酸酶以及连接子上串联的组织蛋白酶的切割位点则进一步保证毒素的肿瘤选择性释放。基石药业专有的ADC技术平台，已经摆满了BIC/FIC分子。有双抗ADC。CS5007（EGFR/HER3 ADC）对EGFR和HER3信号传导具有强效的协同阻断活性，目标适应症涵盖非小细胞肺癌、头颈鳞状细胞癌及结直肠癌等实体瘤；CS5008（DLL3/SSTR2 ADC）通过同时靶向小细胞肺癌、神经内分泌癌和神经内分泌瘤等疾病中频繁共表达的SSTR2与DLL3，旨在克服单靶点疗法难以突破的肿瘤异质性治疗瓶颈。有全新靶点ADC。CS5006 (ITGB4 ADC)靶向全新靶点ITGB4，在非小细胞肺癌、头颈鳞状细胞癌、食管鳞状细胞癌等实体瘤领域有广阔的应用前景。整合素β4 (ITGB4)是一种跨膜蛋白，仅与整合素α6 (ITGA6) 结合形成异二聚体（α6β4），并以层粘连蛋白作为细胞外配体。ITGB4被视为多种肿瘤的标志物，其高表达与多种肿瘤的侵袭性和不良预后相关。扩大能力圈，还有自免多抗。CS2013为靶向两个对B细胞发育至关重要的靶点的双特异性分子，旨在治疗系统性红斑狼疮（SLE）、IgA肾病（IgAN）及B细胞介导自身免疫性疾病。CS2015是一种双特异分子，可同时阻断两种互补且具有协同作用的通路，加强抑制Th2媒介的免疫反应，旨在治疗特应性皮炎(AD)、哮喘、系统性硬化症(SS)、化脓性皮肤炎(HS)等疾病。基石归来仍是追风少年，既有扑面而来的朝气，又有勤勉踏实的作风，令人心安。产品线形成良好的梯度，3个商业化药物产生现金流，2个重磅药物（CS5001、CS2009）提供成长性和大BD潜力，众多早研管线带来无限可能性。成长的烦恼都随风而去吧，从今往后，在创新之路上发力奔跑。

抗体药物偶联物临床结果引进/卖出临床1期临床2期

2025-03-27

·PRNewswire

CStone Pharmaceuticals Announces 2024 Annual Results and Recent Business Progress

Financial Performance: Strong Year-over-Year Improvemen t - Total Revenue: RMB 407.2 million, including RMB 232.1 million in licensing and royalty income. - Net Loss Reduction: 71.5% year-over-year improvement. Key Product Advancements - Sugemalimab (Anti-PD-L1 mAb) - Regulatory Milestones: - China: Approved for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). - EU & UK: Approved for first-line treatment of stage IV non-small cell lung cancer (NSCLC); stage III NSCLC new indication application submitted to EMA. - Global Partnerships: Three strategic partnerships across 40+ countries, to accelerate global commercialization. - Avapritinib (AYVAKIT® ) - Localized Production: Approved for localized manufacturing in China, enhancing cost efficiency. - Commercial Collaboration: Partnered with Hengrui to expand market access in China. Clinical Pipeline Progress - CS5001 (ROR1 ADC): - Leading Position: Top 2 globally in clinical development for ROR1-targeted ADCs. - Phase I Clinical Data: Demonstrated encouraging monotherapy efficacy in aggressive/indolent lymphomas with a manageable safety profile; positioned for accelerated registration. - Phase Ib Expansion: Evaluating first-line/frontline, monotherapy/combination therapies in lymphomas and solid tumors across the U.S., Australia, and China. - CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody): - First-in-Human Trial: Global Phase I study initiated in Australia; first patient dosed. - Preclinical Differentiation: Superior tumor suppression vs. benchmarked competitors; potential first-in-class/best-in-class IO backbone therapy. Pipeline 2.0: Fueling Long-Term Innovation - More than 9 Differentiated Candidates: Focus on first-in-class/best-in-class assets, including multispecific antibodies and ADCs, with global rights and broad therapeutic potential. - Proprietary ADC Platform: Enables rapid development of high-value candidates, reinforcing leadership in next-generation oncology. SUZHOU, China, March 27, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today reported 2024 annual results and recent business updates. Business Highlights For the year ended December 31, 2024 and up until the date of this results announcement, key milestones have been achieved across regulatory approvals, clinical advancements, and strategic collaborations, reinforcing our position as a leader in innovative therapeutics. A shortlist of our achievements over this period includes: Commercial Products • CEJEMLY® (sugemalimab), anti-PD-L1 antibody – Global expansion and regulatory approvals Sugemalimab secured three new drug application approvals in 2024, including its fifth indication in mainland China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). Sugemalimab also gained approvals in the EU and UK for first-line treatment of stage IV NSCLC, marking its entry into major international markets. We have recently completed the regulatory submission to the European Medicines Agency (EMA) for the new indication application of sugemalimab in the treatment of Stage III NSCLC. – Strategic alliances drive global commercialization Partnered with Ewopharma AG in May 2024 for commercialization in Central and Eastern Europe (CEE) and Switzerland. Collaborated with Pharmalink Store – L.L.C – O.P.C in November 2024 to expand access across the Middle East, North Africa (MENA) Region and South Africa. Entered an agreement with SteinCares in January 2025 for Latin America (LATAM). Additional partnerships in Western Europe, Southeast Asia, and Canada are anticipated in 2025. – Robust clinical data reinforce efficacy GEMSTONE-304 Study: Final progression-free survival (PFS) and interim overall survival (OS) data for the first-line esophageal squamous cell carcinoma (ESCC) published in Nature Medicine (February 2024). GEMSTONE-302 Study: Four-year OS data for stage IV NSCLC presented at the 2024 Congress of European Society for Medical Oncology (ESMO), confirming sustained survival benefits. GEMSTONE-303 Study: Final PFS and OS analysis for GC/GEJC with combined positive score (CPS) ≥5 published in the top-tier medical journal-Journal of the American Medical Association (JAMA) (February 2025). ESMO Guideline Recognition: CEJEMLY® recommended as first-line NSCLC therapy in ESMO's 2025 Non-Oncogene-Addicted Metastatic NSCLC Living Guidelines, covering both squamous and non-squamous NSCLC (February 2025). • AYVAKIT ® (avapritinib), KIT/PDGFRA inhibitor – Localized manufacturing in China The National Medical Products Administration of China (NMPA) approved domestic production of AYVAKIT ® tablets (300 mg and 100 mg) in June and August 2024 respectively. Full transition to localized supply is expected in 2025, improving cost efficiency. – NRDL inclusion enhances accessibility AYVAKIT® (avapritinib) has been included to China's National Reimbursement Drug List (NRDL), effective January 1, 2024 for unresectable or metastatic gastrointestinal stromal tumor (GIST), harboring the PDGFRA exon 18-mutated, including PDGFRA D842V mutations. This significantly improves AYVAKIT ®'s affordability for eligible patients. – Commercial partnership with Hengrui In July 2024, we forged a new partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd., granting them the exclusive promotion rights in mainland China to amplify commercial reach and profitability. • GAVRETO ® (pralsetinib), RET inhibitor – Progress towards localized manufacturing The NMPA's Center for Drug Evaluation (CDE) accepted the manufacturing localization and bioequivalence (BE) study application in April 2024, and regulatory review is ongoing. – Sustained collaboration with Allist Commercial operations has been transferred to Shanghai Allist Pharmaceuticals Co., Ltd in the first half of 2024 under an exclusive agreement signed in November 2023. Collaboration remains strong to maximize market penetration. Clinical Stage Core Assets • CS5001 (ROR1 ADC) – Phase Ib clinical trial with registration potential A global multicenter clinical trial of CS5001 is actively enrolling patients across the United States of America (U.S.), Australia and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas with potential to be expanded into a Phase II single-arm registrational study. Additional cohorts, including CS5001 in combination with R-CHOP (Rituximab + Cyclophosphamide + Hydroxydaunorubicin + Vincristine + Prednisone) for the first-line diffuse large B-cell lymphoma (DLBCL), and CS5001 in combination with standard of cares (SOC) for front-line DLBCL will be initiated to expand the therapeutic potential of CS5001 across all DLBCL stages. CS5001 is also being studied as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors, underscoring its versatility across oncology indications. – Compelling clinical data at ASCO & ASH 2024 Phase Ia data for CS5001 presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the 66th American Society of Hematology (ASH) Annual Meeting demonstrated that CS5001 is so far the first receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC) known to demonstrate clinical anti-tumor activity in both solid tumors and lymphomas. Clinical data of CS5001 revealed superior efficacy and favorable safety profile as a monotherapy for both aggressive and indolent advanced lymphomas. At the tentative recommended Phase II dose (RP2D) (125 μg/kg), CS5001 achieved an objective response rate (ORR) of 70% in non-Hodgkin lymphoma (NHL) and 100% in Hodgkin lymphoma (HL). These results support its potential as a faster-to-market candidate and a frontline combination therapy backbone. • CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) – Global Phase I clinical trial initiated A global multicenter first-in-human (FIH) trial among solid tumors has been launched in Australia in December 2024, with subsequent expansion to China and the U.S.. The first patient was dosed in March 2025. – Potential FIC/BIC next-generation I/O backbone Preclinical data presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) highlighted its first-in-class (FIC) or best-in-class (BIC) potential with superior antitumor activity compared to potential competitors benchmarks, including PD-1/CTLA-4 or PD-1/VEGF bispecific antibody and PD-1/ CTLA-4 combination therapies. Unique trispecific mechanism positions CS2009 as a next-generation immuno-oncology backbone with broad applicability. Preclinical/IND-enabling Stage Programs and ADC Platform CStone's preclinical pipeline includes more than nine promising candidates, each with global rights and focusing on FIC/BIC profiles with broad indications. These candidates include multispecific antibodies, ADCs and radionuclide drug conjugates (RDC) covering various therapeutic fields such as oncology, autoimmune diseases, and metabolic disorders. The Company is dedicated to delivering clinical value through the development of these Pipeline 2.0 candidates, which will undergo international, multi-center clinical trials to maximize their global potential. CStone has also developed an in-house ADC technology platform featuring proprietary linkers, optimized for diverse targets and payloads. This platform supports multiple upcoming ADC projects in Pipeline 2.0, including CS5007 (dual targeting epidermal growth factor receptor (EGFR) & human epidermal growth factor receptor 3 (HER3)), CS5005 (targeting somatostatin receptor 2 (SSTR2)), CS5008 (dual targeting delta-like ligand 3 (DLL3) & SSTR2) and CS5006 (targeting ITGB4). Future and Outlook As we look to the future, we reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments. Concurrently, we aim to maximize the global commercial potential of our approved therapies through strategic collaborations and localized manufacturing enhancements. Key growth drivers in 2025 include: • Clinical milestones – Progress CS5001 (ROR1 ADC) and CS2009 (PD-1/VEGF/CTLA-4 trispecific) towards pivotal trials and in parallel pursue global partnerships to expedite development. – Advance early-stage candidates (e.g., CS2011, CS5007, CS5005, CS5008, CS5006) into clinical stages within the next two years. • Commercial excellence – Maximize the value of approved products through strategic collaborations and manufacturing localization (e.g., AYVAKIT®, GAVRETO®) to enhance profitability and market reach. – Accelerate ex-China commercialization of CEJEMLY® (sugemalimab) via regional partnerships. • Innovation and technology – Strengthen proprietary platforms (e.g., ADC technology) to sustain pipeline growth. – Present key clinical data at major conferences (e.g., AACR, ESMO, ASH) Financial Highlights International Financial Reporting Standards (IFRS) Measures: • Revenue was RMB407.2 million for the year ended December 31, 2024, composed of RMB175.1 million in sales of pharmaceutical products (avapritinib and pralsetinib), RMB204.0 million in license fee income and RMB28.1 million in royalty income of sugemalimab, representing a year-on-year increase of RMB108.3 million, or 113.1%, in license fee which was largely offset by a decrease in revenue from sales of pharmaceutical products, such that total revenue decreased by RMB56.6 million, or 12.2%, year on year. • Research and development expenses were RMB134.7 million for the year ended December 31, 2024, representing a decrease of RMB393.1 million from RMB527.8 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third-party contracting costs. • Administrative expenses were RMB77.8 million for the year ended December 31, 2024, representing a decrease of RMB104.9 million from RMB182.7 million for the year ended December 31, 2023, primarily due to the decrease in employee costs. • Selling and marketing expenses were RMB133.8 million for the year ended December 31, 2024, representing a decrease of RMB65.5 million from RMB199.3 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs and others which was partially offset by an increase in channel service fee. • Loss for the year was RMB91.2 million for the year ended December 31, 2024, representing a decrease of RMB276.0 million, or 75.2%, from RMB367.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses. • Cash and cash equivalents and time deposits were RMB672.9 million as of December 31, 2024. Non-International Financial Reporting Standards (Non-IFRS) Measures: • Research and development expenses excluding the share-based payment expenses were RMB124.7 million for the year ended December 31, 2024, representing a decrease of RMB410.0 million from RMB534.7 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third party contracting costs. • Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB224.4 million for the year ended December 31, 2024, representing a decrease of RMB113.8 million from RMB338.2 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs. • Loss for the year excluding the share-based payment expenses was RMB94.0 million for the year ended December 31, 2024, representing a decrease of RMB236.2 million, or 71.5%, from RMB330.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses. 2024 Annual Results Conference Call The Company will host a 2024 annual results conference call at 10:00 a.m. (Beijing Time) on Friday March 28, 2025. Please attend the conference call through the link: (Password:067784). About CStone CStone Pharmaceuticals (HKEX: 2616), founded in late 2015, is an innovation-driven biopharmaceutical company focused on advancing cutting-edge oncology therapies. Committed to addressing unmet medical needs globally, the company has achieved remarkable milestones since its inception, including the successful launch of four novel therapeutics and securing 16 regulatory approvals across nine indications. CStone's robust pipeline features 16 high-potential candidates, including first-in-class and best-in-class assets such as antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. The company further distinguishes itself through a seasoned leadership team with comprehensive expertise in drug development—from preclinical research and clinical trials to manufacturing, business development, and commercialization. For more information about CStone, please visit . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期上市批准引进/卖出临床结果ASH会议

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	Pfizer Inc.	2023-12-08
食管鳞状细胞癌	中国	基石药业（苏州）有限公司	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	基石药业（苏州）有限公司	2021-12-20
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
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

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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（苏州）有限公司	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（苏州）有限公司	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（苏州）有限公司	2019-03-28
胃腺癌	临床3期	中国	基石药业（苏州）有限公司	2019-01-22
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
非小细胞肺癌 III期	临床3期	中国	基石药业（苏州）有限公司	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, 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	壓選淵艱積壓選壓餘膚(糧鬱鹹廠選夢醖願齋夢) = 觸糧壓簾鹹蓋鑰鑰觸齋獵網壓餘淵艱糧鬱糧獵 (鹽醖醖構構膚窪顧簾餘, 13.3 ~ 17.8) 更多	积极	2025-02-24
				Placebo + CAPOX	壓選淵艱積壓選壓餘膚(糧鬱鹹廠選夢醖願齋夢) = 積窪網夢壓遞範憲夢餘獵網壓餘淵艱糧鬱糧獵 (鹽醖醖構構膚窪顧簾餘, 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	艱醖願糧願遞蓋觸鏇選(遞構廠願製壓艱餘網積) = 衊獵壓襯膚顧鹹餘廠壓網鏇範壓築遞觸選廠壓 (顧餘襯衊獵壓鹹艱膚廠 ) 更多	积极	2024-09-14
				Placebo + Platinum-based chemotherapy	艱醖願糧願遞蓋觸鏇選(遞構廠願製壓艱餘網積) = 蓋艱遞衊廠遞餘選襯網網鏇範壓築遞觸選廠壓 (顧餘襯衊獵壓鹹艱膚廠 ) 更多
NCT03595657 (GEMSTONE-201, CTgov)	临床2期	结外NK-T细胞淋巴瘤	80	sugemalimab (CS1001)	憲夢憲顧顧餘觸範襯醖 = 窪醖淵製網壓醖餘憲範醖願憲膚夢觸範艱積簾 (遞窪鏇顧遞餘齋淵鹽壓, 廠構鏇憲餘鏇鏇艱鬱範 ~ 鬱膚觸夢夢築憲蓋遞顧) 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	蓋鬱網繭鑰鑰積網窪獵(憲簾淵夢夢糧製鑰窪製) = 壓簾鹽顧襯觸製鏇鹽醖餘製範鑰憲鑰積願鹽簾 (艱襯廠襯壓夢窪範壓壓 ) 更多	积极	2024-05-24
				Sugemalimaby (RT) plus Sugemalimab	觸築壓齋範膚鹽襯顧鏇(繭網構觸醖範網獵鬱鑰) = 蓋鹹齋艱構夢鹹範選糧積獵範淵蓋選餘醖鏇鹹 (夢醖築範範鹹廠簾顧製 ) 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	憲積構壓鬱廠膚構餘鏇(壓觸範選範壓齋鏇獵襯) = 廠醖製鑰廠簾構蓋願齋製遞範憲鹽簾鹽廠鹹願 (網積願積構鹹獵憲顧餘 ) 更多	积极	2024-02-01
				placebo+chemotherapy	憲積構壓鬱廠膚構餘鏇(壓觸範選範壓齋鏇獵襯) = 繭艱淵築膚網襯遞選構製遞範憲鹽簾鹽廠鹹願 (網積願積構鹹獵憲顧餘 ) 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%)	簾壓艱憲襯鹹窪艱網願(願醖製鑰襯積壓襯構壓) = 觸窪憲網鬱獵襯鏇衊願膚鏇築衊襯顧淵衊鬱觸 (夢遞鑰夢鹹簾廠獵艱遞, 13.27 ~ 17.81) 更多	积极	2023-10-21
				Placebo + CAPOX (PD-L1 Expression Level >=5%)	簾壓艱憲襯鹹窪艱網願(願醖製鑰襯積壓襯構壓) = 淵餘憲鹽鹽觸艱淵艱膚膚鏇築衊襯顧淵衊鬱觸 (夢遞鑰夢鹹簾廠獵艱遞, 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	積積廠獵衊製壓餘夢醖(齋艱鹽淵製齋糧繭積積) = 繭憲鏇淵艱鹹鏇醖願積淵壓繭襯構膚淵選遞餘 (積鹽鑰襯糧構醖淵淵餘 ) 更多	积极	2023-07-01
				Placebo + FP	積積廠獵衊製壓餘夢醖(齋艱鹽淵製齋糧繭積積) = 膚憲鑰膚壓蓋齋壓顧艱淵壓繭襯構膚淵選遞餘 (積鹽鑰襯糧構醖淵淵餘 ) 更多
NCT03789604 (GEMSTONE-302, ASCO2023)	N/A	非小细胞肺癌一线	-	Sugemalimab + chemotherapy	鹽鑰觸鑰襯築壓淵蓋顧(壓積憲簾淵選構簾夢蓋) = 廠顧製築窪鹹齋簾獵膚選範蓋蓋遞鬱簾艱憲餘 (壓壓膚積齋襯遞積鏇鬱 )	积极	2023-05-31
				Placebo + chemotherapy	鹽鑰觸鑰襯築壓淵蓋顧(壓積憲簾淵選構簾夢蓋) = 獵餘淵積觸積製構憲膚選範蓋蓋遞鬱簾艱憲餘 (壓壓膚積齋襯遞積鏇鬱 )
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	顧簾憲齋蓋夢選壓築淵(簾遞窪醖齋積鹽襯繭鏇) = 鑰鹹壓鹹夢淵鹽範艱廠廠憲艱艱蓋壓選製簾壓 (範醖製壓夢艱選繭齋鹹 ) 更多	积极	2022-11-11
				Oxaliplatin+Capecitabine+Placebo	顧簾憲齋蓋夢選壓築淵(簾遞窪醖齋積鹽襯繭鏇) = 齋衊遞廠製遞願蓋選餘廠憲艱艱蓋壓選製簾壓 (範醖製壓夢艱選繭齋鹹 ) 更多
NCT03595657 (GEMSTONE-201, ASCO2022) 人工标引	临床2期	淋巴瘤	80	sugemalimab	獵膚簾襯壓構淵構網醖(鹹淵窪願選簾鹽顧築鑰) = 鹽鏇襯選襯衊餘夢鹽餘網繭鹹艱憲鑰獵醖顧齋 (膚鏇夢餘憲憲顧鏇壓鬱, 34.8 ~ 57.8) 更多	积极	2022-06-02