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2024-11-01

申办/合作机构

基石药业（苏州）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

NCT06097962 / Recruiting早期临床1期

Exploratory Study of NK510 Combined With PD-1 Blockade in the Treatment of Relapsed and Refractory Advanced NSCLC

This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced NSCLC.NK510 will be administered in combination with PD-1 blockade. Patients are required to undergo a biopsy for confirmation of tumor PD-L1 expression,and EGFR,ROS1,ALK gene must be negative. The safety and efficacy of this treatment will be evaluated.

开始日期2023-07-01

申办/合作机构

上海贝斯昂科生物科技有限公司

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）

2024-03-01·Nature medicine1区 · 医学

First-line sugemalimab with chemotherapy for advanced esophageal squamous cell carcinoma: a randomized phase 3 study

1区 · 医学

Article

作者: Ji, Yanxia ; Bai, Yuxian ; Zhou, Fuyou ; Ni, Jing ; Pan, Yueyin ; Zhang, Zhen ; Li, Qingshan ; Shi, Qingmei ; Liu, Bo ; Hu, Jin ; Wang, Jufeng ; Zhang, Jingdong ; Huang, Rong ; Yang, Shujun ; Bai, Wei ; Ye, Feng ; Li, Na ; Chen, Long ; Deng, Ting ; Chen, Zhendong ; Qu, Chenglin ; Zhou, Jun ; Yin, Xianli ; Xu, Yan ; Li, Jin ; Wang, Bo ; Gao, Shegan ; Liu, Lianke ; Yang, Jason ; Cang, Shundong ; Luo, Hui ; Yang, Quanliang

Although antiprogrammed death 1 antibody plus chemotherapy has recently been approved for first-line esophageal squamous cell carcinoma (ESCC), antiprogrammed death-ligand 1 antibody may offer another combination option in this setting. In this multicenter, randomized, double-blinded phase 3 trial a total of 540 adults (aged 18-75 years) with unresectable, locally advanced, recurrent or metastatic ESCC and who had not received systemic treatment were enrolled. All patients were randomized at 2:1 to receive either sugemalimab (an anti-PD-L1 antibody; 1,200 mg) or placebo every 3 weeks for up to 24 months, plus chemotherapy (cisplatin 80 mg m^-² on day 1 plus 5-fluorouracil 800 mg m^-² day^-1 on days 1-4) every 3 weeks for up to six cycles. At the prespecified interim analysis this study had met dual primary endpoints. With a median follow-up of 15.2 months, the prolongation of progression-free survival was statistically significant with sugemalimab plus chemotherapy compared with placebo plus chemotherapy (median 6.2 versus 5.4 months, hazard ratio 0.67 (95% confidence interval 0.54-0.82), P = 0.0002) as assessed by blinded independent central review. Overall survival was also superior with sugemalimab chemotherapy (median 15.3 versus 11.5 months, hazard ratio 0.70 (95% confidence interval 0.55-0.90, P = 0.0076). A significantly higher objective response rate (60.1 versus 45.2%) as assessed by blinded independent central review was observed with sugemalimab chemotherapy. The incidence of grade 3 or above treatment-related adverse events (51.3 versus 48.4%) was comparable between the two groups. Sugemalimab plus chemotherapy significantly prolonged progression-free survival and overall survival in treatment-naïve patients with advanced ESCC, with no unexpected safety signal. The ClinicalTrials.gov identifier is NCT04187352 .

Journal of chemotherapy (Florence, Italy)

Clinical benefit of anti-PD-1/PD-L1 plus chemotherapy in first-line treatment for patients over the age of 65 or 75 with metastatic non-small cell lung cancer (NSCLC)

Review

作者: Sadaoui, Nassyma ; Chouaïd, Christos ; Bouharati, Djamila ; Landre, Thierry ; Taleb, Chérifa

Anti-PD-1/PD-L1 plus chemotherapy (CT) is considered the standard of care in first line treatment of metastatic NSCLC. However, the clinical benefit of this combination in older patients is controversial. We performed a meta-analysis of phase III randomized trials that compared PD-1/PD-L1 inhibitor plus CT with CT alone in first line of treatment for older patients with advanced NSCLC. Subgroups of patients over 65 and over 75 were analyzed. The outcomes included overall survival (OS) and progression-free survival (PFS). A fixedeffect model was used. We analyzed ten trials with an anti-PD-1 (camrelizumab, cemiplimab, nivolumab, pembrolizumab, tislelizumab or toripalimab) and six trials with an anti-PD-L1 (atezolizumab, durvalumab or sugemalimab), including 3666 patients over the age of 65 (41%) and 282 patients over the age of 75 (<10%). For patients over 65 years of age, anti-PD- 1/PD-L1 + CT was significantly associated (hazard ratio [95% confidence interval]) with prolonged OS (0.79 [0.72-0.86]; p < 0.00001) and P FS (0.63 [0.58-0.68]; p < 0.00001) compared to CT alone. Survival benefits occurred in both anti-PD-1 and anti-PD-L1 trials. For patients over 75 years of age, OS benefit was not statistically significant (0.88 [0.67-1.16]; p = 0.37). For patients over the age of 65 with untreated NSCLC, the anti-PD-1/PD-L1 combination with CT, compared with CT alone, is associated with significantly improved OS and PFS. Due to the low number of patients, it is difficult to conclude for those over 75.

2024-01-19·Medicine

Advances and challenges of first-line immunotherapy for non-small cell lung cancer: A review

Review

作者: Zhou, Haining ; Yan, Hang ; Luo, Xinyue ; Zhang, Jun ; Guo, Haiyang ; Qin, Chao

The current use of immune checkpoint inhibitors (ICIs) for the treatment of lung cancer has dramatically changed the clinical strategy for metastatic non-small cell lung cancer (mNSCLC). As a result of great achievements in clinical trials, 6 programmed death-1 inhibitors (sintilimab, camrelizumab, tislelizumab, pembrolizumab, cemiplimab, and nivolumab), 2 programmed death-ligand 1 inhibitors (sugemalimab and atezolizumab), and 1 cytotoxic T lymphocyte-associated antigen-4 inhibitor (ipilimumab) have been approved as first-line treatment for mNSCLC by the US Food and Drug Administration. Recently, research on ICIs has shifted from a large number of second-line to first-line settings in clinical trials. Results from first-line trials have shown that almost all driver-negative mNSCLC are treated with ICIs and significantly prolong patient survival; however, the low response rate and adverse reactions to immunotherapy remain to be addressed. Here, we summarize the use of ICIs, including monotherapy and combination therapy, in the first-line treatment of mNSCLC in recent years and discuss the low response rate and adverse reactions of ICIs as well as the challenges and expectations for the first-line treatment of mNSCLC in the future.

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项与舒格利单抗相关的新闻（医药）

2024-09-10

·IQVIA艾昆纬

IQVIA发布 | 2024上半年中国PD-(L)1药物市场回顾

中国PD-(L)1市场概览基于IQVIA肿瘤动态信息数据库（Oncology Dynamics™，OD）最新数据，2024上半年中国PD-(L)1市场报告正式出炉。数据显示，2024上半年肿瘤治疗免疫类药物PD-(L)1的市场患者使用占比呈现较大的增长，恢复到之前的两位数增长率。与2023上半年相比，同比增长率为13.7%；与2023下半年环比，增长率为12.4%，较之2023下半年，增长速度加快，患者使用占比保持持续上升。截至2024年8月，今年已有3个PD-(L)1类新产品上市。国内第7个获批上市的PD-L1，也是第5个国产PD-L1贝莫苏拜单抗，在2024年5月初首次获批上市，首个适应症为广泛期小细胞肺癌一线治疗；国内首个获批上市的VEGFR-A/PD-1双抗依沃西单抗在2024年5月末获批上市，首个适应症为非小细胞肺癌二线治疗；国内第11个获批上市的PD-1，也是第9个国产PD-1恩朗苏拜单抗，在2024年6月末获批上市，首个适应症为宫颈癌二线及后线治疗。目前共有20个PD-(L)1产品在国内获批上市。已上市的产品中，2024年至今有5个产品有新适应症获批。可瑞达在2月和6月分别获批了胆道癌和胃或胃食管结合部腺癌相关的新适应症；拓益在1月、4月和6月获批了非小细胞肺癌、肾细胞癌、小细胞肺癌和三阴性乳腺癌相关的新适应症；百泽安在1月、4月和6月获批了肝细胞癌，胃或胃食管结合部腺癌和小细胞肺癌关的新适应症；安尼可在4月获批了鼻咽癌相关的新适应症；择捷美在3月获批了胃或胃食管结合部腺癌相关的新适应症。同时，截至2024年8月，PD-(L)1领域尚有3个新药在首次上市申请中，共计4项申请，菲诺利单抗（神州细胞工程有限公司），塔戈利单抗（四川科伦博泰生物医药）以及罗氏的阿替利珠单抗皮下注射，预计分别将在2025年2月、6月、7月获批上市。另外双靶免疫药物也有新产品申请中，如康方生物的VEGF-A；PD-1（依沃西单抗）和齐鲁制药的CTLA4；PD-1（艾帕洛利单抗+托沃瑞利单抗），预计将于2024年下半年获批。同时，2024年至目前，已上市的20个PD-(L)1产品中，有11个产品，共24项新受理的扩展新适应症的上市申请在进行中。其中帕博利珠单抗、纳武利尤单抗、派安普利单抗都有预计能在2024年获批上市的新适应症，比如纳武利尤单抗的MSI-H或dMMR实体瘤和结直肠癌新适应症，预计将于2024年10月获批上市。详解PD-(L)1市场截至2024年8月，目前的20款已上市的PD-(L)1类产品，其中13个PD-1（其中2个为双抗CTLA4/PD-1和VEGF-A/PD-1）、7个PD-L1，涉及10多个瘤种和相关的泛瘤种。目前从产品的市场患者份额来看，总体和2023下半年相仿，2024上半年国产品牌仍占主导，国产品牌总计占PD-(L)1市场83%的患者份额。从IQVIA艾昆纬Oncology Dynamic™监测的12个城市市场表现来看，一线城市较二线城市的PD-(L)1使用占比相对略高。在所有PD-(L)1品牌中，基于OD数据库的样本病例数量来看，2024上半年总体患者份额的前3位仍均为国产品牌，达伯舒继2023下半年份额明显上升后，2024上半年的份额保持稳定；随后依次是百泽安和艾瑞卡，百泽安份额保持稳定，艾瑞卡份额继续有所下降。可瑞达份额2024上半年略有下降。总体来看，与2023下半年相仿，市场格局仍相对集中，前2位品牌份额目前超过一半，达56%；前3位共占超过65%的患者份额；进口品牌中，可瑞达（K药）的患者份额排名稳定，位居第4位（进口药中位居第一），泰圣奇的患者份额和排名都有上升，目前位居第7位（进口药中位居第二），欧狄沃（O药）的患者份额排名下降，位居第9位。 2023年版（2024年1月开始执行）的医保目录（NRDL）中，有4个国产品牌续约，暂无进口品牌和其它国产品牌进入医保目录。在所有PD-(L)1药物治疗的瘤种中，基于OD数据库的样本病例数来看，2024上半年非小细胞肺癌仍是免疫治疗的主要领域，占PD-(L)1类用药物患者量的28%，消化道肿瘤领域也占据相当的比重，其中肝癌和食管癌占比上升，目前肝癌占14%，胃癌占12%，食管癌占9%。从治疗线看，晚期治疗特别是晚期一线治疗的患者使用PD-(L)1类用药物的比例较高，患者使用份额达28%，与2023下半年相比，患者使用份额增长4%，且患者体量是最大的人群；晚期三线及以上治疗是目前所有治疗线中患者使用份额增长最快的，与2023下半年相比，患者使用份额增长5%，患者使用份额达29%；新辅助治疗在2023上半年患者份额迅速上涨后，在2024上半年保持小幅上涨，患者使用份额达23%。更多内容请订阅完整报告《中国PD-(L)1药物市场动态报告（2024上半年）》《中国PD-(L)1药物市场动态报告（2024上半年）》主要目录 OD数据库介绍 PD-(L)1的上市和适应症更新及最新医保情况 PD-(L)1的整体竞争格局与趋势主要瘤种PD-(L)1药物渗透与主要治疗方案，PD-(L)1品牌分布和趋势，以及竞争格局主要PD-(L)1品牌的瘤种贡献与趋势免疫靶点的检测率现状和趋势药物治疗的疗程 OD覆盖的12个样本城市一线：北京市、上海市、广州市二线：成都市、重庆市、南京市、沈阳市、天津市、武汉市、西安市、杭州市、济南市样本医院：210家左右样本医院，99%以上为三甲医院(包括综合及专科医院)，极少量三乙医院。以上数据来源：IQVIA肿瘤动态信息数据库《中国PD-(L)1药物市场动态报告（2024上半年）》 (具体数据以实际报告为准) 更多详情，敬请垂询： Mark Liao IQVIA艾昆纬高级执行总监、中国肿瘤领域解决方案负责人 yuan.liao@iqvia.com Jessica Yang IQVIA艾昆纬肿瘤动态数据库产品经理 jessica.yang2@iqvia.com 声明原创内容的最终解释权以及版权归IQVIA艾昆纬中国所有。如需转载文章，请发送邮件至iqviagcmarketing@iqvia.com。

上市批准免疫疗法

2024-09-03

·药融圈

超162亿美元！手握创新药的国内biotech出海盘点（2024年1-9月）

▲10月26-27日成都中国临床试验产业发展大会免费报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。中国药企出海是当前医药行业的一个重要趋势，这一趋势反映了中国药企在研发创新、市场拓展以及国际化战略方面的积极进展。据不完全统计，2024年1月至今至少有21起中国药企对外授权事件（因公众号定位，未统计小分子药物）。从产品分类来看：有6款ADC产品、7款单抗产品、5款双抗产品、4款GLP-1产品、2款RNAi产品、1款疫苗产品、1款核药产品。国外药企“掘金”国产ADC的热情始终居高不下。从企业来看：达成出海交易次数较多的是：百奥赛图（3次）、百奥泰生物（2次）和宜联生物（2次）。从交易金额来看：21起出海交易总价值超162亿美元。其中交易金额最高的为舶望制药，以41.65亿美元将多款RNAi疗法授权诺华；此外，7项交易总价值超过10亿美元。普众发现&Adcendo 2024年8月20日，普众发现和Adcendo共同宣布，双方就代号为ADCE-T02（普众发现研发代号AMT-754）的一种新型、高度差异化的靶向组织因子（Anti-TF）的抗体偶联药物（ADC）达成许可协议，Adcendo将获得在大中华区以外的全球独家开发和商业化权利，而普众发现将保留在大中华地区（包括中国大陆、香港特别行政区、澳门特别行政区及台湾地区）的开发和商业化权利。根据协议的财务条款，普众发现将获得数千万美元的首付款，并在达成后续开发、监管及商业里程碑时，将收取总计超过10亿美元的总里程碑付款，以及基于全球（不包括大中华地区）净销售额的个位数至低两位数百分比的销售提成。 ADCE-T02是一种新型、高度差异化的Anti-TF ADC。其独特的抗体设计能够减弱对凝血通路的影响，同时，T1000-exatecan连接子-有效载荷技术平台经研究证明，能够放大“旁观者效应”、提高连接子稳定性，并具备克服耐药性机制的潜力。这些差异化的特性有望转化为更高的临床治疗响应率、更长的疗效持续时间以及更好的安全性，拥有更优异的治疗窗口。ADCE-T02已在澳洲申报进入临床试验，预计将于近期申报美国IND。宜明昂科&Instil 2024年8月1日，宜明昂科与Instil Bio宣布达成协议，Instil将获得宜明昂科专有的PD-L1xVEGF双特异性抗体IMM2510以及下一代CTLA-4抗体IMM27M在大中华区以外的开发和商业化权利。根据协议条款，Instil全资子公司（SynBioTx）将获得IMM2510和IMM27M在大中华地区以外的全球开发和商业化权利，而宜明昂科将保留在大中华地区(包括台湾、澳门和香港)的开发和商业化权利。宜明昂科将获得高达5,000万美元的首付款及潜在近期付款，并将在达成若干开发、监管及商业里程碑时，有望收取总计超过20亿美元的里程碑付款，以及基于全球（不包括大中华地区）销售净额的个位数至低两位数百分比的销售提成。 IMM2510是一种新型的、潜在同类最优的PD-L1xVEGF双特异性抗体，由抗PD-L1抗体融合到血管内皮生长因子 (VEGF) 受体而组成，结合VEGF。IMM2510已经完成了一项用于晚期实体瘤的剂量递增临床试验，并显示出多个疗效事件，其中包括PD-1抑制剂治疗失败的鳞状非小细胞肺癌 (NSCLC) 患者。 IMM27M是具有增强型ADCC活性的新一代CTLA-4抗体，旨在促进肿瘤内调节性T细胞耗损，以提高第一代CTLA-4抗体的疗效并降低其毒性。IMM27M已经完成了一项剂量递增的临床试验，显示了对晚期实体瘤患者的抗肿瘤活性，并于2024年7月在中国进入与IMM2510的联合研究。辐联科技&SK Biopharmaceuticals 2024年7月17日，放射性药物治疗公司辐联科技宣布其与生物科技公司SK Biopharmaceuticals签署了一项对外授权许可协议。根据该协议，辐联科技授予SK公司对于FL-091放射性药物在全球范围内进行临床研究、开发、生产和商业化的独家权利，针对靶向神经降压素受体1型（NTSR1）阳性的癌症。 FL-091是一种小分子放射性配体载体，旨在通过特异性结合NTSR1，将放射性治疗药物精准递送至癌细胞。NTSR1是一种受体蛋白，在包括结直肠癌和胰腺癌在内的多种实体瘤中选择性高表达。该项交易总额为5.715亿美元，包含首付款、研发及商业里程碑付款，另有特许权使用费未计算在内。SK公司将引进靶向NTSR1的放射性药物偶联物（RDC）项目FL-091及其备选化合物，并将其开发成一款创新型抗肿瘤药物。SK公司还对辐联科技其他预选的RDC项目拥有优先谈判权。昱言科技&Ipsen 2024年7月11日，Ipsen（益普生）和昱言科技（Foreseen Biotechnology）公司宣布了用于治疗癌症的ADC药物FS001的独家全球许可协议。昱言科技将获得高达10.3亿美元的资金，包括首付款、开发、监管和商业化重要里程碑付款。根据协议条款，益普生将负责Ⅰ期临床试验准备活动，包括提交IND申请以及所有后续临床开发、生产和全球商业化活动。 FS001是一种具有FIC潜力的ADC药物，靶向一种全新的肿瘤相关抗原，该抗原在许多实体肿瘤中过表达，并在肿瘤增殖和转移中起关键作用。此次FS001的加入，标志着益普生获得第二款授权ADC，丰富了益普生的ADC管线矩阵。益普生高级副总裁兼早期开发主管 Mary Jane Hinrichs 表示将计划启动I期临床试验，在选定的实体肿瘤类型中评估 FS001，希望这将为世界各地的癌症患者提供关键的新疗法。康诺亚：Belenos 7月9日，康诺亚的全资附属公司--成都康诺亚，与Belenos Biosciences公司已订立许可协议。根据许可协议，康诺亚授予Belenos在全球(除大中华地区)开发、生产及商业化集团候选药物CM512及CM536的独家权利（研究、开发、注册、生产及商业化）。CM512及CM536均为康诺亚自主开发的双特异性抗体。作为对价，成都康诺亚将收取1500万美元的首付款和近期付款，而一桥香港控股有限公司将收取Belenos约30.01%的股权。在达成若干开发、监管及商业里程碑后，成都康诺亚亦可收取最多1.70亿美元的额外付款。于CM512及CM536 首次商业销售后开始的指定时间段内，成都康诺亚亦有权从Belenos收取销售净额的分层特许权使用费。除另有协定外，Belenos将负责承担CM512及CM536在许可地区的所有开发、监管及商业化活动的成本。就许可协议而言，Belenos与成都康诺亚将订立供应协议，据此，Belenos将有权向成都康诺亚或其合同生产商采购所需数量的CM512及CM536以便进行该等临床试验。CM512于今年5月申报IND，CM536处于临床前阶段。麦科思生物&Day One 2024年6月18日，美国纳斯达克上市公司Day One Biopharmaceuticals公告已与来自中国上海的麦科思生物（MabCare Therapeutics）达成独家许可协议，Day One将拥有在大中华区以外地区开发、生产和商业化MTX-13的全球独家权利。根据本次协议条款，MabCare Therapeutics获得5500万美元（约合3.99亿人民币）首付款，并有资格获得额外最多达的11.52亿美元的开发、监管注册和商业化的里程碑付款，以及大中华区以外地区净销售额的低至个位数特许权使用费（royalties）。明济生物&艾伯维 6月13日，明济生物和艾伯维（AbbVie）共同宣布一项开发FG-M701的许可协议。FG-M701是一种用于治疗炎症性肠病的下一代TL1A抗体，目前正处于临床前开发阶段。 FG-M701是靶向TL1A的全人源单克隆抗体，该靶点在炎症性肠病中已获得临床验证。与第一代TL1A抗体相比，FG-M701通过独特的工程化改造，旨在为炎症性肠病治疗提供更高的疗效并减少给药频率，具备成为“best-in-class”的潜力。根据协议条款，艾伯维将获得FG-M701在全球进行开发、生产和商业化的独家许可权。明济生物将获得1.5亿美元的首付款和近期里程碑付款，并有资格获得后续高达15.6亿美元的临床开发、监管注册和商业化里程碑付款，以及高达净销售额低两位数比例的分级特许权使用费。康方生物&Summit 2024年6月3日，康方生物宣布公司与Summit Therapeutics签署了补充许可协议，在双方原有关于PD-1/VEGF双特异性抗体依沃西的合作许可协议下，拓展依沃西的许可市场范围。根据补充许可协议，康方生物将获得7000万美元的首付款和里程碑款，以及依沃西在新增许可市场的销售提成（提成比例与2022年12月5日双方签订的合作协议的比例一致）。康方生物将继续为包括新增许可市场在内的所有许可市场供应依沃西单抗注射液，并获得供货收入。同时，在补充许可协议中，双方进一步强化了包括临床试验数据、上市申报文件等成果的跨地区共享合作条款，以加速依沃西在全球各地区的监管注册及商业化。 Summit将新增获得依沃西在中美、南美、中东和非洲等相关市场的开发及商业化独家权益。同时，Summit将继续负责包括新增许可市场在内的所有许可地区的临床开发、产品注册及商业化，及其所有相关费用。百奥泰&STADA 5月28日，百奥泰宣布已与STADA公司就BAT2506（一款参照欣普尼开发的戈利木单抗生物类似药）签署授权许可及商业化协议。根据协议条款，百奥泰将负责BAT2506的研发、生产以及商业化供应，STADA将负责BAT2506在欧盟、英国、瑞士以及其他部分欧洲国家市场的商业化。在达到相应的里程碑事件后，百奥泰可获得首付款加上里程碑款总金额最高至1.575亿美元，以及净销售额的两位数百分比作为收入分成。戈利木单抗是靶向TNF-α的抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而抑制TNF-α的活性。戈利木单抗原研产品已经在全球范围内被批准用于活动性银屑病关节炎、中度至重度活动性类风湿关节炎、活动性强直性脊柱炎和中度至重度溃疡性结肠炎。 BAT2506是百奥泰根据中国NMPA、美国FDA、欧洲EMA生物类似药相关指导原则开发的戈利木单抗生物类似药，目前已完成全球3期临床研究。其3期临床研究旨在银屑病关节炎（PsA）患者中比较BAT2506与戈利木单抗原研产品的疗效和安全性。基石药业&Ewopharma 5月27日，基石药业宣布已与欧洲制药公司Ewopharma建立战略商业化合作伙伴关系，将舒格利单抗在中欧和东欧的商业化权利授予 Ewopharma。根据这项许可和商业化协议，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。这包括欧盟成员国保加利亚、克罗地亚、捷克共和国、爱沙尼亚、匈牙利、拉脱维亚、立陶宛、波兰、罗马尼亚、斯洛伐克和斯洛文尼亚，以及非欧盟国家阿尔巴尼亚、波斯尼亚和黑塞哥维那、科索沃、北马其顿、摩尔多瓦、黑山和塞尔维亚。基石药业制药公司将获得高达 5130 万美元（相当于约 3.7 亿美元）的首期付款以及后续的注册和销售里程碑付款。基石药业将通过向 Ewopharma 销售产品获得国际收入，Ewopharma 将负责定价、报销、营销、分销和其他相关事宜，基石药业将负责供应产品并为相关品牌提供必要的培训和支持。宜联生物&BioNtech 5月27日，宜联生物与BioNTech就宜联生物TMALIN® ADC技术平台开发针对限定的某几个前沿创新靶点的ADC产品的独家选择权及相应全球独家许可。根据新协议条款，宜联生物将获得2500万美元的首付款，并有资格获得最高可达 18 亿美元的开发、监管和商业化里程碑付款，以及未来基于全球年度销售净额的梯度特许权使用费。作为协议的一部分，宜联生物将享有BioNTech未来寻求这些ADC产品在大中华区（中国大陆、香港、澳门、台湾）任一或多个地区市场对外授权或转让时的优先合作权。早在2023年10月，宜联生物就与BioNTech因YL202/BNT326，一款靶向HER3的ADC项目达成战略合作和全球许可协议。百奥赛图&吉利德 2024年2月19日，百奥赛图宣布与吉利德科学达成一项抗体评估和选择协议。该协议授权吉利德使用百奥赛图针对广泛的药物靶点建立的全人抗体库进行相关靶点的抗体评估。在三年提名期内，吉利德将提名他们感兴趣的多个靶点并评估相应抗体，并有权选择获得特定抗体用于全球范围内治疗性产品的开发。根据协议，百奥赛图将会获得一笔付款，使得吉利德能够评估针对选定靶点的特定抗体。针对每个被提名的靶点被选定的抗体，百奥赛图将有权获得选择权行权费，开发、监管和销售里程碑付款，及个位数净销售额分成。百奥赛图&Radiance 2024年1月8日，百奥赛图（北京）医药科技股份有限公司宣布与Radiance Biopharma就ADC产品达成一项独家选择与授权协议。该协议使得Radiance有权选择获得一款百奥赛图同类首创全人HER2/TROP2双特异性抗体偶联药物（双抗ADC）的授权，用于针对任何人类疾病的治疗性产品在全球范围内的开发、生产和商业化。HER2和TROP2是两个肿瘤相关抗原（TAAs），已被发现在多种肿瘤类型中共表达，包括乳腺癌、胃癌、结直肠癌、膀胱癌、胰腺癌和非小细胞肺癌。根据协议，如果 Radiance行使了选择权，百奥赛图将有权获得选择权行使费、许可费、开发和商业化里程碑付款，以及个位数净销售额分成；如果Radiance再授权给第三方，百奥赛图还将获得分许可费。总结 2023年，中国本土药企License-out的交易数量持续增长、交易规模不断刷新，全年共发生58起License-out事件，首次超过了License-in的项目数量。随着前沿技术不断突破，新药生产制造技术能力不断提高，中国创新药研发呈现出了前所未有的活跃态势。多款国产创新药迎来成果收获期，为中国药企出海提供了坚实的产品基础。随着中国药企出海步伐的加快，未来中国药企在国际市场的竞争力将不断提升。同时，中国药企也将更加注重国际合作与共赢，通过与国际领先企业的合作与交流，共同推动全球医药行业的发展。参考资料：各公司官网版权声明：本文转自生物药大时代，如不希望被转载的媒体或个人可与我们联系，我们将立即删除【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

引进/卖出抗体药物偶联物临床1期疫苗临床2期

2024-09-02

·PRNewswire

Global Cancer Monoclonal Antibodies Market to Cross ~USD 157 Billion Mark by 2030 | DelveInsight

The increasing demand for cancer monoclonal antibodies is mainly driven by the rising incidence of cancer, the growing prevalence of risk factors like smoking, radiation exposure, unhealthy lifestyles, and other contributing factors. Additionally, the surge in research and development activities by market players is expected to further fuel this demand throughout the forecast period from 2024 to 2030. LAS VEGAS, Sept. 2, 2024 /PRNewswire/ -- DelveInsight's Cancer Monoclonal Antibodies Market Insights report provides the current and forecast market analysis, individual leading cancer monoclonal antibodies companies' market shares, challenges, cancer monoclonal antibodies market drivers, barriers, trends, and key market cancer monoclonal antibodies companies in the market. Key Takeaways from the Cancer Monoclonal Antibodies Market Report As per DelveInsight estimates, North America is anticipated to dominate the global cancer monoclonal antibodies market during the forecast period. In the application segment of the cancer monoclonal antibodies market, the breast cancer category had a significant revenue share in the cancer monoclonal antibodies market in 2023. Notable cancer monoclonal antibodies companies such as GSK plc, F. Hoffmann-La Roche Ltd., Merck & Co., Inc., Novartis AG, Johnson and Johnson Services Inc., Spectrum Pharmaceuticals Inc., Eurofins Scientific, Genmab AS, Bristol Myers Squibb Company, Elli Lilly and Company, Amgen, Inc., AbbVie Inc., AstraZeneca Plc., CStone Pharmaceuticals, HiFiBiO Therapeutics, and several others, are currently operating in the cancer monoclonal antibodies market. In April 2024, CE approved the VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU® (trastuzumab deruxtecan) may be considered as a targeted treatment. In December 2023, CStone Pharmaceuticals announced that the National Medical Products Administration (NMPA) of China approved the supplemental biologics license application (sBLA) for sugemalimab (Cejemly®) in combination with fluorouracil and platinum-based chemotherapy as first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Sugemalimab became the world's first anti-PD-L1 monoclonal antibody approved for the first-line ESCC indication. To read more about the latest highlights related to the cancer monoclonal antibodies market, get a snapshot of the key highlights entailed in the Global Cancer Monoclonal Antibodies Market Report Cancer Monoclonal Antibodies Overview Monoclonal antibodies (mAbs) have revolutionized cancer treatment by offering highly targeted therapies that specifically attack cancer cells while sparing healthy tissue. These antibodies are laboratory-made molecules designed to bind to specific antigens on the surface of cancer cells. By recognizing these unique markers, monoclonal antibodies can interfere with the growth and spread of cancer in several ways. For example, they can block signals that stimulate cancer cell proliferation, mark cancer cells for destruction by the immune system, or deliver toxic substances directly to the cancer cells. This specificity reduces the side effects typically associated with conventional chemotherapy and radiation, making mAbs an essential component of modern oncology. There are several types of monoclonal antibodies used in cancer treatment, including naked mAbs, which work by themselves, and conjugated mAbs, which are linked to drugs or radioactive particles. Some well-known examples include Rituximab, used in the treatment of certain types of lymphoma, and Trastuzumab, which targets HER2-positive breast cancer. These therapies have shown significant success in improving survival rates and quality of life for many patients. However, challenges remain, such as the development of resistance by cancer cells and the high cost of production. Ongoing research aims to overcome these hurdles by developing more effective and affordable mAbs, as well as combining them with other treatments to enhance their efficacy. Cancer Monoclonal Antibodies Market Insights North America held the largest share of the cancer monoclonal antibodies market in 2023, driven by several factors. The region's leading position is attributed to the rising incidence of cancers, greater exposure to carcinogens such as smoking, radiation, and viruses, and recent regulatory approvals that favor the growth of the cancer monoclonal antibodies market in North America. Furthermore, the increasing number of regulatory approvals for these antibodies is expected to further stimulate market growth. For instance, in October 2022, the FDA approved the combination of durvalumab (IMFINZI), a human monoclonal antibody, with the experimental drug tremelimumab for treating unresectable hepatocellular carcinoma. The large patient population in North America is likely to drive demand for cancer monoclonal antibodies, leading to market expansion in the coming years. Therefore, the combined influence of these factors is expected to contribute significantly to the growth of the cancer monoclonal antibodies Market in North America from 2024 to 2030. To know more about why North America is leading the market growth in the cancer monoclonal antibodies market, get a snapshot of the Cancer Monoclonal Antibodies Market Outlook Cancer Monoclonal Antibodies Market Dynamics The global market for cancer monoclonal antibodies has experienced significant growth over the past decade, driven by the increasing incidence of cancer, advancements in biotechnology, and the rising demand for targeted therapies. Monoclonal antibodies, which are designed to specifically target cancer cells while sparing healthy tissue, have become a cornerstone in the treatment of various cancers. Their specificity and reduced side effects compared to traditional chemotherapy have made them an attractive option for both patients and healthcare providers. One of the key dynamics shaping the cancer monoclonal antibodies market is the ongoing innovation in antibody engineering. Techniques such as antibody-drug conjugates, bispecific antibodies, and immune checkpoint inhibitors have expanded the therapeutic potential of mAbs, leading to the development of more effective and versatile cancer treatments. These innovations have not only enhanced the efficacy of existing therapies but have also opened up new avenues for addressing previously untreatable or resistant forms of cancer. The competitive landscape of the market is also influenced by the expiration of patents on several blockbuster mAbs, paving the way for biosimilars to enter the market. Biosimilars, which are essentially generic versions of biologic drugs, offer similar efficacy at a lower cost, making cancer treatment more accessible. However, the introduction of biosimilars has also intensified competition among pharmaceutical companies, driving the need for continuous innovation and the development of next-generation therapies to maintain market share. Regulatory and reimbursement challenges also play a crucial role in the market dynamics. The stringent regulatory requirements for the approval of mAbs, coupled with the high costs associated with their development and manufacturing, can pose barriers to market entry. Additionally, securing favorable reimbursement from healthcare systems is critical for the widespread adoption of these therapies. As healthcare budgets become increasingly strained, especially in the wake of the COVID-19 pandemic, the cost-effectiveness of mAbs will likely be a focal point in discussions between pharmaceutical companies, regulators, and payers. In conclusion, the cancer monoclonal antibodies market is poised for continued growth, driven by technological advancements, the entry of biosimilars, and the rising demand for personalized cancer therapies. However, the market will need to navigate challenges related to regulation, competition, and cost-effectiveness to sustain its momentum. As research and development in the field of immuno-oncology continue to advance, the landscape of cancer treatment is likely to evolve, offering new hope for patients and further solidifying the role of monoclonal antibodies in cancer care. Get a sneak peek at the cancer monoclonal antibodies market dynamics @ Cancer Monoclonal Antibodies Market Dynamics Analysis Cancer Monoclonal Antibodies Market Assessment Cancer Monoclonal Antibodies Market Segmentation Cancer Monoclonal Antibodies Market Segmentation By Type: Humanized Antibodies, Chimeric Antibodies, Murine Antibodies Cancer Monoclonal Antibodies Market Segmentation By Application: Blood Cancer, Breast Cancer, Liver Cancer, Colorectal Cancer, and Others Cancer Monoclonal Antibodies Market Segmentation By End Users: Hospitals, Research Institutions & Laboratories, and Others Cancer Monoclonal Antibodies Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the cancer monoclonal antibodies market are set to emerge as the trendsetter explore @ Cancer Monoclonal Antibodies Companies Table of Contents Interested in knowing the cancer monoclonal antibodies market by 2030? Click to get a snapshot of the Cancer Monoclonal Antibodies Market Trends Related Reports Monoclonal Antibodies Competitive Landscape Monoclonal Antibodies Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key monoclonal antibodies companies, including Novartis , Novartis, Gmax Biopharm, Omeros Corporation, Merck Sharp & Dohme, Disc Medicine, Eledon Pharmaceuticals, Alexion AstraZeneca Rare Disease, Chinook Therapeutics, Omeros Corporation, Novo Nordisk, Merck KGaA, Bristol-Myers Squibb, Jacobio Pharmaceuticals, Nectin Therapeutics Ltd, Y-mAbs Therapeutics, OncoResponse, Inc., Fate Therapeutics, Pelican Therapeutics, Inc., Heat Biologics, Oncternal Therapeutics, Phanes Therapeutics, Pharmacyclics LLC, Immunitas Therapeutics, Hummingbird Bioscience, Inc., Sanofi, Takeda, Agenus Inc., Aulos Bioscience, Inc., ChemomAb Ltd, Celldex Therapeutics, Celgene, Janssen Research & Development, LLC, Adaptive Biotechnologies, BeiGene, Vaccinex Inc., Jasper Therapeutics, Inc., Shanghai Junshi Bioscience Co., Ltd., TopAlliance Biosciences, Inc., among others. Cancer Therapy Market Cancer Therapy Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key cancer therapy companies, including GlaxoSmithKline, Eli Lilly & Company, F. Hoffmann-La Roche Ltd, AbbVie Inc., Amgen Inc, Sanofi, Merck & Co., Inc, Novartis AG, Pfizer Inc, AstraZeneca, Bristol Myers Squibb., Gilead Sciences, Inc., Janssen Global Services, LLC, Elekta AB, Varian Medical Systems, Inc., Accuray Incorporated, Pyrexar Medical, Eckert & Ziegler, IBA, Panacea Medical Technologies Pvt. Ltd., among others. Oncology Drugs Market Oncology Drugs Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key oncology drugs companies, including GlaxoSmithKline, Eli Lilly & Company, F. Hoffmann-La Roche Ltd, AbbVie Inc., Amgen Inc, Sanofi, Merck & Co., Inc, Novartis AG, Pfizer Inc, AstraZeneca, Bristol Myers Squibb., Gilead Sciences, Inc., Janssen Global Services, LLC, BAYER AG., Celldex Therapeutics Inc., Alaunos Therapeutics, Inc., Astellas Pharma Inc., Genentech, Inc., Sandoz International GmbH, BeiGene, among others. Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

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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	基石药业	2024-07-26
转移性非小细胞肺癌	冰岛	基石药业	2024-07-26
转移性非小细胞肺癌	列支敦士登	基石药业	2024-07-26
转移性非小细胞肺癌	挪威	基石药业	2024-07-26
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

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适应症	最高研发状态	国家/地区	公司	日期
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	Wuxi Biologics (Cayman), Inc.	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
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
肝细胞癌	临床2期	中国	基石药业（苏州）有限公司	2019-12-16
实体瘤	临床2期	澳大利亚	基石药业（苏州）有限公司	2019-12-13

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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


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	願積糧壓糧願鬱製願鬱(夢獵觸觸夢鹹廠選築願) = 醖艱簾觸鹽範衊觸壓衊蓋壓鏇觸鏇窪廠憲製壓 (鏇鹹膚鑰網夢獵餘顧繭 ) 更多	积极	2024-09-14
				Placebo + Platinum-based chemotherapy	願積糧壓糧願鬱製願鬱(夢獵觸觸夢鹹廠選築願) = 廠鏇膚簾夢繭艱衊糧顧蓋壓鏇觸鏇窪廠憲製壓 (鏇鹹膚鑰網夢獵餘顧繭 ) 更多
NCT03595657 (GEMSTONE-201, CTgov)	临床2期	结外NK-T细胞淋巴瘤	80	sugemalimab (CS1001)	遞糧衊觸獵襯鹽餘選夢(積簾鏇網憲觸齋鏇襯襯) = 築襯鹽憲糧網餘壓選築積鏇鑰鑰齋遞製衊夢簾 (憲齋壓淵網糧餘醖鹽鹹, 鹹構鹽鹽夢獵鹽夢願願 ~ 簾築範鹽鏇鏇廠選繭簾) 更多	-	2024-06-18
ASCO2024 人工标引	N/A	非小细胞肺癌二线 \| 一线	-	Sugemalimab plus chemo (1L therapy)	淵網鑰醖選鏇範糧簾願(獵蓋遞願製壓艱夢壓顧) = 簾廠艱衊築鑰鹽艱蓋衊壓網範顧窪顧鏇觸範餘 (壓艱網顧鹹繭選衊構夢 ) 更多	积极	2024-05-24
				Sugemalimab plus chemo (pts receiving additional thoracic RT concurrent with 1L systematic therapy)	齋蓋憲構簾鹽壓襯積觸(製繭鹽願觸艱願製鑰鏇) = 積餘鏇鹹鑰鏇淵鏇築糧膚簾衊製選簾獵鹹鏇糧 (鏇獵鏇範糧選蓋淵繭夢 ) 更多
NCT04187352 (Pubmed) 人工标引	临床3期	晚期食管鳞状细胞癌一线	540	Sugemalimab + Chemotherapy	網鹹遞艱獵繭鏇蓋艱襯(衊獵簾積壓齋製願積鏇) = 艱鬱鑰獵簾蓋構簾淵壓鏇醖鹽鹽襯簾廠簾鹹網 (窪壓糧網壓廠襯鹽憲獵 ) 更多	积极	2024-03-01
				Placebo + Chemotherapy	網鹹遞艱獵繭鏇蓋艱襯(衊獵簾積壓齋製願積鏇) = 鹹鬱鬱窪獵觸蓋鹽積廠鏇醖鹽鹽襯簾廠簾鹹網 (窪壓糧網壓廠襯鹽憲獵 ) 更多
NCT04187352 (Literature) 人工标引	临床3期	晚期食管鳞状细胞癌一线	540	sugemalimab+chemotherapy	網鹹簾醖繭餘壓膚蓋衊(衊遞淵積夢構蓋襯鑰餘) = 糧糧鑰繭製艱構構構築壓簾製齋齋醖鑰壓願鹹 (齋遞願淵網鹽鑰鏇鬱遞 ) 更多	积极	2024-02-01
				placebo+chemotherapy	網鹹簾醖繭餘壓膚蓋衊(衊遞淵積夢構蓋襯鑰餘) = 選糧鬱醖顧積顧醖遞選壓簾製齋齋醖鑰壓願鹹 (齋遞願淵網鹽鑰鏇鬱遞 ) 更多
NCT03802591 (GEMSTONE-303, ESMO2023) 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%)	網繭窪觸廠衊選壓廠壓(願網淵鏇壓遞糧齋願網) = 鑰範窪鬱襯糧憲遞顧蓋糧觸餘選糧築壓夢衊顧 (網鹽製鹹選餘構遞糧餘, 13.27 ~ 17.81) 更多	积极	2023-10-21
				Placebo + CAPOX (PD-L1 Expression Level >=5%)	網繭窪觸廠衊選壓廠壓(願網淵鏇壓遞糧齋願網) = 構築網廠糧夢艱衊艱獵糧觸餘選糧築壓夢衊顧 (網鹽製鹹選餘構遞糧餘, 10.64 ~ 14.06) 更多
NCT04187352 (GEMSTONE-304, ESMO_GI2023)	临床3期	局部晚期食管鳞状细胞癌 \| 不能切除的食管鳞状细胞癌一线 PD-L1	540	Sugemalimab + FP	繭窪獵獵遞鑰衊齋衊鹽(糧鬱構積遞艱蓋簾顧積) = 製鬱鹽選齋糧鏇顧艱糧廠淵構壓鏇醖製齋鑰夢 (餘獵糧觸襯鑰淵築齋築 ) 更多	积极	2023-07-01
				Placebo + FP	繭窪獵獵遞鑰衊齋衊鹽(糧鬱構積遞艱蓋簾顧積) = 獵齋糧蓋醖範淵網醖淵廠淵構壓鏇醖製齋鑰夢 (餘獵糧觸襯鑰淵築齋築 ) 更多
NCT03789604 (GEMSTONE-302, Pubmed)	临床3期	转移性非小细胞肺癌一线	479	Sugemalimab	夢築願鹽製襯壓製蓋壓(蓋顧衊築鏇襯鏇襯鬱鏇) = 繭網繭簾蓋鑰蓋鹹顧繭窪築鏇膚築醖觸範築糧 (艱選繭選窪鏇網憲鬱鑰 )	积极	2023-06-15
				Placebo	夢築願鹽製襯壓製蓋壓(蓋顧衊築鏇襯鏇襯鬱鏇) = 蓋鏇餘齋壓廠餘觸選壓窪築鏇膚築醖觸範築糧 (艱選繭選窪鏇網憲鬱鑰 )
GEMSTONE-302 (ASCO2023)	N/A	非小细胞肺癌一线	-	Sugemalimab + chemotherapy	蓋鏇鑰願糧蓋鏇網膚醖(繭襯簾廠壓觸築鑰選餘) = 積膚鏇鏇膚夢鹹襯襯餘醖遞夢簾鑰壓鬱積艱憲 (蓋顧製顧製膚膚襯顧鹽 )	积极	2023-05-31
				Placebo + chemotherapy	蓋鏇鑰願糧蓋鏇網膚醖(繭襯簾廠壓觸築鑰選餘) = 艱蓋餘願廠艱衊繭齋鹽醖遞夢簾鑰壓鬱積艱憲 (蓋顧製顧製膚膚襯顧鹽 )
GEMSTONE-201 (Pubmed)	临床2期	结外NK-T细胞淋巴瘤	80	Sugemalimab	鹽鹹選遞蓋憲餘構醖齋(範網衊鹹範齋醖顧窪鏇) = 蓋膚願願製選憲範鏇觸築膚獵窪蓋製鹹憲築獵 (窪鑰選廠簾簾積艱網齋, 33.6 ~ 56.6) 更多	积极	2023-03-30