科伦生物技术公司将在2025年ASCO年会上展示六项临床研究的结果-动脉网

Keluniotech to Present Results of Six Clinical Studies at 2025 ASCO Annual Meeting

CISION 等信源发布 2025-04-24 13:06



可切换为仅中文







CHENGDU, China

中国成都

，

April 24, 2025

2025年4月24日

/PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) announced that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held in

/PRNewswire/ -- 四川科伦博泰生物医药股份有限公司（6990.HK）宣布，将在2025年美国临床肿瘤学会（ASCO）年会上展示六项由科伦主导的临床研究结果，会议将于

Chicago

芝加哥

from

从

May 30 to June 3

5月30日至6月3日

. Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan

结果包括其TROP2抗体药物偶联物（ADC）sacituzumab tirumotecan的数据。

(sac-TMT)

（圣母大学教学硕士）

, anti-PD-L1 mAb

，抗PD-L1单克隆抗体

tagitanlimab

替雷利珠单抗

, and RET inhibitor

，和RET抑制剂

KL590586 (A400/EP0031).

KL590586 (A400/EP0031)。

The abstracts for these studies will be published on the ASCO's official website on

这些研究的摘要将在ASCO的官方网站上发布。

May 22, 2025

2025年5月22日

, local time.

，当地时间。

Detailed information on the studies selected for ASCO 2025 are as follows:

以下是入选ASCO 2025的研究的详细信息：

Title:

标题：

Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.

Sacituzumab tirumotecan（sac-TMT）治疗先前接受过治疗的晚期EGFR突变非小细胞肺癌（NSCLC）患者：来自随机OptiTROP-Lung03研究的结果。

Presentation Type:

演示类型：

Oral

口服

Abstract Number:

摘要编号：

8507

Session Date and Time:

会议日期和时间：

6/1/2025

2025年6月1日

8:00 AM-11:00 AM CDT

上午8:00 - 上午11:00 中央夏令时间

Title:

标题：

Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study.

Tagitanlimab联合吉西他滨和顺铂对比安慰剂作为复发或转移性鼻咽癌（R/M NPC）一线治疗的随机、双盲、3期研究结果。

Presentation Type:

演示类型：

Oral

口服

Abstract Number:

摘要编号：

6004

Session Date and Time:

会议日期和时间：

5/31/2025

2025年5月31日

1:15 PM-4:15 PM CDT

下午1:15 - 下午4:15 中央夏令时间

Title:

标题：

Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase II OptiTROP-Breast05 study.

Sacituzumab tirumotecan（sac-TMT）作为不可切除的局部晚期/转移性三阴性乳腺癌（a/m TNBC）的一线治疗：来自II期OptiTROP-Breast05研究的初步结果。

Presentation Type:

演示类型：

Rapid oral

快速口服

Abstract Number:

摘要编号：

1019

Session Date and Time:

会议日期和时间：

5/30/2025

2025年5月30日

2:45 PM-4:15 PM CDT

下午2点45分至下午4点15分（中部夏令时间）

Title:

标题：

Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study.

Sacituzumab tirumotecan（sac-TMT）联合tagitanlimab（抗PD-L1）用于一线（1L）晚期非小细胞肺癌（NSCLC）：来自II期OptiTROP-Lung01研究的非鳞状细胞队列。

Presentation Type:

演示类型：

Poster

海报

Abstract Number:

摘要编号：

8529

Session Date and Time:

会话日期和时间：

5/31/2025

2025年5月31日

1:30 PM-4:30 PM CDT

下午1:30 - 下午4:30 中央夏令时间

Title:

标题：

Sacituzumab Tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study.

Sacituzumab Tirumotecan（sac-TMT）治疗先前接受过治疗的局部晚期或转移性（LA/M）非小细胞肺癌（NSCLC）患者（pts）携带不常见EGFR突变：来自2期研究的初步结果。

Presentation Type:

演示类型:

Poster

海报

Abstract Number:

摘要编号：

8615

Session Date and Time:

会议日期和时间：

5/31/2025

2025年5月31日

1:30 PM-4:30 PM CDT

下午1:30 - 下午4:30 中央夏令时间

Title:

标题：

Results from a phase I study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer.

KL590586在晚期RET突变型髓样甲状腺癌患者中的I期研究结果。

Presentation Type:

演示类型：

Poster

海报

Abstract Number:

摘要编号：

6098

Session Date and Time:

会话日期和时间：

6/2/2025

2025年6月2日

9:00 AM-12:00 PM CDT

上午9:00 - 下午12:00 中央夏令时间

About Sac-TMT

关于Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as Non-small Cell Lung Cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4.

Sac-TMT是公司的一款核心产品，是一种新型的人源TROP2 ADC，公司拥有其自主知识产权，靶向治疗非小细胞肺癌（NSCLC）、乳腺癌（BC）、胃癌（GC）、妇科肿瘤等晚期实体瘤。Sac-TMT采用一种新型连接子将有效载荷与抗体结合，该有效载荷是一种贝洛替康衍生物的拓扑异构酶I抑制剂，药物抗体比（DAR）为7.4。

Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis.

Sac-TMT通过重组抗TROP2人源化单克隆抗体特异性识别肿瘤细胞表面的TROP2，随后被肿瘤细胞内吞并在细胞内释放KL610023。KL610023作为一种拓扑异构酶I抑制剂，诱导肿瘤细胞的DNA损伤，从而导致细胞周期阻滞和凋亡。

In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells..

此外，它还会在肿瘤微环境中释放 KL610023。鉴于 KL610023 具有膜渗透性，因此能够发挥旁观者效应，或者换句话说杀死相邻的肿瘤细胞。

在

May 2022

2022年5月

, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc.,

公司授权了MSD（默克公司，即Merck & Co., Inc.的商标名）独家权利，

Rahway, NJ

新泽西州拉威市

, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of

，美国）开发、使用、制造和商业化 sac-TMT 在所有地区之外的领土上

Greater China

大中华区

(includes Mainland China,

（包括中国大陆，

Hong Kong

香港特别行政区

，

Macau

澳门

, and

，以及

Taiwan

台湾

）。

To date, two indications for sac-TMT have been approved and marketed in

到目前为止，已有两个 sac-TMT 的适应症获得批准并上市。

China

中国

for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy.

用于治疗不可切除的局部晚期或转移性三阴性乳腺癌（TNBC）成年患者，这些患者至少接受过两种先前的系统治疗（其中至少一种用于晚期或转移性环境），以及EGFR突变阳性的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者，这些患者在EGFR-TKI治疗和铂类化疗后出现疾病进展。

Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the National Medical Products Administration (NMPA), and was included in the priority review and approval process.

Sac-TMT成为国内首个拥有全球知识产权并获得全面上市批准的抗体药物偶联物（ADC），同时也是全球首个在肺癌适应症中获批上市的TROP2 ADC。此外，Sac-TMT针对治疗在接受EGFR酪氨酸激酶抑制剂（EGFR-TKI）治疗后进展的EGFR突变局部晚期或转移性非小细胞肺癌（NSCLC）成年患者的NDA申请已获中国国家药品监督管理局（NMPA）受理，并被纳入优先审评审批程序。

As of today, Kelun-Biotech has initiated 8 registrational clinical studies in .

截至今天，科伦博泰已开展了8项确证性临床研究。

China

中国

. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.

默沙东已启动12项正在进行的三期全球临床试验，评估Sac-TMT单药或与帕博利珠单抗或其他药物联合用于多种癌症治疗。这些研究由默沙东赞助并主导。

About Tagitanlimab

关于Tagitanlimab

Tagitanlimab is the first PD-L1 monoclonal antibody (mAb) globally to receive authorization for the first-line treatment of NPC. Previously, the National Medical Products Administration (NMPA) has approved the marketing in

Tagitanlimab是全球首个获得鼻咽癌一线治疗授权的PD-L1单克隆抗体（mAb）。此前，国家药品监督管理局（NMPA）已批准其上市。

China

中国

of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

Tagitanlimab联合顺铂和吉西他滨用于一线治疗R/M NPC患者，以及单药治疗既往2L+化疗失败后的复发或转移性NPC患者。

About KL590586 (

关于 KL590586 (

A400/EP0031)

A400, a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. We are currently conducting pivotal clinical study for both 1L and 2L+ advanced RET+ NSCLC as well as a phase

A400，一种新型的下一代选择性RET抑制剂，用于治疗携带RET变异的非小细胞肺癌（NSCLC）、甲状腺髓样癌（MTC）及其他实体瘤。我们目前正在对一线和二线及以上治疗的晚期RET阳性非小细胞肺癌进行关键临床研究，并已进入阶段。

/2 clinical study for RET+ MTC and solid tumor in

/2 临床研究，针对RET+ MTC和实体瘤

China

中国

。

在

March 2021

2021年3月

, we granted Ellipses Pharma, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside

，我们授予了英国一家国际肿瘤药物开发公司Ellipses Pharma独家许可，允许其在境外开发、生产和商业化这种药物。

Greater China

大中华区

and certain Asian countries under the code EP0031.

以及代码为EP0031的某些亚洲国家。

在

March 2024

2024年3月

, it was announced that EP0031/A400 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In

，宣布EP0031/A400被FDA授予快速通道资格，用于治疗RET融合阳性的非小细胞肺癌。在

April 2024

2024年4月

, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE.

，EP0031/A400已获FDA批准进入第2阶段临床开发，目前在美国、英国、欧盟和阿联酋开放。

About Kelun-Biotech

关于科伦生物技术

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in .

科伦博泰（6990.HK）是科伦药业（002422.SZ）的控股子公司，专注于创新生物药物和小分子药物的研发、生产、商业化及全球合作。公司重点布局实体瘤、自身免疫、炎症及代谢性疾病等重大疾病领域，并致力于建立全球化药物开发与产业化平台，以满足未被满足的医疗需求。

China

中国

and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage.

公司致力于成为创新药物领域的全球领先企业。目前，公司拥有 30 余项在研重要创新药项目，其中 3 个项目已获批上市，1 个项目处于 NDA 阶段，10 余个项目处于临床阶段。

The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit .

该公司建立了世界领先的专有ADC平台之一OptiDC™，拥有1个已获批上市的ADC项目、1个处于NDA阶段的ADC项目，以及多个处于临床或临床前研究阶段的ADC或新型ADC项目。欲了解更多信息，请访问。

https://kelun-biotech.com/

。

SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

来源：四川科伦博泰生物医药股份有限公司

WANT YOUR COMPANY'S NEWS

希望贵公司的新闻

FEATURED ON PRNEWSWIRE.COM?

荣登PRNEWSWIRE.COM？

440k+

44万+

Newsrooms &