SAN FRANCISCO and SUZHOU, China

美国旧金山和中国苏州

,

，

Sept. 23, 2026

2026年9月23日

/PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that clinical data for its IBI363/TAK-928 (PD-1/IL-2.

/美通社/ -- 信达生物制药有限公司（“信达生物”）（港交所：01801）是一家世界级的生物制药公司，致力于开发、生产和商业化用于治疗肿瘤、心血管和代谢、自身免疫、眼科及其他主要疾病的高质量药物。该公司宣布，其IBI363/TAK-928（PD-1/IL-2）的临床数据

α-biased

α-偏置

bispecific fusion protein)

双特异性融合蛋白）

*

*

, IBI343/TAK-921 (Arcotatug Tavetecan, CLDN18.2 ADC)

，IBI343/TAK-921（Arcotatug Tavetecan，CLDN18.2 ADC）

*

*

, IBI3001(EGFR/B7H3 ADC)

，IBI3001（EGFR/B7H3 抗体偶联药物）

*

*

, IBI354(HER2 ADC) and TYVYT® (sintilimab injection)

，IBI354（HER2 ADC）和达伯舒®（信迪利单抗注射液）

**

**

will be presented at the 2026 European Society For Medical Oncology (ESMO) Annual Meeting from Oct 23 to Oct 27, 2026, in Madrid, Spain. In particular, the results from a registrational Phase 3 clinical trial (G-HOPE-001) of IBI343/TAK-921 (Arcotatug Tavetecan, CLDN18.2 ADC)

将于2026年10月23日至10月27日在西班牙马德里举行的2026年欧洲肿瘤内科学会（ESMO）年会上公布。特别是，IBI343/TAK-921（Arcotatug Tavetecan，CLDN18.2 ADC）的注册性III期临床试验（G-HOPE-001）结果

*

*

has been accepted for Late-Breaking Abstract (LBA) and will be orally presented during the ESMO proffered paper session.

已被接受为晚期突破摘要（LBA），并将在ESMO优选论文环节进行口头报告。

Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent,

周辉博士，信达生物首席研发官（肿瘤学）

stated: 'At the 2026 ESMO Annual Meeting, we will publish the registrational Phase 3 data for the globally advanced Arcotatug Tavetecan (CLDN18.2 ADC) in third‑line gastric cancer through LBA. We will also present additional data from IBI363 studies in NSCLC and preliminary data in first-line gastric cancer, further validating its broad potential as a next-generation immuno-oncology therapy.

表示：“在2026年欧洲肿瘤内科学会（ESMO）年会上，我们将通过晚期摘要（LBA）公布Arcotatug Tavetecan（CLDN18.2 ADC）在全球范围内用于三线胃癌治疗的注册性III期临床试验数据。我们还将展示IBI363在非小细胞肺癌（NSCLC）研究中的额外数据，以及在一线胃癌治疗中的初步数据，进一步验证其作为下一代免疫肿瘤疗法的广泛潜力。”

In addition, we will unveil global multicenter Phase 1 data for the first-in-class IBI3001 (EGFR/B7H3 ADC) for the first time, as well as Phase 2 data for the potentially best-in-class IBI354 (HER2 ADC) in first-line breast cancer. Innovent remains committed to pushing the boundaries of cancer treatment and delivering more innovative, effective, and potentially life-saving therapeutic options to physicians and patients.'.

此外，我们将首次公布全球多中心Ⅰ期临床数据，涉及首创的IBI3001（EGFR/B7H3抗体偶联药物），以及潜在同类最优的IBI354（HER2抗体偶联药物）在乳腺癌一线治疗中的Ⅱ期临床数据。信达生物始终致力于推动癌症治疗的边界，为医生和患者提供更多创新、有效且可能挽救生命的治疗选择。

Abstracts of Next-gen IO+ADC Pipeline

下一代IO+ADC流水线摘要

1.

1.

Presentation Title: Arcotatug

演示标题：Arcotatug

T

T

avatecan (IBI343/TAK-921) versus treatment of physician's choice (TPC) in previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA): First interim analysis of the randomized, open-label, phase 3, G-HOPE-001 study

avatecan（IBI343/TAK-921）对比医生选择的治疗方案（TPC）在既往接受过治疗的晚期胃癌或胃食管结合部腺癌（G/GEJA）患者中的疗效：随机、开放标签、III期G-HOPE-001研究的首次中期分析

Final Publication Number: LBA77

最终出版号：LBA77

Session Type: Proffered Paper

会议类型：推荐论文

Session Name: Gastrointestinal tumour, upper digestive

会议名称：上消化道胃肠道肿瘤

Room: Almeria Auditorium - Hall 9

会议室：阿尔梅里亚礼堂 - 9号厅

Session Date & Time: October 23, 2026 13:30 PM - 15:00 PM CET

会议日期和时间：2026年10月23日 13:30 - 15:00（中欧时间）

Presenter: Dr. Kohei Shitara (Kashiwa, Japan, Chiba)

演讲者：Kohei Shitara 博士（日本千叶县柏市）

2.  Presentation Title: IBI363 (TAK-928) plus chemotherapy as first line (1L) treatment for advanced non-small cell lung cancer (NSCLC): Update of a phase 1b study

2. 报告题目：IBI363 (TAK-928) 联合化疗作为晚期非小细胞肺癌（NSCLC）的一线（1L）治疗：一项 Ib 期研究的更新

Final Publication Number: 1044P

最终出版编号：1044P

Session Type: Poster

会议类型：海报展示

Session Title: Developmental Therapeutics

会议主题：发育治疗学

Session Date & Time: October 23, 2026 15:15 PM - 16:00 PM CET

会议日期和时间：2026年10月23日 15:15 - 16:00（中欧时间）

Presenter: Dr. Haiyan Tu, Guangdong Provincial People's Hospital

主讲人：涂海燕博士，广东省人民医院

3.

3.

Presentation Title: IBI363 (TAK-928) plus XELOX as the first line (1L) treatment for advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA)

报告题目：IBI363（TAK-928）联合XELOX作为晚期胃癌或胃食管结合部腺癌（G/GEJA）的一线（1L）治疗

**

**

Final Publication Number: 1008RO

最终出版号：1008RO

Session Type: Rapid Oral

会议类型：快速口头报告

Session Title: Developmental

会议主题：发育

Therapeutics

治疗学

Session Date & Time: October 25, 2026 08:30 AM - 10:00 AM CET

会议日期和时间：2026年10月25日 上午08:30 - 10:00（中欧时间）

Room: Cordoba Auditorium - Hall 4

房间：科尔多瓦礼堂 - 4号厅

Presenter: Dr. Pengfei Yu, Zhejiang Cancer Hospital

主讲人：于鹏飞博士，浙江省肿瘤医院

4.

4.

Presentation Title: IBI363 (TAK-928) plus bevacizumab (Bev) vs docetaxel (DTX) in patients (pts) with locally advanced or metastatic immunotherapy (IO)-resistant lung adenocarcinoma (LUAC) without actionable genomic alterations: a randomized phase Ib study

报告题目：IBI363（TAK-928）联合贝伐珠单抗（Bev）对比多西他赛（DTX）治疗无可操作基因组改变且对免疫治疗（IO）耐药的局部晚期或转移性肺腺癌（LUAC）患者（pts）：一项随机Ib期研究

Final Publication Number: 1952RO

最终出版编号：1952RO

Session Type: Rapid Oral

会议类型：快速口头报告

Session Title: Investigational Immunotherapy

会议主题：研究性免疫治疗

Session Date & Time: October 24, 2026 08:30 AM - 10:00 AM CET

会议日期和时间：2026年10月24日 上午08:30 - 10:00（中欧时间）

Room: Cadiz Auditorium - NCC

会议室：卡迪斯礼堂 - NCC

Presenter: Dr. Jianya Zhou, The First Affiliated Hospital of Zhejiang University School of Medicine

演讲者：周建娅博士，浙江大学医学院附属第一医院

5.

5.

Presentation Title: Safety and efficacy of IBI3001, an anti-EGFR/B7H3 bispecific ADC, in patients (pts) with advanced solid tumors: Results of a multi-regional phase 1 study

报告题目：IBI3001（一种抗EGFR/B7H3双特异性抗体偶联药物）在晚期实体瘤患者中的安全性和有效性：一项多区域Ⅰ期研究的结果

Final Publication Number: 1001O

最终出版号：1001O

Session Type: Proffered Paper

会议类型：推荐论文

Session Title: Developmental Therapeutics

会议主题：发育治疗学

Session Date & Time: October 24, 2026 14:45 PM - 16:15 PM CET

会议日期和时间：2026年10月24日 14:45 - 16:15（中欧时间）

Room: Cordoba Auditorium - Hall 4

会议室：科尔多瓦礼堂 - 4号厅

Presenter: Dr. Yi Hu, Chinese PLA General Hospital

演讲者：胡毅博士，中国人民解放军总医院

6.

6.

Presentation Title: IBI354 plus pertuzumab as first-line (1L) treatment for patients (pts) with HER2-positive, unresectable locally advanced or metastatic breast cancer (BC): Results from a phase 2 study

报告题目：IBI354联合帕妥珠单抗作为HER2阳性、不可切除的局部晚期或转移性乳腺癌（BC）患者（pts）的一线（1L）治疗：一项2期研究的结果

Final Publication Number: 1776P

最终出版号：1776P

Session Type: Poster

会议类型：海报展示

Session Date & Time: October 24, 2026 12:00 PM - 12:45 PM CET

会议日期和时间：2026年10月24日 中午12:00 - 12:45（中欧时间）

Presenter: Dr. Xiaohua Zeng, Chongqing University Cancer Hospital

主讲人：曾晓华博士，重庆大学附属肿瘤医院

Abstracts of TYVYT®(sintilimab)

泰逸®（信迪利单抗）摘要

1.

1.

Presentation Title: Under the neoadjuvant chemoimmunotherapy strategy, reducing the cycles of chemotherapy may yield similar efficacy to the standard treatment model: a randomized, non-controlled cohort study on resectable non-small cell Iung cancer

报告题目：在新辅助化疗联合免疫治疗策略下，减少化疗周期数可能获得与标准治疗方案相似的疗效：一项针对可手术非小细胞肺癌的随机、非对照队列研究

Abstract Number: 6528

摘要编号：6528

Session Type: Poster Session

会议类型：海报展示

Presenter: Dr. Xiaolong Yan, Tangdu Hospital‌

主讲人：闫小龙博士，唐都医院

2.

2.

Presentation Title: Sintilimab combined with bevacizumab and induction chemotherapy in the treatment of N2-3 nasopharyngeal carcinoma: A Prospective, single-arm, multicenter phase ll clinical study

报告题目：信迪利单抗联合贝伐珠单抗及诱导化疗治疗N2-3期鼻咽癌：一项前瞻性、单臂、多中心II期临床研究

Abstract Number: 2868

摘要编号：2868

Session Type: Poster Session

会议类型：海报展示环节

Presenter: Dr. Feng Jiang, Zhejiang Cancer Hospital

主讲人：冯江博士，浙江省肿瘤医院

3.

3.

Presentation Title: Sintilimab in combination with Cetuximab and Chemotherapy as first-line treatment for MSS/pMMR and RAS/BRAF wild-type metastatic colorectal cancer (CALLIOPSIS): a phase Ib/II dose escalation and expansion trial

报告题目：信迪利单抗联合西妥昔单抗及化疗作为MSS/pMMR且RAS/BRAF野生型转移性结直肠癌的一线治疗（CALLIOPSIS）：一项Ib/II期剂量递增及扩展试验

Abstract Number: 4276

摘要编号：4276

Session Type: Poster Session

会议类型：海报展示环节

Presenter: Dr. Ying Wang, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen

演讲嘉宾：王颖博士，中国医学科学院肿瘤医院深圳医院

4.

4.

Presentation Title: Efficacy of Fruquintinib Plus Sintilimab in Special Populations with Advanced Renal Cell Carcinoma: A Subgroup Analysis of FRUSICA-2 Study

报告题目：呋喹替尼联合信迪利单抗在晚期肾细胞癌特殊人群中的疗效：FRUSICA-2研究的亚组分析

Abstract Number: 3367eP

摘要编号：3367eP

Session Type: ePoster

会议类型：电子海报

Presenter: Dr. Kaiwei Yang, Peking University First Hospital

演讲者：杨凯威博士，北京大学第一医院

5.

5.

Presentation Title: Association between dose adjustment and treatment outcomes in patients with advanced renal cell carcinoma receiving Fruquintinib plus Sintilimab: A post-hoc analysis of the FRUSICA-2 trial

报告题目：接受呋喹替尼联合信迪利单抗治疗的晚期肾细胞癌患者剂量调整与治疗结局之间的关联：FRUSICA-2试验的事后分析

Abstract Number: 3655eP

摘要编号：3655eP

Session Type: ePoster

会议类型：电子海报

Presenter: Dr. Yuanyuan Qu, Fudan University Shanghai Cancer Center

主讲人：屈媛媛博士，复旦大学附属肿瘤医院

6.

6.

Presentation Title: Efficacy and safety of IBI351 plus cetuximab β±FOLFIRI inpatients with KRAS G12C-mutated metastatic colorectal cancer (the CRUCIAL study)

报告题目：IBI351联合西妥昔单抗±FOLFIRI治疗KRAS G12C突变转移性结直肠癌患者的疗效与安全性（CRUCIAL研究）

Abstract Number: 885eP

摘要编号：885eP

Session Type: ePoster

会议类型：电子海报

Session Title: Gastrointestinal Cancer—Colorectal and Anal

会议主题：胃肠道癌症——结直肠癌与肛管癌

Session Date & Time: Oct 23, 2026 – Oct 27, 2026 online

会议日期和时间：2026年10月23日 – 2026年10月27日，线上举行

Presenter: Dr. Weng Shanshan, The Second Affiliated Hospital of Zhejiang University School of Medicine

主讲人：翁珊珊博士，浙江大学医学院附属第二医院

*Innovent entered into a license and collaboration agreement with Takeda for co-development and co-commercialization of IBI363 (Takeda R&D code: TAK-928), ex-China rights of Arcotatug Tavetecan (Innovent/Takeda R&D Code: IBI343/TAK-921) and an option right of IBI3001. Please refer to the announcement for more information..

信达生物与武田制药就共同开发和商业化IBI363（武田研发代号：TAK-928）、Arcotatug Tavetecan的大中华区以外权益（信达/武田研发代号：IBI343/TAK-921）以及IBI3001的选择权达成许可与合作协议。更多信息请参阅相关公告。

**Rapid oral #1008RO is from an investigator-initiated clinical trial (IIT).

**快速口头报告 #1008RO 来自一项研究者发起的临床试验（IIT）。

***Abstracts of TYVYT ®(sintilimab) are from IITs,

***TYVYT®（信迪利单抗）的摘要来自研究者发起的临床试验（IITs），

except for abstract #3367eP, #3655eP.

摘要 #3367eP 和 #3655eP 除外。

About Innovent

关于信达生物

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases.

信达生物是一家领先的生物制药公司，成立于2011年，其使命是为全球患者提供负担得起的高质量生物制药。该公司发现、开发、制造并商业化针对一些最难治疾病的创新药物。其开创性疗法用于治疗癌症、心血管和代谢疾病、自身免疫性疾病以及眼部疾病。

Innovent has launched 20 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 19 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center..

信达生物已上市20款产品。目前有1项资产处于国家药品监督管理局（NMPA）审评阶段，5项资产处于III期或关键性临床试验阶段，另有19个分子处于早期临床阶段。信达生物与包括礼来、罗氏、武田、辉瑞、赛诺菲、Incyte、LG化学和MD安德森癌症中心在内的30多家全球医疗健康企业建立了合作关系。

Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.

秉持“以诚信为本，以行动致胜”的宗旨，信达生物坚守行业最高标准，协同合作推动生物医药行业发展，让优质药物惠及大众。

For more information, visit

更多信息，请访问

www.innoventbio.com

www.innoventbio.com

, or follow Innovent on

，或在以下平台关注信达生物

Facebook

脸书

and

和

LinkedIn

领英

.

。

Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s).

声明：(1) 信达生物不推荐使用任何未经批准的药物和/或适应症。

(2) Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®), Pirtobrutinib Tablets (Jaypirca®) and abemaciclib (Verzenios®) are products discovered and developed by Eli Lilly.

(2) 雷莫西尤单抗注射液（Cyramza®）、塞尔帕替尼胶囊（Retsevmo®）、皮托布替尼片（Jaypirca®）和阿贝西利（Verzenios®）是由礼来公司发现并开发的产品。

Forward-looking statement

前瞻性声明

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words 'anticipate', 'believe', 'estimate', 'expect', 'intend' and similar expressions, as they relate to Innovent Biologics ('Innovent'), are intended to identify certain of such forward-looking statements.

本新闻稿可能包含某些前瞻性陈述，这些陈述因其性质而受到重大风险和不确定性的影响。“预期”、“相信”、“估计”、“期望”、“打算”及类似表述，在与信达生物制药（“信达”）相关时，旨在识别此类前瞻性陈述。

The Company does not intend to update these forward-looking statements regularly..

本公司不打算定期更新这些前瞻性陈述。

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict.

这些前瞻性陈述是基于本公司管理层在作出这些陈述时，对未来事件所持有的信念、假设、预期、估计、预测和理解。这些陈述并非对未来发展的保证，并受到风险、不确定性和其他因素的影响，其中一些因素超出本公司的控制范围且难以预测。

Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions..

因此，由于我们业务、公司竞争环境以及政治、经济、法律和社会条件的未来变化或发展，实际结果可能与前瞻性陈述中包含的信息存在重大差异。

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

本公司、董事及员工（a）不承担更正或更新本网站所载前瞻性陈述的义务；且（b）在任何前瞻性陈述未实现或被证明为不正确的情况下，不承担任何责任。

SOURCE Innovent Biologics

来源：信达生物

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