SAN FRANCISCO and SUZHOU, China

旧金山和中国苏州

,

，

April 21, 2026

2026年4月21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 first-in-class IBI363 (PD-1/IL-2.

/PRNewswire/ -- 信达生物制药（Innovent Biologics, Inc.）（HKEX: 01801），一家致力于开发、生产和商业化高质量药物用于治疗肿瘤、心血管及代谢疾病、自身免疫疾病、眼科疾病及其他重大疾病的国际一流生物制药公司，宣布其首创的IBI363（PD-1/IL-2）的临床数据。

α-biased

α-偏差

bispecific fusion protein)

双特异性融合蛋白

*

*

as well as TYVYT® (sintilimab injection)

以及TYVYT®（信迪利单抗注射液）

**

**

will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 to June 2, 2026, in Chicago, Illinois, U.S.

将于2026年5月29日至6月2日在美国伊利诺伊州芝加哥举行的2026年美国临床肿瘤学会（ASCO）年会上公布。

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

周辉博士，信达生物制药（研发）首席官（肿瘤学），

stated: 'We are excited to announce that at the 2026 ASCO Annual Meeting, we will present new PoC data of IBI363 in NSCLC, across both IO-resistant and first-line settings. With robust PoC data for IO-resistant NSCLC now in hand, we are moving IBI363 into MRCT pivotal development, an important step toward tackling a major global unmet medical need.

声明：“我们很高兴地宣布，在2026年ASCO年会上，我们将展示IBI363在非小细胞肺癌（NSCLC）中的新的概念验证（PoC）数据，涵盖免疫治疗耐药和一线治疗环境。随着目前在手的针对免疫治疗耐药非小细胞肺癌的强大PoC数据，我们正将IBI363推进到多区域临床试验（MRCT）关键开发阶段，这是解决全球重大未满足医疗需求的重要一步。”

At the same time, we are .

同时，我们是。

encouraged

鼓励

by the promising dose optimization data in first-line NSCLC, and we look forward to continued maturation of PoC full data to inform our next steps. Innovent will continue to push the boundaries of cancer care, as we are dedicated to delivering physicians and patients more innovative, effective, and life-saving treatment options.'.

一线NSCLC中剂量优化数据前景令人鼓舞，我们期待PoC完整数据的进一步成熟，以指导我们的下一步行动。信达将继续推动癌症治疗的边界，我们致力于为医生和患者提供更具创新性、更有效、更能挽救生命的治疗选择。

Abstracts of IBI363(PD-1/IL-2

IBI363（PD-1/IL-2）的摘要

α

α

-biased

-偏见

bispecific fusion protein)

双特异性融合蛋白）

1.  Presentation Title: IBI363 (TAK-928) plus chemotherapy as first line (1L) treatment for advanced non-small cell lung cancer (NSCLC).

1. 演讲标题：IBI363 (TAK-928) 联合化疗作为晚期非小细胞肺癌（NSCLC）的一线（1L）治疗。

Abstract Number: 8586

摘要编号：8586

Session Type: Poster

会议类型：海报

Session Title: Lung Cancer/Non-Small Cell Metastatic

会议标题：肺癌/非小细胞转移性

Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月31日 上午9:00-中午12:00 中央夏令时

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

主讲人：涂海燕博士，广东省人民医院

2.  Presentation Title: First-in-class PD-1/IL-2

2. 演讲标题：首创PD-1/IL-2

α-bias

α-偏差

bispecific antibody IBI363 (TAK-928) in patients (pts) with advanced immunotherapy-resistant non-small cell lung cancer (NSCLC): updated results from a phase I study.

双特异性抗体IBI363（TAK-928）在晚期免疫治疗耐药的非小细胞肺癌（NSCLC）患者中的应用：一项I期研究的更新结果。

Abstract Number: 2618

摘要编号：2618

Session Type: Poster

会议类型：海报展示

Session Title: Developmental Therapeutics/Immunotherapy

会议标题：发育治疗学/免疫治疗学

Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT

会议日期与时间：2026年5月30日 下午1:30-4:30 中央夏令时

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

讲者：周建娅博士，浙江大学医学院附属第一医院

3.  Presentation Title: Randomized phase 3 study (MarsLight-11) evaluating IBI363 (TAK-928) versus docetaxel in patients (pts) with squamous non-small cell lung cancer (sqNSCLC) after prior chemotherapy (chemo) and immunotherapy (IO).

第三项：随机三期研究（MarsLight-11），评估IBI363（TAK-928）与多西他赛在既往接受过化疗和免疫治疗的鳞状非小细胞肺癌（sqNSCLC）患者中的疗效。

Abstract Number: TPS8673

摘要编号：TPS8673

Session Type: Poster

会议类型：海报展示

Session Title: Lung Cancer/Non-Small Cell Metastatic

会议标题：肺癌/非小细胞转移性

Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月31日 上午9:00-中午12:00 中央夏令时

Presenter: Dr. Roy S. Herbst, Yale School of Medicine

讲者：罗伊·S·赫布斯特博士，耶鲁大学医学院

Abstracts of TYVYT®(sintilimab)

TYVYT®（信迪利单抗）摘要

1.

1.

Presentation Title: Adjuvant sintilimab plus bevacizumab following curative resection of spontaneously ruptured hepatocellular carcinoma: A prospective exploratory phase II study (CLEAR-2)

演讲标题：肝细胞癌自发破裂治愈性切除术后使用信迪利单抗联合贝伐珠单抗辅助治疗：一项前瞻性探索性II期研究（CLEAR-2）

Abstract Number: TPS4254

摘要编号：TPS4254

Session Type: Poster

会议类型：海报展示

Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

会议标题：胃肠道癌症——胃食管、胰腺和肝胆

Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月30日，上午9:00-12:00（中部夏令时）

Presenter: Dr. Yongjun Chen, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

主讲人：陈永军博士，上海交通大学医学院附属瑞金医院

2.

2.

Presentation Title: Neoadjuvant chemoradiotherapy with or without PD-1 blockade in pMMR/MSS low rectal cancer patients (CHOICE II): A multi-center, open-label, randomized controlled trial.

演讲标题：在pMMR/MSS低位直肠癌患者中使用或不使用PD-1阻断剂的新辅助放化疗（CHOICE II）：一项多中心、开放标签、随机对照试验。

Abstract Number: 3640

摘要编号：3640

Session Type: Poster

会议类型：海报展示

Session Title: Gastrointestinal Cancer—Colorectal and Anal

会议标题：胃肠道癌症——结直肠和肛门

Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月30日，上午9:00-中午12:00（中部夏令时）

Presenter: Dr. Wei Zhang, Changhai Hospital

主讲人：张伟博士，长海医院

3.

3.

Presentation Title: Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC): A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study

演讲标题：IBI310联合信迪利单抗对比索拉非尼在晚期肝细胞癌（aHCC）一线治疗中的有效性与安全性：一项随机、开放标签、对照、多中心III期临床研究

Abstract Number: 4148

摘要编号：4148

Session Type: Poster

会议类型：海报展示

Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

会议标题：胃肠道癌症——胃食管、胰腺和肝胆

Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月30日，上午9:00-中午12:00（中部夏令时）

Presenter: Dr. Jia Fan, Zhongshan Hospital, Fudan University

讲者：樊嘉博士，复旦大学中山医院

4.

4.

Presentation Title: CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer.

演示标题：CONCEPT（西妥昔单抗联合呋喹替尼治疗 ± 免疫疗法）：一项多中心、随机、开放标签的II期试验，用于一线pMMR RAS/BRAF野生型不可切除的转移性结直肠癌。

Abstract Number: TPS3680

摘要编号：TPS3680

Session Type: Poster

会议类型：海报

Session Title: Gastrointestinal Cancer—Colorectal and Anal

会议标题：胃肠道癌症——结直肠和肛门

Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月30日，上午9:00-中午12:00（中部夏令时）

Presenter: Dr. Yue Liu, The Second Affiliated Hospital of Zhejiang University School of Medicine.

讲者：刘悦博士，浙江大学医学院第二附属医院。

5.

5.

Presentation Title: Long-term survival and biomarker analysis of neoadjuvant chemoradiotherapy with or without PD-1 antibody sintilimab in pMMR locally advanced rectal cancer: A randomized clinical trial.

演讲标题：新辅助放化疗联合或不联合PD-1抗体信迪利单抗在pMMR局部晚期直肠癌中的长期生存和生物标志物分析：一项随机临床试验。

Abstract Number: 3610

摘要编号：3610

Session Type: Poster

会议类型：海报展示

Session Title: Gastrointestinal Cancer—Colorectal and Anal

会议标题：胃肠道癌症——结直肠和肛门

Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月30日 上午9:00-中午12:00 中央夏令时

Presenter: Dr. Xiao Weiwei, Sun Yat-sen University Cancer Center

主讲人：肖巍巍博士，中山大学肿瘤中心

6.

6.

Presentation Title: Larynx preservation via chemotherapy-free neoadjuvant sintilimab-cetuximab-SBRT and response-adapted treatment in locally advanced laryngeal cancer: A phase II, single-arm clinical trial (The NeoVOICE study).

演示标题：通过无化疗的新辅助信迪利单抗-西妥昔单抗-SBRT及根据反应调整的治疗实现喉保留治疗局部晚期喉癌：一项II期、单臂临床试验（NeoVOICE研究）。

Abstract Number: 6095

摘要编号：6095

Session Type: Poster

会议类型：海报

Session Title: Head and Neck Cancer

会议标题：头颈癌

Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT

会议日期与时间：2026年5月30日 下午1:30-4:30 中央夏令时

Presenter: Dr. Song Ming, Sun Yat-sen University Cancer Center

主讲人：宋明博士，中山大学肿瘤中心

7.

7.

Presentation Title: Pathological complete response and ctDNA analyses in SCIENCE: Results from a randomized, phase III trial of neoadjuvant chemotherapy plus sintilimab and chemoradiotherapy plus sintilimab versus chemoradiotherapy in resectable locally advanced esophageal squamous cell carcinoma.

演示标题：病理完全缓解与ctDNA分析在《科学》杂志上：来自一项随机、III期新辅助化疗加信迪利单抗和放化疗加信迪利单抗对比放化疗治疗可切除局部晚期食管鳞状细胞癌的试验结果。

Abstract Number: LBA4082

摘要编号：LBA4082

Session Type: Poster

会议类型：海报展示

Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary

会议标题：胃肠道癌症——胃食管、胰腺和肝胆

Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月30日 上午9:00-中午12:00 中央夏令时

Presenter: Dr. Xuefeng Leng, Sichuan Cancer Hospital

主持人：冷雪峰博士，四川肿瘤医院

8.

8.

Presentation Title: Sintilimab (PD-1 antibody) Plus Gemcitabine and Docetaxel (GT) as First-line or Later-line Therapy in Patients with Advanced Epithelioid Sarcoma: A Prospective, Multicenter, Single-arm, Phase II Clinical Study.

演讲标题：信迪利单抗（PD-1抗体）联合吉西他滨和多西他赛（GT）作为晚期上皮样肉瘤患者的一线或后线治疗：一项前瞻性、多中心、单臂、II期临床研究。

Abstract Number: 11574

摘要编号：11574

Session Type: Poster

会议类型：海报

Session Title: Sarcoma

会议标题：肉瘤

Session Date & Time: June 1, 2026 1:30 PM-4:30 PM CDT

会议日期与时间：2026年6月1日 下午1:30-4:30（中部夏令时）

Presenter: Dr. Xiaowei Zhang, Fudan University Shanghai Cancer Center

主讲人：张晓伟博士，复旦大学上海癌症中心

9.

9.

Presentation Title: Sintilimab plus Anlotinib and Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma: A Prospective, Phase II Clinical Trial.

演示标题：信迪利单抗联合安罗替尼和化疗作为晚期恶性胸膜间皮瘤的一线治疗：一项前瞻性II期临床试验。

Abstract Number: 8050

摘要编号：8050

Session Type: Poster

会议类型：海报

Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

会议标题：肺癌——非小细胞局部区域/小细胞/其他胸部癌症

Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT

会议日期与时间：2026年5月31日 上午9:00-中午12:00 中央夏令时

Presenter: Dr. Jianchun Duan, Cancer Hospital, Chinese Academy of Medical Sciences

主讲人：段建春博士，中国医学科学院肿瘤医院

*Innovent entered into a license and collaboration agreement with Takeda for co-development and co-commercialization of IBI363 (Takeda R&D code: TAK-928). Please refer to the announcement for more information.

*信达与武田就共同开发和共同商业化IBI363（武田研发代码：TAK-928）达成许可及合作协议。欲了解更多信息，请参阅公告。

**Abstracts of TYVYT ®(sintilimab) are from investigator-initiated clinical trials (IIT),

TYVYT®（信迪利单抗）的摘要来自研究者发起的临床试验 (IIT)，

except for abstract #4148.

除了摘要#4148。

About Innovent

关于信达

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、制造和商业化针对一些最棘手疾病的创新药物。其开创性疗法治疗癌症、心血管和代谢、自身免疫和眼科疾病。

Innovent has launched 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center..

信达生物已将18款产品推向市场，其中5款处于III期或关键性临床试验阶段，另有14款分子处于早期临床阶段。信达生物与超过30家全球医疗保健公司建立了合作伙伴关系，包括礼来、罗氏、武田、赛诺菲、Incyte、LG化学以及MD安德森癌症中心。

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. For more information, visit

信达恪守“始于信，达于行”的理念，致力于维护最高标准的行业规范，并携手合作共同推动生物医药行业的发展，使一流的药物能够得到广泛使用。欲了解更多信息，请访问

www.innoventbio.com

www.innoventbio.com

, or follow Innovent on Facebook and LinkedIn.

，或者在Facebook和LinkedIn上关注信达。

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

声明：(1) 信达不建议使用任何未经批准的药物/适应症。

（

（

2

2

）

）

Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.

Ramucirumab（Cyramza）和Selpercatinib（Retsevmo）以及Pirtobrutinib（Jaypirca）由礼来公司开发。

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。与信达生物制药（“信达”）相关的诸如“预期”、“相信”、“估计”、“期望”、“意图”及类似表述的词语旨在识别其中某些前瞻性陈述。

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

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.

这些前瞻性声明是基于公司管理层在作出这些声明时对未来事件的现有信念、假设、期望、估计、预测和理解。这些声明并非对未来发展的保证，且受风险、不确定性和其他因素的影响，其中一些因素超出公司的控制范围并且难以预测。

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，由于我们业务的未来发展或变化、公司竞争环境以及政治、经济、法律和社会状况的影响，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.

公司、董事及公司员工：(a) 没有义务纠正或更新本网站中包含的前瞻性陈述；且 (b) 在任何前瞻性陈述未能实现或被证明不正确的情况下，不承担任何责任。

SOURCE Innovent Biologics

来源：信达生物

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