SAN FRANCISCO

旧金山

and SUZHOU,

和苏州，

China

中国

,

，

Aug. 24, 2025

2025年8月24日

/PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, ophthalmology and other major therapeutic areas, today announced that the U.S.

/PRNewswire/ -- 信达生物制药集团（“信达生物”）（港交所代码：01801），一家致力于在肿瘤、心血管及代谢疾病、自身免疫、眼科及其他主要治疗领域开发、生产和商业化高质量药物的世界级生物制药公司，今日宣布，美国

Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a global Phase 3 clinical trial (MarsLight-11) of IBI363 in immunotherapy(IO)-resistant squamous non-small cell lung cancer (NSCLC). IBI363 is Innovent's self-discovered novel PD-1/IL-2.

美国食品药品监督管理局（FDA）已批准启动IBI363在免疫治疗（IO）耐药的鳞状非小细胞肺癌（NSCLC）中的全球III期临床试验（MarsLight-11）的新药临床试验（IND）申请。IBI363是信达生物自主研发的新型PD-1/IL-2。

α-bias

α-偏差

bispecific antibody fusion protein. The upcoming study will be the first global Phase 3 trial of IBI363 and represents a significant milestone in advancing a first-in-class, dual-immune activation immunotherapy for this large patient population. Besides, the pivotal trial of IBI363 head-to-head against pembrolizumab (Keytruda.

双特异性抗体融合蛋白。即将进行的研究将是IBI363的全球首个三期试验，标志着为这一庞大的患者群体推进首创、双重免疫激活免疫疗法的重要里程碑。此外，IBI363的关键试验将与派姆单抗（Keytruda）进行头对头的对比。

®

®

) in the treatment of melanoma is underway in

）在黑色素瘤治疗中的应用正在

China

中国

.

。

IBI363 as a Next-generation IO therapy Set for First Global Phase 3 Lung Cancer Trial

IBI363作为下一代IO疗法，即将开展全球首个三期肺癌试验

This IND clearance follows recent positive feedback from the U.S. FDA at the End-of-Phase 2 (EOP2) meeting. Major alignments of the Phase 3 program were reached regarding the dose selection, study design, and other critical considerations. Innovent has also received IND approval from

这项IND许可是在近期美国FDA在第二阶段结束（EOP2）会议上给予的积极反馈之后获得的。关于第三阶段计划的剂量选择、研究设计及其他关键考虑事项，已达成主要一致。信达生物也已获得IND批准。

China's

中国的

National Medical Products Administration (NMPA) for this program. In parallel, Innovent has initiated communications and submissions to other major Health authorities. IBI363 has also received Fast Track Designation (FTD) from the FDA and Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in .

国家药品监督管理局（NMPA）开展该项目。同时，信达生物已开始与其他主要健康机构进行沟通和提交。IBI363还获得了美国食品药品监督管理局（FDA）的快速通道资格（FTD）以及国家药品监督管理局（NMPA）的突破性疗法认定（BTD）。

China

中国

for this indication.

适用于此指征。

The multi-regional, randomized, controlled Phase 3 trial will enroll approximately 600 patients globally including

这项多区域、随机、对照的三期临床试验将全球招募大约600名患者，包括

China

中国

, U.S.,

，美国，

Canada

加拿大

, EU, UK, and

，欧盟、英国和

Japan

日本

, etc. The study will evaluate the efficacy and safety of IBI363 3 mg/kg monotherapy compared with docetaxel in patients with unresectable, locally advanced or metastatic squamous NSCLC who have experienced disease progression following platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy. The primary endpoint is overall survival..

等等。该研究将评估IBI363 3 mg/kg单药疗法与多西他赛相比，在接受过铂类化疗和抗PD-1/PD-L1免疫治疗后疾病进展的不可切除、局部晚期或转移性鳞状非小细胞肺癌患者中的疗效和安全性。主要终点是总生存期。

IBI363's Breakthrough Data Validates its Dual-immune Activation Mechanism, Stepwise Development in Multiple Tumor Types

IBI363的突破性数据验证了其双重免疫激活机制，在多种肿瘤类型中逐步开发

At ASCO 2025, Phase

在2025年ASCO，阶段

1b

1b

/2 results demonstrated meaningful and durable clinical activity in areas of high unmet need, including

/2 的结果表明，在高度未满足需求的领域，包括临床活性方面，展现了显著且持久的效果，

IO-resistant lung cancer

抗药性肺癌

, traditionally 'cold tumors' such as

，传统上“冷肿瘤”如

acral and mucosal melanoma

肢端和黏膜黑色素瘤

, and

，以及

microsatellite stable (MSS) colorectal cancer

微卫星稳定（MSS）结直肠癌

.

。

These promising data position IBI363 as a potential first-in-class dual-immune activation therapy with broad applicability across difficult-to-treat cancers. Innovent is rapidly progressing IBI363 into registrational studies, with a pivotal program in melanoma already ongoing, a global Phase 3 trial in squamous NSCLC expected to start shortly, and a registration strategy in colorectal cancer in planning..

这些令人鼓舞的数据表明，IBI363 作为一种潜在的首创双免疫激活疗法，在难治性癌症中具有广泛的适用性。信达生物正在快速推进 IBI363 进入注册研究阶段，其中黑色素瘤的关键项目已在进行中，预计即将启动一项针对鳞状非小细胞肺癌的全球 III 期试验，同时结直肠癌的注册策略也在规划中。

In parallel, multiple Phase

同时，多个阶段

1b

1b

/2 trials are evaluating IBI363 both as monotherapy and in combinations in first-line NSCLC, first-line CRC, and additional tumor types, including platinum-resistant ovarian cancer (PROC), EGFR+ NSCLC, and neoadjuvant therapy for non-squamous NSCLC. This comprehensive development strategy is designed to maximize the value of IBI363 and expand its potential to address multiple large global oncology markets and improve patient outcomes..

两项试验正在评估IBI363在一线非小细胞肺癌、一线结直肠癌以及其他肿瘤类型（包括铂耐药卵巢癌（PROC）、EGFR+非小细胞肺癌和非鳞状非小细胞肺癌新辅助治疗）中的单药疗法及联合疗法。这一全面的开发策略旨在最大化IBI363的价值，拓展其在多个全球大型肿瘤市场中的潜力，并改善患者的治疗效果。

Roy S. Herbst

罗伊·S·赫布斯特

, MD, PhD, Deputy Director and Chief of Medical Oncology and Hematology for Yale Cancer Center and Smilow Cancer Hospital, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology at

医学博士，哲学博士，耶鲁癌症中心和斯米洛癌症医院副主任兼肿瘤学和血液学主任，医学（肿瘤学）恩赛因讲席教授及药理学教授，任职于

Yale School of Medicine

耶鲁大学医学院

, shared,

，共享，

'Lung cancer remains the most prevalent malignant tumor worldwide, with particularly high incidence and mortality rates globally. Non-small cell lung cancer constitutes the majority of these cases. Although immunotherapy has significantly improved survival outcomes for some patients, those who do not respond to such treatments and lack driver gene mutations have limited therapeutic options, underscoring the urgent need for enhanced clinical interventions..

肺癌仍然是全球最常见的恶性肿瘤，其发病率和死亡率在全球范围内居高不下。非小细胞肺癌占其中的大多数病例。尽管免疫疗法显著改善了部分患者的生存结果，但对那些对该治疗无反应且缺乏驱动基因突变的患者，治疗选择十分有限，凸显出迫切需要更有效的临床干预措施。

Clinical research of the PD-1/IL-2

PD-1/IL-2的临床研究

α-biased

α-偏差

bispecific molecule IBI363 has revealed encouraging findings.  Preliminary trials have demonstrated that IBI363 not only induces tumor remission in a subset of patients but also achieves disease stability in the majority of patients, indicating durable anti-tumor activity. In comparison to traditional chemotherapy, IBI363 appears to offer potential advantages in both objective response rate (ORR) and progression-free survival (PFS), providing new hope for patients diagnosed with lung cancer.'.

双特异性分子IBI363展现了令人鼓舞的发现。初步试验表明，IBI363不仅在部分患者中诱导肿瘤缓解，而且在大多数患者中实现了疾病稳定，显示出持久的抗肿瘤活性。与传统化疗相比，IBI363在客观缓解率（ORR）和无进展生存期（PFS）方面似乎提供了潜在优势，为肺癌患者带来了新的希望。

Professor

教授

Shun Lu

陆舜

from the Oncology Department of Shanghai Chest Hospital, stated:

上海市胸科医院肿瘤科表示：

'As a first-in-class PD-1/IL-2

‘作为第一类PD-1/IL-2

α-biased

α-偏差

bispecific antibody fusion protein, IBI363 acts by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is engineered to retain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2.

双特异性抗体融合蛋白IBI363通过同时阻断PD-1/PD-L1通路和激活IL-2通路发挥作用。IBI363的IL-2部分经过工程改造，在保留对IL-2Rα亲和力的同时减少与IL-2Rβ和IL-2Rγ的结合，从而降低毒性。其PD-1结合部分不仅阻断PD-1，还选择性递送IL-2。

This dual mechanism targets and activates tumor-specific T cells co-expressing PD-1 and IL-2α, enabling more precise and effective stimulation of this T-cell subpopulation. IBI363 has demonstrated robust antitumor activity across multiple tumor models and has shown remarkable efficacy in IO-resistant, PD-L1 low expression, and cold tumor settings..

这种双重机制靶向并激活共表达 PD-1 和 IL-2α 的肿瘤特异性 T 细胞，从而能够更精准、更有效地刺激这一 T 细胞亚群。IBI363 在多种肿瘤模型中展现出强大的抗肿瘤活性，并在免疫治疗耐药、PD-L1 低表达和冷肿瘤环境中表现出显著的疗效。

The promising data associated with IBI363 offers a novel treatment avenue for patients with non-small cell lung cancer who have not responded to immunotherapy. As research progresses, this innovative therapy holds the potential to bridge clinical gaps and provide the possibility of long-term survival for a greater number of patients.'.

IBI363相关的令人鼓舞的数据为那些对免疫疗法没有反应的非小细胞肺癌患者提供了一种新的治疗途径。随着研究的进展，这种创新疗法有潜力弥补临床差距，并为更多患者提供长期生存的可能性。

Dr.

博士

Hui Zhou

惠州

, Chief R&D Officer for Oncology Pipeline at Innovent Biologics, said,

信达生物制药肿瘤学管线的首席研发官表示，

'Today's IND clearance marks a significant milestone as we initiate the first global Phase 3 trial of our next-generation IO therapy, IBI363 (PD-1/IL-2α-bias). If successful, this trial could bring a potentially transformative treatment to patients with squamous NSCLC worldwide, who currently have limited options after checkpoint inhibitor therapy.

“今天获得的IND批准标志着我们启动下一代IO疗法IBI363（PD-1/IL-2α-偏向）的全球首个三期临床试验的重要里程碑。如果试验成功，这项研究可能为全球鳞状非小细胞肺癌患者带来一种潜在的革命性治疗方案，这些患者目前在接受免疫检查点抑制剂治疗后选择有限。

Concurrently, we are exploring IBI363 in a broad global clinical program and look forward to more data and continued development in the future..

同时，我们正在广泛的全球临床项目中探索IBI363，期待未来获得更多的数据并继续开发。

This achievement also signifies a milestone for Innovent's global innovation strategy, rooted in our mission

这一成就也标志着信达生物全球创新战略的一个里程碑，立足于我们的使命

to 'empower patients worldwide with affordable, high-quality biopharmaceuticals' and our vision to 'build a global premier biopharmaceutical leader.'

以“为全球患者提供负担得起的高质量生物制药”为使命，并以“打造全球领先的生物制药企业”为愿景。

Having developed a highly competitive pipeline aligned with our globalization strategy, we have prioritized the global R&D of our assets, alongside expanding our international team and footprint to accelerate the development and access of innovative therapies worldwide.

我们已经建立了一条与全球化战略高度契合、极具竞争力的管线，并优先推进资产的全球研发，同时扩大我们的国际团队和布局，以加速创新疗法在全球范围内的开发和可及性。

In addition to IBI363, Innovent is advancing a broader pipeline for global development, including next-generation ADC programs such as bispecific and dual-payload ADCs. We believe our robust pipeline and ongoing R&D efforts will continue to expand our impact in oncology on a global scale.'

除了IBI363，信达生物还在推进更广泛的全球开发管线，包括下一代ADC项目，如双特异性和双载荷ADC。我们相信，我们强大的管线和持续的研发努力将继续在全球范围内扩大我们在肿瘤领域的影响。

About Innovent Biologics

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，使命是为全球患者提供负担得起的高质量生物制药。公司发现、开发、生产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 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center..

信达生物已上市16款产品，有2个新药申请正在审评中，4项资产处于III期或关键性临床试验，还有15个分子处于早期临床阶段。信达生物与30多家全球医药公司建立了合作伙伴关系，包括礼来、赛诺菲、Incyte、LG化学和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

信达秉持“始于信，达于行”的理念，致力于维护最高的行业标准，携手推进生物制药行业的发展，从而使一流的药物能够广泛普及。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:

声明：

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

（1）信达不建议使用任何未经批准的药物/适应症。

（2）Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company.

（2）Ramucirumab（Cyramza）、Selpercatinib（Retsevmo）和Jaypirca（pirtobrutinib）由礼来公司开发。

Forward-Looking Statements

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, Inc. ('Innovent' or 'Company'), 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（简称“信达”或“公司”）相关的诸如“预期”、“相信”、“估计”、“预计”、“意图”等词语及其类似表达，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，并受风险、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 materialize 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；(b) 如果任何前瞻性陈述未能实现或被证明不正确，概不承担责任。

SOURCE Innovent Biologics

来源：信达生物

WANT YOUR COMPANY'S NEWS

想要你公司的新闻吗

FEATURED ON PRNEWSWIRE.COM?

荣登PRNEWSWIRE.COM？

440k+

44万+

Newsrooms &

新闻编辑室 &

Influencers

影响者

9k+

9k+

Digital Media

数字媒体

Outlets

插座

270k+

27万+

Journalists

记者

Opted In

已选择加入

GET STARTED

开始使用