/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, autoimmune, metabolic, ophthalmology and other major diseases, announced completion of the first patient dosing for IBI3020, its first-in-class dual-payload CEACAM5 ADC, in Phase 1 clinical trial for the treatment of patients with advanced solid tumors.

/PRNewswire/ -- 全球领先的生物制药公司信达生物制药（Innovent Biologics, Inc.，简称“信达生物”）（港交所代码：01801），致力于开发、生产和商业化治疗肿瘤、自体免疫、代谢、眼科及其他重大疾病的高质量药物，今日宣布其同类首创双载荷CEACAM5 ADC药物IBI3020在针对晚期实体瘤患者的1期临床试验中完成首例患者给药。

IBI3020 is the first dual-payload ADC developed from Innovent's proprietary DuetTx.

IBI3020是信达生物基于其独有的DuetTx开发的首款双载荷抗体偶联药物（ADC）。

dual-payload ADC platform and the first dual-payload ADC globally known in the same class to complete the first-in-human dosing.

双载荷ADC平台，且是全球同类产品中首个完成人体首次给药的双载荷ADC。

The study is an open-label, multi-regional Phase 1 study evaluating the safety, tolerability, and preliminary efficacy of IBI3020 in participants with advanced solid tumors, as well as determining the recommended Phase 2 dose (RP2D). The study has received IND approval in the U.S. recently and will be conducted in both .

该研究是一项开放标签、多区域的1期临床研究，评估IBI3020在晚期实体瘤患者中的安全性、耐受性和初步疗效，并确定推荐的2期剂量（RP2D）。该研究最近已在美国获得IND批准，将在两地进行。

China

中国

and the U.S.

和美国

As a global first-in-class ADC candidate, IBI3020 is generated from Innovent's proprietary DuetTx® dual-payload ADC platform.

作为全球首个同类ADC候选药物，IBI3020源自信达生物自有的DuetTx®双载荷ADC平台。

The internationalization of the CEACAM5-dependent ADC occurs after IBI3020 selectively binds to CEACAM5-expressing tumor cells, followed by lysosomal degradation. This process releases two types of cytotoxic payloads, leading to cell killing of tumor cells.

CEACAM5依赖性ADC的国际化发生在IBI3020选择性结合到表达CEACAM5的肿瘤细胞之后，接着发生溶酶体降解。这一过程释放两种类型的细胞毒性载荷，导致肿瘤细胞的杀伤。

In preclinical studies, IBI3020 has demonstrated robust antitumor activity across various tumor-bearing pharmacology models, with a notable bystander killing effect. Additionally, IBI3020 has shown favorable safety characteristics in preclinical models, with an overall manageable safety profile.

在临床前研究中，IBI3020在多种荷瘤药理学模型中展现出强大的抗肿瘤活性，并具有显著的旁观者杀伤效应。此外，IBI3020在临床前模型中显示出良好的安全性，整体安全性特征可控。

Professor

教授

Yu Jinming

于金明

, Shandong Cancer Hospital, stated:'

，山东省肿瘤医院表示：‘

Carcinoembryonic antigen (CEA), also known as CEACAM5, is a glycosylphosphatidylinositol-anchored cell-surface glycoprotein involved in cell adhesion, invasion, and metastasis of cancer cells. There is a significant clinical need for effective therapies in advanced colorectal cancer, non-squamous lung cancer, gastric cancer, pancreatic cancer, and others.

癌胚抗原 (CEA)，也称为 CEACAM5，是一种糖基磷脂酰肌醇锚定的细胞表面糖蛋白，参与癌细胞的粘附、侵袭和转移。在晚期结直肠癌、非鳞状肺癌、胃癌、胰腺癌及其他癌症中，对有效疗法存在显著的临床需求。

CEACAM5 is overexpressed in these solid tumors but shows limited expression in healthy tissues, making it a potentially safe and promising therapeutic target. The dual payload of IBI3020 consists of two types of payloads that have been clinically validated. This dual-payload design has demonstrated enhanced tumor-killing effects in preclinical studies.

CEACAM5 在这些实体瘤中过表达，但在健康组织中表达有限，这使其成为一个潜在安全且有前景的治疗靶点。IBI3020 的双载荷由两种已经过临床验证的载荷组成。这种双载荷设计在临床前研究中显示出增强的肿瘤杀伤效果。

We look forward to observing the clinical profiles and potential breakthrough of IBI3020 in terms of safety, tolerability, and efficacy in clinical trials.'.

我们期待在临床试验中观察IBI3020在安全性、耐受性和有效性方面的临床特征和潜在突破。

Dr.

博士

Hui Zhou

惠州市

, Senior Vice President of Innovent,

，信达高级副总裁，

stated

声明

: 'We are pleased to announce the successful dosing of the first patient dose with IBI3020. We will continue to advance the global development of IBI3020, aiming to offer better treatment options for patients with advanced solid tumors. Innovent possesses innovative ADC technology platforms with independent intellectual property rights.

我们很高兴地宣布，首位患者已成功接受IBI3020的给药。我们将继续推进IBI3020的全球开发，旨在为晚期实体瘤患者提供更好的治疗选择。信达拥有具有自主知识产权的创新ADC技术平台。

Multiple ADC molecules have clinically validated their differentiated competitiveness. IBI3020, Innovent's first dual-payload ADC, has successfully entered clinical trials and is the first dual-payload ADC globally known in the same class to complete the first-in-human dosing, marking a breakthrough in Innovent's ADC technology.

多个ADC分子已临床验证其差异化竞争力。信达生物首款双载荷ADC药物IBI3020已成功进入临床阶段，是全球同类型中首个完成首例人体给药的双载荷ADC，标志着信达生物ADC技术实现突破。

We will continue our 'IO+ADC' strategy, focusing on next-generation innovations with global potential to benefit cancer patients worldwide.'.

我们将继续推进“IO+ADC”战略，专注具有全球潜力的下一代创新，造福全球癌症患者。

About IBI3020

关于IBI3020

IBI3020 is a global first-in-class ADC candidate developed from Innovent's proprietary DuetTx® dual-payload ADC platform. The CEACAM5 dependent ADC internalization occurs after IBI3020 selectively binds to the CEACAM5-expressing tumor cells, followed by the lysosomal degradation. This process releases two types of cytotoxic payloads, leading to tumor cell killing..

IBI3020 是信达生物基于其专有的 DuetTx® 双载荷 ADC 平台开发的全球首个同类 ADC 候选药物。IBI3020 选择性结合到表达 CEACAM5 的肿瘤细胞后，发生 CEACAM5 依赖性的 ADC 内化，随后通过溶酶体降解。这一过程释放两种类型的细胞毒性载荷，从而导致肿瘤细胞杀伤。

The multi-regional Phase 1 study of IBI3020, initiated in China, assesses the safety, tolerability, and preliminary efficacy of IBI3020 in patients with advanced solid tumors and aims to determine the recommended Phase 2 dose (RP2D). The study has also received IND approval in the U.S. recently and will be conducted in .

在中国启动的IBI3020多区域I期研究评估了IBI3020在晚期实体瘤患者中的安全性、耐受性和初步疗效，并旨在确定推荐的II期剂量（RP2D）。该研究最近也获得了美国的IND批准，并将在美国开展。

China

中国

and the U.S.

以及美国

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，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 15 products in the market. It has 3 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 16 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center..

信达生物已上市15款产品，有3个新药申请处于审评阶段，3项资产处于III期或关键性临床试验阶段，还有16个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合作，包括礼来、赛诺菲、Incyte、Adimab、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“诚信为本，行动致胜”的理念，坚持行业最高标准实践，与各方携手合作，推动生物医药行业发展，使一流药物能广为可及。欲了解更多信息，请访问