SAN FRANCISCO and SUZHOU, China

旧金山和中国苏州

,

，

Oct. 26, 2026

2026年10月26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 cancer, metabolic, autoimmune and other major diseases, today announced that a New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) has been accepted for review by the China National Medical Products Administration (NMPA).

/美通社/ -- 信达生物制药（苏州）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癌症、代谢性疾病、自身免疫性疾病及其他重大疾病的高质量药物。该公司今日宣布，信迪利单抗联合诺吉来赛尔注射液（GC101）的新适应症申请已获中国国家药品监督管理局（NMPA）受理并进入审评阶段。

The application is proposed to be sintilimab in combination with Nolgileucel Injection (GC101) for the treatment of patients with unresectable or metastatic melanoma whose disease has progressed following at least two lines of prior systemic therapy, including PD-1 antibody therapy. This would be the 11th indication for sintilimab, further consolidating its position as a cornerstone therapy in immuno-oncology (IO)..

该申请拟批准信迪利单抗联合Nolgileucel注射液（GC101），用于治疗至少经过两条既往系统性治疗（包括PD-1抗体治疗）后疾病进展的不可切除或转移性黑色素瘤患者。这将是信迪利单抗的第11个适应症，进一步巩固其作为免疫肿瘤学（IO）基石治疗的地位。

The new indication application is primarily based on the results of the pivotal Phase II clinical study MIZAR-003. MIZAR-003 (NCT04943913) is a pivotal Phase II, multicenter, randomized, open-label, parallel-controlled study designed to evaluate the efficacy and safety of GC101 TIL cell injection with sintilimab support in melanoma patients who have failed or are intolerant to anti-PD-1 antibody therapy.

新适应症申请主要基于关键性II期临床研究MIZAR-003的结果。MIZAR-003（NCT04943913）是一项关键性II期、多中心、随机、开放标签、平行对照研究，旨在评估在抗PD-1抗体治疗失败或不耐受的黑色素瘤患者中，联合信迪利单抗支持的GC101肿瘤浸润淋巴细胞（TIL）细胞注射的疗效和安全性。

The study results were first presented as an oral Late-Breaking Abstract (LBA 9509) at the 2026 ASCO Annual Meeting in June 2026. As of the data cutoff date of May 12, 2.

研究结果首次于2026年6月在2026年美国临床肿瘤学会（ASCO）年会上以口头晚期突破摘要（LBA 9509）的形式公布。截至2026年5月12日的数据截止日期，

026, the

026，这

primary endpoint was met. In patients with advanced melanoma who had failed prior anti-PD-1 antibody therapy and had received a median of 2 prior lines of systemic therapy, the median progression-free survival (mPFS) in the experimental arm reached 4.3 months, significantly superior to 1.6 months in the chemotherapy control arm, with a 57% reduction in the risk of disease progression or death (HR=0.43, 95% CI: 0.26–0.68; P=0.0002).

主要终点达成。在既往抗PD-1抗体治疗失败且中位接受过2线先前全身系统治疗的晚期黑色素瘤患者中，试验组的中位无进展生存期（mPFS）达到4.3个月，显著优于化疗对照组的1.6个月，疾病进展或死亡风险降低57%（HR=0.43，95% CI：0.26–0.68；P=0.0002）。

Meanwhile, adverse reactions in the experimental arm were manageable. Grade ≥3 adverse reactions were mainly preconditioning-induced hematologic toxicity, and the median .

与此同时，试验组的不良反应可控。≥3级不良反应主要为预处理引起的血液学毒性，中位数为。

AE duration was

不良事件持续时间为

comparable and rapidly reversible in experimental arm (8 days vs 13 days); most patients recovered without additional interventio

在实验组中相当且迅速可逆（8天 vs 13天）；大多数患者无需额外干预即可恢复

n.

名词

'Treatment options are very limited for patients with advanced, treatment-resistant melanoma,' said

“对于晚期、难治性黑色素瘤患者，治疗选择非常有限，”

Professor Guo Jun, Vice President of Peking University Cancer Hospital, Director of the Department of Melanoma and Sarcoma Medical Oncology, and Director of the Department of Urologic Oncology.

郭军教授，北京大学肿瘤医院副院长，黑色素瘤与肉瘤内科主任，泌尿肿瘤科主任。

'For patients whose disease continues to progress after prior PD-1 antibody therapy and multiple lines of systemic treatment, subsequent treatment presents significant challenges, and there is an urgent clinical need for more effective treatment options. The MIZAR-003 study demonstrated positive antitumor activity and a favorable safety profile in this patient population, offering a new treatment option for patients with unresectable or metastatic melanoma who have experienced disease progression following at least two prior systemic therapies, including an anti-PD-1 antibody.

对于既往接受过PD-1抗体治疗及多线全身治疗后疾病仍持续进展的患者，后续治疗面临重大挑战，临床上亟需更有效的治疗选择。MIZAR-003研究在该患者人群中显示出积极的抗肿瘤活性和良好的安全性特征，为至少经过两种既往全身治疗（包括抗PD-1抗体）后出现疾病进展的不可切除或转移性黑色素瘤患者提供了新的治疗选择。

We look forward to sintilimab and Nolgileucel bringing further benefits to patients.'.

我们期待信迪利单抗和Nolgileucel为患者带来更多获益。

'We are pleased that the 11th indication application for sintilimab has been accepted for review by the NMPA, with the potential to offer a more effective treatment option for patients with advanced melanoma in China,' said

“我们很高兴信迪利单抗的第11项适应症上市申请已获国家药品监督管理局（NMPA）受理并进入审评阶段，这有望为中国晚期黑色素瘤患者提供一种更有效的治疗选择。”

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

周辉博士，信达生物肿瘤研发首席官。

'This acceptance further consolidates the position of sintilimab as a cornerstone therapy in immuno-oncology. It also marks another milestone for us in advancing the full life-cycle management of this product and continuously maximizing its clinical value.'

“这一批准进一步巩固了信迪利单抗作为免疫肿瘤学基石疗法的地位。这也标志着我们在推进该产品全生命周期管理、持续最大化其临床价值方面又迈出了重要一步。”

About Sintilimab

关于信迪利单抗

Sintilimab, marketed as TYVYT

信迪利单抗，商品名：达伯舒（TYVYT）

®

®

(sintilimab injection) in China, is an innovative PD-1 inhibitor co-developed and commercialized by Innovent Biologics and Eli Lilly and Company. Sintilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells. By blocking the PD-1/programmed death-ligand 1 (PD-L1) pathway, which contributes to tumor immune tolerance, sintilimab reactivates the antitumor activity of lymphocytes to treat cancer..

（信迪利单抗注射液）在中国是由信达生物与礼来公司共同开发并商业化的创新PD-1抑制剂。信迪利单抗是一种人免疫球蛋白G4（IgG4）单克隆抗体，能特异性结合T细胞表面的PD-1分子。通过阻断导致肿瘤免疫耐受的PD-1/程序性死亡配体1（PD-L1）通路，信迪利单抗可重新激活淋巴细胞的抗肿瘤活性，从而用于癌症治疗。

[i]

[i]

About Nolgileucel Injection (GC101)

关于诺吉乐注射液（GC101）

GC101 was developed using the DeepTIL™ cell enrichment and expansion platform independently developed by Juncell Therapeutics. It is

GC101 是利用 Juncell Therapeutics 自主研发的 DeepTIL™ 细胞富集与扩增平台开发的。它是

Juncell's

Juncell的

most advanced tumor-infiltrating lymphocyte (TIL) therapy program and the world's first TIL therapy that does not require high-intensity lymphodepletion chemotherapy or IL-2 administration.  The pivotal Phase II study of GC101 in malignant melanoma has met its primary endpoint, and GC101 has been included in the .

最先进的肿瘤浸润淋巴细胞（TIL）治疗项目，以及全球首个无需高强度淋巴清除化疗或白细胞介素-2（IL-2）给药的TIL疗法。GC101在恶性黑色素瘤中的关键性II期研究已达到主要终点，且GC101已被纳入。

CSCO Guidelines for the Diagnosis and Treatment of Melanoma (2026 Edition)

CSCO黑色素瘤诊疗指南（2026版）

. The study of GC101 for advanced NSCLC is in Phase II, while its use as adjuvant therapy following surgery for glioma is expected to enter a Phase II clinical study.

GC101 用于晚期非小细胞肺癌的研究正处于 II 期临床试验阶段，而其作为胶质瘤术后辅助治疗的应用预计将进入 II 期临床研究。

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. Innovent has launched 20 products in the market. It has 1 asset under NDA review, 5 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage..

信达生物是一家领先的生物制药公司，成立于2011年，其使命是让全球患者能够获得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。信达生物已有20款产品上市。目前有1个资产处于新药上市申请（NDA）审评阶段，5个资产处于III期或关键性临床试验阶段，另有20多个分子处于早期临床阶段。

Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the high-quality outbound internationalization of China's innovative drug industry..

信达生物已与礼来、罗氏、武田、辉瑞、赛诺菲、Incyte 以及 MD 安德森癌症中心等全球知名企业建立了30多项战略合作伙伴关系，总价值超过人民币3500亿元。这些举措为中国创新药行业的高质量国际化出海树立了标杆。

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.

秉承“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，携手合作推动生物医药行业发展，让优质药物惠及更广泛的人群。

For more information, visit

更多信息，请访问

www.innoventbio.com

www.innoventbio.com

, or follow Innovent on Facebook and LinkedIn.

，或在 Facebook 和 LinkedIn 上关注信达生物。

Statement:

声明：

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

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 (Cyramza

2) 雷莫芦单抗（Cyramza

®

®

) and selpercatinib (Retsevmo

）和塞尔帕替尼（Retsevmo

®

®

), pirtobrutinib (Jaypirca

)，匹托布替尼（Jaypirca

®

®

) and abemaciclib (Verzenios

）和阿贝西利（Verzenios

®

®

) were developed by Eli Lilly and Company.

）由礼来公司开发。

Disclaimer: Innovent does not recommend any off-label usage.

免责声明：信达生物不推荐任何超说明书用药。

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, 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面临重大风险和不确定性。“预期”、“相信”、“估计”、“预计”、“打算”等类似表述，在与信达生物相关联时，旨在识别此类前瞻性陈述。

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

信达生物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 Innovent 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 Innovent's control and are difficult to predict.

这些前瞻性陈述基于信达生物管理层在作出这些陈述时，对未来事件的现有信念、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，并受风险、不确定性及其他因素的影响，其中某些因素超出信达生物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, Innovent's competitive environment and political, economic, legal and social conditions..

因此，由于我们的业务、信达生物的竞争环境以及政治、经济、法律和社会条件未来可能发生变化或发展，实际结果可能与前瞻性陈述中所载信息存在重大差异。

Innovent, the Directors and the employees of Innovent 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.

信达生物、信达生物的董事及员工（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能实现或被证实为不正确的情况下，不承担任何责任。

Reference

参考

[i]  Wang J, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. DOI: 10.1080/19420862.2019.1654303.

[i] Wang J, 等. PD-1信号的持久阻断将信迪利单抗的临床前疗效与其临床获益联系起来. mAbs 2019;11(8): 1443-1451. DOI: 10.1080/19420862.2019.1654303.

SOURCE Innovent Biologics

来源：信达生物

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