SAN FRANCISCO

旧金山

and SUZHOU,

苏州，

China

中国

,

，

June 1, 2025

2025年6月1日

/PRNewswire/ -- Innovent Biologics, Inc (Suzhou) (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 the data from Phase 1 and Phase 2 clinical studies of IBI363, first-in-class PD-1/IL-2.

/PRNewswire/ -- 世界级生物制药公司信达生物制药（苏州）有限公司（港交所代码：01801），专注于开发、生产和商业化用于治疗肿瘤、心血管及代谢疾病、自身免疫、眼科及其他重大疾病的高质量药物，宣布了其首创的PD-1/IL-2类药物IBI363的1期和2期临床研究数据。

α-bias

α-偏差

bispecific antibody fusion protein, for the treatment of  'immune cold tumor' —immunotherapy-pretreated melanoma  (acral and mucosal subtypes) were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

双特异性抗体融合蛋白，用于治疗“免疫冷肿瘤”——经免疫治疗预处理的黑色素瘤（肢端和黏膜亚型），在2025年美国临床肿瘤学会（ASCO）年会上进行了口头报告。

IBI363 has shown breakthrough efficacy in patients with heavily-treated melanoma subtypes - which are traditionally treatment-resistant 'cold' tumors,

IBI363在经过多线治疗的黑色素瘤亚型患者中展现出突破性的疗效——这些亚型通常属于对传统治疗耐药的“冷”肿瘤。

and a pivotal registration trial for IBI363 is currently ongoing.

IBI363的关键注册试验目前正在进行中。

Innovent Biologics is conducting clinical studies in

信达生物正在进行临床研究在

China

中国

,

，

the United States

美国

, and

，以及

Australia

澳大利亚

to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma—focusing on IO-resistant and cold tumors.

探索IBI363在多种肿瘤适应症中的有效性和安全性，包括免疫抵抗、冷肿瘤和一线治疗。在今年的ASCO会议上，IBI363报告了前三个探索适应症——非小细胞肺癌（NSCLC）、结直肠癌（CRC）和黑色素瘤——的1/2期临床数据，重点关注IO抵抗和冷肿瘤。

The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited..

数据全面展示了IBI363在这些适应症中的突破性临床结果，从强劲的肿瘤应答到长期生存获益。这些发现为该药物新颖的作用机制有效转化为临床成果提供了有力支持，并暗示了其在更广泛临床开发中的潜力，为治疗选择仍然有限的免疫治疗领域带来了新的希望。

A Phase 1/2 clinical study of PD-1/IL-2

PD-1/IL-2的1/2期临床研究

α-bia

α-双面

s

s

bispecific antibody fusion protein (IBI363) in the treatment of advanced 'cold' tumor subtypes (acral and mucosal) malignant melanoma

双特异性抗体融合蛋白（IBI363）在治疗晚期“冷”肿瘤亚型（肢端和黏膜）恶性黑色素瘤中的应用

The data presented at this ASCO meeting are from two multi-center Phase 1 and 2 clinical studies (registration no.: NCT05460767, NCT06081920) designed to evaluate the efficacy and safety of IBI363 monotherapy in the treatment of advanced melanoma. As of

本次ASCO会议上公布的数据来自两项多中心I/II期临床研究（注册号：NCT05460767，NCT06081920），旨在评估IBI363单药治疗晚期黑色素瘤的疗效和安全性。截至

April 7, 2025

2025年4月7日

, a total of 31 patients with unresectable, locally advanced or metastatic acral and mucosal melanoma who had previously received immunotherapy were enrolled and treated at the dosage of 1 mg/kg Q2W, and 64.5% of them had ≥2 lines of prior treatment.

共有 31 名既往接受过免疫治疗的不可切除、局部晚期或转移性肢端和黏膜黑色素瘤患者入组，并接受了 1 mg/kg Q2W 的治疗，其中 64.5% 的患者既往接受过 ≥2 线治疗。

Breakthrough efficacy of IBI363 monotherapy has been achieved in patients with 'immune-cold' melanoma, with notable durable response and prolonged survival benefit:

IBI363单药治疗在“免疫冷”黑色素瘤患者中取得了突破性的疗效，具有显著的持久应答和延长的生存获益：

In patients with at least one post-baseline tumor assessment (n=30), the confirmed objective response rate (cORR) was 23.3%, including 25.0% for mucosal type and 20.0% for acral type. The disease control rate (DCR) reached 76.7%, with 85.0% in mucosal type and 60.0% in acral type.

在至少接受过一次基线后肿瘤评估的患者中（n=30），确认的客观缓解率（cORR）为23.3%，其中黏膜型为25.0%，肢端型为20.0%。疾病控制率（DCR）达到了76.7%，其中黏膜型为85.0%，肢端型为60.0%。

In patients treated with 1 mg/kg Q2W with confirmed responses (n=7),

在每2周接受1 mg/kg治疗且有确认应答的患者中（n=7），

a durable response was observed with a median duration of response (DoR) of 14.0 months

观察到持久的反应，反应持续时间（DoR）中位数为14.0个月。

and events of 42.9%.

事件占42.9%。

In patients treated with 1 mg/kg Q2W (n = 31) had a median progression-free survival (PFS) of 5.7 (2.7, 6.8) months, which was significantly longer than data from previous studies (PFS less than 3 months

在以1 mg/kg Q2W治疗的患者（n = 31）中，中位无进展生存期（PFS）为5.7（2.7，6.8）个月，明显长于以往研究的数据（PFS少于3个月）。

[1]

[1]

). The median follow-up time was 14.7 months, the median overall survival (OS) was 14.8 (9.9, NC) months, and the median OS of patients with mucosal subtype was 19.3 (9.9, NC) months. The overall 12-month OS rate was 61.5%.

）。中位随访时间为14.7个月，中位总生存期（OS）为14.8（9.9，未计算）个月，黏膜亚型患者的中位总生存期为19.3（9.9，未计算）个月。总体12个月的总生存率为61.5%。

In terms of safety, IBI363 was generally well tolerated. Among the subjects treated with 1 mg/kg Q2W (n = 31), the treatment-related adverse events (TRAEs) with an incidence > 30% were arthralgia, rash, and hyperthyroidism, most of which were Grade 1 or 2. The overall incidence of Grade ≥ 3 TRAEs was 29.0%, and only 3.2% of subjects discontinued treatment due to TRAEs.

在安全性方面，IBI363总体耐受性良好。在以1 mg/kg Q2W剂量治疗的受试者（n = 31）中，发生率超过30%的治疗相关不良事件（TRAEs）包括关节痛、皮疹和甲状腺功能亢进，其中大多数为1级或2级。总体上，≥3级TRAEs的发生率为29.0%，仅有3.2%的受试者因TRAEs而停止治疗。

Overall safety was manageable, and no new safety risks were found..

总体安全性可控，未发现新的安全风险。

Acral+Mucosal

肢端+粘膜

(1mg/kg Q2W)

（1mg/kg 每2周一次）

N=31

N=31

Confirmed ORR, % (95% CI)

确认的客观缓解率（ORR），百分比（95%置信区间）

23.3 (9.9, 42.3)

23.3 (9.9, 42.3)

DCR, % (95% CI)

DCR，%（95% CI）

76.7 (57.7, 90.1)

76.7（57.7，90.1）

Median PFS, months (95% CI)

中位无进展生存期，月（95% 置信区间）

5.7 (2.7, 6.8)

5.7（2.7，6.8）

Median OS, months (95% CI)

中位OS，月（95% CI）

14.8 (9.9, NC)

14.8 (9.9, 未计算)

12-month OS rate, % (95% CI)

12个月总生存率，%（95%置信区间）

61.5 (39.8, 77.3)

61.5（39.8，77.3）

Median OS follow-up, months

中位OS随访，月数

14.7

14.7

A pivotal Phase 2 registrational study of IBI363 in the treatment of advanced acral and mucosal malignant melanoma has been initiated

IBI363治疗晚期肢端和黏膜恶性黑色素瘤的关键性2期注册研究已经启动。

Innovent Biologics announced a trial in progress (TiP) . It is a randomized, open-label, multi-center Phase 2 study evaluating the efficacy and safety of IBI363 monotherapy compared to pembrolizumab (Keytruda®) in patients with unresectable, locally advanced or metastatic mucosal and acral melanoma who have not received prior systemic treatment.

信达生物宣布了一项正在进行的试验 (TiP)。这是一项随机、开放标签、多中心的二期研究，评估 IBI363 单药疗法与 pembrolizumab（Keytruda®）在未接受过系统性治疗的不可切除、局部晚期或转移性粘膜和肢端黑色素瘤患者中的疗效和安全性。

As the first pivotal registration trial of IBI363, this study is designed to directly compare IBI363 monotherapy with pembrolizumab in this patient population. A total of 180 patients are planned to be enrolled and randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC)..

作为IBI363的首个关键注册试验，本研究旨在直接比较IBI363单药与帕博利珠单抗在此患者群体中的疗效。计划总共招募180名患者，并以1:1的比例随机分组。主要终点是由独立审查委员会（IRC）评估的无进展生存期（PFS）。

The first patient was dosed in

第一名患者已给药

March 2025

2025年3月

, marking a significant step in advancing IBI363's development in melanoma. Additional studies exploring IBI363 in combination therapies across other cancer types are also ongoing.

，这标志着IBI363在黑色素瘤开发中的一个重要进展。此外，探索IBI363在其他癌症类型中联合疗法的更多研究也在进行中。

Professor

教授

Guo Jun

郭俊

from Peking University Cancer Hospital and the Principal Investigator of Melanoma Studies on IBI363

来自北京大学肿瘤医院，IBI363黑色素瘤研究的首席研究员

said: 'Although melanoma is a relatively rare malignant tumor in

说：“虽然黑色素瘤是一种相对罕见的恶性肿瘤在

China

中国

, it has a high mortality rate, and its incidence continues to rise each year. Historically, patients with melanoma who have not received immunotherapy have had a median PFS of only about 3 months, which highlights a significant unmet clinical need. Notably, non-cutaneous melanoma (especially mucosal melanoma) accounts for a large proportion of cases in .

，死亡率高，发病率逐年上升。既往未经免疫治疗的黑色素瘤患者中位PFS仅约3个月，存在显著未满足的临床需求。值得注意的是，非皮肤型黑色素瘤（尤其是黏膜黑色素瘤）在 中占比较高。

China

中国

and is considered a 'cold tumor', typically unresponsive to traditional immunotherapy. In these cases, the response rate to PD-1 monotherapy is often below 15%, offering limited clinical benefit. More effective treatments are urgently needed

并且被认为是一种“冷肿瘤”，通常对传统免疫疗法无反应。在这些情况下，PD-1单药治疗的响应率通常低于15%，提供的临床益处有限。更有效的治疗方法亟待开发。

[2]

[2]

. IBI363 addresses this challenge by transforming 'cold tumors' into 'hot tumors' through dual activation of the PD-1 and IL-2 pathways. The data presented in this study showed that IBI363 delivers significantly improved efficacy compared to previous studies in cold tumor subtypes and standard of care therapies, while maintaining a favorable safety profile.

IBI363通过双重激活PD-1和IL-2通路，将“冷肿瘤”转化为“热肿瘤”，从而应对这一挑战。本研究中展示的数据表明，与之前在冷肿瘤亚型和标准治疗疗法中的研究相比，IBI363表现出显著提升的疗效，同时保持了良好的安全性。

IBI363 has the potential to become a new standard in immunotherapy for malignant melanoma in .

IBI363有潜力成为恶性黑色素瘤免疫治疗的新标准。

China

中国

, providing a long-needed treatment option for patients with acral and mucosal malignant melanoma.'

`, 为患有肢端和黏膜恶性黑色素瘤的患者提供了亟需的治疗选择。'

Dr.

博士

Zhou Hui

周慧

, Senior Vice President of Innovent Biologics,

，信达生物制药高级副总裁，

said: 'At present, there is a huge unmet clinical need for the treatment of unresectable, locally advanced or metastatic mucosal and acral melanoma in

表示：“目前，对于无法切除、局部晚期或转移性黏膜和肢端黑色素瘤的治疗，存在巨大的未满足临床需求。

China

中国

. Approved PD-1 therapies have not substantially improved first-line outcomes in melanoma, and the clinical benefits remain limited

已批准的PD-1疗法并未显著改善黑色素瘤的一线治疗结果，且临床益处仍然有限。

[3]

[3]

. IBI363 is leading the evolution of next-generation immunotherapy. By leveraging a dual-mechanism of 'PD-1 blockade + IL-2 directed activation', IBI363 enhances T cell function and expands T cell populations to reshape the tumor immune microenvironment. IBI363 has shown excellent efficacy and safety results in the treatment of patients with immune-cold melanoma subtypes.

IBI363引领了下一代免疫治疗的革新。通过利用“PD-1阻断+IL-2定向激活”的双重机制，IBI363增强T细胞功能并扩增T细胞群体，从而重塑肿瘤免疫微环境。在治疗免疫冷型黑色素瘤亚型患者中，IBI363展现了卓越的疗效和安全性结果。

A Phase 2 pivotal registrational study is currently underway. Positive results in patients with mucosal and acral melanoma are highly anticipated, offering hope for a more effective treatment option. Meanwhile, we are accelerating the global development of IBI363 across multiple tumor types, with the goal of making this innovative treatment accessible to patients around the world.'.

目前，一项二期关键注册研究正在进行中。黏膜和肢端黑色素瘤患者的阳性结果备受期待，为更有效的治疗选择带来了希望。同时，我们正在加快IBI363在全球范围内的开发，覆盖多种肿瘤类型，目标是让这一创新疗法惠及全球患者。

About Melanoma

关于黑色素瘤

Melanoma is a malignant tumor that develops from melanocytes. While it accounts for only 3% of all skin cancers, it has the highest mortality rate and is the most prone to metastasis. In

黑色素瘤是一种由黑色素细胞发展而来的恶性肿瘤。尽管它仅占所有皮肤癌的3%，但其死亡率最高，也是最容易发生转移的。

China

中国

, both the incidence and mortality rates of melanoma are rising annually. Based on tumor location, melanoma is classified into cutaneous, acral, and mucosal subtypes. Melanoma in Chinese populations differs significantly from that in Caucasian populations in

，黑色素瘤的发病率和死亡率均逐年上升。根据肿瘤部位，黑色素瘤分为皮肤型、肢端型和黏膜型。中国人群的黑色素瘤与高加索人群在

Europe

欧洲

and

和

the United States

美国

with regard to pathogenesis, biological behavior, histological morphology, treatment methods, and prognosis

关于发病机制、生物学行为、组织学形态、治疗方法和预后

[4]

[4]

. For patients with advanced cutaneous and acral melanoma with BRAF V600 mutation, a combination of BRAF and MEK inhibitors is the preferred treatment. For those without this mutation, chemotherapy combined with anti-angiogenic drugs is often considered as first-line treatment. Although pembrolizumab was approved in .

对于患有BRAF V600突变的晚期皮肤和肢端黑色素瘤患者，首选治疗方法是BRAF和MEK抑制剂的联合使用。对于没有这种突变的患者，化疗联合抗血管生成药物通常被认为是首选治疗方法。虽然派姆单抗已被批准用于。

Sep. 2024

2024年9月

for first-line treatment of melanoma, the clinical benefit of PD-1 inhibitors in this setting remains modest. In second-line treatment, agents different from those used in the first line are generally preferred. For patients not previously treated with a PD-1 inhibitor, it can be considered as a second-line option.

对于黑色素瘤的一线治疗，PD-1抑制剂在此情况下的临床益处仍然有限。在二线治疗中，通常优选与一线治疗不同的药物。对于之前未接受过PD-1抑制剂治疗的患者，可将其考虑为二线治疗的选择。

In advanced mucosal melanoma, median PFS for patients without prior immunotherapy is only about 3 months. Given the limited efficacy of current treatments for non-cutaneous melanomas, especially mucosal subtypes, which are more prevalent in .

在晚期黏膜黑色素瘤中，未接受过先前免疫治疗的患者的中位无进展生存期（PFS）仅为约3个月。鉴于当前治疗方法对非皮肤黑色素瘤（尤其是黏膜亚型）疗效有限，并且这些亚型在某些人群中更常见。

China

中国

, there is an urgent need for more effective therapies.

，迫切需要更有效的治疗方法。

About IBI363 (PD-1/IL-2

关于IBI363（PD-1/IL-2）

α-bias

α-偏差

bispecific antibody fusion protein)

双特异性抗体融合蛋白)

IBI363 is the world's first PD-1/IL-2

IBI363是全球首个PD-1/IL-2

α-bias

α-偏差

bispecific fusion protein independently developed by Innovent Biologics. It integrates two key functions: blockade of the PD-1/PD-L1 pathway and activation of the IL-2 signaling pathway. The IL-2 arm of IBI363 has been engineered to retain affinity for IL-2 Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity.

由信达生物自主研发的双特异性融合蛋白，整合了阻断PD-1/PD-L1通路和激活IL-2信号通路两项关键功能。IBI363的IL-2臂经过工程改造，在保留对IL-2 Rα亲和力的同时，减少了与IL-2Rβ和IL-2Rγ的结合，从而降低了毒性。

The PD-1 binding arm enables simultaneous PD-1 blockage and selective delivery of IL-2. This differential targeting strategy exploits the fact that newly activated tumor-specific T cells co-express PD-1 and IL-2α, which allows for more precise and efficient targeting and activation of this T cell subset.

PD-1结合臂能够同时实现PD-1阻断和IL-2的选择性递送。这种差异性靶向策略利用了新激活的肿瘤特异性T细胞共表达PD-1和IL-2α的事实，从而可以更精确、高效地靶向和激活这一T细胞亚群。

IBI363 not only showed good anti-tumor activity in a variety of tumor-bearing pharmacological models but also showed prominent anti-tumor efficacy in PD-1 resistance and metastasis models..

IBI363不仅在多种荷瘤药理学模型中显示出良好的抗肿瘤活性，而且在PD-1耐药和转移模型中也显示出显著的抗肿瘤效力。

Driven by urgent clinical needs, Innovent Biologics is conducting clinical studies in

受迫切的临床需求推动，信达生物正在进行临床研究

China

中国

,

，

the United States

美国

, and

，以及

Australia

澳大利亚

to assess the efficacy and safety of IBI363 across multiple tumor types. The first pivotal registration trial of IBI363 has been initiated for the treatment of mucosal and acral melanoma without immunotherapy.

以评估IBI363在多种肿瘤类型中的疗效和安全性。IBI363的首个关键注册试验已经启动，用于治疗未接受过免疫疗法的黏膜型和肢端型黑色素瘤。

IBI363 has been granted two fast track designations by the FDA for the treatment of advanced squamous non-small cell lung cancer and melanoma, respectively.

IBI363已分别获得FDA授予的用于治疗晚期鳞状非小细胞肺癌和黑色素瘤的两项快速通道资格。

IBI363 has also been granted Two Breakthrough Therapy Designations by the National Medical Products Administration (NMPA) for the treatment of advanced melanoma and squamous NSCLC.

IBI363还获得了国家药品监督管理局（NMPA）授予的两项突破性疗法认定，用于治疗晚期黑色素瘤和鳞状非小细胞肺癌。

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。公司致力于发现、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、心血管和代谢疾病、自身免疫疾病以及眼科疾病。

Innovent has launched 15 products in the market. It has 3 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, Adimab, LG Chem and MD Anderson Cancer Center..

信达生物已上市15款产品，有3个新药申请处于监管审评中，4项资产处于III期或关键性临床试验中，还有15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”的信条，坚守行业实践的最高标准，与各方携手合作，共同推动生物制药行业的发展，使一流的药品能够广泛普及。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。

For more information, please visit the company's website:

有关更多信息，请访问公司网站：

www.innoventbio.com

www.innoventbio.com

or the company's LinkedIn account.

或公司的领英账户。

Statement:

声明：

1. Innovent Biologics does not recommend the use of unapproved drugs/indications.

1. 信达生物不建议使用未获批的药物/适应症。

2. Ramucirumab injection (Ciranza®), selpercatinib capsules (Ritu®) and pirtobrutinib tablets (Capra®) were developed by Eli Lilly and Company

2. 雷莫芦单抗注射液（Ciranza®）、塞尔潘替尼胶囊（Ritu®）和皮托布鲁替尼片（Capra®）由礼来公司开发。

Forward-Looking Statement

前瞻性声明

The information in this press release may contain certain forward-looking statements. These statements are inherently risky and uncertain. The use of the words 'anticipate,' 'believe,' 'predict,' 'expect,' 'intend' and similar expressions in connection with the Company are intended to identify forward-looking statements.

本新闻稿中的信息可能包含某些前瞻性陈述。这些陈述本身具有风险性和不确定性。公司使用“预期”、“相信”、“预测”、“期待”、“意图”等词语及相关类似表达旨在识别前瞻性陈述。

The Company is under no obligation to continually update these predictive statements..

公司没有义务不断更新这些预测性声明。

These forward-looking statements are based on the Company's management's existing views, assumptions, expectations, estimates, forecasts, and understandings of future matters at the time of the statements. These statements are not guarantees for future development and are subject to risks, uncertainties, and other factors, some of which are beyond the control of the Company and are difficult to predict.

这些前瞻性陈述是基于公司管理层在作出陈述时对未来的事项的现有观点、假设、期望、估计、预测和理解。这些陈述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。

As a result, actual results may differ materially from those contained in such forward-looking statements as a result of future changes and developments in our business, competitive environment, political, economic, legal and social conditions..

因此，由于我们业务、竞争环境、政治、经济、法律和社会条件的未来变化和发展，实际结果可能与这些前瞻性陈述中包含的内容存在重大差异。

The Company, its directors and employee agents have no obligation to (a) correct or update any forward-looking statements contained in this Website; and (b) any liability arising from the fact that any forward-looking statements cannot be realized or are rendered incorrect.

公司、其董事和员工代理人没有义务 (a) 纠正或更新本网站中包含的任何前瞻性陈述；以及 (b) 承担因任何前瞻性陈述无法实现或被证明不正确而产生的任何责任。

REFERENCES

参考文献

[1].   Cui C, Yan X, Li B, et al.  Real-world clinical outcomes of anticancer treatments and prognostic factors in patients with advanced melanoma in China.  International Journal of Surgery Oncology.  2020; 5.  e97-e97.  doi:10.1097/IJ9.0000000000000097.

[1]. 崔灿，闫晓，李波等。中国晚期黑色素瘤患者抗癌治疗的真实世界临床结果及预后因素。《国际外科肿瘤学杂志》。2020年；第5卷。e97-e97。doi:10.1097/IJ9.0000000000000097。

[2].   Cui C, Chen Y, Luo Z, et al.  Safety and efficacy of Pucotenlimab (HX008) - a humanized immunoglobulin G4 monoclonal antibody in patients with locally advanced or metastatic melanoma: a single-arm, multicenter, phase II study.  BMC Cancer.  2023;23(1):121.  Published 2023 Feb 6.  doi:10.1186/s12885-022-10473-y.

[2].   崔灿，陈勇，罗震等。Pucotenlimab（HX008）- 一种人源化免疫球蛋白G4单克隆抗体在局部晚期或转移性黑色素瘤患者中的安全性和有效性：一项单臂、多中心、II期研究。BMC癌症。2023；23（1）：121。发表于2023年2月6日。doi:10.1186/s12885-022-10473-y。

[3].   Si L, Zhang X, Shu Y, et al.  A Phase Ib Study of Pembrolizumab as Second-Line Therapy for Chinese Patients With Advanced or Metastatic Melanoma (KEYNOTE-151).Transl Oncol.  2019;12(6):828-835.  doi:10.1016/j.tranon.2019.02.007

[3].   司立，张晓，舒悦，等。一项关于帕博利珠单抗作为二线治疗中国晚期或转移性黑色素瘤患者的Ib期研究（KEYNOTE-151）。《转化肿瘤学》。2019年；12(6):828-835。doi:10.1016/j.tranon.2019.02.007

[4].   Diagnostic and Therapeutic Guidelines for Melanoma (2022 Edition)

[4]. 黑色素瘤诊断与治疗指南（2022版）

SOURCE Innovent Biologics

来源：信达生物

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