Nanjing, China — June 1, 2025 — Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs”) today announced the presentation of groundbreaking clinical data from a multicenter phase Ib/II clinical trial evaluating LBL-024, an anti-PD-L1/4-1BB bispecific antibody, in combination with etoposide plus platinum-based chemotherapy for treatment-naive patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC).

中国南京——2025年6月1日——南京领跑生物实验室有限公司（“领跑生物”）今日宣布，在一项多中心Ib/II期临床试验中，展示了突破性的临床数据。该试验评估了抗PD-L1/4-1BB双特异性抗体LBL-024与依托泊苷联合铂类化疗，用于治疗初治的晚期肺外神经内分泌癌（EP-NEC）患者。

The results were featured in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting..

结果在2025年美国临床肿瘤学会（ASCO）年会上的口头报告环节中展示。

ASCO is recognized as the world’s most prestigious oncology conference, serving as a global stage for unveiling transformative scientific and clinical advancements. The Oral Sessions are highly competitive, served for studies demonstrating significant clinical relevance or scientific innovation. In 2025, ASCO received a record-breaking 7,775 abstract submissions, with 32 Chinese-led studies selected for oral presentation - among them, the LBL-024 trial (NCT06157827)..

ASCO被认为是世界上最具声望的肿瘤学会议，是展示变革性科学和临床进展的全球舞台。口头报告环节竞争激烈，入选的研究需展示出显著的临床相关性或科学创新。2025年，ASCO收到了创纪录的7775份摘要投稿，其中32项由中国主导的研究被选为口头报告，其中包括LBL-024试验（NCT06157827）。

The study, led by Professor

该研究由教授领导

Shen Lin

林申

of Peking University Cancer Hospital and conducted across multiple clinical centers, evaluates the efficacy and safety of LBL-024 combined with etoposide plus platinum-based chemotherapy as a first-line treatment for advanced EP-NEC.

北京大学肿瘤医院开展，并在多个临床中心进行，评估LBL-024联合依托泊苷加铂类化疗作为晚期EP-NEC一线治疗的疗效和安全性。

Robust Anti-Tumor Activity Observed with LBL-024 Plus Chemotherapy

观察到LBL-024联合化疗具有强大的抗肿瘤活性

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In 52 efficacy-evaluable patients, the

在52名可评估疗效的患者中，

overall response rate (ORR)

总体缓解率（ORR）

across all dose levels was

在所有剂量水平上

75.0%

75.0%

and the

和

disease control rate (DCR)

疾病控制率 (DCR)

was

是

92.3%,

92.3%，

significantly outperforming historical ORR data (30%-55%) with chemotherapy alone.

显著优于单纯化疗的历史ORR数据（30%-55%）。

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The 15 mg/kg in dose optimization demonstrated the strongest anti-tumor activity, achieving an

在剂量优化中，15 mg/kg 表现出最强的抗肿瘤活性，实现了

ORR

客观缓解率

of

的

83.3%

83.3%

and a

和一个

DCR

DCR

of

的

100%.

100%。

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57.7% (30/52)

57.7% (30/52)

of the patients experienced

患者经历了

>50% tumor shrinkage

肿瘤缩小超过50%

.

。

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As of April 15th, 2025, with a median follow-up of

截至2025年4月15日，中位随访时间为

8.2 months

8.2个月

, progression-free survival (PFS) data remains immature, but trends indicate promising durability across all the dose groups.

，无进展生存期（PFS）数据尚不成熟，但趋势显示在所有剂量组中均具有良好的持久性。

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In the phase Ib dose escalation stage,

在Ib期剂量递增阶段，

no dose-limiting toxicities (DLTs)

无剂量限制性毒性（DLTs）

were observed. Most treatment-emergent adverse events (TEAEs) were Grade 1–2 and manageable, primarily associated with chemotherapy, including hematologic toxicity and nausea. No unexpected safety signals were identified.

大多数治疗中出现的不良事件（TEAEs）为1-2级且可管理，主要与化疗相关，包括血液学毒性和恶心。未发现意外的安全信号。

Leadership Perspectives

领导力视角

Dr. Charles Cai,

蔡查尔斯博士，

Chief Medical Officer of Leads Biolabs, stated:” We are thrilled to share these exciting clinical data, which strongly support the advancement of LBL-024 into a pivotal phase III trial as a first-line treatment for EP-NEC. Our strategy prioritizes efficient development through single-arm registrational trial in underserved indications, while also maximizing value through broad indication expansion.

Leads Biolabs首席医学官表示：“我们非常高兴分享这些令人振奋的临床数据，它们强有力地支持LBL-024推进到关键的III期试验，作为EP-NEC的一线治疗。我们的策略是通过在服务不足的适应症中进行单臂注册试验来优先实现高效开发，同时通过广泛的适应症扩展来最大化价值。”

LBL-024 received regulatory clearance in April 2024 to initiate a single-arm pivotal trial in China, marking the first 4-1BB targeted agent globally to reach this stage. With its expanded use now demonstrated in first-line settings and active studies in cancers such as SCLC and NSCLC, LBL-024 is poised to offer promising transformative therapeutic options for more cancer patients worldwide.”.

LBL-024于2024年4月获得监管批准，在中国启动单臂关键试验，成为全球首个进入该阶段的4-1BB靶向药物。随着其在一线治疗中的应用得到进一步验证，并在小细胞肺癌（SCLC）和非小细胞肺癌（NSCLC）等癌症中积极开展研究，LBL-024有望为全球更多癌症患者提供前景广阔的变革性治疗选择。

Dr. Xiaoqiang Kang,

康小强博士，

Founder, Chairman and CEO of Leads Biolabs, added, “It is deeply encouraging to see LBL-024 featured consecutively in ASCO oral presentations. From target selection to molecular design, our R&D approach has focused on differentiated innovation to address pressing clinical challenges. The success of LBL-024 reflects our commitment to pioneering innovation at the source—breaking free from homogeneity to deliver genuinely impactful therapies.

领博生物创始人、董事长兼首席执行官补充道：“连续在ASCO口头报告中展示LBL-024，这令人深受鼓舞。从靶点选择到分子设计，我们的研发策略始终聚焦于差异化的创新，以应对迫切的临床挑战。LBL-024的成功反映了我们致力于源头上的开创性创新——打破同质化，提供真正有影响力的治疗方案。”

We remain dedicated to addressing unmet needs, advancing breakthrough therapeutics, and improving outcomes for patients across the globe.”.

我们仍然致力于满足未满足的需求，推进突破性治疗，并改善全球患者的治疗效果。"