HONG KONG

香港

,

，

Dec. 10, 2025

2025年12月10日

/PRNewswire/ -- Akeso, Inc. (9926.HK) ('Akeso' or the 'Company') announced the presentation of a Phase II clinical study that included a longer-term efficacy data evaluating ivonescimab (a PD-1/VEGF bispecific antibody) combined with chemotherapy as a first-line treatment for locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) at the 2025 European Society for Medical Oncology Immuno-Oncology Congress (ESMO IO) in London, UK..

/PRNewswire/ -- 康方生物（9926.HK）宣布，在英国伦敦举行的2025年欧洲肿瘤内科学会免疫肿瘤学大会（ESMO IO）上，展示了其II期临床研究的长期疗效数据，该研究评估了依沃西单抗（一种PD-1/VEGF双特异性抗体）联合化疗作为一线治疗局部晚期不可切除或转移性三阴性乳腺癌（TNBC）的效果。

Based on positive efficacy and safety profile, the ivonescimab combination therapy for first-line TNBC was previously included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Currently, the multicenter, randomized, double-blind Phase III clinical trial (HARMONi-BC1/AK112-308) for this indication is currently ongoing..

基于积极的有效性和安全性 profile，伊沃西单抗联合疗法用于一线治疗 TNBC 此前已被中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入突破性治疗药物认定（BTD）名单。目前，针对该适应症的多中心、随机、双盲 III 期临床试验（HARMONi-BC1/AK112-308）正在进行中。

Preliminary results from this study were previously announced at the European Society for Medical Oncology (ESMO) Congress 2024 and the 2024 San Antonio Breast Cancer Symposium (SABCS). With the follow-up period now extended to 22.1 months, the study further validates the efficacy and safety profile of the ivonescimab regimen in first-line TNBC treatment..

本研究的初步结果此前已在2024年欧洲肿瘤内科学会（ESMO）大会和2024年圣安东尼奥乳腺癌研讨会（SABCS）上公布。随着随访期现已延长至22.1个月，该研究进一步验证了ivonescimab方案在一线治疗三阴性乳腺癌（TNBC）中的疗效和安全性。

As of July 15, 2025, a total of 36 patients with TNBC were enrolled. The median age was 55 years, 83.3% of patients had a PD-L1 combined positive score (CPS) <10, and 55.6% had received prior taxane-based neo/adjuvant therapy. As of the data cutoff, 35 patients had undergone at least one post-baseline tumor assessment and were included in the efficacy analysis set.

截至2025年7月15日，共招募了36名TNBC患者。患者中位年龄为55岁，83.3%的患者PD-L1联合阳性评分（CPS）<10，55.6%的患者曾接受过基于紫杉烷的新辅助/辅助治疗。截至数据截止时，35名患者已进行了至少一次基线后的肿瘤评估，并被纳入疗效分析集。

The results showed that the ivonescimab combined with chemotherapy regimen demonstrated efficient tumor relief, disease control, and survival benefits in all PD-L1 subgroups of TNBC patients receiving first-line treatment. The key results are:.

结果显示，在接受一线治疗的三阴性乳腺癌（TNBC）患者的所有PD-L1亚组中，伊沃西单抗联合化疗方案展现了有效的肿瘤缓解、疾病控制和生存获益。关键结果如下：。

The objective response rate (ORR) for the overall population was 80.0%, the disease control rate (DCR) was 100.0%, and the median duration of response (mDOR) was 12.2 months; the median progression-free survival (mPFS) was 15.2 months, with a 12-month PFS rate of 56.3%.

总体人群的客观缓解率（ORR）为80.0%，疾病控制率（DCR）为100.0%，中位缓解持续时间（mDOR）为12.2个月；中位无进展生存期（mPFS）为15.2个月，12个月的无进展生存率（PFS）为56.3%。

In the CPS≥10 subgroup, the ORR was 83.3%, the DCR was 100%, the mDOR was 12.2 months; the mPFS was 15.9 months, with a 12-month PFS rate of 66.7%.

在CPS≥10的亚组中，ORR为83.3%，DCR为100%，mDOR为12.2个月；mPFS为15.9个月，12个月的PFS率为66.7%。

In the CPS<10 subgroup, the ORR was 79.3%, the DCR was 100%, the mDOR was 9.9 months; the mPFS was 13.04 months, with a 12-month PFS rate of 54.3%.

在CPS<10亚组中，ORR为79.3%，DCR为100%，mDOR为9.9个月；mPFS为13.04个月，12个月的PFS率为54.3%。

In the CPS≥1 subgroup, the ORR was 72.2%, the DCR was 100%, the mDOR was 12.2 months; the mPFS was 15.9 months, with a 12-month PFS rate of 63.8%.

在CPS≥1亚组中，ORR为72.2%，DCR为100%，mDOR为12.2个月；mPFS为15.9个月，12个月的PFS率为63.8%。

Overall survival (OS) data is not yet mature.

总生存期（OS）数据尚未成熟。

Ivonescimab combined with chemotherapy as first-line treatment for TNBC demonstrated a good safety profile. No treatment-related adverse events (TRAEs) led to discontinuation or death in this study, and the most common TRAEs were mostly grade 1-2.

伊沃尼西单抗联合化疗作为三阴性乳腺癌（TNBC）的一线治疗表现出良好的安全性。本研究中，无治疗相关不良事件（TRAEs）导致停药或死亡，最常见的TRAEs大多为1-2级。

Forward-Looking Statement of Akeso, Inc

康方生物前瞻性声明

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This announcement by Akeso, Inc. (9926.HK, 'Akeso') contains 'forward-looking statements'. These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso.

康方生物科技（9926.HK，简称“康方”）本公告包含“前瞻性陈述”。这些陈述反映了康方管理层当前的信念和期望，并受到重大风险和不确定性的约束。这些陈述无意作为任何投资决策或购买康方证券的依据。

There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements..

无法保证本公告中提及的候选药物或康方生物其他研发管线中的候选药物将获得必要的监管批准或取得商业成功。如果基本假设被证明不准确，或者风险或不确定性变为现实，实际结果可能与前瞻性陈述中所述的结果存在重大差异。

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions..

风险和不确定性包括但不限于：行业总体状况和竞争；经济因素，包括利率和汇率的波动；中国、美国以及国际制药行业监管和医疗保健法规的影响；全球医疗成本控制趋势；技术进步及竞争对手获得的新产品和专利；新产品开发固有的挑战，包括获得监管批准；康方生物准确预测未来市场状况的能力；生产困难或延误；国际经济的财务不稳定性和主权风险；对康方生物专利及其他创新产品保护措施的有效性依赖；以及面临诉讼（包括专利诉讼）和/或监管行动的风险。

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

除法律要求外，Akeso不承担任何义务公开修订这些前瞻性陈述以反映本日期之后的事件或情况。

About Akeso

关于康方生物

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.

康方生物（港交所代码：9926.HK）是一家领先的生物制药公司，致力于全球首创或同类最佳的创新生物药物的研究、开发、生产和商业化。公司成立于2012年，创建了以全方位端到端药物开发平台（ACE平台）和双特异性抗体药物开发技术（Tetrabody）为核心的独特一体化研发创新体系，并建立了符合GMP标准的生产体系和具有先进运营模式的商业化体系，逐步发展成为一家具有全球竞争力、专注于创新解决方案的生物制药公司。

With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs.

通过全方位集成的多功能平台，康方生物内部正在癌症、自身免疫疾病、炎症、代谢疾病和其他主要疾病领域开发超过50种创新资产的强大管线。其中，26个候选药物已进入临床试验阶段（包括15种双特异性/多特异性抗体和双特异性ADC）。

Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise..

此外，7个新药已实现商业化。通过高效和突破性的研发创新，康方生物始终整合全球优质资源，开发同类首创、同类最佳的新药，为全球患者提供可负担的治疗性抗体，并不断创造更多的商业价值与社会价值，成为全球领先的生物制药企业。

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SOURCE Akeso, Inc.

来源：康方生物

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