Akeso, Inc., a Hong Kong–listed biopharmaceutical company focused on innovative biological medicines, has announced updated results from the pivotal Phase III HARMONi-6 study of its PD-1/VEGF bispecific antibody ivonescimab in combination with chemotherapy for first-line treatment of squamous non-small cell lung cancer (sq-NSCLC), presented at the 2025 ESMO Asia Congress.

康方生物，一家专注于创新生物药物的香港上市生物制药公司，宣布了其PD-1/VEGF双特异性抗体依沃西单抗联合化疗用于一线治疗鳞状非小细胞肺癌（sq-NSCLC）的关键III期HARMONi-6研究的更新结果，该结果在2025年ESMO亚洲大会上公布。

The data, delivered in an oral presentation by Professor Shun Lu of Shanghai Chest Hospital, underscore both statistically significant efficacy and meaningful quality-of-life advantages for patients when compared with a tislelizumab-based regimen, reinforcing ivonescimab as a competitive asset in China’s highly active immuno-oncology landscape.[2].

上海胸科医院陆舜教授在口头报告中展示了该数据，与基于替雷利珠单抗的治疗方案相比，这些数据凸显了统计学上显著的疗效和对患者生活质量有意义的优势，进一步巩固了伊沃西单抗在中国高度活跃的免疫肿瘤领域中的竞争优势。[2]。

From a B2B and industry strategy perspective, the HARMONi-6 update is important for several reasons. First, it provides additional clinical validation for Akeso’s bispecific antibody platform, demonstrating that dual targeting of PD-1 and VEGF can translate into differentiated outcomes in a crowded checkpoint inhibitor market.

从B2B和行业战略的角度来看，HARMONi-6更新之所以重要，有以下几个原因。首先，它为Akeso的双特异性抗体平台提供了更多的临床验证，证明了在竞争激烈的检查点抑制剂市场中，PD-1和VEGF的双重靶向能够转化为差异化的效果。

Positive Phase III data in first-line sq-NSCLC, a large and high-unmet-need segment in China and broader Asia, strengthens the company’s negotiating position with partners, payers, and regulators. Second, these data come after China’s Center for Drug Evaluation (CDE) accepted a supplemental New Drug Application (sNDA) for ivonescimab combined with chemotherapy in July 2025, meaning the updated efficacy and quality-of-life findings may further support the product’s value proposition as the NMPA review advances.[2].

一线治疗sq-NSCLC的III期临床试验取得积极数据，这一领域在中国及更广泛的亚洲地区具有巨大且未满足的需求，从而增强了公司与合作伙伴、支付方和监管机构的谈判地位。其次，这些数据是在中国药品审评中心（CDE）于2025年7月接受ivonescimab联合化疗的补充新药申请（sNDA）之后获得的，这意味着更新的有效性和生活质量研究结果可能进一步支持该产品在NMPA审评推进过程中的价值主张。[2]

Quality-of-life outcomes are increasingly scrutinized by health technology assessment bodies, provincial tender committees, and hospital decision-makers in Asia. Demonstrating that ivonescimab plus chemotherapy can improve or preserve patient-reported quality-of-life measures relative to an established PD-1 regimen can influence formulary positioning, price negotiations, and inclusion in future national reimbursement discussions.

生活质量结果正受到亚洲卫生技术评估机构、省级招标委员会和医院决策者越来越多的审查。证明伊沃西单抗联合化疗相对于已确立的PD-1方案能够改善或维持患者报告的生活质量指标，可以影响处方集定位、价格谈判以及未来国家报销讨论中的纳入。

For pharma executives and market access leaders, the HARMONi-6 update signals that ivonescimab may not only be competitive on traditional survival and response endpoints, but could also provide a compelling health-economic narrative around reduced symptom burden and potentially lower supportive care utilization.

对于制药业高管和市场准入负责人来说，HARMONi-6 的更新表明，ivonescimab 不仅可能在传统的生存率和响应终点上具有竞争力，还可能围绕减轻症状负担和潜在降低支持性护理使用提供一个引人注目的健康经济学叙述。

This is especially relevant in China’s evolving DRG and value-based procurement environment, where differentiation beyond response rate is critical..

这在中国不断发展的DRG和基于价值的采购环境中尤为重要，在这些环境中，超越响应率的差异化至关重要。

The announcement also illustrates Akeso’s broader R&D and globalization strategy. With more than 50 innovative assets in its pipeline, including 26 clinical-stage candidates and a strong focus on bispecific and multispecific antibodies, Akeso is positioning itself as a next-generation oncology and immunology innovator from China with global aspirations.[2] Ivonescimab is one of the flagship molecules in this strategy.

该公告还展示了康方生物更广泛的研发和全球化战略。康方生物的产品管线中拥有超过50种创新资产，其中包括26个处于临床阶段的候选药物，并专注于双特异性和多特异性抗体。康方生物正将自己定位为一家来自中国、具有全球抱负的下一代肿瘤学和免疫学创新者。[2] 依沃西单抗（Ivonescimab）是这一战略中的旗舰分子之一。

Beyond China, Akeso’s partner Summit Therapeutics is running the global multicenter Phase III HARMONi-3 study, which compares ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy as first-line therapy in advanced NSCLC across both squamous and non-squamous histologies.[2] For global and regional business development teams, the updated HARMONi-6 results de-risk the mechanism and may increase confidence in the global program, potentially opening the door to additional territorial partnerships or co-commercialization arrangements in Asia-Pacific and other emerging markets..

在中国以外，阿斯利康的合作伙伴Summit Therapeutics正在开展全球多中心III期HARMONi-3研究，该研究比较了伊沃西单抗联合化疗与帕博利珠单抗联合化疗作为一线治疗在晚期非小细胞肺癌（包括鳞状和非鳞状组织学类型）中的疗效。[2] 对于全球及区域业务发展团队而言，更新的HARMONi-6结果降低了该机制的风险，可能增强对全球项目的信心，或为亚太地区及其他新兴市场的更多区域性合作或共同商业化安排打开大门。

For clinical development and regulatory teams, the HARMONi-6 dataset further refines the evidence base that can be leveraged in discussions with regulators in Asia beyond China. Regulators in markets such as South Korea, Southeast Asia, and potentially the Middle East often consider robust China Phase III data, especially when supported by global trials.

对于临床开发和监管团队而言，HARMONi-6 数据集进一步完善了可在除中国以外的亚洲地区与监管机构讨论时利用的证据基础。韩国、东南亚甚至可能中东市场的监管机构通常会考虑强有力的中国三期数据，特别是当这些数据得到全球试验支持时。

As ESMO Asia is a major regional scientific platform, presenting these updated results there not only enhances scientific visibility but also helps build KOL advocacy across multiple Asian oncology centers. This advocacy can in turn influence clinical guideline inclusion, investigator-initiated trial activity, and the speed of uptake once approvals are secured..

由于ESMO亚洲是一个重要的区域性科学平台，在那里展示这些更新的结果不仅增强了科学可见性，还有助于在多个亚洲肿瘤中心建立关键意见领袖（KOL）的支持。这种支持反过来可以影响临床指南的纳入、研究者发起的试验活动以及在获得批准后的采纳速度。

The manufacturing and supply chain implications are also notable. Akeso has invested in a fully integrated GMP-compliant manufacturing system, supporting both domestic and potential export supply of biologics.[2] As ivonescimab progresses toward potential commercialization in additional indications and markets, scaling biologics production while controlling costs will be essential to compete with multinational players and domestic PD-1 incumbents.

制造业和供应链的影响也十分显著。康方生物已经投资建立了完全一体化的符合GMP标准的生产体系，支持生物制品的国内供应及潜在的出口需求。[2] 随着依沃西单抗在更多适应症和市场中迈向可能的商业化，扩大生物制品生产规模同时控制成本，将是与跨国公司和国内PD-1领域现有企业竞争的关键。

The HARMONi-6 update, by strengthening commercial visibility and likely demand projections, can inform capacity planning, technology transfer timelines with partners, and decisions on additional bioreactor deployments or CDMO engagement. For equipment and technology providers, Akeso’s trajectory presents ongoing opportunities in single-use systems, process analytics, and digital manufacturing solutions tailored to high-volume antibody production..

HARMONi-6 更新通过加强商业可见性和需求预测，可以为产能规划、与合作伙伴的技术转让时间表以及关于额外生物反应器部署或CDMO合作的决策提供信息。对于设备和技术供应商而言，Akeso的发展轨迹在一次性使用系统、过程分析技术以及针对大规模抗体生产的数字化制造解决方案方面提供了持续的机会。

From an alliance and portfolio management standpoint, the ivonescimab program exemplifies a cross-border co-development model in which an innovative Chinese biologic serves as the backbone therapy for both domestic and international growth. Summit Therapeutics’ global responsibilities for HARMONi-3 illustrate how regional strengths are being combined: Akeso’s discovery and early development capabilities and local regulatory expertise in China, paired with Summit’s experience and networks in North America and other global markets.

从联盟和投资组合管理的角度来看，ivonescimab项目体现了一种跨境共同开发模式，其中一种创新的中国生物药物作为国内外增长的支柱疗法。Summit Therapeutics在HARMONi-3中的全球责任展示了如何结合区域优势：Akeso在中国的发现和早期开发能力以及本地监管专业知识，加上Summit在北美及其他全球市场的经验与网络。

As other Asian biopharma companies evaluate their own out-licensing and co-development options, the evolution of ivonescimab’s clinical and commercial story will provide a reference case for structuring risk-sharing, milestone design, and commercialization rights in multi-regional clinical programs..

随着其他亚洲生物制药公司评估各自的对外授权和共同开发选项，ivonescimab的临床和商业故事的发展将为多区域临床项目中构建风险分担、里程碑设计和商业化权利提供一个参考案例。

For investors and corporate strategists, the updated HARMONi-6 results come at a time when global attention on Chinese oncology innovation is intensifying. Competitive pressure in the PD-1 class has driven consolidation and price erosion in China, but differentiated mechanisms and bispecific formats are viewed as key to sustaining value.

对于投资者和企业战略家而言，更新的HARMONi-6结果发布之际，全球对中国肿瘤创新的关注正在加剧。PD-1类竞争压力已促使中国市场的整合与价格下跌，但差异化机制和双特异性形式被视为维持价值的关键。

Ivonescimab’s performance in a large Phase III trial with meaningful quality-of-life benefits helps validate Akeso’s bispecific antibody platform and could influence valuation, partnership terms, and the company’s ability to access capital for later-stage programs. Moreover, by demonstrating clear clinical advantages against another PD-1–based regimen, Akeso is signaling that Chinese-origin biologics can move from fast followers to first- or best-in-class competitors, a shift with strategic implications for multinational pharma companies assessing in-licensing or M&A opportunities across Asia..

伊沃尼西单抗在一项大型 III 期试验中表现出显著的生活质量益处，这有助于验证康方生物的双特异性抗体平台，并可能影响其估值、合作条款以及公司为后期项目获取资金的能力。此外，通过展示出相对于另一种基于 PD-1 的治疗方案的明显临床优势，康方生物表明了中国原创生物药可以从快速跟随者转变为同类第一或最佳竞争者，这一转变对跨国制药公司在评估亚洲地区的许可引进或并购机会时具有战略意义。