Ivonescimab

HONG KONG , Sept. 17, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that AK158D1, its investigational next-generation bispecific antibody-drug conjugate (ADC) targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA). The trial will assess the candidate in patients with advanced malignant solid tumors. AK158D1 is Akeso's fourth ADC to enter clinical development and joins the Company's growing clinical-stage ADC portfolio, which includes AK146D1 (TROP2/Nectin-4), AK138D1 (HER3), and AK157D1 (B7-H3). It is also Akeso's second bispecific ADC to reach the clinic, further advancing the Company's global strategy of combining next-generation immuno-oncology (IO2.0) approaches with next-generation ADC platforms (ADC2.0). EGFR (epidermal growth factor receptor) and TROP2 (trophoblast cell surface antigen 2) constitute a highly promising target pair for bispecific ADC therapeutic development, with broad co-expression across a spectrum of solid tumor types. Each target has well-validated anti-tumor mechanisms of action, and their dual targeting holds significant synergistic anti-tumor potential. To date, single-target ADCs directed against either EGFR or TROP2 have been constrained by three key clinical limitations: narrow tumor coverage, off-target toxicity, and multidrug resistance. As a next-generation dual-targeting ADC, AK158D1 integrates the precise tumor recognition enabled by bispecific antibodies, a highly potent cytotoxic payload, and an enhanced safety pro create a potential breakthrough ADC to address the shortcomings of conventional single-target ADC modalities. Preclinical data for AK158D1 have demonstrated potent anti-tumor activity with a favorable safety profile, supporting its potential as a novel therapeutic option for a wide range of patients, including those who are refractory to, intolerant, or ineligible for existing standard of care regimens. Akeso is advancing its IO2.0 + ADC2.0 strategy, built on proprietary bispecific and multi-specific antibody technology and centered on cornerstone IO2.0 assets including ivonescimab and cadonilimab. Through this approach, the Company is elevating treatment standards for major diseases worldwide and building a broad oncology portfolio to create next-generation standard of care. Leveraging its technological leadership in bispecific and multi-specific antibodies, Akeso is systematically building a comprehensive global IO2.0 + ADC2.0 therapeutic matrix for major diseases worldwide. In the immuno-oncology field, Akeso has two approved bispecific antibodies for cancer treatment. The Company is actively evaluating ivonescimab and cadonilimab in combination with its proprietary next-generation ADC candidates. Increasingly, global partners recognize both ivonescimab and cadonilimab as preferred agents for combination regimens and breakthrough therapy explorations across a wide spectrum of tumor types. In the ADC space, Akeso has built a pipeline of highly differentiated next-generation candidates, including AK146D1, AK138D1, AK157D1 and AK158D1, which are already in clinical development. These agents are designed to address the narrow therapeutic window and safety limitations commonly associated with first-generation ADCs. About AK158D1 AK158D1 is a bispecific ADC developed by Akeso, featuring a humanized antibody that dually targets EGFR and TROP2. Preclinical pharmacodynamic studies have shown strong antigen-binding affinity and robust in vitro and in vivo pharmacological activity. About Akeso 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, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the Company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, nearly 30 candidates have advanced into clinical trials, including 15 bispecific or multi-specific antibodies and bispecific ADCs. Eight innovative drugs are commercially available, and two additional drugs with three indications are currently under regulatory review for marketing approval. Akeso is committed to becoming a global leader in biopharmaceuticals through efficient and breakthrough innovation in R&D, developing novel therapies that are first-in-class or best-in-class, and providing better disease solutions for patients around the world. Forward-Looking Statements 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. 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. 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 the 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 Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. 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. View original content: SOURCE Akeso, Inc.

华盛顿正在重新划定对华投资边界，但生物医药没有被简单关在门外。 据路透社近日报道，美国财政部在研究相关限制时，考虑为药物许可交易保留空间。美国药企仍可能获得中国企业研发药物的海外权益，前提是不涉及敏感病原体、生物武器等安全事项。 这不是全面放行，也不是规则已经落地。 现行美国对外投资安全机制源于2023年8月签署的行政令。美国财政部2024年10月公布最终规则，并于2025年1月生效，重点覆盖半导体、量子信息和部分人工智能技术。 白宫2025年2月发布的投资政策备忘录，又要求审视生物技术等领域。财政部所说的目标，是处理特定的“国家安全风险”，而不是禁止所有中美商业往来。 转折也由此出现。外界原本担心，生物医药可能复制芯片领域的限制方式；路透社披露的信息却显示，药物研发、授权合作与敏感生物技术可能被区别对待。 这种区别有现实基础。 药品行业常见的“许可引进”，并不等同于收购一家中国公司。美国药企可以支付首付款、研发里程碑款和销售分成，换取某款候选药物在特定地区的开发、生产或商业化权利。 如果最终规则保留这条通道，美国公司便能继续补充研发管线。至于普通股权投资、董事席位和数据共享是否受到更严格限制，仍要看正式文本如何设置门槛。 国会层面的动作同样需要分开看。2024年，美国众议院通过过《生物安全法案》相关版本，重点是限制联邦资金流向被列名的生物技术企业，但该法案当届并未完成全部立法程序。 采购限制，不等于全面禁售。 美国药企真正焦虑的，是一批重磅药物陆续失去市场独占保护。默沙东年报显示，Keytruda在2024年销售额接近295亿美元，其核心专利将在本十年后段面临到期压力。 百时美施贵宝的Revlimid则已受到仿制药竞争，并非尚未到来的风险。两者所处阶段不同，却共同解释了行业常说的“专利悬崖”：旧产品收入下滑，新产品必须及时接棒。 但药物研发无法按财务日历准时交货。 医药行业提出的“易房定律”，描述的是研发效率长期承压。至于一款新药究竟需要多少年、多少资金，不同机构统计口径差异较大，因为失败项目和资本成本是否计入，会改变最终数字。 可以确认的是，临床失败率仍然较高。美国食品药品监督管理局要求候选药物完成分阶段试验，早期数据不错，并不意味着一定能够获批上市。 这时，中国创新药的价值开始被重新估算。近年来，默沙东、阿斯利康、诺华、吉利德等公司通过公告披露了多笔中国药物授权交易，覆盖抗体偶联药物、双特异性抗体和小分子药物。 ADC是其中较受关注的一类。它通常由抗体、连接子和细胞毒性载荷组成，目标是把药物更多送到特定肿瘤细胞附近，但“精准”不代表没有副作用，脱靶毒性仍需临床验证。 微观层面，康方生物的依沃西单抗提供了一个观察窗口。在中国开展的HARMONi-2三期试验中，这款双特异性抗体与默沙东Keytruda进行了“头对头”比较。 康方生物公布的结果显示，在特定PD-L1阳性晚期非小细胞肺癌患者中，依沃西单抗的中位无进展生存期约为11.1个月，对照组约为5.8个月，疾病进展或死亡风险比为0.51。 这组数据改变了部分市场判断。 不过，边写到这里也需要校准：该研究主要在中国入组，总生存期数据是否成熟、不同人群能否复现结果，以及美国监管机构是否认可全球试验数据，仍是后续需要回答的问题。 美国合作方Summit还在推进全球临床研究。只有当国际多中心数据达到预设终点，并通过FDA审评，依沃西单抗才可能真正进入美国市场。 因此，把财政部的政策取向解释为“美国认输”，证据并不充分。更接近事实的说法是，安全部门希望控制敏感技术外流，而药企、患者和医疗体系又需要更多候选药物，两套目标正在同一份规则中寻找边界。 路透社报道呈现的是规则制定中的权衡，并不能证明患者团体或药企游说单独决定了结果。美国政府究竟会放宽到什么程度，还取决于国会立法、交易审查标准及最终豁免范围。 真正可检验的问题有三个：药物许可是否被正式排除在限制之外，少数股权投资是否设置额外条件，以及涉及临床数据的平台合作会不会被纳入审查。 在这些问题落定前，中美医药合作更可能呈现“交易继续、审查加细”的状态，而非完全脱钩或毫无限制。政治可以提高交易成本，却很难替代药物疗效、监管证据和患者需求。 目前可以确认的是，中国创新药已经进入跨国药企的管线选择范围；尚未确定的，则是华盛顿最终会把安全边界画在哪里。