图文来源：上海和誉生物医药科技有限公司
2026年7月2日，上海和誉生物医药科技有限公司（以下简称“和誉医药”，港交所代码：02256）宣布，与阿斯利康（AstraZeneca，LSE/STO/NYSE: AZN）签署战略合作协议，共同推进一项新型靶免联合疗法治疗非小细胞肺癌（NSCLC）的临床研究。该研究是一项多中心、开放的I/II期临床试验，将评估和誉医药自主研发的同类首创（First-in-class）口服小分子PD-L1抑制剂ABSK043（lumipodlin）联合阿斯利康第三代EGFR-TKI泰瑞沙®（甲磺酸奥希替尼片，以下简称“奥希替尼”），用于治疗EGFR突变合并PD-L1阳性的局部晚期或转移性NSCLC患者中的安全性和疗效。
该研究的新药临床试验申请（IND）已于5月20日获得国家药品监督管理局（NMPA）批准，本项II期研究由和誉医药主导，和誉医药和阿斯利康将共同分担该临床试验的相关责任。
Lumipodlin是一款潜在的First-in-class口服小分子PD-L1抑制剂，除了口服给药的优势，还表现出其他差异化优势。目前，以奥希替尼为代表的第三代EGFR-TKI已成为EGFR突变晚期NSCLC的一线标准治疗方案。然而，对于EGFR突变合并PD-L1高表达的患者，其疗效劣于PD-L1低表达或阴性患者1,2，在EGFR突变合并PD-L1阳性的NSCLC患者中长期存在未被满足的治疗需求。
参考文献
1. Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. J Thorac Oncol. 2020;15(1):138–143.
2. Niu J, Jing X, Xu Q, et al. Strong PD-L1 affect clinical outcomes in advanced NSCLC treated with third-generation EGFR-TKIs. Future Oncol. 2024;20(32):2481-2490.
关于Lumipodlin（ABSK043）
Lumipodlin是一款由和誉医药自主研发并拥有完全权益的新型高度选择性口服小分子PD-L1抑制剂。癌细胞可以利用PD-1及其配体PD-L1这些免疫检查点来逃避免疫监管和清除，抑制或限制T细胞应答。Lumipodlin可与PD-L1受体特异性结合并诱导其从细胞表面内吞，有效地抑制PD-1/PD-L1的相互作用，解除PD-L1介导的T细胞活化抑制作用。Lumipodlin在多个临床前模型中展现出与已获批PD-L1抗体相当的抗肿瘤功效。截至目前，全球已有多款PD-1/PD-L1抗体药物获批上市，但并无PD-1/PD-L1小分子药物获批。Lumipodlin目前正在澳大利亚和中国开展针对晚期实体肿瘤的I期临床试验。
关于奥希替尼
奥希替尼是一种不可逆的第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），在治疗EGFR突变非小细胞肺癌（包括伴中枢神经系统转移）患者中显示出临床疗效。奥希替尼（40mg和80mg每日一次口服片剂）已在全球范围内用于治疗其适应症的患者。阿斯利康将继续探索奥希替尼用于治疗不同疾病分期的EGFR突变非小细胞肺癌患者。
关于阿斯利康
阿斯利康（LSE/STO/NYSE: AZN）是一家科学至上的全球生物制药企业，专注于研发、生产及营销处方类药品，重点关注肿瘤、罕见病以及包括心血管肾脏及代谢、呼吸及免疫在内的生物制药等领域。阿斯利康全球总部位于英国剑桥，业务遍布超过125个国家，创新药物惠及全球数百万患者。更多信息，请访问www.astrazeneca.com。
声明：本文涉及的联合治疗的适应症并未在中国获批，阿斯利康和和誉医药不推荐任何未被批准的药品使用。
Abbisko Therapeutics and AstraZeneca Enter a Strategic Collaboration to Conduct the Clinical Trial of Lumipodlin (ABSK043), a First-in-Class Oral PD-L1 Inhibitor, in Combination with TAGRISSO® for NSCLC
2 July 2026, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced that it has entered into a strategic collaboration agreement with AstraZeneca (LSE/STO/NYSE: AZN) to jointly advance the clinical development of a novel IO-TKI combination therapy for non-small cell lung cancer (NSCLC). As a multicenter, open-label Phase I/II clinical study, the combination will evaluate the safety and efficacy of Abbisko’s first-in-class oral small-molecule PD-L1 inhibitor, lumipodlin (ABSK043), in combination with AstraZeneca’s third-generation EGFR-TKI, TAGRISSO® (osimertinib), for the treatment of patients with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC.
On May 20, 2026, the investigational new drug (IND) application for the combination study was cleared by the National Medical Products Administration (NMPA). This Phase II study will be led by Abbisko, and both Abbisko and AstraZeneca will share responsibilities for the clinical trial.
Lumipodlin is a potentially first-in-class oral small molecule PD-L1 inhibitor with unique properties beyond its route of administration. Currently, third-generation EGFR-TKIs represented by osimertinib have become the front-line standard of care for EGFR-mutated NSCLC. However, patients with EGFR-mutant and high PD-L1 expression derive less benefit from EGFR-TKIs than those with low or negative PD-L1 expression1,2. There is a long-standing unmet medical need for patients with EGFR mutated, PD-L1 positive NSCLC.
References
1. Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. J Thorac Oncol. 2020;15(1):138–143.
2. Niu J, Jing X, Xu Q, et al. Strong PD-L1 affect clinical outcomes in advanced NSCLC treated with third-generation EGFR-TKIs. Future Oncol. 2024;20(32):2481-2490.
About Lumipodlin (ABSK043)
Lumipodlin is a novel, orally bioavailable, highly selective small molecule PD-L1 inhibitor independently developed and wholly owned by Abbisko Therapeutics. Tumor cells can exploit immune checkpoints such as PD-1 and its ligand PD-L1 to evade immune detection and clearance, thereby suppressing or limiting T-cell responses. Lumipodlin selectively binds to the PD-L1 receptor and induces its internalization from the cell surface, effectively inhibiting the PD-1/PD-L1 interaction and alleviating PD-L1-mediated suppression of T-cell activation. In preclinical models, lumipodlin has demonstrated anti-tumor efficacy comparable to approved PD-L1 antibodies. While several PD-1/PD-L1 monoclonal antibodies have been approved worldwide, there are currently no approved orally bioavailable PD-1/PD-L1 small molecule drugs. Lumipodlin is currently being explored in an ongoing Phase I clinical trial for advanced solid tumors in Australia and China.
About Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in EGFRm NSCLC, including against central nervous system metastases. Tagrisso (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.
About Abbisko Therapeutics
Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology.
Please visit www.abbisko.com for more information.
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.
Disclaimer: The indication for the combination therapy referenced in this document has not been approved in China. AstraZeneca and Abbisko Therapeutics do not recommend the use of any unapproved medicines.
关于和誉
和誉医药（香港联交所代码：02256）成立于2016年，是一家立足中国，着眼全球的创新药研发公司。公司的创始人和管理团队拥有多年顶尖跨国药企的研发和管理经验，并参与了多个临床及上市新药的研发。和誉医药专注于肿瘤新药研发，以小分子肿瘤精准治疗和小分子肿瘤免疫治疗药物为核心，着眼病患及医药市场的需求，秉承国际新药开发的理念和标准，致力于开发新颖及高潜力药物靶点的潜在first-in-class或best-in-class创新药物，用于改善中国及全球病人的生活质量。自成立以来，和誉医药已经建立了丰富的创新产品管线，涵盖肿瘤精准治疗领域以及肿瘤免疫治疗领域。
