2025年12月1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)今日宣布,公司将在2025年欧洲肿瘤内科学会亚洲年会(ESMO Asia 2025)上公布其在研口服小分子PD-L1抑制剂ABSK043联合上海艾力斯医药科技股份有限公司(以下简称“艾力斯”,上交所代码:688578)第三代EGFR-TKI甲磺酸伏美替尼开展的II期临床研究(ABSK043-202)的初步结果。 ESMO Asia 2025将于2025年12月5日至7日在新加坡举行。大会期间,上海交通大学医学院附属上海胸科医院陆舜教授将以壁报形式展示ABSK043-202研究剂量递增阶段的结果。展示内容将包括不同剂量ABSK043联合伏美替尼治疗EGFR阳性突变、既往接受过治疗的局部晚期或转移性非小细胞肺癌(NSCLC)患者的安全性和耐受性数据,以及抗肿瘤活性的初步评估结果。 壁报展示信息如下: 标题:ABSK043联合伏美替尼治疗EGFR突变的晚期NSCLC患者: II期研究结果 报告编号:165P 报告人:陆舜教授 时间:2025/12/5 17:15-18:15(UTC+8) 地点:新加坡新达城(Suntec Singapore)国际会展中心(壁报区) 关于ABSK043 ABSK043为一款全新的具备优异活性及高度选择性的口服小分子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。ABSK043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。ABSK043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。ABSK043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。 关于伏美替尼 伏美替尼是中国原研、具有自主知识产权的第三代EGFR-TKI,分别于2021年3月、2022年6月获批EGFR突变的局部晚期或转移性NSCLC成人患者的二线、一线治疗适应症,并均已被纳入国家医保目录。目前伏美替尼针对EGFR 20外显子插入突变NSCLC患者一线治疗适应症的包括中国、美国、英国、法国、日本、韩国等多个国家在内的全球多中心III期注册临床研究正在顺利进行中。此外,伏美替尼针对EGFR 20外显子插入突变NSCLC治疗的适应症获得中、美监管机构的突破性疗法认定;针对NSCLC EGFR敏感突变辅助治疗、PACC突变NSCLC一线治疗、EGFR敏感突变NSCLC伴脑转移患者治疗、EGFR非经典突变辅助治疗的注册临床研究也在顺利推进中。 关于艾力斯 上海艾力斯医药科技股份有限公司成立于2004年3月,是一家以全球医药市场需求为导向,专注于肿瘤治疗领域,集新药研发、生产和商业化为一体的创新型制药企业。艾力斯医药以科技关爱生命为发展理念,以开发首创药物和同类最佳药物为首要目标。历经20年坚持不懈的努力,艾力斯已经成功自主研发,获批两款创新药,具备持续创制具有自主产权的疗效确切、市场最优的抗肿瘤新药之综合实力。2020年12月2日,上海艾力斯医药科技股份有限公司正式在上海证券交易所科创板挂牌上市(股票代码:688578)。 Abbisko Therapeutics to Present Preliminary Phase II Results of Oral PD-L1 Inhibitor ABSK043 Combined with Furmonertinib in NSCLC at ESMO Aisa 1 December 2025, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced that it will present the preliminary results from its Phase II clinical study (ABSK043-202) evaluating the investigational oral small-molecule PD-L1 inhibitor ABSK043 in combination with the 3rd generation EGFR-TKI furmonertinib from Shanghai Allist Pharmaceuticals Co., Ltd. ("Allist", SSE code: 688578.SS) at the European Society for Medical Oncology Asia Congress 2025 (ESMO Asia 2025). ESMO Asia 2025 will be held from December 5 to 7 in Singapore. During the congress, Professor Shun Lu from Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, will present a poster featuring the dose escalation results from the ABSK043-202 study. The presentation will include safety and tolerability data from different dose levels of ABSK043 combined with furmonertinib in previously treated, EGFR-mutant, locally advanced or metastatic non-small cell lung cancer (NSCLC) patients, as well as preliminary assessment of anti-tumor activity. Poster presentation details are as follows: Title: ABSK043 plus firmonertinib (Firmo) for the treatment of advanced non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: Results from a phase II Study Presentation Number: 165P Speakers: Shun Lu (Shanghai, CN) Time: Friday, December 5, 2025, 17:15–18:15 (UTC+8) Location: Exhibition (Poster area), Suntec Singapore, Singapore About ABSK043 ABSK043 is a novel, orally bioavailable, highly selective small molecule PD-L1 inhibitor 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. ABSK043 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, ABSK043 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. ABSK043 is currently being explored in an ongoing Phase I clinical trial for advanced solid tumors in Australia and China. About Furmonertinib Furmonertinib is a self-developed 3rd generation of EGFR-TKI with independent IP from China. It is approved by CDE for the second-line and first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutations in March 2021 and June 2022, respectively, both of which are included in the National Reimbursement Drug List. Thus far, the global multi-center (including China, the United States, the United Kingdom, France, Japan, South Korea, etc.), registrational Phase III clinical study of Furmonertinib is well advanced, which is used for the first-line treatment of NSCLC patients harboring EGFR Exon 20 insertion mutations. In addition, Furmonertinib has been granted as Breakthrough Therapy Designation in China and the United States for the treatment of NSCLC with EGFR Exon 20 insertion mutations. The registrational clinical studies for adjuvant treatment of NSCLC with EGFR-sensitive mutations, first-line treatment for NSCLC with PACC mutations, treatment of EGFR-sensitizing mutation NSCLC with brain metastases, and adjuvant treatment for NSCLC with uncommon EGFR mutations are also progressing smoothly. 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 Allist Shanghai Allist Pharmaceuticals Co., Ltd, founded in March, 2004, is an innovative pharmaceutical company with a fully integrated system for research and development, manufacturing, and commercialization of novel oncology drugs with a purpose to meet with medical needs across the globe. On December 2nd, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange (stock number: 688578). 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。 更多信息,欢迎访问 www.abbisko.com。
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“誉”你相约|和誉医药将在ESMO Asia公布口服PD-L1抑制剂ABSK043联合伏美替尼治疗NSCLC的II期临床初步结果
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