2025年8月20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，其在研的口服小分子PD-L1抑制剂ABSK043与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）KRAS G12C抑制剂戈来雷塞片开展联合用药治疗KRAS G12C突变的非小细胞肺癌（NSCLC）的临床研究申请获中国国家药品监督管理局药品审评中心（CDE）批准。今年3月，和誉医药与艾力斯就联合用药达成合作协议。
此次获批的研究是“一项评估ABSK043联合枸橼酸戈来雷塞治疗携带KRAS G12C突变的局部晚期或转移NSCLC患者的安全性、耐受性和有效性的开放性II期临床研究”。
此前，ABSK043还与艾力斯自主研发的甲磺酸伏美替尼片进行联合用药，用于治疗晚期非小细胞肺癌，并于2024年12月完成首例患者给药。
ABSK043治疗晚期实体瘤患者的最新I期研究结果展示出ABSK043具有良好的安全性和抗肿瘤活性，PD-L1高表达组、EGFR突变组和KRAS突变组的有效率更高。
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。
关于戈来雷塞
枸橼酸戈来雷塞片是一款KRAS G12C抑制剂，目前已在中国、美国及欧洲多国启动多项针对晚期实体瘤患者的临床试验，包括与SHP2抑制剂AST-24082联用治疗非小细胞肺癌，以及单药治疗胰腺癌的注册性临床研究等。其中，胰腺癌适应症在美国获得孤儿药认定，并在中国获得突破性治疗药物认定。2025年5月，戈来雷塞获中国国家药品监督管理局批准上市。
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 Announces IND Clearance from the CDE for ABSK043 in Combination with Glecirasib from Allist Pharmaceuticals, for the Treatment of NSCLC
20 August 2025, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the IND application for Abbisko’s investigational oral PD-L1 inhibitor, ABSK043, combined with Shanghai Allist Pharmaceuticals Co., Ltd. ("Allist" hereafter, SSE code: 688578.SS) KRAS G12C inhibitor, glecirasib, for the treatment of NSCLC patients with KRAS G12C mutation. In March, Abbisko Therapeutics and Allist entered into a cooperation agreement to explore ABSK043 in combination with glecirasib.
A clinical study of NSCLC will be conducted under the title “A Phase II, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of ABSK043 Combined With Glecirasib in Patients With KRAS G12C Mutated, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)”.
The parties previously disclosed a separate collaboration to explore the combination of ABSK043 and furmonertinib (IVESA), developed by Allist, for the treatment of advanced non-small cell lung cancer. First-patient dosing for this study occurred in December 2024.
Results from an updated Phase I study showed that ABSK043 demonstrated a favorable safety profile and impressive anti-tumor activity as a single agent, with higher response rates in the subset of patients with high PD-L1 expression, and EGFR or KRAS mutations.
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 Glecirasib
Glecirasib (AST-24081) is a KRAS G12C inhibitor. A number of clinical trials are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor AST-24082 in NSCLC and monotherapy trials in pancreatic cancer. Additionally, the pancreatic cancer indication has received orphan drug designation in the United States and breakthrough therapy designation in China. In May 2025, Glecirasib was approved for market launch by the China NMPA.
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. In accordance with its development concept“Advancing Long Life with Innovation of Science and Technology”, Allist is dedicated to self-develop First-in-class and Best-in-class drug candidates. After 20 years of endeavor, Allist has successfully developed and received approvals of two innovative drugs by its own. 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.SS).
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。
