Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the 'Company') today announced that the Company has received a clinical trial notice approving the investigational new drug application for the its CLDN18.2-directed antibody-drug conjugate (ADC) SKB315 in combination of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab for the first-line treatment of gastric cancer / gastro-oesophageal junction cancer (GC/GEJC) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)..

四川科伦博泰生物医药股份有限公司（「公司」）今日宣布，公司已收到国家药品监督管理局（NMPA）药品审评中心（CDE）核准签发的临床试验通知书，批准其CLDN18.2靶向抗体药物偶联物（ADC）SKB315联合抗程序性死亡配体1（PD-L1）单克隆抗体（mAb）泰特利单抗（tagitanlimab）用于一线治疗胃癌/胃食管交界处癌（GC/GEJC）的试验性新药申请。

SKB315 is a novel CLDN18.2-directed ADC for advanced solid tumors, configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. Building upon ongoing monotherapy studies in CLDN-expressing tumors such as GC/GEJC and pancreatic ductal adenocarcinoma, the Company is also initiating clinical studies of its combination therapy with immunotherapy for the first-line treatment of CLDN-positive GC/GEJC..

SKB315 是一种新型的靶向 CLDN18.2 的 ADC，用于治疗晚期实体瘤，配备了自主研发的人源化 CLDN18.2 单克隆抗体以及独特的载荷-连接子设计。基于正在进行的针对表达 CLDN 的肿瘤（如胃癌/胃食管结合部腺癌和胰腺导管腺癌）的单药治疗研究，公司还启动了其与免疫疗法联合用于一线治疗 CLDN 阳性胃癌/胃食管结合部腺癌的临床研究。

Tagitanlimab is the first PD-L1 mAb to receive authorization for the first-line treatment of nasopharyngeal carcinoma (NPC). It has been approved by the NMPA for marketing in China as a combination therapy with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic (R/M) NPC, as well as monotherapy for the treatment of patients with R/M NPC who have failed after prior 2L+ chemotherapy..

Tagitanlimab是首个获得鼻咽癌（NPC）一线治疗授权的PD-L1单克隆抗体。它已获中国国家药品监督管理局（NMPA）批准上市，与顺铂和吉西他滨联合用于复发或转移性（R/M）鼻咽癌患者的一线治疗，以及作为单药治疗既往二线及以上化疗失败的R/M鼻咽癌患者。

Previously, tagitanlimab in combination with TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) granted Breakthrough Therapy Designation by the CDE of the NMPA of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations..

此前，Tagitanlimab联合TROP2导向的抗体药物偶联物（ADC）Sacituzumab Tirumotecan（Sac-TMT）被中国国家药品监督管理局（NMPA）药品审评中心（CDE）授予突破性疗法认定，用于一线治疗局部晚期或转移性非鳞状非小细胞肺癌（NSCLC），且无可操作基因组改变。

Encouraging clinical development progress has been made in recent years with combination strategies based on PD-(L)1 antibodies. The innovative ADC SKB315 combined with the PD-L1 monoclonal antibody tagitanlimab is expected to generate synergistic effects through their distinct mechanisms of action, overcoming tumor heterogeneity among different patients and delivering greater survival benefits..

近年来，基于PD-(L)1抗体的联合策略在临床开发中取得了令人鼓舞的进展。创新的ADC药物SKB315与PD-L1单克隆抗体塔吉坦利单抗联合使用，有望通过其独特的作用机制产生协同效应，克服不同患者之间的肿瘤异质性，带来更大的生存获益。

About Kelun-Biotech

关于科伦生物技术

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world.

科伦博泰（6990.HK）是科伦药业（002422.SZ）的控股子公司，专注于创新生物药物和小分子药物的研发、生产、商业化及全球合作。公司聚焦于实体瘤、自身免疫、炎症及代谢性疾病等重大疾病领域，并致力于建立全球化药物开发与产业化平台，以满足中国及全球未被满足的医疗需求。

The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage.

公司致力于成为创新药物领域的全球领先企业。目前，公司拥有30余项重点创新药物项目在研，其中3个项目已获批上市，1个项目处于NDA阶段，10余个项目处于临床阶段。

The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/..

该公司建立了世界领先的专有ADC平台之一OptiDC™，拥有1个已获批上市的ADC项目、1个处于NDA阶段的ADC项目，以及多个处于临床或临床前研究阶段的ADC和新型DC资产。欲了解更多信息，请访问https://kelun-biotech.com/。