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科濟藥業-B:自願公告 - 舒瑞基奧侖賽注射液中國確證性II期臨床試驗已完成入組

CARSGEN-B: VOLUNTARY ANNOUNCEMENT - COMPLETION OF ENROLLMENT OFCONFIRMATORY PHASE II CLINICAL TRIAL OFSATRICABTAGENE AUTOLEUCEL IN CHINA

HKEX ·  Aug 19 08:01

Summary by Futu AI

科济药业宣布其舒瑞基奧侖賽注射液在中國進行的確證性II期臨床試驗已完成入組和隨機。該試驗旨在評估該藥物治療Claudin18.2表達陽性、經過至少兩種治療失敗的晚期胃癌╱食管胃結合部腺癌患者的有效性和安全性。舒瑞基奧侖賽注射液是一種靶向Claudin18.2蛋白的自體CAR-T細胞候選產品,已獲美國FDA「再生醫學先進療法」認定及歐洲藥品管理局的優先藥物資格。科济药业專注於創新CAR-T細胞療法,致力於治療血液惡性腫瘤和實體瘤,並已建立從靶點發現到商業規模生產的研發平台。
科济药业宣布其舒瑞基奧侖賽注射液在中國進行的確證性II期臨床試驗已完成入組和隨機。該試驗旨在評估該藥物治療Claudin18.2表達陽性、經過至少兩種治療失敗的晚期胃癌╱食管胃結合部腺癌患者的有效性和安全性。舒瑞基奧侖賽注射液是一種靶向Claudin18.2蛋白的自體CAR-T細胞候選產品,已獲美國FDA「再生醫學先進療法」認定及歐洲藥品管理局的優先藥物資格。科济药业專注於創新CAR-T細胞療法,致力於治療血液惡性腫瘤和實體瘤,並已建立從靶點發現到商業規模生產的研發平台。
Kexi Pharmaceutical announced that the confirmatory Phase II clinical trial of its Shruti Kyolonsay injection has completed enrollment and randomization in China. The trial aims to evaluate the efficacy and safety of the drug in treating advanced gastric/esophageal gastroesophageal junction adenocarcinoma patients who express positive Claudin18.2 and have undergone at least two treatments. Shruti Kyolonsay injection is a self CAR-T cell candidate product targeting Claudin18.2 protein, which has been recognized by the US FDA's "Advanced Therapy for Regenerative Medicine" and has priority drug qualification from the European Medicines Agency. Kexi Pharmaceutical focuses on innovative CAR-T cell therapy for the treatment of hematological malignancies and solid tumors, and has established a research and development platform from target discovery to commercial-scale production.
Kexi Pharmaceutical announced that the confirmatory Phase II clinical trial of its Shruti Kyolonsay injection has completed enrollment and randomization in China. The trial aims to evaluate the efficacy and safety of the drug in treating advanced gastric/esophageal gastroesophageal junction adenocarcinoma patients who express positive Claudin18.2 and have undergone at least two treatments. Shruti Kyolonsay injection is a self CAR-T cell candidate product targeting Claudin18.2 protein, which has been recognized by the US FDA's "Advanced Therapy for Regenerative Medicine" and has priority drug qualification from the European Medicines Agency. Kexi Pharmaceutical focuses on innovative CAR-T cell therapy for the treatment of hematological malignancies and solid tumors, and has established a research and development platform from target discovery to commercial-scale production.

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