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藥明巨諾-B：自願公告 - 業務更新2024歐洲風濕病學大會上公佈瑞基奧侖賽注射液用於治療活動性系統性紅斑狼瘡中國成人患者中的初步臨床數據

JW THERAP-B: VOLUNTARY ANNOUNCEMENT - RESEARCH AND DEVELOPMENT UPDATE PRELIMINARY CLINICAL DATA ON RELMA-CEL INJECTION IN ADULTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS IN CHINA AT THE EULAR 2024 CONGRESS

Hong Kong Stock Exchange ·  May 30 16:31
Summary by Futu AI
藥明巨諾-B於2024年歐洲風濕病學大會（EULAR 2024）上公佈了其自主開發的CAR-T細胞免疫治療產品瑞基奧侖賽（relma-cel）在中國成人活動性系統性紅斑狼瘡（SLE）患者中的最新臨床數據。這項單臂、開放、多中心劑量探索研究（NCT05765006）截至2024年4月8日已入組12例受試者，並完成了不同劑量組的安全性、藥代和藥效動力學（PK/PD）以及療效探索。初步數據顯示，在25M劑量組的3例受試者中，經過單次CAR-T細胞靜脈輸注後，體徵和症狀持續改善，SELENA-SLEDAI評分顯著降低，並達到SLE應答指數4（SRI-4），未再使用激素及免疫抑制劑等SLE治療藥物。研究還顯示瑞基奧侖賽具有良好的安全性和耐受性。目前，該研究仍在進行中，以收集更多患者的長期隨訪數據。藥明巨諾表示，這些結果為其在紅斑狼瘡及其他自身免疫疾病中進一步開發提供了證據和信心。
藥明巨諾-B於2024年歐洲風濕病學大會（EULAR 2024）上公佈了其自主開發的CAR-T細胞免疫治療產品瑞基奧侖賽（relma-cel）在中國成人活動性系統性紅斑狼瘡（SLE）患者中的最新臨床數據。這項單臂、開放、多中心劑量探索研究（NCT05765006）截至2024年4月8日已入組12例受試者，並完成了不同劑量組的安全性、藥代和藥效動力學（PK/PD）以及療效探索。初步數據顯示，在25M劑量組的3例受試者中，經過單次CAR-T細胞靜脈輸注後，體徵和症狀持續改善，SELENA-SLEDAI評分顯著降低，並達到SLE應答指數4（SRI-4），未再使用激素及免疫抑制劑等SLE治療藥物。研究還顯示瑞基奧侖賽具有良好的安全性和耐受性。目前，該研究仍在進行中，以收集更多患者的長期隨訪數據。藥明巨諾表示，這些結果為其在紅斑狼瘡及其他自身免疫疾病中進一步開發提供了證據和信心。
The pharmaceutical company Jeleno-B announced the latest clinical data on its independently developed CAR-T cell immunotherapy product Rykiolense (relma-cel) in patients with active systemic lupus erythematosus (SLE) in adult active systemic lupus erythematosus (SLE) in China at the 2024 European Congress of Rheumatology (EULAR 2024). This single-arm, open-label, multicenter dose discovery study (NCT05765006) enrolled 12 subjects as of 8 April 2024 and completed safety, pharmacokinetics and pharmacokinetics (PK/PD), and efficacy explorations of different dose groups. PRELIMINARY DATA SHOW THAT IN 3 SUBJECTS IN THE 25M DOSE GROUP, SIGNS AND SYMPTOMS CONTINUED TO IMPROVE AFTER A SINGLE CAR-T CELL INTRAVENOUS INFUSION, AND SELENA-SLEDAI SCORES DECREASED SIGNIFICANTLY AND ACHIEVED SLE RESPONSE INDEX 4 (SRI-4) WITHOUT THE USE OF DRUGS FOR SLE TREATMENT SUCH...Show More
The pharmaceutical company Jeleno-B announced the latest clinical data on its independently developed CAR-T cell immunotherapy product Rykiolense (relma-cel) in patients with active systemic lupus erythematosus (SLE) in adult active systemic lupus erythematosus (SLE) in China at the 2024 European Congress of Rheumatology (EULAR 2024). This single-arm, open-label, multicenter dose discovery study (NCT05765006) enrolled 12 subjects as of 8 April 2024 and completed safety, pharmacokinetics and pharmacokinetics (PK/PD), and efficacy explorations of different dose groups. PRELIMINARY DATA SHOW THAT IN 3 SUBJECTS IN THE 25M DOSE GROUP, SIGNS AND SYMPTOMS CONTINUED TO IMPROVE AFTER A SINGLE CAR-T CELL INTRAVENOUS INFUSION, AND SELENA-SLEDAI SCORES DECREASED SIGNIFICANTLY AND ACHIEVED SLE RESPONSE INDEX 4 (SRI-4) WITHOUT THE USE OF DRUGS FOR SLE TREATMENT SUCH AS HORMONES AND IMMUNOSUPPRESSANTS. Research has also shown that Ricky Allen has good safety and tolerance. Currently, the study is still underway to collect data on long-term follow-up of more patients. The results provide evidence and confidence for its further development in lupus erythematosus and other autoimmune diseases, according to the drugmaker.

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