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科濟藥業-B：內幕消息公告 - 國家藥品監督管理局批准BCMA CAR-T產品赛恺泽（澤沃基奧侖賽注射液）新藥上市申請用於治療復發或難治性多發性骨髓瘤成人患者，既往經過至少3線治療後進展（至少使用過一種蛋白酶體抑制劑及免疫調節劑）

CARSGEN-B: INSIDE INFORMATION ANNOUNCEMENT - THE NMPA APPROVES THE BCMA CAR-T THERAPY ZEVORCABTAGENE AUTOLEUCEL FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE PROGRESSED AFTER AT LEAST 3 PRIOR LINES OF THERAPY (I

香港交易所 ·  Feb 29 23:26
Summary by Moomoo AI
科濟藥業-B（股份代號：2171）於2024年3月1日宣布，其自體BCMA CAR-T候選產品賽愷澤®（澤沃基奧侖賽注射液，產品編號：CT053）已獲得國家藥品監督管理局（NMPA）的新藥上市申請（NDA）批准，用於治療復發或難治性多發性骨髓瘤成人患者，這些患者既往經過至少3線治療後進展，並至少使用過一種蛋白酶體抑制劑及免疫調節劑。賽愷澤®的獲批基於在中國進行的開放標籤、單臂、多中心II期臨床試驗（LUMMICAR STUDY 1，NCT03975907）的數據，該試驗結果顯示賽愷澤®具有良好的療效和安全性。科濟藥業表示，隨著中國老齡化的加速和人口預期壽命的提高，多發性骨髓瘤患者數量預計將持續增加。賽愷澤®也在北美進行1b/2期臨床試驗，評估其治療復發或難治性多發性骨髓瘤的安全性及療效。此外，賽愷澤®已獲得美國FDA的再生醫學先進療法(RMAT)及孤兒藥稱號，以及歐洲藥品管理局(EMA)的優先藥物(PRIME)及孤兒藥產品稱號。
科濟藥業-B（股份代號：2171）於2024年3月1日宣布，其自體BCMA CAR-T候選產品賽愷澤®（澤沃基奧侖賽注射液，產品編號：CT053）已獲得國家藥品監督管理局（NMPA）的新藥上市申請（NDA）批准，用於治療復發或難治性多發性骨髓瘤成人患者，這些患者既往經過至少3線治療後進展，並至少使用過一種蛋白酶體抑制劑及免疫調節劑。賽愷澤®的獲批基於在中國進行的開放標籤、單臂、多中心II期臨床試驗（LUMMICAR STUDY 1，NCT03975907）的數據，該試驗結果顯示賽愷澤®具有良好的療效和安全性。科濟藥業表示，隨著中國老齡化的加速和人口預期壽命的提高，多發性骨髓瘤患者數量預計將持續增加。賽愷澤®也在北美進行1b/2期臨床試驗，評估其治療復發或難治性多發性骨髓瘤的安全性及療效。此外，賽愷澤®已獲得美國FDA的再生醫學先進療法(RMAT)及孤兒藥稱號，以及歐洲藥品管理局(EMA)的優先藥物(PRIME)及孤兒藥產品稱號。
KOCHI PHARMACEUTICAL-B (STOCK CODE: 2171) ANNOUNCED ON MARCH 1, 2024 THAT ITS SELF-PROPRIETARY BCMA CAR-T CANDIDATE PRODUCT SAICAIZE® (ZEVOCYOLUNCAY INJECTION, PRODUCT NO.: CT053) HAS RECEIVED NEW DRUG LISTING APPLICATION (NDA) APPROVAL FROM THE NATIONAL DRUG ADMINISTRATION (NMPA) FOR THE TREATMENT OF RECURRENCE Adult patients with relapsed or incurable multiple myeloma who have progressed after at least 3 lines of treatment and have used at least one protease inhibitor and immunomodulator. THE APPROVAL OF SAICAIZE® IS BASED ON DATA FROM AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE II CLINICAL TRIAL (LUMMICAR STUDY 1, NCT03975907) CONDUCTED IN CHINA, THE RESULTS OF WHICH SHOW THAT SAICAIZE® HAS GOOD EFFICACY AND SAFETY. The number of patients with multiple myeloma is expected to continue to increase, according to...Show More
KOCHI PHARMACEUTICAL-B (STOCK CODE: 2171) ANNOUNCED ON MARCH 1, 2024 THAT ITS SELF-PROPRIETARY BCMA CAR-T CANDIDATE PRODUCT SAICAIZE® (ZEVOCYOLUNCAY INJECTION, PRODUCT NO.: CT053) HAS RECEIVED NEW DRUG LISTING APPLICATION (NDA) APPROVAL FROM THE NATIONAL DRUG ADMINISTRATION (NMPA) FOR THE TREATMENT OF RECURRENCE Adult patients with relapsed or incurable multiple myeloma who have progressed after at least 3 lines of treatment and have used at least one protease inhibitor and immunomodulator. THE APPROVAL OF SAICAIZE® IS BASED ON DATA FROM AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE II CLINICAL TRIAL (LUMMICAR STUDY 1, NCT03975907) CONDUCTED IN CHINA, THE RESULTS OF WHICH SHOW THAT SAICAIZE® HAS GOOD EFFICACY AND SAFETY. The number of patients with multiple myeloma is expected to continue to increase, according to the acceleration of aging in China and the increase in the life expectancy of the population, Kozin Pharmaceuticals said. Saikaize® is also conducting a Phase 1b/2 clinical trial in North America to evaluate the safety and efficacy of its treatment of relapsed or intractable multiple myeloma. In addition, Saikaze® has been awarded the Regenerative Medicine Advanced Therapeutics (RMAT) and Orphan Drug Designation from the U.S. FDA, as well as the Priority Drug (PRIME) and Orphan Drug Product designation from the European Medicines Agency (EMA).

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