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金斯瑞生物科技：海外監管公告：傳奇生物宣布歐盟委員會批准CARVYKTI用於復發難治性多發性骨髓瘤患者的二線治療

GENSCRIPT BIO: OVERSEAS REGULATORY ANNOUNCEMENT: LEGEND BIOTECH CORPORATION ANNOUNCES THE EUROPEAN COMMISSION''S APPROVAL OF CARVYKTI FOR SECOND-LINE TREATMENT OF PATIENTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA

Hong Kong Stock Exchange ·  Apr 23 08:27
Summary by Futu AI
金斯瑞生物科技股份有限公司（「金斯瑞生物科技」）宣布，其非全資附屬公司傳奇生物科技股份有限公司（「傳奇生物」）的CAR-T療法CARVYKTI®（ciltacabtagene autoleucel，cilta-cel）已於2024年4月22日獲得歐盟委員會批准，用於治療復發性難治性多發性骨髓瘤成年患者的二線治療。這些患者至少接受過一種治療，包括蛋白酶體抑制劑和免疫調節劑，並在最後一次治療中顯示出疾病進展，對來那度胺耐藥。傳奇生物於紐約時間2024年4月22日向美國證券交易委員會提交了相關的6-K表格。這項批准基於CARTITUDE-4研究的積極結果，該研究顯示CARVYKTI®在既往接受過一到...展開全部
金斯瑞生物科技股份有限公司（「金斯瑞生物科技」）宣布，其非全資附屬公司傳奇生物科技股份有限公司（「傳奇生物」）的CAR-T療法CARVYKTI®（ciltacabtagene autoleucel，cilta-cel）已於2024年4月22日獲得歐盟委員會批准，用於治療復發性難治性多發性骨髓瘤成年患者的二線治療。這些患者至少接受過一種治療，包括蛋白酶體抑制劑和免疫調節劑，並在最後一次治療中顯示出疾病進展，對來那度胺耐藥。傳奇生物於紐約時間2024年4月22日向美國證券交易委員會提交了相關的6-K表格。這項批准基於CARTITUDE-4研究的積極結果，該研究顯示CARVYKTI®在既往接受過一到三線治療的復發和來那度胺難治性多發性骨髓瘤成人患者中，無進展生存期有統計學意義和臨床意義。傳奇生物首席執行官黃穎博士表示，這一批准可能改變多發性骨髓瘤患者的治療模式。美國食品藥品監督管理局（FDA）亦於2024年4月5日批准CARVYKTI®用於相同患者群。金斯瑞生物科技提醒股東及潛在投資者注意投資風險。
Kingsway Biotechnology Co., Ltd. (“Kingsley Biotechnology”) Announces that CAR-T Therapy CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) of its non-wholly-owned subsidiary Legendary Biotechnology Co., Ltd. (“Legendary Biotech”) has been acquired by the European Commission on 22 April 2024 Approved for the treatment of second-line therapy in adult patients with relapsed difficult-to-treat multiple myeloma. These patients received at least one treatment, including protease inhibitors and immunomodulators, and showed disease progression at the last treatment and were resistant to adenamine. Legendary Bio filed the relevant Form 6-K with the U.S. Securities and Exchange Commission on April 22, 2024, New York time. THIS APPROVAL IS BASED ON THE POSITIVE RESULTS OF THE CARTITUDE-4 STUDY, WHICH SHOWS THAT CARVYKTI® IS STATISTICALLY AND CLINICALLY...Show More
Kingsway Biotechnology Co., Ltd. (“Kingsley Biotechnology”) Announces that CAR-T Therapy CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) of its non-wholly-owned subsidiary Legendary Biotechnology Co., Ltd. (“Legendary Biotech”) has been acquired by the European Commission on 22 April 2024 Approved for the treatment of second-line therapy in adult patients with relapsed difficult-to-treat multiple myeloma. These patients received at least one treatment, including protease inhibitors and immunomodulators, and showed disease progression at the last treatment and were resistant to adenamine. Legendary Bio filed the relevant Form 6-K with the U.S. Securities and Exchange Commission on April 22, 2024, New York time. THIS APPROVAL IS BASED ON THE POSITIVE RESULTS OF THE CARTITUDE-4 STUDY, WHICH SHOWS THAT CARVYKTI® IS STATISTICALLY AND CLINICALLY SIGNIFICANT IN PATIENTS WITH RECURRENT AND NON-PROGRESSED MULTIPLE MYELOMA ADULT PATIENTS WHO HAVE PREVIOUSLY RECEIVED ONE- TO THREE-LINE THERAPY. The approval could change the treatment pattern for patients with multiple myeloma, said Dr. Wong Ying, CEO of Legendary Biology. THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) ALSO APPROVED CARVYKTI® ON APRIL 5, 2024 FOR THE SAME PATIENT POPULATION. Kingsway Biotechnology reminds shareholders and potential investors to be aware of investment risks.

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