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金斯瑞生物科技：海外監管公告: 傳奇生物宣佈美國FDA批准CARVYKTI用於復發或難治性多發性骨髓瘤患者二線治療

GENSCRIPT BIO: OVERSEAS REGULATORY ANNOUNCEMENT: LEGEND BIOTECH ANNOUNCES THE U.S. FDA''S APPROVAL OF CARVYKTI FOR SECOND-LINE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

香港交易所 ·  Apr 8 19:43
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®（西達基奧侖賽，cilta-cel）已於2024年4月5日獲得美國食品藥品管理局（FDA）批准，用於治療復發或難治性多發性骨髓瘤成人患者的二線治療。這些患者至少接受過一線治療，包括蛋白酶體抑制劑和免疫調節劑，並對來那度胺產生耐藥。此次批准基於CARTITUDE-4研究的積極結果，顯示CARVYKTI®能顯著改善無進展生存期（PFS）。傳奇生物首席執行官黃穎博士表示，這一批准將改變多發性骨髓瘤的治療格局，為患者提供早期治療方案中的個性化免疫療法。金斯瑞生物科技提醒股東及潛在投資者注意投資風險，並於買賣公司證券時審慎行事。
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®（西達基奧侖賽，cilta-cel）已於2024年4月5日獲得美國食品藥品管理局（FDA）批准，用於治療復發或難治性多發性骨髓瘤成人患者的二線治療。這些患者至少接受過一線治療，包括蛋白酶體抑制劑和免疫調節劑，並對來那度胺產生耐藥。此次批准基於CARTITUDE-4研究的積極結果，顯示CARVYKTI®能顯著改善無進展生存期（PFS）。傳奇生物首席執行官黃穎博士表示，這一批准將改變多發性骨髓瘤的治療格局，為患者提供早期治療方案中的個性化免疫療法。金斯瑞生物科技提醒股東及潛在投資者注意投資風險，並於買賣公司證券時審慎行事。
Kingsway Biotechnology Co., Ltd. (“Kingsley Biotechnology”) Announces that CAR-T Therapy CARVYKTI® (Cidachiolense, cilta-cel) of its non-wholly-owned subsidiary Legendary Biotechnology Co., Ltd. (“Legendary Biotech”) has been granted U.S. food drug management on April 5, 2024 FDA approved a two-line therapy for the treatment of adult patients with relapsed or incurable multiple myeloma. These patients received at least one line of treatment, including protease inhibitors and immunomodulators, and developed drug resistance to radamine. This approval is based on the positive results of the CARTITUDE-4 study, showing that CARVYKTI® can significantly improve progression-free survival (PFS). The approval will change the treatment landscape for multiple myeloma by offering patients personalized immunotherapy in early treatment plans, said Dr. Wong Wing, CEO of Legendary Bios. Kingsway Biotechnology reminds shareholders and potential investors to be aware of investment risks and to exercise caution when buying and selling company securities.
Kingsway Biotechnology Co., Ltd. (“Kingsley Biotechnology”) Announces that CAR-T Therapy CARVYKTI® (Cidachiolense, cilta-cel) of its non-wholly-owned subsidiary Legendary Biotechnology Co., Ltd. (“Legendary Biotech”) has been granted U.S. food drug management on April 5, 2024 FDA approved a two-line therapy for the treatment of adult patients with relapsed or incurable multiple myeloma. These patients received at least one line of treatment, including protease inhibitors and immunomodulators, and developed drug resistance to radamine. This approval is based on the positive results of the CARTITUDE-4 study, showing that CARVYKTI® can significantly improve progression-free survival (PFS). The approval will change the treatment landscape for multiple myeloma by offering patients personalized immunotherapy in early treatment plans, said Dr. Wong Wing, CEO of Legendary Bios. Kingsway Biotechnology reminds shareholders and potential investors to be aware of investment risks and to exercise caution when buying and selling company securities.
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