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和黃醫藥：自願性公告－和黃醫藥與信達生物宣佈呋喹替尼 (fruquintinib) 聯合信迪利單抗 (sintilimab)用於治療晚期子宮內膜癌的中國新藥上市申請獲受理並獲納入優先審評

HUTCHMED: VOLUNTARY ANNOUNCEMENT - HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

香港交易所 · Apr 2 00:27

HUTCHMED +2.64%

Summary by Moomoo AI

和黃醫藥與信達生物宣布，其聯合開發的新藥呋喹替尼和信迪利單抗用於治療晚期子宮內膜癌的中國新藥上市申請已獲國家藥品監督管理局受理並納入優先審評。這項聯合療法於2023年7月已被納入突破性治療品種，旨在治療既往系統性抗腫瘤治療後疾病進展的患者。FRUSICA-1是支持此申請的II期臨床試驗，其數據將於近期學術會議上發表。和黃醫藥研發負責人石明博士表示，這標誌著在中國改寫這種疾病治療格局的重要一步。信達生物的周輝博士也對新藥上市申請獲受理表示興奮，並期待能改善中國子宮內膜癌患者的預後。呋喹替尼在中國已獲批上市，並於2023年11月在美國獲批。信迪利單抗在中國已獲批七項適應症。和黃醫藥是一家專注於癌症和免疫性疾病治療的生物醫藥公司，已有三款藥物在中國上市，其中一款在美國上市。

WA-HUANG PHARMACEUTICALS AND XINDA BIO ANNOUNCED THAT THEIR JOINT DEVELOPMENT APPLICATION FOR A NEW CHINESE DRUG FOR FURUQUINITINE AND CINDYLIONE ANTIDOTE FOR THE TREATMENT OF LATE ENDOMETRIAL CANCER HAS BEEN ACCEPTED AND INCLUDED IN PRIORITY REVIEW BY THE NATIONAL DRUG ADMINISTRATION. This combination therapy was included in a breakthrough treatment line in July 2023 aimed at treating patients with disease progression both after systemic antitumor therapy. FRUSICA-1 is a Phase II clinical trial supporting this application and its data will be published at a recent academic conference. This marks an important step in reshaping the treatment landscape of this disease in China, said Dr. Shi Ming, head of research and development at Wah Wong Medicine. Dr. Zhou Fai of Shinda Biologics is also excited about the acceptance of the new drug's listing application and looks forward to improving the prognosis for endometrial cancer patients in China. Furuquinetine has been approved for sale in China and approved in the United States in November 2023. Seven indications have been approved for use in China against syndylisone. Wah Wong Pharmaceuticals is a biopharmaceutical company focused on the treatment of cancer and immune diseases. Three drugs are already listed in China, one of which is listed in the United States.

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