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信達生物：自願公告 - 國家藥品監督管理局受理信迪利單抗聯合呋喹替尼用於治療晚期子宮內膜癌的新藥上市申請並授予優先審評

INNOVENT BIO: VOLUNTARY ANNOUNCEMENT - THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION ACCEPTED THE NEW DRUG APPLICATION AND GRANTED PRIORITY REVIEW DESIGNATION FOR SINTILIMAB COMBINATION WITH FRUQUINTINIB FOR THE TREATMENT OF ADVANCED ENDOMETRIAL CANCER

香港交易所 ·  Apr 2 00:25
Summary by Moomoo AI
信達生物製藥有限公司宣布，中國國家藥品監督管理局（NMPA）已正式受理信迪利單抗與呋喹替尼聯合療法的新藥上市申請（NDA），並授予優先審評資格。該聯合療法用於治療經過系統性抗腫瘤治療後疾病進展，且不適合進行根治性手術或放療的晚期子宮內膜癌患者。FRUSICA-1為支持此NDA的II期臨床試驗，其結果將於近期學術會議發表。信迪利單抗在中國已獲批七項適應症，並納入國家醫保目錄。呋喹替尼在中國和美國均已獲批上市，並在中國獲納入國家醫保藥品目錄。信達生物對此次NDA獲受理及優先審評表示興奮，認為此舉將加強公司在中國的領導地位，並為子宮內膜癌患者帶來新的治療選擇。
信達生物製藥有限公司宣布，中國國家藥品監督管理局（NMPA）已正式受理信迪利單抗與呋喹替尼聯合療法的新藥上市申請（NDA），並授予優先審評資格。該聯合療法用於治療經過系統性抗腫瘤治療後疾病進展，且不適合進行根治性手術或放療的晚期子宮內膜癌患者。FRUSICA-1為支持此NDA的II期臨床試驗，其結果將於近期學術會議發表。信迪利單抗在中國已獲批七項適應症，並納入國家醫保目錄。呋喹替尼在中國和美國均已獲批上市，並在中國獲納入國家醫保藥品目錄。信達生物對此次NDA獲受理及優先審評表示興奮，認為此舉將加強公司在中國的領導地位，並為子宮內膜癌患者帶來新的治療選擇。
SINDA BIOPHARMACEUTICAL CO., LTD. ANNOUNCED THAT THE CHINA NATIONAL MEDICINES REGULATORY AUTHORITY (NMPA) HAS FORMALLY ACCEPTED THE APPLICATION FOR A NEW DRUG LISTING (NDA) FOR THE COMBINATION THERAPY OF SINDILISONE ANTIFUNDINE AND FURUQUINTININE AND GRANTED PRIORITY REVIEW ELIGIBILITY. This combination therapy is used to treat disease progression after systemic antitumor therapy and is not suitable for patients with late endometrial cancer who have undergone radical surgery or chemotherapy. FRUSICA-1 is a Phase II clinical trial supporting this NDA, the results of which will be published at a recent academic conference. Seven indications have been approved for use in China and included in the National Health Insurance Catalog. Furuquinetine has been approved in both China and the United States and is included in the National Pharmaceutical Catalogue in China. Sinda-Bio is excited about the acceptance and priority review of this NDA, believing that the move will strengthen the company's leadership in China and bring new treatment options for patients with endometrial cancer.
SINDA BIOPHARMACEUTICAL CO., LTD. ANNOUNCED THAT THE CHINA NATIONAL MEDICINES REGULATORY AUTHORITY (NMPA) HAS FORMALLY ACCEPTED THE APPLICATION FOR A NEW DRUG LISTING (NDA) FOR THE COMBINATION THERAPY OF SINDILISONE ANTIFUNDINE AND FURUQUINTININE AND GRANTED PRIORITY REVIEW ELIGIBILITY. This combination therapy is used to treat disease progression after systemic antitumor therapy and is not suitable for patients with late endometrial cancer who have undergone radical surgery or chemotherapy. FRUSICA-1 is a Phase II clinical trial supporting this NDA, the results of which will be published at a recent academic conference. Seven indications have been approved for use in China and included in the National Health Insurance Catalog. Furuquinetine has been approved in both China and the United States and is included in the National Pharmaceutical Catalogue in China. Sinda-Bio is excited about the acceptance and priority review of this NDA, believing that the move will strengthen the company's leadership in China and bring new treatment options for patients with endometrial cancer.
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