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康方生物：自願公告 - 國家藥品監督管理局受理開坦尼（卡度尼利，PD-1 /CTLA-4）用於一線治療宮頸癌的新適應症上市申請

AKESO: VOLUNTARY ANNOUNCEMENT - THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION ACCEPTED THE SUPPLEMENTAL NEW DRUG APPLICATION FOR CADONILIMAB (PD-1/CTLA-4) AS FIRST-LINE TREATMENT FOR CERVICAL CANCER

Hong Kong Stock Exchange ·  Apr 24 08:15
Summary by Futu AI
康方生物科技（開曼）有限公司（「康方生物」）於2024年4月24日宣布，國家藥品監督管理局（NMPA）正式受理其自主研發的雙特異性抗體開坦尼®（卡度尼利，PD-1/CTLA-4）用於一線治療持續、復發或轉移性宮頸癌的新適應症上市申請。此次申請基於AK104–303研究結果，該研究為全球首個相關的III期臨床試驗，主要研究終點包括無進展生存期和總生存期。開坦尼®於2022年6月已獲NMPA批准用於治療二/三線宮頸癌，並於2024年1月提交胃癌一線治療的新適應症上市申請。康方生物正進行多項臨床試驗，涵蓋宮頸癌、胃癌等多種癌症。
康方生物科技（開曼）有限公司（「康方生物」）於2024年4月24日宣布，國家藥品監督管理局（NMPA）正式受理其自主研發的雙特異性抗體開坦尼®（卡度尼利，PD-1/CTLA-4）用於一線治療持續、復發或轉移性宮頸癌的新適應症上市申請。此次申請基於AK104–303研究結果，該研究為全球首個相關的III期臨床試驗，主要研究終點包括無進展生存期和總生存期。開坦尼®於2022年6月已獲NMPA批准用於治療二/三線宮頸癌，並於2024年1月提交胃癌一線治療的新適應症上市申請。康方生物正進行多項臨床試驗，涵蓋宮頸癌、胃癌等多種癌症。
Kangfang Biotechnology (Cayman) Co., Ltd. (“Kangfang Biotech”) announced on April 24, 2024 that the National Drug Administration (NMPA) has officially accepted its independently developed bi-specific antibody Caitani® (Cadonilli, PD-1/CTLA-4) for the first-line treatment of continuous, recurrent or metastatic cervix Application for the listing of new indications for cancer. This application is based on the results of the AK104—303 study, which is the world's first relevant Phase III clinical trial with major study endpoints including progression-free survival and total survival. Kaitani® was approved by the NMPA in June 2022 for the treatment of 2/3-line cervical cancer and submitted a new indication application for the first-line treatment of gastric cancer in January 2024. Kangfang Biome is conducting several clinical trials covering a variety of cancers such as cervical cancer, stomach cancer, etc.
Kangfang Biotechnology (Cayman) Co., Ltd. (“Kangfang Biotech”) announced on April 24, 2024 that the National Drug Administration (NMPA) has officially accepted its independently developed bi-specific antibody Caitani® (Cadonilli, PD-1/CTLA-4) for the first-line treatment of continuous, recurrent or metastatic cervix Application for the listing of new indications for cancer. This application is based on the results of the AK104—303 study, which is the world's first relevant Phase III clinical trial with major study endpoints including progression-free survival and total survival. Kaitani® was approved by the NMPA in June 2022 for the treatment of 2/3-line cervical cancer and submitted a new indication application for the first-line treatment of gastric cancer in January 2024. Kangfang Biome is conducting several clinical trials covering a variety of cancers such as cervical cancer, stomach cancer, etc.
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