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康方生物：自願公告 - 國家藥品監督管理局已受理開坦尼（卡度尼利，PD-1 /CTLA-4）聯合化療用於一線治療胃癌的新適應症上市申請

AKESO: VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTED THE SUPPLEMENTAL NEW DRUG APPLICATION FOR CADONILIMAB (PD-1/CTLA-4) IN COMBINATION WITH CHEMOTHERAPY AS FIRST-LINE TREATMENT FOR GASTRIC CANCER

香港交易所 ·  Jan 4 19:22
Summary by Moomoo AI
康方生物科技（開曼）有限公司宣布，國家藥品監督管理局（NMPA）已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）聯合XELOX化療方案用於一線治療不可手術切除的局部晚期、復發或轉移性胃或胃食管結合部腺癌的新適應症上市申請。此申請基於III期臨床試驗AK104–302的數據，該試驗顯示卡度尼利聯合化療顯著延長了患者的總生存期，且安全性與既往研究結果一致。胃癌是全球常見惡性腫瘤，本公司相信此新適應症將為患者提供更佳的治療選擇，並有潛力拓展市場。開坦尼®於2022年6月已獲批用於治療宮頸癌，並正在進行多項臨床試驗以探索其他適應症。公司提醒股東及潛在投資者，無法保證最終能成功銷售開坦尼®，買賣股份需審慎行事。公告日期為2024年1月5日。
康方生物科技（開曼）有限公司宣布，國家藥品監督管理局（NMPA）已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）聯合XELOX化療方案用於一線治療不可手術切除的局部晚期、復發或轉移性胃或胃食管結合部腺癌的新適應症上市申請。此申請基於III期臨床試驗AK104–302的數據，該試驗顯示卡度尼利聯合化療顯著延長了患者的總生存期，且安全性與既往研究結果一致。胃癌是全球常見惡性腫瘤，本公司相信此新適應症將為患者提供更佳的治療選擇，並有潛力拓展市場。開坦尼®於2022年6月已獲批用於治療宮頸癌，並正在進行多項臨床試驗以探索其他適應症。公司提醒股東及潛在投資者，無法保證最終能成功銷售開坦尼®，買賣股份需審慎行事。公告日期為2024年1月5日。
Kangfang Biotechnology (Cayman) Co., Ltd Announces that the National Drug Administration (NMPA) Has Officially Accepted Its Self-Developed Bi-Specific Antibody Caetani® (Cadonilli, PD-1/CTLA-4) Combined XELOX Chemotherapy Solution for First-Line Treatment of Local Latency, Relapse or Transition of Non-Surgical Removal New Indication Application for Displaced Gastric or Gastroesophageal Associated Bladder Cancer THIS APPLICATION IS BASED ON DATA FROM PHASE III CLINICAL TRIAL AK104—302, WHICH SHOWED THAT CADONILLI COMBINED CHEMOTHERAPY SIGNIFICANTLY EXTENDED THE OVERALL SURVIVAL OF PATIENTS, AND THE SAFETY WAS CONSISTENT WITH PREVIOUS STUDIES. Stomach cancer is a common malignant tumor worldwide and we believe this new treatment will provide patients with better treatment options and have the potential to expand the market. Kaitani® was approved in June 2022 for the treatment of cervical cancer and is undergoing multiple clinical trials to explore additional indications. The Company reminds shareholders and potential investors that there is no guarantee of a successful sale of Kaitani® and that trading shares should be exercised with caution. The announcement date is 5 January 2024.
Kangfang Biotechnology (Cayman) Co., Ltd Announces that the National Drug Administration (NMPA) Has Officially Accepted Its Self-Developed Bi-Specific Antibody Caetani® (Cadonilli, PD-1/CTLA-4) Combined XELOX Chemotherapy Solution for First-Line Treatment of Local Latency, Relapse or Transition of Non-Surgical Removal New Indication Application for Displaced Gastric or Gastroesophageal Associated Bladder Cancer THIS APPLICATION IS BASED ON DATA FROM PHASE III CLINICAL TRIAL AK104—302, WHICH SHOWED THAT CADONILLI COMBINED CHEMOTHERAPY SIGNIFICANTLY EXTENDED THE OVERALL SURVIVAL OF PATIENTS, AND THE SAFETY WAS CONSISTENT WITH PREVIOUS STUDIES. Stomach cancer is a common malignant tumor worldwide and we believe this new treatment will provide patients with better treatment options and have the potential to expand the market. Kaitani® was approved in June 2022 for the treatment of cervical cancer and is undergoing multiple clinical trials to explore additional indications. The Company reminds shareholders and potential investors that there is no guarantee of a successful sale of Kaitani® and that trading shares should be exercised with caution. The announcement date is 5 January 2024.
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