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中國生物製藥：自願公告 - 1類創新藥富馬酸安奈克替尼膠囊「UNECRITINIB (TQ-B3101)」獲批上市

SINO BIOPHARM: VOLUNTARY ANNOUNCEMENT - APPROVAL FOR MARKETING OF CATEGORY 1 INNVOATIVE DRUG UNECRITNIB FUMARATE CAPSULES "UNECRITINIB (TQ-B3101)"

Hong Kong Stock Exchange ·  Apr 30 16:31
Summary by Futu AI
中國生物製藥有限公司宣佈，旗下自主研發的1類創新藥富馬酸安奈克替尼膠囊「Unecritinib (TQ-B3101)」，商品名為安柏尼，已於2024年4月30日獲得中國國家藥品監督管理局的上市批准。該藥物用於治療ROS1陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者，是首個獲批的國產靶向藥。臨床試驗數據顯示，安奈克替尼具有良好的療效與安全性，主要療效指標客觀緩解率(ORR)達81.08%，且不良事件發生率低。此藥物的上市，滿足了中國NSCLC患者中對ROS1陽性治療的巨大未滿足需求，提供了新的治療選擇。
中國生物製藥有限公司宣佈，旗下自主研發的1類創新藥富馬酸安奈克替尼膠囊「Unecritinib (TQ-B3101)」，商品名為安柏尼，已於2024年4月30日獲得中國國家藥品監督管理局的上市批准。該藥物用於治療ROS1陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者，是首個獲批的國產靶向藥。臨床試驗數據顯示，安奈克替尼具有良好的療效與安全性，主要療效指標客觀緩解率(ORR)達81.08%，且不良事件發生率低。此藥物的上市，滿足了中國NSCLC患者中對ROS1陽性治療的巨大未滿足需求，提供了新的治療選擇。
China Biopharmaceuticals Co., Ltd. announced that its independently developed class 1 innovative drug Annektinib Fumarate Capsule “Unecritinib (TQ-B3101)”, the product name Amberni, was approved for listing by the National Drug Administration of China on April 30, 2024. THE DRUG IS THE FIRST APPROVED DOMESTICALLY TARGETED DRUG FOR THE TREATMENT OF ROS1-POSITIVE LOCALLY LATE-STAGE OR TRANSFERABLE NON-SMALL CELL LUNG CANCER (NSCLC) ADULT PATIENTS. Clinical trial data show that Anactinic has good efficacy and safety, with a major efficacy endpoint objective mitigation rate (ORR) of 81.08%, and a low incidence of adverse events. The launch of this drug, which meets the huge unmet demand for ROS1-positive treatment among NSCLC patients in China, offers new treatment options.
China Biopharmaceuticals Co., Ltd. announced that its independently developed class 1 innovative drug Annektinib Fumarate Capsule “Unecritinib (TQ-B3101)”, the product name Amberni, was approved for listing by the National Drug Administration of China on April 30, 2024. THE DRUG IS THE FIRST APPROVED DOMESTICALLY TARGETED DRUG FOR THE TREATMENT OF ROS1-POSITIVE LOCALLY LATE-STAGE OR TRANSFERABLE NON-SMALL CELL LUNG CANCER (NSCLC) ADULT PATIENTS. Clinical trial data show that Anactinic has good efficacy and safety, with a major efficacy endpoint objective mitigation rate (ORR) of 81.08%, and a low incidence of adverse events. The launch of this drug, which meets the huge unmet demand for ROS1-positive treatment among NSCLC patients in China, offers new treatment options.
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