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信達生物：自願公告 - 國家藥品監督管理局受理ROS1抑制劑他雷替尼的第二項新藥上市申請

INNOVENT BIO: VOLUNTARY ANNOUNCEMENT - THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION ACCEPTED THE SECOND NEW DRUG APPLICATION FOR TALETRECTINIB (ROS1 INHIBITOR)

香港交易所 ·  Mar 4 18:30
Summary by Moomoo AI
信達生物製藥有限公司宣佈，中國國家藥品監督管理局已正式受理其新一代ROS1酪氨酸激酶抑制劑他雷替尼的第二項新藥上市許可申請，用於治療未經ROS1 TKI治療的局部晚期或轉移性ROS1陽性非小細胞肺癌成人患者的一線治療。此次申請基於臨床II期研究TRUST-I的積極結果，並計劃在2024年進一步更新數據。他雷替尼先前已獲優先審評資格，用於治療既往接受過ROS1 TKI治療的同類患者。信達生物與葆元醫藥合作，在大中華區共同開發和商業化他雷替尼，並已獲得美國FDA的突破性療法認定。公司將繼續與監管機構保持溝通，希望為ROS1陽性NSCLC患者提供新的治療選擇。
信達生物製藥有限公司宣佈，中國國家藥品監督管理局已正式受理其新一代ROS1酪氨酸激酶抑制劑他雷替尼的第二項新藥上市許可申請，用於治療未經ROS1 TKI治療的局部晚期或轉移性ROS1陽性非小細胞肺癌成人患者的一線治療。此次申請基於臨床II期研究TRUST-I的積極結果，並計劃在2024年進一步更新數據。他雷替尼先前已獲優先審評資格，用於治療既往接受過ROS1 TKI治療的同類患者。信達生物與葆元醫藥合作，在大中華區共同開發和商業化他雷替尼，並已獲得美國FDA的突破性療法認定。公司將繼續與監管機構保持溝通，希望為ROS1陽性NSCLC患者提供新的治療選擇。
SINDA BIOPHARMACEUTICAL CO., LTD. ANNOUNCES THAT CHINA'S NATIONAL DRUG ADMINISTRATION HAS FORMALLY ACCEPTED THE MARKETING AUTHORIZATION APPLICATION FOR THE SECOND NEW DRUG FOR ITS NEW GENERATION ROS1 TYROS1 KINASE INHIBITOR TARRETINI FOR THE TREATMENT OF LOCAL LATE-STAGE OR TRANSIENT ROS1-POSITIVE NON-SMALL CELL LUNG CANCER PATIENTS WITHOUT ROS1 TKI THERAPY The first line of treatment. This application is based on the positive results of the Phase II clinical study TRUST-I and plans to update the data further in 2024. His retini was previously eligible for priority review for the treatment of the same type of patients who have previously been treated with ROS1 TKI. Sinda Biologics has partnered with Baoyuan Pharmaceuticals to co-develop and commercialize tharetini in the Greater China region and has been approved as a breakthrough therapy by the U.S. FDA. The company will continue to communicate with regulators looking to provide new treatment options for ROS1-positive NSCLC patients.
SINDA BIOPHARMACEUTICAL CO., LTD. ANNOUNCES THAT CHINA'S NATIONAL DRUG ADMINISTRATION HAS FORMALLY ACCEPTED THE MARKETING AUTHORIZATION APPLICATION FOR THE SECOND NEW DRUG FOR ITS NEW GENERATION ROS1 TYROS1 KINASE INHIBITOR TARRETINI FOR THE TREATMENT OF LOCAL LATE-STAGE OR TRANSIENT ROS1-POSITIVE NON-SMALL CELL LUNG CANCER PATIENTS WITHOUT ROS1 TKI THERAPY The first line of treatment. This application is based on the positive results of the Phase II clinical study TRUST-I and plans to update the data further in 2024. His retini was previously eligible for priority review for the treatment of the same type of patients who have previously been treated with ROS1 TKI. Sinda Biologics has partnered with Baoyuan Pharmaceuticals to co-develop and commercialize tharetini in the Greater China region and has been approved as a breakthrough therapy by the U.S. FDA. The company will continue to communicate with regulators looking to provide new treatment options for ROS1-positive NSCLC patients.
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