share_log

康方生物:自願公告依達方(依沃西注射液,PD-1 /VEGF)獲得國家藥品監督管理局批准上市

AKESO: VOLUNTARY ANNOUNCEMENT(IVONESCIMAB INJECTION) OBTAINEDNMPA'S MARKETING APPROVAL IN CHINA

HKEX ·  May 24 12:25

Summary by Futu AI

康方生物科技(開曼)有限公司(「康方生物」)宣布,其自主研發的新藥依達方®(依沃西注射液,PD-1/VEGF)已於2024年5月獲得中國國家藥品監督管理局(NMPA)的上市批准。該藥物為全球首創的雙特異性抗體,適用於治療經EGFR-TKI治療後進展的局部晚期或轉移性非鱗狀非小細胞肺癌(nsq-NSCLC)。依達方®的批准基於一項在中國進行的III期臨床研究,該研究顯示藥物在延長無進展生存期(PFS)和總生存期(OS)方面的有效性。肺癌在全球範圍內具有高發病率和高死亡率,而EGFR突變是中國NSCLC患者中最主要的突變類型。依達方®提供了一種新的治療選擇,以滿足耐藥進展後患者的需求。康方生物提醒投資者,在買賣公司股份時應保持謹慎。
康方生物科技(開曼)有限公司(「康方生物」)宣布,其自主研發的新藥依達方®(依沃西注射液,PD-1/VEGF)已於2024年5月獲得中國國家藥品監督管理局(NMPA)的上市批准。該藥物為全球首創的雙特異性抗體,適用於治療經EGFR-TKI治療後進展的局部晚期或轉移性非鱗狀非小細胞肺癌(nsq-NSCLC)。依達方®的批准基於一項在中國進行的III期臨床研究,該研究顯示藥物在延長無進展生存期(PFS)和總生存期(OS)方面的有效性。肺癌在全球範圍內具有高發病率和高死亡率,而EGFR突變是中國NSCLC患者中最主要的突變類型。依達方®提供了一種新的治療選擇,以滿足耐藥進展後患者的需求。康方生物提醒投資者,在買賣公司股份時應保持謹慎。
Kangfang Biotechnology (Cayman) Co., Ltd. (“Kangfang Biotech”) announced that its independently developed new drug Itapang® (Ivoxi Injection, PD-1/VEGF) has been approved for listing by the National Medicines Regulatory Authority of China (NMPA) in May 2024. The drug is the world's first bi-specific antibody for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSQ-NSCLC) that progresses after treatment with EGFR-TKI. THE APPROVAL OF IDAFANG® IS BASED ON A PHASE III CLINICAL STUDY CONDUCTED IN CHINA, WHICH DEMONSTRATED THE DRUG'S EFFICACY IN PROLONGING PROGRESSION-FREE SURVIVAL (PFS) AND TOTAL SURVIVAL (OS). Lung cancer has high morbidity rates and high mortality rates worldwide, and EGFR mutations are the predominant mutation type in Chinese NSCLC patients. IDAFANG® offers a new treatment option to meet the needs of patients with advanced drug resistance. Kangfang Bio reminds investors to exercise caution when buying and selling company shares.
Kangfang Biotechnology (Cayman) Co., Ltd. (“Kangfang Biotech”) announced that its independently developed new drug Itapang® (Ivoxi Injection, PD-1/VEGF) has been approved for listing by the National Medicines Regulatory Authority of China (NMPA) in May 2024. The drug is the world's first bi-specific antibody for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSQ-NSCLC) that progresses after treatment with EGFR-TKI. THE APPROVAL OF IDAFANG® IS BASED ON A PHASE III CLINICAL STUDY CONDUCTED IN CHINA, WHICH DEMONSTRATED THE DRUG'S EFFICACY IN PROLONGING PROGRESSION-FREE SURVIVAL (PFS) AND TOTAL SURVIVAL (OS). Lung cancer has high morbidity rates and high mortality rates worldwide, and EGFR mutations are the predominant mutation type in Chinese NSCLC patients. IDAFANG® offers a new treatment option to meet the needs of patients with advanced drug resistance. Kangfang Bio reminds investors to exercise caution when buying and selling company shares.

The translation is provided by third-party software.


The information provided by Futu AI is automatically generated by third-party artificial intelligence (AI) software based on news content. It is only available to users located outside of China mainland.


The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.