榮昌生物-B(09995.HK)兩項新藥臨床研究申請獲藥監局批准
榮昌生物-B(09995.HK)公布,國家藥監局(NMPA)相繼批准公司產品注射用維迪西妥單抗(商品名:愛地希)兩項新藥臨床研究申請(IND)。
該兩項新藥臨床研究申請分別為注射用維迪西妥單抗(商品名:愛地希)單藥或與特瑞普利單抗注射液(商品名:拓益)聯合或序貫化療新輔助治療HR陰性、HER2低表達乳腺癌患者的新藥臨床研究申請(IND),以及注射用維迪西妥單抗(商品名:愛地希)聯合特瑞普利單抗注射液(商品名:拓益)及化療或注射用曲妥珠單抗(赫賽汀)一線治療HER2表達局部晚期或轉移性胃癌(包括胃食管結合部腺癌)患者的新藥臨床研究申請(IND)。
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