中國生物製藥(01177.HK)治療腎癌藥物獲藥品註冊證書
中國生物製藥(01177.HK)公布,集團開發的腫瘤領域重點產品「蘋果酸舒尼替尼膠囊」(晴尼舒)已獲國家藥監局頒發藥品註冊證書,將進一步豐富集團腫瘤領域的產品線。
該產品按照化藥新4類申報,視同通過仿製藥質量和療效一致性評價,批准的適應症為:不能手術的晚期腎細胞癌;甲磺酸伊馬替尼治療失敗或不能耐受的胃腸間質瘤;不可切除、轉移性高分化進展期胰腺神經內分泌瘤)成年患者。
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