恆瑞醫藥(600276.SH):藥品聯合治療晚期惡性腫瘤方案獲准臨牀試驗
格隆匯5月12日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司近日收到國家藥監局核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。
蘋果酸法米替尼膠囊是公司創新研發的小分子多靶點酪氨酸激酶抑制劑。注射用卡瑞利珠單抗是人源化抗PD-1單克隆抗體,可與人PD-1受體結合並阻斷PD-1/PD-L1通路,恢復機體的抗腫瘤免疫力,從而形成癌症免疫治療基礎。SHR2554是公司開發的新型、高效、選擇性的口服EZH2抑制劑,擬被應用於惡性腫瘤的治療。
經審查,2020年3月2日受理的申請符合藥品註冊的有關要求,同意按照提交的方案開展蘋果酸法米替尼膠囊聯合注射用卡瑞利珠單抗、SHR2554片治療晚期惡性腫瘤的臨牀試驗。
截至目前,蘋果酸法米替尼膠囊、注射用卡瑞利珠單抗、SHR2554片的累計研發費用分別為1.16億元、9.243億元、3672萬元。
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