上海醫藥(02607.HK):抗腫瘤藥SPH6516片獲臨試批准通知書
格隆匯8月31日丨上海醫藥(02607.HK)發佈公吿,近日,上海醫藥開發的“SPH6516片”收到國家藥監局核准簽發的《藥物臨牀試驗批准通知書》,將於近期啟動國內I期臨牀試驗。
根據披露,SPH6516片具有廣譜的抗腫瘤作用,用於晚期實體瘤的治療。其具有激酶抑制活性高、腫瘤細胞增殖抑制活性好、體內抑瘤藥效強以及聯合用藥增效明顯等優點。該項目由上海醫藥集團股份有限公司自主研發,上海醫藥集團股份有限公司擁有完全知識產權。該項目於2019年7月啟動立項,2020年12月完成臨牀前研究,並於2021年6月獲得國家藥監局正式受理。近日,該項目獲得了國家藥監局核准簽發的《藥物臨牀試驗批准通知書》,同意按照已提交的方案開展新藥臨牀試驗。
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