奧賽康(002755.SZ):注射用右雷佐生通過仿製藥一致性評價
格隆匯12月1日丨奧賽康(002755.SZ)公佈,公司全資子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)核准簽發的注射用右雷佐生《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價。
右雷佐生為乙二胺四乙酸(EDTA)的環狀衍生物,可透過細胞膜,在細胞內轉變為開環螯合劑,干擾鐵離子介導的自由基的形成,從而降低蒽環類藥物引起的心臟毒性;右雷佐生已在歐美日等國家上市,2006年,公司開發的注射用右雷佐生(奧諾先®)首家批准上市,用於接受多柔比星治療累積劑量達300mg/m2,並且醫生認為需要繼續使用多柔比星治療的女性轉移性乳腺癌患者。
蒽環類藥物抗瘤活性強、抗瘤譜廣,臨牀需求廣泛;但蒽環類藥物在抗腫瘤細胞的同時,還會引起心臟進展性、不可逆性損傷。右雷佐生是目前臨牀上唯一經過臨牀驗證獲批的心臟保護劑,有助於促使機體對氧自由基清除能力的增強,緩解蒽環類藥物心臟毒性,減輕心臟功能損傷。接受右雷佐生治療的患者充血性心力衰竭(CHF)的發生率顯著降低(3% & 22%)。
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