奧賽康(002755.SZ)：地拉羅司分散片獲批上市
格隆匯6月22日丨奧賽康(002755.SZ)公佈，公司的子公司江蘇奧賽康藥業有限公司(“子公司”)的地拉羅司分散片於近日獲得國家藥品監督管理局(“藥監局”)的藥品註冊批准。
地拉羅司分散片被列入了國家衞健委發佈的《第一批鼓勵仿製藥品目錄》，奧賽康研發的地拉羅司分散片於2018年獲得國家“十三五”“重大新藥創制”科技重大專項課題立項，系國內首仿，視同通過一致性評價。
地拉羅司是目前治療鐵過載唯一有效的藥物。地中海貧血又稱海洋性貧血，是一組嚴重威脅人類健康的致死、致殘的遺傳性血液病，我國重型和中間型地貧患者在30萬人左右。輸血是治療重型和中間型地中海貧血的主要措施。另外，輸血也是骨髓增生異常綜合徵(MDS)主要的維持療法，我國每年約有30萬例左右新發MDS患者。長期輸血易導致繼發性鐵過載，鐵過載是指過多的鐵沉積在人體組織器官，導致細胞損傷和器官功能障礙的病理現象，鐵過載可對心血管、內分泌、肝臟、腎臟、神經系統等產生損害，導致多種疾病，危害嚴重。鐵螯合劑可有效地提高鐵的排泄，降低體內鐵的含量及其在各器官的病理性沉積。
地拉羅司系被FDA批准的第一個能夠常規使用的口服鐵螯合劑，用於治療2歲及以上的患者因輸血而引起的慢性鐵過載，和10歲以上非輸血依賴性地中海貧血(NTDT)綜合徵患者的慢性鐵過載。2012年，地拉羅司在歐盟被批准用於6歲及以上因頻繁輸血(紅細胞壓積≥7ml/kg/月)而導致慢性鐵過載地中海貧血患者的治療。在日本，本品被批准用於治療因輸血引起的鐵過載。
地拉羅司分散片在中國已獲批上市，它的優點是能清除遊離鐵、細胞內鐵，並能阻止心肌細胞攝取鐵，直接從心肌細胞去除多餘的鐵，使得血漿中非轉鐵蛋白持續減少，是輸血導致的慢性鐵過載患者的一線用藥。地拉羅司分散片可以一日一次口服用藥，患者順應性好，保證祛鐵治療得以長期進行。地拉羅司的良好祛鐵有效性、安全性和患者順應性，大大降低了地中海貧血、MDS等需要長期輸血治療的疾病患者的死亡率，並提高了他們的生活質量。地拉羅司分散片為最新版醫保目錄品種，2020年全球銷售額達6.53億美元；PDB數據庫顯示，2020年地拉羅司國內樣本醫院銷售額為1973萬元。
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