石藥集團(01093.HK):“鹽酸米託醌脂質體注射液”獲藥品註冊批件
格隆匯1月11日丨石藥集團(01093.HK)發佈公吿,公司附屬公司石藥集團中諾藥業(石家莊)有限公司開發的“鹽酸米託蒽醌脂質體注射液(10ml:10mg)”已獲得中國國家藥品監督管理局頒發的藥品註冊批件,用於治療復發或難治的外周T細胞淋巴瘤(PTCL)。
該產品為集團自主研發的抗腫瘤納米藥物,也是全球首個上市的米託蒽醌納米藥物,打破了我國在納米藥物研發領域多年沒有創新藥物上市的局面。該產品具有完全知識產權,發明專利已在中國、美國、歐洲、日本等十多個國家和地區獲得授權。該產品的研發獲得了“國家重點研究計劃”、“國家重大新藥創制專項”等多項國家課題的資助。
該產品的設計採用了獨特的載藥、釋藥技術,從而保證了給藥後,納米粒子可以有效的在腫瘤富集,併合理地釋放藥物,進而提高藥物在腫瘤的生物利用度,從而產生顯著改善的療效和安全性。該產品的理性化設計也避免了納米藥物容易出現的皮膚毒性和輸液反應。
該產品為廣譜抗腫瘤納米藥物,目前的臨牀研究數據表明,該產品對卵巢癌、頭頸鱗癌、胰腺癌、乳腺癌、小細胞肺癌、NKT細胞淋巴瘤、軟組織肉瘤等多個瘤種都有顯著改善的治療效果。此外,該品種用於多發性硬化症等神經炎症的臨牀研究也在進行中。該產品在美國已獲得臨牀許可,並取得孤兒藥資格,相關的臨牀試驗正在進行中。該產品的獲批標誌着集團在納米藥物研發和抗腫瘤治療領域的重大進展。該產品有望成為集團的重磅產品,併為腫瘤患者帶來新的用藥選擇。
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