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雙成藥業(002693.SZ):注射用紫杉醇(白蛋白結合型)ANDA發起專利挑戰
格隆匯 12-28 17:21

格隆匯12月28日丨雙成藥業(002693.SZ)公佈,公司於2022年12月27日向美國食品和藥品監督管理局(簡稱“FDA”)提交注射用紫杉醇(白蛋白結合型)的簡化新藥申請(簡稱“ANDA”)的專利挑戰。同時,公司已向原研注射用紫杉醇(白蛋白結合型)上市許可持有人和專利持有人發起專利挑戰通知。

注射用紫杉醇(白蛋白結合型)是一種由白蛋白包裹紫杉醇形成的納米微粒製劑。經白蛋白包裹製成納米微粒後,比其它紫杉醇藥品相比注射用紫杉醇(白蛋白結合型)細胞毒性副作用顯著降低,劑量增大,抗腫瘤作用增強。此外,注射用紫杉醇(白蛋白結合型)可在腫瘤中產生積蓄,定向釋放至腫瘤細胞,具有靶向性,進一步提高藥物的療效。

2022年3月,公司向美國FDA遞交了ANDA上市許可申請。

注射用紫杉醇(白蛋白結合型)原研藥於2005年1月7日獲美國FDA的上市批准,商品名:凱素(Abraxane)。目前美國原研產品還在專利保護期內,最晚專利期至2034年7月12日。注射用紫杉醇(白蛋白結合型)原研藥目前已在中國上市。

公司表示,通過專利挑戰使該產品在專利到期前提前進入美國市場,有利於在該產品獲批後迅速打開海外市場的佈局,為後續在美國開展仿製藥銷售奠定重要的基礎,對公司未來的發展將產生積極的影響。

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