智通财经APP讯，石药集团(01093)发布公告，集团开发的注射用紫杉醇白蛋白纳米粒(速溶型)(SYHX2011G1)已获得美国食品药品监督管理局(FDA)批准，可在美国开展临床试验。
乳腺癌是全球女性最常见的恶性肿瘤，严重危害女性的健康。紫杉烷类药物是用于治疗晚期乳腺癌最常用且有效的细胞毒性化疗药物之一，无论是单独治疗还是联合治疗，均被证明相较于其他类型的化疗药物有更显著的生存获益。该产品是采用专利技术开发的新一代创新型纳米制剂，有望成为全球首个速溶白蛋白结合型紫杉醇制剂。
本次获批的临床适应症为治疗联合化疗失败的转移性乳腺癌或辅助化疗后6个月内复发的乳腺癌。本次临床试验的获批，将进一步丰富集团在国际布局的产品管线，提升集团的国际竞争力。
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