2月28日，石药集团（01093）发布公告，宣布其开发的注射用西罗莫司（白蛋白结合型）已获得中华人民共和国国家药品监督管理局授予的突破性治疗认定，适应症为单药用于恶性血管周围上皮样细胞瘤（PEComa）。该产品通过特殊技术将西罗莫司包裹于人血白蛋白中，克服了口服制剂无法向靶部位递送足够浓度药量的缺点，且无需激素预处理。
目前，该产品正在中国开展多项II期及III期临床研究，涉及乳腺癌、软组织肉瘤、肺癌、肾癌等多种实体瘤及血液瘤。乳腺癌是女性恶性肿瘤中发病率最高的，全球新发病例约230万例。该产品在CDK4/6抑制剂耐药的HR+/HER2-晚期乳腺癌患者中开展临床试验，填补了该领域的临床需求空白。此次获得的突破性治疗认定将有助于加快该产品的开发进度，期待其成为国内首个针对该适应症的标准治疗。
（文章来源：财中社）
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