近日，微芯生物宣布其自主研发的抗肿瘤创新药——西达本胺片（商品名：爱谱沙®）正式获得澳门特别行政区药物监督管理局批准上市。这是该药物继在中国内地获批用于治疗外周T细胞淋巴瘤（PTCL）和乳腺癌之后，首次在境外地区获批，标志着微芯生物国际化战略迈出关键一步。西达本胺是一种具有全新作用机制的口服组蛋白去乙酰化酶（HDAC）抑制剂，通过调控肿瘤细胞的表观遗传状态，抑制其增殖并诱导凋亡。临床研究显示，西达本胺在多种血液系统恶性肿瘤及实体瘤中展现出良好的疗效与安全性。此次在澳门获批，不仅为当地患者提供了新的治疗选择，也为微芯生物未来拓展东南亚及国际市场奠定了基础。微芯生物表示，公司将持续推动西达本胺在全球范围内的注册与临床开发，并积极探索与其他疗法的联合应用，以期惠及更多癌症患者。作为中国原研创新药的代表之一，西达本胺的成功出海彰显了中国生物医药企业从‘跟跑’向‘并跑’乃至‘领跑’转变的能力。
Recently, Chipscreen Biosciences announced that its independently developed anti-cancer drug, Chidamide Tablets (brand name: Epidaza®), has received marketing approval from the Drug Supervision Authority of the Macao Special Administrative Region. This marks the first overseas approval for Chidamide, following its prior approvals in mainland China for the treatment of peripheral T-cell lymphoma (PTCL) and breast cancer, representing a significant milestone in Chipscreen’s internationalization strategy.Chidamide is an orally administered histone deacetylase (HDAC) inhibitor with a novel mechanism of action. It modulates the epigenetic state of tumor cells, thereby inhibiting proliferation and inducing apoptosis. Clinical studies have demonstrated its efficacy and favorable safety profile in various hematologic malignancies and solid tumors. The Macao approval not only offers new therapeutic options for local patients but also lays the groundwork for Chipscreen’s future expansion into Southeast Asian and global markets.Chipscreen stated it will continue advancing global regulatory filings and clinical development of Chidamide, while exploring combination therapies to benefit more cancer patients worldwide. As a flagship example of China-originated innovative medicines, Chidamide’s international success highlights the growing capability of Chinese biopharmaceutical companies to transition from followers to equal—or even leading—players on the global stage.
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