Core Viewpoint - The company has received marketing approvals for its injectable paclitaxel (albumin-bound) from multiple European regulatory authorities, indicating a significant advancement in its product offerings and potential market expansion [1] Group 1: Regulatory Approvals - The company's subsidiary, Seacross Pharma (Europe) Ltd., has obtained marketing licenses from the Dutch Medicines Evaluation Board, the Irish Health Products Regulatory Authority, the Finnish Medicines Agency, and the Swedish Medical Products Agency [1] - The approvals pertain to the injectable paclitaxel (albumin-bound) product, which is a key therapeutic option for various cancer treatments [1] Group 2: Indications for Use - The injectable paclitaxel (albumin-bound) is indicated as a monotherapy for adult patients with metastatic breast cancer who have not responded to first-line treatment and are unsuitable for standard anthracycline-based regimens [1] - It is also indicated for use in combination with gemcitabine for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma [1] - Additionally, it can be used in combination with carboplatin for the initial treatment of adult patients with non-small cell lung cancer who are not candidates for potentially curative surgery and/or radiotherapy [1]
汇宇制药:注射用紫杉醇(白蛋白结合型)获得境外上市许可