Core Viewpoint - The company successfully passed the FDA's cGMP inspection, which is a significant achievement that enhances its competitiveness and supports its expansion into the U.S. raw material drug market [1][2]. Group 1: FDA Inspection Details - The company underwent an FDA cGMP inspection from February 12 to February 17, 2025, focusing on the production of nine active pharmaceutical ingredients [1]. - The inspection covered various systems including quality, production, equipment, laboratory control, and material management [1]. - The company received the Establishment Inspection Report (EIR) confirming the successful completion of the inspection [1]. Group 2: Implications for the Company - Passing the FDA inspection establishes a solid foundation for the company's further expansion into the U.S. raw material drug market [2]. - This achievement is expected to inject momentum into the company's ongoing international market expansion efforts [2]. - The successful inspection is anticipated to enhance the company's overall competitiveness and promote future development [2].

作者｜Stone Jin 微信公众号｜ipozaozhidao 据IPO早知道消息，福建海西新药创制股份有限公司（以下简称"海西新药"）于2025年1月3日正式 向港交所递交招股说明书，拟主板挂牌上市，华泰国际和招银国际担任联席保荐人。 成立于2 012 年的 海西新药 作为 一家处于商业化阶段的创新型制药公司，已商业化的产品组合主 要包括用于消化系统疾病、心血管系统疾病、内分泌系统 疾病、 神经系统疾病及炎症疾病的仿制药 。 根据灼识 咨询 的资料， 这些 治疗领域 占 2023年中国医药销售总额的25%以上。 同时， 海西新药的创新药管线专注于具有重大未满足医疗需求及巨大全球市场潜力的各种适应症的 在研药物，包括一款潜在属同类首款的在研肿瘤药物及另外三款处于临床前阶段，用于治疗肿瘤、眼 科及呼吸系统疾病的创新候选药物。 | | | | 已商業化的仿製藥 | | | | | --- | --- | --- | --- | --- | --- | --- | | 治療領域 | 商標 | 仿製藥名稱 | 納入VBP | 週應症 | ANDA 獲批日期 | 描述 | | 消化系統 | 安必力® | 构構酸莫沙 必 ...