台湾的阿玛兰生物科技成为第一个获得林业发展局批准其疫苗AB-801的当地公司。 Taiwan’s Amaran Biotech becomes first local firm to gain FDA approval for its vaccine adjuvant, AB-801.

以台湾为基地的一家生物技术公司Amaran Biotech,已成为该国第一个因自己开发的AB-801型疫苗而获得林业发展局对二型药品总档案(DMF)的承认的公司。 Amaran Biotech, a Taiwan-based biotech firm, has become the first in the country to receive FDA acknowledgment for a Type II Drug Master File (DMF) for its self-developed vaccine adjuvant AB-801. 副产品来自Quillaja saponaria树,与QS-21相似,可加强免疫反应,减少疫苗中的抗原需要。 The adjuvant, derived from the Quillaja saponaria tree and comparable to QS-21, enhances immune responses and reduces antigen needs in vaccines. DMF的批准验证了该公司的先进制造、质量控制和遵守规章的情况,支持全球疫苗开发。 The DMF approval validates the company’s advanced manufacturing, quality control, and regulatory compliance, supporting global vaccine development. 该公司在新初经营一家经PIC/S GMP认证的设施,获得生物加工优异认证,将在2025年台湾保健+博览会展示其能力。 The company, operating a PIC/S GMP-certified facility in Hsinchu and recognized for bioprocessing excellence, will showcase its capabilities at the 2025 Healthcare+ EXPO Taiwan.