Grifols' GigaGen Receives FDA Clearance Of IND Application For Phase 1 Trial Of Recombinant Polyclonal For HBV Treatment, GIGA-2339
Grifols' GigaGen Receives FDA Clearance Of IND Application For Phase 1 Trial Of Recombinant Polyclonal For HBV Treatment, GIGA-2339
GIGA-2339 is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic hepatitis B virus (HBV) infection; trial initiation expected in Q4 2024
GIGA-2339是第一个用于治疗和功能性治愈慢性乙型肝炎病毒（HBV）感染的重组多克隆疗法，在2024年第4季度预计开始试验。
Containing more than 1,000 fully human recombinant anti-HBV antibodies, GIGA-2339 reproduces the human body's natural immune response
GIGA-2339含有超过1,000种全人重组抗-HBV抗体，重现人体的自然免疫反应。
GigaGen's recombinant polyclonals are part of Grifols' robust innovation strategy and commitment to delivering the next generation of antibody drugs for patients and healthcare professionals
GigaGen的重组多克隆体是基立福强大创新策略和为患者和医疗保健专业人员提供下一代抗体药物承诺的一部分。
SAN CARLOS, Calif. , July 31, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company's first recombinant polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339.
加州圣卡洛斯，2024年7月31日（环球新闻线）--GigaGen公司是基立福的子公司，是一家生物技术公司，致力于推进用于免疫缺陷、传染病和检查站耐药癌症的变革性抗体药物。宣布美国食品和药物管理局（FDA）已批准其新药申请（IND），以评估该公司的第一款重组多克隆药物GIGA-2339用于治疗乙型肝炎病毒（HBV）感染的一期试验。