Transaction to include felzartamab, a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseasesFelzartamab is an investigational anti-CD38 monoclonal antibody that, through its cell depletion approach, has demonstrated clinical proof of concept in rare immune-mediated indications, with plans to advance to Phase 3Proposed acquisition builds on Biogen capabilities in immunology with plans to combine Human Immunology Biosciences expertise in immune-mediated indications with Biogen’s global development and commercial experience in rare diseasesCAMBRIDGE, Mass.

交易包括felzartamab，这是一种潜在的一流治疗候选药物，有望成为一系列免疫介导疾病的流水线产品。felzartamab是一种研究性抗CD38单克隆抗体，通过其细胞耗竭方法，已经证明了罕见免疫介导适应症的临床概念验证，计划推进到第三阶段拟议的收购建立在Biogen免疫学能力的基础上，并计划将人类免疫学生物科学在免疫介导适应症方面的专业知识与Biogen在罕见疾病领域的全球发展和商业经验相结合。马萨诸塞州坎布里奇。

and SOUTH SAN FRANCISCO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Human Immunology Biosciences (HI-Bio™), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for $1.15 billion upfront and up to $650 million in potential milestone payments.

加利福尼亚州南旧金山，2024年5月22日（环球通讯社）--Biogen Inc.（纳斯达克：BIIB）和人类免疫生物科学（HI-Bio™），一家私营临床阶段生物技术公司，专注于针对严重免疫介导疾病（IMD）患者的靶向治疗，今天宣布，两家公司已达成最终协议，根据该协议，Biogen已同意以11.5亿美元的预付款和高达6.5亿美元的潜在里程碑付款收购HI-Bio。

HI-Bio’s lead asset, felzartamab, is a fully human anti-CD38 monoclonal antibody that has been shown in clinical studies to selectively deplete CD38+ cells including plasma cells and natural killer, or NK, cells which may allow for additional applications that improve clinical outcomes in a broad range of immune-mediated diseases.

HI Bio的主要资产felzartamab是一种完全人类抗CD38单克隆抗体，已在临床研究中显示可选择性消耗CD38+细胞，包括浆细胞和自然杀伤细胞或NK细胞，这可能允许其他应用，以改善广泛免疫介导疾病的临床结果。

Felzartamab has received Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for development in the treatment of primary membranous nephropathy (PMN) and has received ODD in the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.

Felzartamab已获得美国食品和药物管理局（FDA）的突破性治疗指定（BTD）和孤儿药物指定（ODD），用于治疗原发性膜性肾病（PMN），并已接受ODD治疗肾移植受者的抗体介导排斥反应（AMR）。

Phase 2 studies have b.

第二阶段研究有b。