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Abelzeta宣布修改与杨森的全球合作与许可协议,现将中国纳入其中

Abelzeta Announces a Modification to Its Worldwide Collaboration and Licensing Agreement With Janssen, Now Extending to Include China

PHARMA FOCUS ASIA 等信源发布 2023-12-15 14:26

可切换为仅中文


AbelZeta Pharma, Inc. ('AbelZeta'), a global clinical-stage biopharmaceutical company specializing in the development of innovative cell-based therapeutic products, has recently made adjustments to its collaboration and license agreement with Janssen Biotech, Inc., a Johnson & Johnson subsidiary. This amendment provides Janssen with the option for exclusive commercialization rights in China for CD20-directed chimeric antigen receptor T (CAR-T) therapies, specifically C-CAR039 and C-CAR066, currently under investigation for the treatment of Non-Hodgkin Lymphoma (NHL).Tony (Bizuo) Liu, Chairman and CEO of AbelZeta, emphasized the promising clinical data for C-CAR039 and C-CAR066, highlighting their potential as leading treatments for relapsed or refractory NHL.

AbelZeta Pharma,Inc.(“AbelZeta”)是一家全球临床阶段的生物制药公司,专门从事基于细胞的创新治疗产品的开发,最近对其与强生子公司Janssen Biotech,Inc.的合作和许可协议进行了调整。该修正案为杨森提供了CD20定向嵌合抗原受体T(CAR-T)疗法在中国的独家商业化权利的选择,特别是C-CAR039和C-CAR066,目前正在研究用于治疗非霍奇金淋巴瘤(NHL)。AbelZeta董事长兼首席执行官Tony(Bizuo)Liu强调了C-CAR039和C-CAR066有希望的临床数据,强调了它们作为复发或难治性NHL的主要治疗方法的潜力。

C-CAR039 has gained regulatory approval from the Centre for Drug Evaluation in China, and a Phase 1b study is currently underway. The collaboration aims to leverage AbelZeta's clinical and manufacturing capabilities with Janssen's global commercialization expertise to advance these therapies for patients in China and worldwide.As part of the agreement, Janssen will pay AbelZeta an option exercise fee, and the latter stands to receive commercialization and sales milestones.C-CAR039 is a bispecific CAR-T therapy targeting CD19 and CD20 antigens, with FDA clearance for Investigational New Drug (IND), and ongoing Phase 1b studies in the U.S.

C-CAR039已获得中国药物评估中心的监管批准,目前正在进行1b期研究。该合作旨在利用AbelZeta的临床和制造能力以及Janssen的全球商业化专业知识,为中国和全球患者推进这些疗法。作为协议的一部分,杨森将支付阿贝尔·泽坦期权行使费,后者将获得商业化和销售里程碑。C-CAR039是一种针对CD19和CD20抗原的双特异性CAR-T疗法,已获得FDA批准用于研究新药(IND),并且正在美国进行1b期研究。

for relapsed/refractory diffuse large B-cell lymphoma (DLBCL).C-CAR066 is an optimized CD20 targeted CAR-T therapy, also with FDA IND clearance, currently undergoing a Phase 1b study in patients with relapsed/refractory DLBCL in the U.S.Non-Hodgkin Lymphoma (NHL) is a prevalent hematological malignancy globally, ranking among the most common cancers.

用于复发/难治性弥漫性大B细胞淋巴瘤(DLBCL)。C-CAR066是一种优化的CD20靶向CAR-T疗法,也具有FDA IND清除率,目前正在对美国复发/难治性DLBCL患者进行1b期研究。非霍奇金淋巴瘤(NHL)是全球普遍存在的血液系统恶性肿瘤,是最常见的癌症之一。

DLBCL, a particularly aggressiv.

DLBCL,一个特别积极的人。