Halozyme Therapeutics, Inc.(Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval of a new indication for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE®, as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma..

Halozyme Therapeutics, Inc.（Halozyme）今日宣布，强生公司旗下的杨森-西拉格国际公司获得了欧洲委员会（EC）对DARZALEX Faspro®（达雷妥尤单抗）与ENHANZE®共同配方的新适应症批准，作为单药疗法用于治疗高风险发展为多发性骨髓瘤的成人冒烟型多发性骨髓瘤（SMM）患者。

'This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma,' said Dr.

“这一批准进一步巩固了DARZALEX Faspro与ENHANZE作为多发性骨髓瘤各阶段基础治疗的地位，”博士表示。

Helen Torley

海伦·托利

, President and CEO of Halozyme. 'We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease.'

，Halozyme总裁兼首席执行官。“我们很高兴新的治疗模式能够解决这种复杂血液病患者的关键需求。”

SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow. The current standard of care for SMM, even in high-risk cases, is active monitoring (or 'Watch and Wait') to track for signs of biochemical progression and/or end-organ damage.

冒烟型骨髓瘤（SMM）是多发性骨髓瘤的一种无症状的中间疾病状态，其特征是骨髓中可检测到异常细胞。对于SMM，即便是高危病例，目前的标准治疗方案是积极监测（或“观察与等待”），以追踪生化进展和/或终末器官损伤的迹象。

This means therapeutic intervention is only offered when the disease progresses..

这意味着只有在疾病进展时才会提供治疗干预。

The EC approval is supported by data from the Phase 3 AQUILA study (NCT03301220), evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM. For more information on the study and its findings, please view Johnson & Johnson's press release issued on .

欧洲委员会的批准得到了三期AQUILA研究（NCT03301220）的数据支持，该研究评估了固定疗程的达拉图单抗皮下注射单药治疗与积极监测在高风险无症状多发性骨髓瘤（SMM）患者中的疗效和安全性。有关该研究及其结果的更多信息，请查阅强生公司发布的新闻稿。

About Halozyme

关于Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden.

Halozyme是一家生物制药公司，致力于推进颠覆性解决方案，以改善新兴和现有疗法的患者体验和治疗效果。作为ENHANZE®药物递送技术的创新者，Halozyme利用其专有的rHuPH20酶开发了经过商业验证的解决方案，用于促进注射药物和液体的皮下递送，目标是通过快速的皮下递送和减轻治疗负担来改善患者的体验。

Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals..

在至少一个主要地区和全球100多个市场中，Halozyme的十种已上市产品在上市后使用中已经惠及了一百万患者的生命。Halozyme将其ENHANZE®技术授权给了包括罗氏、武田、辉瑞、强生、艾伯维、礼来、百时美施贵宝、argenx、ViiV Healthcare、中外制药和Acumen Pharmaceuticals在内的领先制药和生物技术公司。

Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence.

Halozyme还利用其先进的自动注射器技术，自行或与合作伙伴一起开发、生产和销售药物-设备组合产品，这些产品旨在提供商业或功能上的优势，例如提高便利性、可靠性、耐受性，增强患者的舒适度和依从性。

The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc..

公司拥有两种商业专有产品 Hylenex® 和 XYOSTED®，并与梯瓦制药和迈兰公司的附属公司麦克德莫特实验室有限公司合作开发产品并推进产品发展计划。