OCREVUS® subcutaneous (SC) injection offers a new 10-minute administration with comparable efficacy and safety to intravenous (IV) infusion

Provides an additional treatment option without the need for IV facilities, expanding accessibility for patients

提供了额外的治疗选择，无需静脉注射设施，扩大了患者的可及性

SAN DIEGO, June 25, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ('Halozyme') today announced that Roche received European Commission (EC) marketing authorization of OCREVUS® (ocrelizumab) SC co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)..

圣地亚哥，2024年6月25日/PRNewswire/--Halozyme Therapeutics，Inc.（纳斯达克：HALO）（“Halozyme”）今天宣布，罗氏获得了欧盟委员会（EC）的OCREVUS®（ocrelizumab）SC的上市授权，该SC与ENHANZE®（Halozyme专有的重组人透明质酸酶rHuPH20）共同配制，用于治疗复发性多发性硬化症（RMS）和原发性进行性多发性硬化症（PPMS）。。

OCREVUS® SC is a 10-minute injection that maintains the same twice-yearly schedule as the approved IV infusion. The SC injection was designed to be administered by healthcare professionals, with the flexibility to be administered either in the clinic or in settings outside the clinic.

OCREVUS®SC是一种10分钟的注射，与批准的静脉输液保持相同的每年两次的时间表。SC注射旨在由医疗保健专业人员管理，具有在诊所或诊所外环境中管理的灵活性。

'With OCREVUS SC, multiple sclerosis patients in the EU can now have their medicine administered in just 10 minutes, twice per year, and without the need for an IV facility,' said Dr. Helen Torley, president and chief executive officer of Halozyme. 'This creates enhanced flexibility for both patients and providers and represents another example of how Halozyme's breakthrough technologies help to create improved treatment options.'.

Halozyme总裁兼首席执行官海伦·托利（HelenTorley）博士说：“有了OCREVUS SC，欧盟的多发性硬化症患者现在可以在10分钟内服用药物，每年两次，而且不需要静脉注射。”这为患者和提供者提供了增强的灵活性，并且代表了Halozyme突破性技术如何帮助创造改进的治疗选择的另一个例子。”。

The EC approval is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS® in the blood, when administered subcutaneously, and a safety and efficacy profile comparable to the IV formulation in patients with RMS and PPMS. OCREVUS® SC was well tolerated, and no new safety concerns were identified..

EC的批准是基于III期OCARINA II试验的关键数据，该试验显示，当皮下给药时，血液中的OCREVUS®水平不低，并且在RMS和PPMS患者中的安全性和有效性与IV制剂相当。OCREVUS®SC耐受性良好，未发现新的安全问题。。

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 reducing treatment burden for patients.

Halozyme是一家生物制药公司，致力于推进颠覆性解决方案，以改善新兴和既定疗法的患者体验和结果。作为专有酶rHuPH20的ENHANZE®药物输送技术的创新者，Halozyme的商业验证解决方案用于促进注射药物和液体的皮下输送，目的是减轻患者的治疗负担。

Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products 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..

Halozyme已在全球100多个市场的7种商业化产品中使用了80多万名患者，并已将其ENHANZE®技术授权给领先的制药和生物技术公司，包括罗氏（Roche）、武田（Takeda）、辉瑞（Pfizer）、杨森（Janssen）、艾伯维（AbbVie）、礼来（Eli Lilly）、百时美施贵宝（Bristol-Myers Squibb）、阿根克斯（argenx）、维夫医疗（ViiV Healthcare）、楚盖制药（Chugai Ph。。

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还使用其先进的自动注射器技术为自己或与合作伙伴开发，制造和商业化药物-装置组合产品，这些技术旨在提供商业或功能优势，例如改进的便利性，可靠性和耐受性，以及增强患者的舒适性和依从性。

The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals..

该公司拥有两种商业专有产品Hylenex®和XYOSTED®，与包括Teva Pharmaceuticals和Idorsia Pharmaceuticals在内的多家制药公司合作开发商业产品和正在进行的产品开发计划。。

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.

Halozyme总部位于加利福尼亚州圣地亚哥，在新泽西州尤因和明尼苏达州明尼通卡设有办事处。明尼通卡也是其运营设施所在地。

For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.

有关更多信息，请访问www.halozyme.com，并通过LinkedIn和Twitter与我们联系。

Safe Harbor Statement

安全港声明

In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's ENHANZE® drug delivery technology including the possible benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and certain other benefits of ENHANZE® including lowering the treatment burden for patients and alleviating pressure on health care system resources, including potential out-of-hospital administration of OCREVUS® SC.

除历史信息外，本新闻稿中的声明还包括前瞻性声明，包括但不限于有关公司ENHANZE®药物输送技术的声明，包括ENHANZE®的可能益处和属性，ENHANZE®的可能作用方法，其在帮助其他注射治疗药物分散和吸收方面的潜在应用，通过皮下输送促进更快速地输送和管理更大量的注射药物，以及ENHANZE®的某些其他益处，包括降低患者的治疗负担和减轻对医疗保健系统资源的压力，包括潜在的OCREVUS®SC的院外管理。

Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts (including anticipated regulatory submissions, PDUFA dates, potential regulatory approvals, indications and product launches). These forward-looking statements are typically, but not always, identified through use of the words 'believe,' 'enable,' 'may,' 'will,' 'could,' 'intends,' 'estimate,' 'anticipate,' 'plan,' 'predict,' 'probable,' 'potential,' 'possible,' 'should,' 'continue,' and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements.

关于公司ENHANZE®业务的前瞻性声明可能包括由我们合作伙伴的开发和商业化努力（包括预期的监管提交、PDUFA日期、潜在的监管批准、适应症和产品发布）驱动的潜在增长。。

Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered p.

由于多种因素，实际结果可能与这些前瞻性声明中包含的预期存在重大差异，包括公司业务增长或公司合作伙伴p的开发、监管审查或商业化的意外结果或延迟。

Contacts:

联系人：

Tram Bui

电车Bui

VP, Investor Relations and Corporate Communications

投资者关系和企业传播副总裁

609-359-3016

609-359-3016

tbui@halozyme.com

tbui@halozyme.com

Samantha Gaspar

Samantha Gaspar

Teneo

特尼奥

212-886-9356

212-886-9356

samantha.gaspar@teneo.com

samantha.gaspar@teneo.com

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SOURCE Halozyme Therapeutics, Inc.

来源Halozyme Therapeutics，Inc。

Company Codes: NASDAQ-NMS:HALO

公司代码：NASDAQ-NMS：HALO