Study met primary end point and demonstrated successful subcutaneous administration of a 10 mL biologic co-formulated with ENHANZE® in 30 seconds using Halozyme's proprietary high-volume auto-injector

研究达到了主要终点，并证明使用Halozyme专有的大容量自动注射器在30秒内成功皮下注射与ENHANZE®共同配制的10 mL生物制剂

SAN DIEGO, Oct. 16, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ('Halozyme') today announced positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE® drug delivery technology, in approximately 30 seconds.

圣地亚哥，2023年10月16日/PRNewswire/-Halozyme Therapeutics，Inc。（纳斯达克股票代码：HALO）（'Halozyme'）今天宣布了一项临床研究的积极结果，该研究表明皮下注射10毫升代表性生物制品与其ENHANZE®药物输送技术共同配制，在约30秒内。

In the study, the biologic was delivered with Halozyme's proprietary high-volume auto-injector (HVAI) in healthy volunteers. The injection was delivered successfully to all 23 participants and was well tolerated..

在该研究中，该生物制剂在健康志愿者中使用Halozyme专有的大容量自动注射器（HVAI）进行递送。注射成功地交付给所有23名参与者，并且耐受性良好。。

'To our knowledge, this is the first clinical study of its kind,' said Mike LaBarre, chief technical officer of Halozyme. 'Traditional subcutaneous auto-injector delivery methods are typically limited to volumes less than 2 mL or require long delivery times at slow rates for higher volumes. By enabling rapid subcutaneous injection of high volumes of biologic products, our ENHANZE drug delivery technology in combination with our proprietary HVAI has the potential to improve the patient experience for multiple therapies.'.

“据我们所知，这是同类临床研究中的第一项，”Halozyme首席技术官Mike LaBarre说传统的皮下自动注射器递送方法通常限于小于2mL的体积或需要较长的递送时间以较低的速率以获得较高的体积。通过快速皮下注射大量生物制品，我们的ENHANZE药物输送技术与我们专有的HVAI相结合，有可能改善多种疗法的患者体验。

In the study, a representative biologic, immunoglobulin 10%, was delivered to 23 healthy volunteers.  The primary endpoint of the study was achieved with all subjects receiving the completed dose with HVAI, demonstrating that 10 mL of a representative biologic product can be rapidly delivered using Halozyme's ENHANZE® and HVAI technologies..

在该研究中，向23名健康志愿者递送了代表性生物制剂免疫球蛋白10%。该研究的主要终点是所有接受HVAI完成剂量的受试者，证明使用Halozyme的ENHANZE®和HVAI技术可以快速递送10 mL代表性生物制品。。

Data Highlights

数据亮点

96% of participants stated that they would be willing to receive the injection again.

96%的参与者表示愿意再次接受注射。

90% of participants indicated feeling either no pain or mild pain immediately after injection.

90%的参与者表示注射后立即感觉不到疼痛或轻度疼痛。

Erythema, swelling, and induration were generally minimal to mild and resolved by 90 minutes or less.

红斑，肿胀和硬结通常从轻微到轻微，并在90分钟或更短时间内消退。

Biologics delivered subcutaneously through auto-injectors are typically restricted to doses of 1-2 mL. This limitation is caused by hyaluronan, a molecule that inhibits fluid dispersion in the subcutaneous space. Halozyme's ENHANZE® drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally degrades hyaluronan in the subcutaneous space.

通过自动注射器皮下递送的生物制剂通常限于1-2mL的剂量。这种限制是由透明质酸引起的，透明质酸是一种抑制皮下空间中液体分散的分子。Halozyme的ENHANZE®药物输送技术基于专有的重组人透明质酸酶PH20（rHuPH20），这是一种在皮下空间局部降解透明质酸的酶。

This temporarily increases the permeability of the tissue under the skin, allowing space for the biologic to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream..

这暂时增加了皮肤下组织的渗透性，使生物制剂进入空间，使其能够快速分散并吸收到血液中。。

'These results support our continued dedication to providing innovative drug delivery options to patients,' said Helen Torley, chief executive officer of Halozyme. 'Our ENHANZE drug delivery and HVAI technologies have the potential to rapidly deliver large volume therapeutics subcutaneously with the potential for meaningful clinical benefits.'.

Halozyme首席执行官Helen Torley说：“这些结果支持我们继续致力于为患者提供创新的药物输送选择。”我们的ENHANZE药物输送和HVAI技术有可能快速皮下输送大量治疗药物，并具有有意义的临床益处。

Halozyme's HVAI is available to partners for clinical use.

Halozyme的HVAI可供合作伙伴临床使用。

About Halozyme Therapeutics, Inc.Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients.

关于Halozyme Therapeutics，Inc.Halozyme是一家生物制药公司，为新兴和成熟疗法带来颠覆性解决方案，显着改善患者体验和结果。作为具有专有酶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输送，以减轻患者的治疗负担。

Having touched more than 700,000 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, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical..

Halozyme在全球100多个市场的7个商业化产品中涉及70多万患者的上市后使用生命，已将其ENHANZE®技术许可给领先的制药和生物技术公司，包括罗氏，武田，辉瑞，AbbVie，礼来，百时美施贵宝，Alexion，argenx，Horizo​​n Therapeutics，ViiV Healthcare和Chugai pharmaceutical。。

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

Halozyme还利用其先进的自动注射器技术为自己或与合作伙伴一起开发，制造和商业化药品组合产品，这些产品旨在提供商业或功能优势，例如改善的便利性和耐受性，以及增强的患者舒适性和依从性。

The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical, Pfizer and Idorsia Pharmaceuticals..

该公司拥有包括XYOSTED®，TLANDO®和NOCDURNA®在内的商业专有产品组合，并与包括Teva pharmaceutical，Pfizer和Idorsia Pharmaceuticals在内的多家制药公司合作商业产品和持续的产品开发计划。。

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总部设在加利福尼亚州圣地亚哥，并在新泽西州尤因市和明尼苏达州Minnetonka设有办事处.Minnetonka也是其运营设施的所在地。

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

欲了解更多信息，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 development and clinical trial results of a high volume auto-injector and statements concerning the Company's ENHANZE® drug delivery technology (including statements regarding use in combination with the Company's high volume auto-injector) 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 improving the treatment experience for patients.

除历史信息外，本新闻稿中阐述的陈述还包括前瞻性陈述，包括但不限于，关于公司高容量自动注射器的开发和临床试验结果的声明以及关于公司ENHANZE®药物输送技术的声明（包括关于与公司高容量自动注射器结合使用的声明），包括ENHANZE®的可能益处和属性，ENHANZE®可能的行动方式，其有助于分散和吸收其他注射治疗药物的潜在应用，促进通过皮下递送更快速地递送和施用更大量的注射药物，以及ENHANZE®的某些其他益处，包括改善患者的治疗经验。

Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts, including the use of the Company's high-volume auto-injector and ENHANZE® drug delivery technologies to facilitate rapid delivery of large volume therapeutics subcutaneously.

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推动的潜在增长，包括使用公司的大容量自动注射器和ENHANZE®药物输送技术来促进大容量治疗药物的快速交付皮下。

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.

这些前瞻性陈述通常（但并非总是）通过使用“相信”，“启用”，“可能”，“将会”，“可能”，“打算”，“估计”，“预期”，“计划”，“预测”，“可能”，“潜力”，“可能”，“应该”，“继续，'和其他具有类似含义并涉及风险和不确定性的词语，可能导致实际结果与前瞻性陈述中的结果大不相同。

Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including risks that clinical tri.

由于几个因素，包括临床tri的风险，实际结果可能与这些前瞻性声明中包含的预期大不相同。

Contacts:

联络：

Tram BuiVP, Investor Relations and Corporate Communications609-359-3016[email protected]

Tram BuiVP，投资者关系和公司沟通609-359-3016[电子邮件保护]

Dawn SchottlandtArgot Partners212-600-1902[email protected]

道恩苏格兰Argot合作伙伴212-600-1902〔email protected〕

Shannia ColeyCG Life443-471-6830scoley@cglife.com

Shannia ColeyCGLife443-471-6830scoley@cglife.com

SOURCE Halozyme Therapeutics, Inc.

来源Halozyme Therapeutics，Inc。