盐野义推出XOFLUZA®颗粒2%——用于流感治疗和预防的新配方-动脉网

Shionogi Launches XOFLUZA® Granules 2% – New Formulation for Influenza Treatment and Prophylaxis

盐野义等信源发布 2025-11-12 10:38



可切换为仅中文







OSAKA, Japan, Nov. 12, 2025 -

日本大阪，2025年11月12日 -

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; hereafter 'Shionogi') is pleased to announce the launch today of a new formulation of the anti-influenza virus drug XOFLUZA

盐野义制药公司（总部：日本大阪；以下简称“盐野义”）很高兴地宣布，今天推出了抗流感病毒药物XOFLUZA的新配方。

(generic name: baloxavir marboxil; hereafter “XOFLUZA”) – XOFLUZA

（通用名：巴洛沙韦酯；以下简称“XOFLUZA”）——XOFLUZA

Granules 2%.

颗粒 2%。

XOFLUZA is a first-in-class, single-dose oral medicine for both treatment and prophylaxis of influenza with an innovative mechanism of action designed to block viral replication by inhibiting the cap-dependent endonuclease protein, potentially reducing the duration of infectiousness and disease.

XOFLUZA 是一种首创的、单剂量口服药物，用于治疗和预防流感，其创新的作用机制旨在通过抑制依赖帽的内切核酸酶蛋白来阻断病毒复制，从而可能缩短传染性和病程。

1, 2

Furthermore, it has been shown to reduce transmission of influenza from an infected person to household members.

此外，它已被证明可以减少流感从感染者向家庭成员的传播。

XOFLUZA is approved in more than 75 countries, including Japan and the United States, for the treatment of uncomplicated influenza types A and B. In Japan, XOFLUZA is indicated for the treatment and prophylaxis of influenza types A and B in adults and children.

XOFLUZA 已在包括日本和美国在内的 75 多个国家获得批准，用于治疗单纯性 A 型和 B 型流感。在日本，XOFLUZA 适用于成人和儿童的 A 型和 B 型流感的治疗和预防。

Until now, XOFLUZA has only been available in tablet form, but there has been a need for a formulation suitable for patients who have difficulty taking tablets, such as younger children. The newly launched granule formulation is easier to take and allows for appropriate dosing based on age and body weight.

迄今为止，XOFLUZA仅以片剂形式提供，但一直需要一种适合难以服用片剂的患者（如年幼的儿童）的配方。新推出的颗粒剂更容易服用，并且可以根据年龄和体重进行适当的剂量调整。

Furthermore, with its availability for pediatric patients weighing less than 10 kg, it is expected to serve as a new treatment option for pediatric influenza, contributing to the care of a broader range of patients..

此外，由于它适用于体重不足10公斤的儿科患者，预计将成为儿科流感的新治疗选择，有助于为更广泛的患者提供护理。

Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as one of our key focus and is working on the realization of total care for infectious diseases. Shionogi will continue to promote activities so that we can quickly deliver the anti-infective drugs necessary to protect people's health to patients around the world..

盐野义制药致力于“保护全世界人民免受传染病的威胁”作为我们关注的重点之一，并正在努力实现对传染病的全面护理。盐野义将继续推动相关活动，以便尽快将保护人类健康的抗菌药物送到世界各地的患者手中。

About XOFLUZA

关于XOFLUZA

XOFLUZA is a first-in-class, single-dose oral medicine with an innovative mechanism of action designed to block viral replication by inhibiting the cap-dependent endonuclease protein, potentially reducing the duration of infectiousness and disease.

XOFLUZA 是一种首创的、单剂量口服药物，具有创新的作用机制，旨在通过抑制依赖帽的内切核酸酶蛋白来阻断病毒复制，从而可能缩短传染性和病程的持续时间。

1, 2

XOFLUZA’s mechanism of action has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.

XOFLUZA的作用机制已在广泛的流感病毒中显示出效力，包括在非临床研究中对奥司他韦耐药株和禽流感株（H7N9、H5N1）的体外活性。

4, 5

Furthermore, it has been shown to reduce transmission of influenza from an infected person to household members.+ Development and commercialization of this product are conducted under a partnership with the Roche Group, with Shionogi responsible for sales in Japan and Taiwan, and Roche handling sales in other countries.

此外，它已被证明可以减少流感从感染者向家庭成员的传播。+ 该产品的开发和商业化是在与罗氏集团的合作下进行的，盐野义负责日本和台湾的销售，而罗氏则负责其他国家的销售。

XOFLUZA is approved in more than 75 countries, including Japan and the United States, for the treatment of uncomplicated influenza types A and B.10 In Japan, XOFLUZA is indicated for the treatment and prophylaxis of influenza types A and B in adults and children..

XOFLUZA 已在包括日本和美国在内的 75 多个国家获批用于治疗单纯性 A 型和 B 型流感。在日本，XOFLUZA 适用于成人和儿童的 A 型和 B 型流感的治疗和预防。

Forward-Looking Statements

前瞻性声明

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate.

本公告包含前瞻性陈述。这些陈述是基于当前可获得的信息和预期，而这些假设受到风险和不确定性的制约，可能导致实际结果与这些陈述有重大差异。风险和不确定性包括一般国内和国际经济状况，如一般行业和市场状况，以及利率和汇率的变化。

These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations.

这些风险和不确定性尤其适用于与产品相关的前瞻性声明。产品风险和不确定性包括但不限于：临床试验的完成和中止；获得监管批准；有关产品安全性和有效性的主张和担忧；技术进步；重要诉讼的不利结果；国内外医疗改革以及法律法规的变化。

Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise..

对于现有产品，也存在生产和营销风险，包括但不限于无法建立满足需求的生产能力、原材料供应不足以及竞争产品的进入。公司否认任何更新或修改任何前瞻性声明的意图或义务，无论是否由于新信息、未来事件或其他原因。

For Further Information, Contact:

如需更多信息，请联系：

SHIONOGI Website Inquiry Form:

SHIONOGI网站咨询表：

https://www.shionogi.com/global/en/contact.html

References

参考文献

1. Hayden FG, et al.

1. 海登 FG，等。

N Engl J Med.

新英格兰医学杂志。