BEIJING--(BUSINESS WIRE)--Sinovac Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that the Company has completed the phase I clinical trial for its broad-spectrum neutralizing antibody product, the Anti-COVID-19 Antibody SA55 Injection (“SA55 Injection”) in Beijing and has entered the phase II clinical trial in Shanghai after successfully enrolling its first participant recently..

北京-（商业线）-中国生物制药产品领先供应商Sinovac Biotech Ltd.（“Sinovac”或“Company”）（纳斯达克：SVA）宣布该公司已完成其广谱中和抗体产品的I期临床试验，抗COVID-19抗体SA55注射液（“SA55注射液”）在北京成功注册了第一位参与者后，已进入上海的II期临床试验。。

SINOVAC’s SA55 Injection, which is intended for the treatment of COVID-19 infections, was approved for clinical trial in China on May 24, 2023. The phase I clinical trial has confirmed its preliminary safety profile in 40 healthy adults aged 18 to 65 in China.

SINOVAC的SA55注射液用于治疗COVID-19感染，于2023年5月24日获准在中国进行临床试验。I期临床试验证实了其在中国18至65岁的40名健康成人中的初步安全性。

The phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study. It is expected to enroll 150 patients aged 18 and above with mild to moderate COVID-19 infection from nearly 20 medical institutions in China. Participants will be randomly assigned to groups receiving different dosages of SA55 Injection or placebo to evaluate its ability to decrease SARS-CoV-2 virus loads and alleviate clinical symptoms, while assessing its safety.

II期临床试验是一项多中心，随机，双盲，安慰剂对照研究。预计将招募来自中国近20家医疗机构的150名18岁及以上轻度至中度COVID-19感染患者。参与者将被随机分配到接受不同剂量SA55注射或安慰剂的组，以评估其降低SARS-CoV-2病毒载量和缓解临床症状的能力，同时评估其安全性。

Preliminary results are anticipated by the year’s end..

预计年底将取得初步成果。。

Mr. Weidong Yin, Chairman, President and CEO of SINOVAC, said: “After providing over 2.9 billion doses of SINOVAC’s COVID-19 vaccines to the world, we still expect to address the fast-developing COVID-19 virus mutations with a cutting-edge technology. The neutralizing antibody with broad-spectrum effectiveness is our new tool in our ongoing battle against the persistent threat to human health posed by the COVID-19 virus.”.

SINOVAC主席兼首席执行官Weidong Yin先生，他说：“在向全世界提供超过29亿剂SINOVAC的COVID-19疫苗后，我们仍然期望通过尖端技术解决快速发展的COVID-19病毒突变问题。具有广谱有效性的中和抗体是我们的新工具正在与COVID-19病毒对人类健康的持续威胁作斗争“。

“We hope that our SA55 injection can continuously make valuable contributions to COVID-19 prevention and control efforts, not only in China, but also globally,” Mr. Yin added.

尹先生补充说：“我们希望我们的SA55注射液能够为COVID-19的预防和控制工作做出宝贵的贡献，不仅在中国，而且在全球范围内。

The broad-spectrum neutralizing antibody SA55 was founded by a research team led by Dr. Xiaoliang Xie, academician of the Chinese Academy of Sciences and Dr. Yunlong Cao, researcher at Peking University’s Biomedical Pioneering Innovation Center. SA55 injection is a fully humanized antibody, which is screened from the blood of recovered SARS patients who have received three doses of COVID-19 vaccine, and then recombinantly expressed, according to Dr.

广谱中和抗体SA55由中国科学院院士谢晓亮博士和北京大学生物医学开拓创新中心研究员曹云龙博士领导的研究小组创立。SA55注射液是一种完全人源化的抗体，根据Dr。

Xie..

谢。。

Their studies underscore the SA55’s efficacy in neutralizing the omicron variant and its sublineages, including BA.5, BF.7, BQ.1.1, XBB.1.5, BA.2.86 and the currently dominant strain, EG.5. Xie noted that SA55 is reportedly the only clinical antibody that SARS-CoV-2 hasn’t escaped.

他们的研究强调了SA55中和omicron变体及其亚系的功效，包括BA.5，BF.7，BQ.1.1，XBB.1.5，BA.2.86和目前的优势菌株EG.5。谢指出，据报道SA55是SARS-CoV-2未逃逸的唯一临床抗体。

Monoclonal neutralizing antibodies for COVID-19 serve as both treatment and prevention. As a treatment option, their good safety profile and fewer contraindications cater to a broader population than small-molecule drugs for COVID-19.

用于COVID-19的单克隆中和抗体用作治疗和预防。作为一种治疗选择，与COVID-19的小分子药物相比，它们良好的安全性和较少的禁忌症适合更广泛的人群。

As a prevention option, they have the advantage of rapidly increasing antibody levels post-administration and enjoy a longer half-life, making them suitable for immunocompromised individuals and those who would otherwise be ineligible for vaccination. China’s National Medical Products Administration has approved SINOVAC’s SA55 Nasal Spray for clinical trial in the prevention of COVID-19 infections, in April 2023..

作为预防选择，它们具有在给药后快速增加抗体水平并且享受更长半衰期的优点，使得它们适合于免疫功能低下的个体和否则将不适合接种疫苗的个体。2023年4月，中国国家医药产品监督管理局批准了SINOVAC的SA55鼻喷雾剂用于预防COVID-19感染的临床试验。。

About SINOVAC

关于SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of biomedical products that protect against human infectious diseases.

Sinovac Biotech Ltd.（Sinovac）是一家位于中国的生物制药公司，专注于防止人类传染病的生物医学产品的研发，制造和商业化。

SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.

SINOVAC的产品组合包括针对COVID-19，肠道病毒71（EV71）感染的手足口病（HFMD），甲型肝炎，水痘，流感，脊髓灰质炎，肺炎球菌病，腮腺炎等的疫苗。

The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under 'Category 1 Preventative Biological Products' and commercialized in China in 2016.

COVID-19疫苗CoronaVac®已被批准在全球60多个国家和地区使用。甲型肝炎疫苗Healive®于2017年通过了WHO资格预审要求。EV71疫苗Inlive®是“1类预防性生物制品”下的创新疫苗，于2016年在中国商业化。

In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO..

2022年，SINOVAC的Sabin菌株灭活脊髓灰质炎疫苗（sIPV）和水痘疫苗获得了世界卫生组织的资格预审。。

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program..

SINOVAC是第一家获得H1N1流感疫苗Panflu.1®批准的公司，该疫苗为中国政府的疫苗接种运动和储存计划提供了支持。该公司也是中国政府储备计划中H5N1大流行性流感疫苗Panflu®的唯一供应商。。

SINOVAC continually dedicates itself to pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.

SINOVAC不断致力于管道开发，包括但不限于新技术，新疫苗以及其他生物医学产品。我们将不断探索全球战略扩张的机遇。

For more information, please visit the Company’s website at www.sinovac.com.

欲了解更多信息，请访问公司的网站www.sinovac.com。