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北京科兴因少数股权股东的行为暂停流感疫苗生产

2018-05-01

北京时间2018年5月1日,科兴控股生物技术有限公司 (NASDAQ: SVA) (“科兴控股”或“公司”),一家领先的中国生物制药公司,今日宣布公司将暂停流感疫苗生产,并被迫报废在线生产的全部流感疫苗,预计这将导致公司无法在2018-2019年流感季提供流感疫苗。导致这一结果的原因是公司的控股子公司北京科兴生物制品有限公司(“北京科兴”)董事长潘爱华近期对北京科兴实施的恶劣行为。

 

如公司此前所公布的,2018年4月17日,潘爱华与几十名身份不明的人士强行进入北京科兴上地厂区办公场所,限制总经理办公室、财务部等相关人员的人身自由,并试图强行控制北京科兴的公章、法律文件、财务章、财务文件和财务信息系统。此外,该等身份不明人士强行切断电源,中断了北京科兴上地厂区甲型肝炎疫苗和季节性流感疫苗的生产,对北京科兴生产造成严重影响,并很有可能损害产品质量。

 

事件发生后北京科兴立即启动应急响应,并逐步恢复了上地厂区疫苗生产和质量管理工作。流感疫苗车间恢复生产后,公司的质量管理部门继续对生产环境和产品安全进行了多项的评估,但无法彻底排除流感疫苗车间生产环境的安全隐患。公司也正在对上地厂区的其他疫苗生产风险进行评估。

 

 

Sinovac Forced to Temporarily Suspend Flu Vaccine Production Due to Disruptive Actions taken by Minority Shareholder of Sinovac Beijing

BEIJING, May 1, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ:  SVA) ("Sinovac " or the "Company"), a leading provider of biopharmaceutical products in China, today announced it has been forced to temporarily suspend its flu vaccine production and destroy the flu vaccines it is currently producing. The Company expects this will result in its inability to supply flu vaccines for the 2018 to 2019 flu season. These decisions have been made necessary by the actions taken by Aihua Pan, the Chairman of the Board of the Company's controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), who was appointed Chairman by Sinobioway Biomedicine Co., Ltd. ("Sinobioway"), the minority shareholder of Sinovac Beijing.

 

As previously announced, on April 17, 2018, Mr. Pan and dozens of unnamed individuals forcibly entered Sinovac Beijing's corporate offices in Shangdi site and limited the physical movement of the employees in Sinovac Beijing's general manager's office and finance department. This was in an attempt to take control of Sinovac Beijing's official seal, legal documents, accounting seal, financial documents and financial information systems. In attempting to forcibly take control of the Company's corporate offices, these individuals cut power to the facility in Shangdi site, thereby disrupting Sinovac Beijing's hepatitis A and seasonal flu vaccine production, seriously impacting Sinovac Beijing's production and manufacturing processes and very possibly damaging product quality.

 

Sinovac Beijing initiated its emergency response protocol and resumed production and quality management activities step-by-step. Once flu vaccine production was resumed, the quality assurance department performed several assessments of the production environment and vaccine safety. Unfortunately, it was determined that the quality and safety risks associated with salvaging these vaccines were not able to be completely eliminated. The Company is assessing the risk associated with other vaccine production at Shangdi site in parallel. 


关于SINOVAC科兴


科兴控股生物技术有限公司(Sinovac Biotech Ltd.,SINOVAC 科兴)是一家总部位于中国、面向全球的生物制药企业,公司以“为人类消除疾病提供疫苗”为使命,致力于人用疫苗及相关生物制品的研究、开发、生产和供应,为全球疾病预防与控制提供疫苗产品和相关解决方案。

SINOVAC 科兴拥有多元化的疫苗产品组合,覆盖流感、病毒性肝炎、水痘、手足口病、脊髓灰质炎、狂犬病、破伤风和肺炎球菌性疾病等多个疾病领域。其中,甲型肝炎灭活疫苗孩尔来福®、Sabin株脊髓灰质炎灭活疫苗(sIPV)和水痘减毒活疫苗已通过世界卫生组织预认证。

在新发突发传染病及公共卫生应急方面,SINOVAC 科兴积累了丰富的疫苗研发与产业化经验。公司曾针对SARS、H5N1、H1N1及COVID-19等重大公共卫生事件开展疫苗研发,并先后研制出全球首支SARS灭活疫苗(完成I期临床试验)、中国第一支大流行流感灭活疫苗(H5N1)盼尔来福®、全球首支甲型H1N1流感疫苗盼尔来福.1®,以及全球应用最广泛的新冠灭活疫苗克尔来福®

除已上市产品外,SINOVAC 科兴正持续推进创新研发管线,涵盖联合疫苗、重组蛋白疫苗,以及mRNA技术和抗体产品等新一代技术与产品平台,持续拓展在疾病预防与生物医药领域的技术布局。

秉持对创新与全球健康的长期承诺,SINOVAC 科兴持续深化与科研机构、国际组织及本地合作伙伴的合作,拓展全球业务布局。通过技术合作、本地化生产和产业协作,公司致力于提升高品质疫苗在全球不同地区的可及性,更好地满足当地疾病防控和医疗需求,并增强对未来公共卫生挑战的应对能力。