Sinovac Biotech Ltd.

Sinovac Biotech Ltd. Sinovac focuses on research, development, manufacturing and marketing of human-use and animal-use vaccines.

临床研究显示SINOVAC科兴新冠疫苗克尔来福®对人体凝血功能和血糖水平没有产生不良影响 具有良好的安全性2023年5月31日,《免疫学前沿》 (Frontiers in Immunology)在线发布了山东省疾病预防控制中心、山东省乳山市...
04/06/2023

临床研究显示SINOVAC科兴新冠疫苗克尔来福®对人体凝血功能和血糖水平没有产生不良影响 具有良好的安全性

2023年5月31日,《免疫学前沿》 (Frontiers in Immunology)在线发布了山东省疾病预防控制中心、山东省乳山市疾病预防控制中心和SINOVAC科兴在山东省开展的一项科兴新型冠状病毒灭活疫苗克尔来福®基础免疫的实验室指标安全性Ⅳ期临床研究论文,研究显示接种克尔来福®对人体的凝血功能和血糖水平不会造成不良影响,具有良好的安全性。

该论文题为《新冠灭活疫苗克尔来福®对凝血功能和血糖的影响:一项随机、对照、开放性IV期临床研究》(Effect of an Inactivated Coronavirus Disease 2019 Vaccine, CoronaVac, on Blood Coagulation and Glucose: A Randomized, Controlled, Open-Label Phase Ⅳ Clinical Trial)。

2021年3月以来,部分欧洲国家及美国陆续报告了接种某腺病毒载体新冠疫苗后出现血栓形成伴血小板减少综合征 (Thrombosis with thrombocytopenia syndrome, TTS) 的病例。欧洲药品管理局 (European medicines Agency, EMA)、美国食品药品监督管理局(Food and Drug Administration, FDA) 和世界卫生组织 (World Health Organization, WHO) 对这些病例进行了评估,评估后发现TTS病例与上述疫苗接种之间可能存在因果关系。

鉴于当时新冠灭活疫苗已在世界各地广泛接种,但接种后是否会出现TTS的研究较少,亟需通过研究确认新冠灭活疫苗是否会对凝血功能造成影响。

2021年7-12月,山东省疾病控制预防中心、山东省乳山市疾病控制预防中心和SINOVAC科兴共同开展了一项IV期临床试验,以评估新冠灭活疫苗克尔来福®的免疫原性和安全性,尤其是对人体凝血功能和血糖水平的影响。该研究参照创新型疫苗Ⅰ期临床试验设计,在18岁及以上人群中,通过动态监测方式,全面系统地评价克尔来福®两剂次基础免疫对凝血功能(血小板计数、血小板因子4 HIT 抗体、血沉、凝血酶原时间,活化部分凝血酶原时间,D二聚体、纤维蛋白原,凝血酶时间、国际标准化比率)和空腹血糖等实验室指标的影响。研究同时评估了接种克尔来福®后血清中新冠中和抗体水平的动态变化,作为机体免疫系统激活情况的参考。

研究的对照疫苗为SINOVAC科兴已上市的另两款疫苗,23价肺炎球菌多糖疫苗(以下简称“23价肺炎疫苗”)和甲型肝炎灭活疫苗孩尔来福®(以下简称“甲肝灭活疫苗”)。

研究共入组270名18周岁及以上的受试者,其中18-59周岁135人,60周岁及以上135人,受试者按2:1比例随机分配到克尔来福®组和对照组。克尔来福®组的180名受试者接种两剂次克尔来福®,接种间隔28天;对照组的90名受试者第1剂接种23价肺炎疫苗,第2剂接种甲肝灭活疫苗,两种疫苗接种间隔28天。研究人员在受试者接种疫苗后的第0、4、14、28、32、42、56天采集受试者空腹时的静脉血,用于动态监测疫苗接种后的空腹血糖和凝血功能的变化情况及安全性,并评估接种克尔来福®后抗体水平的动态变化。

研究结果显示,在克尔来福组®完成基础免疫后的第14天,受试者体内针对新冠病毒原型株的中和抗体阳转率达到峰值,为89.31%。安全性方面,克尔来福®组和对照组的不良反应发生率分别为43.6%和52.2%,所有不良反应事件的严重程度均为轻度或中度,研究中没有发现与三种疫苗相关的严重实验室指标异常情况和严重不良事件 (Serious Adverse Event, SAE)。

该研究结果为克尔来福®的安全性提供了有力的临床证据,也证实了SINOVAC科兴23价肺炎疫苗和甲肝灭活疫苗均具有良好的实验室指标安全性。

截至目前,全球已有超过600项有关克尔来福®的临床或真实世界研究发表,涉及健康成年人、老年人、儿童、孕产妇、特殊健康状况人群。其中,巴西、智利、哥伦比亚、土耳其等多国的合作伙伴和当地大学、科研机构、临床医院等还开展了大量涉及老年人和特殊健康状况人群(肿瘤、器官移植、透析患者,以及糖尿病、心血管疾病、肾病等其他慢性疾病患者等)的研究,这些研究表明老年人群和特殊健康状况人群接种克尔来福®具有良好的安全性和免疫原性,且在奥密克戎变异株流行背景下新冠灭活疫苗仍然安全有效。

克尔来福®于2021年6月1日通过世界卫生组织评审,列入世卫紧急使用清单。至今,克尔来福®已在60多个国家、地区及国际组织获批使用,在16个国家、地区和国际组织获批未成年人使用,全球累计供应量超29亿剂,是全球使用最广泛的新冠疫苗之一。

2022年11月,克尔来福®被世卫生推荐使用年龄扩展至3岁及以上,成为世卫紧急使用清单(Emergency Use Listing,EUL)中首个扩展用于低至3岁人群的新冠疫苗,也是目前世卫紧急使用清单中唯一被推荐在3至4岁儿童中使用的新冠疫苗。

SINOVAC科兴新冠广谱中和抗体SA55获国家药监局批准开展临床试验2023年5月24日,中国国家药品监督管理局(以下简称:NMPA)批准SINOVAC科兴旗下北京科兴中维生物技术有限公司与昌平实验室曹云龙/谢晓亮课题组联合开发的新型冠状...
04/06/2023

SINOVAC科兴新冠广谱中和抗体SA55获国家药监局批准开展临床试验

2023年5月24日,中国国家药品监督管理局(以下简称:NMPA)批准SINOVAC科兴旗下北京科兴中维生物技术有限公司与昌平实验室曹云龙/谢晓亮课题组联合开发的新型冠状病毒广谱中和抗体SA55(以下简称:新冠中和抗体SA55)注射剂用于新型冠状病毒感染治疗的临床试验申请。

今年4月21日,NMPA已经批准新冠中和抗体SA55鼻喷雾剂用于预防新型冠状病毒感染的临床试验申请。

新冠中和抗体SA55由昌平实验室谢晓亮/曹云龙课题组研制,授权SINOVAC科兴进行产业化开发。新冠中和抗体SA55由研发团队采用首创的高通量测序技术从约13000种抗体库中挑选出能高效结合多种不同冠状病毒共有且不易突变的保守位点的中和抗体。

研究显示1-2,新冠中和抗体SA55能够高效中和包括XBB、XBB.1、XBB.1.5在内的多种奥密克戎变异株,是对目前世界卫生组织认定为需要留意变异株(Variants of Interest)仍保持高中和活性的广谱单克隆抗体。

近期,广东省公共卫生研究院对新冠中和抗体SA55进行了针对当前流行毒株XBB真病毒的中和试验。试验结果显示,新冠中和抗体SA55能有效中和XBB变异株,再一次印证了其具有广谱性的这一科学结论。

新冠单克隆中和抗体可用于新冠病毒感染的预防和治疗。基于其给药后可快速提高体内抗体水平,同时半衰期长的特点,可以在免疫抑制人群,以及不适合接种疫苗的人群中用于预防新冠感染;作为治疗用药,新冠中和抗体具有安全性良好、用药禁忌少等特点,相比新冠小分子药物,适用人群更广。

自2019年初新冠病毒被报告以来,单克隆抗体药物在新冠病毒感染的防治两端发挥着关键作用。然而,随着新冠病毒不断变异和发生逃逸,对单克隆抗体药物带来很大挑战,全球都在寻找可以应对新冠病毒各种变异株的有效疗法。广谱中和抗体被认为是预防及治疗新型冠状病毒感染的重要手段。

目前,SINOVAC科兴正全力推动新冠中和抗体SA55鼻喷及注射剂型的临床试验相关工作,且已经具备在GMP(药品生产质量管理规范)条件下大规模生产的能力。此外,SINOVAC科兴仍在开展多项针对新型冠状病毒的研究,以期为新型冠状病毒感染预防及治疗提供更多有力武器。

31/08/2022

SINOVAC科兴新冠疫苗在智利获批用于6月龄儿童
2022-08-26

当地时间8月23日,智利公共卫生研究院批准SINOVAC科兴新冠疫苗克尔来福®紧急使用的最低接种年龄由三岁降至六个月,儿童需接种两剂克尔来福®,接种间距为14-28天。这是继本月初克尔来福®首次于中国香港获批使用于6月以上儿童后,又一次获批用于6月龄以上儿童。截至目前,科兴新冠疫苗克尔来福®是全球唯一获批用于6月龄儿童的新冠灭活疫苗。

SINOVAC科兴于2021年开始在南非、智利、马来西亚、菲律宾等国开展了在6月龄-17岁健康人群中的多中心、随机、双盲、安慰剂对照III期临床研究。研究显示,克尔来福®在6-35月龄儿童中具有良好的安全性和免疫原性,既往感染的6-35月龄儿童接种克尔来福®也未出现严重不良反应,且能诱导较高的中和抗体水平。

克尔来福®是自智利2021年2月起启动全国大规模新冠疫苗后接种的主要疫苗,在智利接种总剂次已超过2600万。此前,中国驻智利大使牛清报表示,科兴疫苗是智利最早批量获得的新冠疫苗,在2021年上半年助力智利成为世界上疫苗接种最快的国家之一。

智利千禧免疫学与免疫疗法研究所所长卡勒吉斯(Alexis Kalergis)也曾表示,智利接种初期依靠SINOVAC科兴疫苗建立起来的基础免疫产生了很好的效果,有效控制了新的变种病毒的出现。卡勒吉斯认为,相对于异源疫苗增强接种的接种策略,使用灭活疫苗同源增强接种同样能够产生整体的免疫保护,而且安全性更好。

除新冠疫苗研究外,近期,SINOVAC科兴也在智利启动了四价流感病毒裂解疫苗的III期临床研究,研究将助力该疫苗在全球的应用。

作为SINOVAC国际布局的重要组成部分,今年5月,科兴控股(智利)有限公司工厂开工建设,工厂将致力于新冠疫苗、甲肝疫苗及流感疫苗等现有产品的灌装与生产,建成后预计年产能将达到5000万剂。工厂将有效弥补智利乃至拉丁美洲的疫苗缺口,帮助拉丁美洲获得高质量疫苗,从而提升当地疫情防控能力。

截至目前,克尔来福®已在全球超过60个国家和地区及国际组织获批使用,其中印尼、泰国、巴西、智利、哥伦比亚等14个国家和地区已经批准用于儿童和青少年接种。

02/05/2018

北京科兴因少数股权股东的行为暂停流感疫苗生产

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.

Here We Are!17 YEARS for Sinovac Road!
01/05/2018

Here We Are!
17 YEARS for Sinovac Road!

01/05/2018

北京时间2018年4月30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,今日宣布公司计划报废保存于上地厂区1号厂房内的用于23价肺炎球菌多糖疫苗生产的菌种,并被迫暂停迎接生产现场检查的车间内各项准备工作。导致这一结果的原因是公司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。潘先生是由北京科兴的少数股东未名生物医药股份有限公司(“未名生物”)委派任命的董事长。

如公司此前所公布的,北京时间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。未名生物方面的人员一直强占公司一号厂房至今,并禁止北京科兴的员工进入。

北京科兴开发的23价肺炎球菌多糖疫苗的生产车间位于一号厂房内,用于肺炎疫苗生产的菌种部分保存于车间冰箱内。按照公司内部质量管理文件规定,每天上、下午均需巡视冰箱温度并记录。由于员工被阻挠进入,无法保证菌种等关键原材料的质量,因此北京科兴计划报废储存于此的菌种,暂停为申请该疫苗生产批件而进行的现场检查的准备工作。公司认为上述行为会导致肺炎球菌多糖疫苗的上市时间延后。

23价肺炎球菌多糖疫苗是北京科兴自主研发的疫苗,该疫苗用于保护两岁以上人群免受肺炎球菌感染。该疫苗研发自2008年启动,2014年获得临床批件,2017年完成临床试验,并于当年6月正式提交生产申请。

Sinovac Forced to Plan to Destroy Bacterial Seeds intended for Pneumo Vaccine Production and Postpone Site Inspection

BEIJING, April 30, 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 destroy the bacterial seeds intended for use in the production of its 23-valent pneumococcal polysaccharide vaccine, or PPV, and to suspend all preparations for and ultimately postpone the China Food and Drug Administration (CFDA) inspection of the manufacturing site necessary for 23-valent PPV production approval. 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 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 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. One of the Company's buildings has been occupied by these individuals since this date, and Sinovac Beijing employees are still not permitted to enter.

Portions of the 23-valent PPV manufacturing facility, as well as one of the refrigerators where the bacterial seeds are stored, is located in the occupied building. In accordance with the Company's internal quality management regulations, employees are required to inspect and record the temperature of the refrigerator twice daily. With Sinovac Beijing employees unable to enter the facilities and perform these quality checks, the Company has no assurances as to the quality of bacterial seeds and other key materials stored in this building for use in the production of the 23-valent PPV. As a result, Sinovac Beijing has been left with no choice but to plan to destroy the bacterial seeds and suspend preparations for the CFDA site inspection required for production approval. The Company expects this will delay the commercialization of its 23-valent PPV.

Sinovac Beijing's 23-valent PPV is designed to prevent streptococcus pneumoniae (pneumococcus) infections in people over two years old. The vaccine development was initiated in 2008 and was approved for human clinical trial in 2014. The clinical studies were completed in 2017 and the production license application was submitted to the CFDA in June 2017.

01/05/2018

北京科兴网站被迫暂停使用

北京时间2018年 4月30日,科兴控股生物技术有限公司(NASDAQ: SVA),一家领先的中国生物制药公司宣布,未名生物医药有限公司代表及公司控股子公司北京科兴董事长潘爱华在未获得授权的前提下,不恰当地夺取了公司网站(www.sinovac.com.cn / www.sinovac.com)的控制权并关闭了该网站。出于谨慎的考虑, 公司决定暂时停止网站访问, 以避免因任何进一步的未经授权的访问或篡改而误导对网站信息感兴趣的利益相关者。

对公司网站的不当控制是潘先生和未名对科兴业务干预的又一明显证明。

公司建议所有的监管机构、股东、客户、员工以及其他相关机构在公司重新获得网站控制权前,仅通过PR Newswire和美国证监会获得官方英文信息,通过官方微信公众号(疫苗之益,微信号:SinovacBiotech)获得官方中文信息。

Sinovac Temporarily Blocks Access to Its Websites

BEIJING, April 30, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ:SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that Aihua Pan, the Chairman of the Board of the Company's controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), who was appointed by Sinobioway Biomedicine Co., Ltd. ("Sinobioway"), the minority shareholder of Sinovac Beijing, inappropriately and without authorization seized control of the Company's websites, www.sinovac.com and www.sinovac.com.cn. Out of an abundance of caution, the Company has temporarily blocked the access to the websites to avoid any further unauthorized access or tampering that could mislead any interested stakeholders.

The misappropriation of the Company's websites is another blatant attempt by Mr. Pan and Sinobioway to interfere with Sinovac's business.

The Company advises all regulators, shareholders, customers, employees, and other interested stakeholders that authorized English messages from the Company will be distributed via the Company's PR Newswire account and filings with the U.S. Securities and Exchange Commission and authorized Chinese messages from the Company will be distributed via the Company's official WeChat public account (account name: SinovacBiotech) until the Company regains control of its websites.

25/08/2017

Sinovac Biotech Announces Certain Updates Relating to Delayed Filing of Annual Report on Form 20-F

BEIJING Aug. 14, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA)("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today that The NASDAQ Stock Market ("NASDAQ") has accepted the Company's plan to regain compliance with NASDAQ Listing Rule 5250(c)(1) (the "Rule") and granted an exception to the Company to extend the deadline for complying with the Rule to October 30, 2017.The Company may regain compliance at any time before October 30, 2017 upon filing with the SEC its Annual Report on form 20-F for the year ended December 31, 2016 (the "2016 Annual Report").In the event that the Company does not satisfy the terms set forth in the extension, NASDAQ will provide written notification that the Company's common shares will be subject to delisting proceedings. At that time, the Company may appeal NASDAQ's determination for a panel review.
As announced previously, on May 1, 2017, the Company filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission (the "SEC") regarding the delayed filing of the 2016 Annual Report. On July 10, 2017, the Company submitted a compliance plan to NASDAQ to support its request for an extension of time to regain compliance with NASDAQ's continued listing requirements. The submission of the compliance plan is in response to a written letter from the Listing Qualifications Department of NASDAQ dated May 10, 2017 indicating that the Company was not in compliance with the Rule because the Company had failed to file the 2016 Annual Report within four months after the end of year 2016 and did not expect that it will be able to file the 2016 Annual Report within the 15-day extension period.
The 2016 Annual Report was delayed because Company's Audit Committee (the "Audit Committee") required additional time for its internal investigation regarding allegations raised in a research report by Geoinvesting. The investigation has slowed completion of the Company's financial statements and audit for the year ended December 31, 2016.The Company's management and the Audit Committee are continuing to work diligently to complete the 2016 Annual Report and file it with the SEC as soon as possible.
After the Company publicly announced the internal investigation arising from the Geoinvesting report, the SEC staff notified the Company of an enforcement inquiry related to the matters discussed in the article. The SEC staff subsequently issued a subpoena requesting documents related to the internal investigation. The Company, at the direction of the Audit Committee and with the assistance of independent counsel, has been cooperating with the SEC in response to the staff's requests for information.
In June 2017, the Company became aware of certain judgments based on bribery charges issued by Chinese courts in four provinces against various officials of the Chinese Center for Disease Control (the "CDC"). While these judgments appear to reflect an industry-wide investigation focused on CDC officials, they also referenced eight of the Company's former and current salespersons, together with sales personnel from several other Chinese vaccine companies and distributors. However, these judgments did not name the Company or any of its directors, officers and employees as defendants. Upon becoming aware of these judgments, the Audit Committee expanded its internal investigation to review matters related to these judgments and the Company's sales practices and policies.
On July 3, 2017, a securities class action complaint was filed in the U.S. District Court for the District of New Jersey against the Company and three of its current and former officers: Mr. Weidong Yin, the Company's current chief executive officer, Ms. Nan Wang, the Company's current chief financial officer, and Mr. Danny Chung, the Company's former chief financial officer. The complaint asserts that statements in the Company's annual filings for fiscal years 2012 through 2015 were false and misleading because they failed to disclose matters relating to the alleged bribery incidents, among other allegations. The Company is vigorously defending this lawsuit.
On July12, 2017, another securities class action complaint was filed in the Supreme Court of the State of New York against the Company and certain directors, among others. The complaint alleges that the Company's directors breached their fiduciary duties by, among other things, initiating a self-dealing going-private transaction at a per share consideration that is less than the true value of their investment in the Company. The complaint also alleges that the Company aided and abetted those alleged breaches of fiduciary duties by the Company's directors. The complaint seeks, among other things, an injunction preventing completion of the going-private transaction, damages (including rescissory damages) in favor of the plaintiff and the class, and the fees and costs associated with the litigation. The Company is vigorously defending this lawsuit as well.

http://www.sinovac.com/?optionid=754&auto_id=837

Sinovac Biotech Ltd.(NasdaqGS:SVA) is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines for infectious diseases with significant unmet medical need.

04/07/2017

科兴控股生物技术有限公司签署私有化最终协议

北京时间2017年 6月26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宣布已与公司董事长兼首席执行官尹卫东先生注册成立的Sinovac (Cayman) Limited (“母公司”) 和母公司全资拥有的Sinovac Amalgamation Sub Limited (“合并子公司”)签订合并协议(“合并协议”),合并协议规定母公司将以大约4.018亿美元收购科兴控股(“交易”)。
  尹卫东先生和赛富基金组成的买方团计划由康桥资本,尚珹资本,维梧资本及其各自的关联机构依据投资承诺函提供的资金完成并购交易。
  根据合并协议,母公司将以每普通股7美元现金的价格收购公司。这一价格相当于公司收到由公司董事长兼首席执行官尹卫东先生和SAIF Partners IV L.P. (“赛富基金”)领导的买方团发出的非限定性私有化邀约当日(即2016年2月1日)纳斯达克股票收盘价的 30天成交量加权平均价格的132.1%,也相当于60日成交量加权平均价格的130%。
  截至2017年6月23日,买方团中的留存股东持有公司约29.5%股份。根据合并协议条款,除尹卫东先生和赛富基金持有的公司股票外,公司其他股东将于交易立即生效前注销持有的股票,以取得每普通股7美元的现金对价。
  公司董事会批准董事会之特别委员会提交的建议,即批准合并协议及合并协议项下的交易,并形成董事会决议提请公司股东大会审议并批准合并协议及合并协议项下的交易。董事会之特别委员会全部由公司独立董事组成,与母公司,合并子公司或买方团任何人均无关联。特别委员会在独立财务顾问和法律顾问协助下与买方团进行交易谈判。
  交易预计于2017年下半年完成交割,交易交割的先决条件符合市场惯例,其中包括由持有参加公司股东大会2/3或以上股份的股东批准合并协议和交易的决议。一旦交易完成,公司将成为私有公司,公司股票将停止在纳斯达克上市交易。

http://www.sinovac.com.cn/?optionid=468&auto_id=1679

科兴控股(NasdaqGS:SVA)以“为人类消除疾病提供疫苗”为使命,致力于疫苗及其相关产品的研究开发、生产和销售,是第一家在北美上市的中国疫苗企业。公司拥有三家人用疫苗企业北京科兴、大连科兴、科兴中维。上市产品包括EV71型手足口病疫苗益尔来福,甲肝灭活疫苗孩尔来福等。

04/07/2017

Sinovac Biotech Ltd. Enters into Definitive Agreement for Going-Private Transaction

BEIJING, June 26, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it has entered into a definitive amalgamation agreement (the “Amalgamation Agreement”) with Sinovac (Cayman) Limited (“Parent”) and Sinovac Amalgamation Sub Limited (“Amalgamation Sub”), a wholly owned subsidiary of Parent, pursuant to which Sinovac will be acquired by Parent in a transaction valued at approximately US$401.8 million.

Pursuant to the Amalgamation Agreement, Parent will acquire the Company for cash consideration equal to US$7.00 per common share of the Company (each, a “Share”). This represents a premium of 32.1% and 30%, respectively, over the Company’s 30- and 60-trading day volume-weighted average price as quoted by NASDAQ prior to the Company’s announcement on February 1, 2016 that it had received a non-binding “going-private” proposal from Mr. Weidong Yin, the chairman, president and chief executive officer of the Company, and SAIF Partners IV L.P. (“SAIF”) and/or its affiliates to acquire all of the outstanding Shares not already owned by them.

The consideration to be paid to holders of Shares pursuant to the Amalgamation Agreement also represents an increase of approximately 13.3% from the original US$6.18 per Share offer price in the “going-private” proposal announced on February 1, 2016.

Immediately following the consummation of the transactions contemplated by the Amalgamation Agreement, Parent will be beneficially owned by a consortium (the “Buyer Consortium”) comprising Mr. Yin, SAIF, C-Bridge Healthcare Fund II, L.P. (“C-Bridge Capital”), Advantech Capital L.P. (“Advantech Capital”), Vivo Capital Fund VIII, L.P. and Vivo Capital Surplus Fund VIII, L.P. (together with Vivo Capital Fund VIII, L.P., “Vivo Capital”). As of June 23, 2017, the members of the Buyer Consortium beneficially own in the aggregate approximately 29.5% of the issued and outstanding Shares.
..

http://www.sinovac.com/?optionid=754&auto_id=835

Sinovac Biotech Ltd.(NasdaqGS:SVA) is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines for infectious diseases with significant unmet medical need.

17/06/2017

Sinovac Biotech Announces Receipt of NASDAQ Letter

BEIJING, May 16, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA)(”Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced today that it is delaying its Annual Report on Form 20-F for the year ended December 31, 2016 (the “2016 Annual Report”) and that it received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market ("NASDAQ").
On May 1, 2017, Sinovac filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission (the "SEC") regarding the delayed filing of its 2016 Annual Report. Sinovac does not expect that it will be able to file the 2016 Annual Report within the 15-day extension period. The Company’s Audit Committee requires additional time for its internal investigation regarding allegations raised in a research report by Geoinvesting. The investigation has slowed completion of the Company’s financial statements and audit for the year ended December 31, 2016. Management and the Audit Committee of the Company's Board of Directors are continuing to work diligently to complete its 2016 Annual Report and file it with the SEC as soon as possible.
After the Company publicly announced the internal investigation arising from the Geoinvesting article, the SEC staff notified the Company of an enforcement inquiry related to the matters discussed in the article. The SEC staff subsequently issued a subpoena requesting documents related to the internal investigation. The Company, at the direction of the Audit Committee and with the assistance of independent counsel, is cooperating with the SEC in response to the staff’s requests for information.
On May 10, 2017, Sinovac received a written notice from the Listing Qualifications Department of NASDAQ indicating that the Company is not in compliance with Listing Rule 5250(c)(1) because the Company has failed to file its 2016 Annual Report within four months after the end of year 2016 and does not expect that it will be able to file the 2016 Annual Report within the 15-day extension period.
Under the NASDAQ Listing Rules, the Company has 60 days from the receipt of the letter to submit a plan to NASDAQ as to how it plans to regain compliance with NASDAQ's continued listing requirements. If the Company is still unable to file its 2016 Annual Report by that time, then the Company intends to submit a compliance plan on or prior to that date. If NASDAQ accepts the Company's plan, NASDAQ can grant an exception of up to 180 calendar days from the filing's due date, or until October 30, 2017, to regain compliance. The Company may regain compliance at any time during this 180-day period upon filing with the SEC its 2016 Annual Report, as well as all subsequent required periodic financial reports that are due within that period. If NASDAQ does not accept the Company's plan, Sinovac will have the opportunity to appeal that decision to a NASDAQ Hearings Panel.
The NASDAQ notification letter has no immediate effect on the listing and trading of Sinovac's common shares on the NASDAQ Capital Market.

http://www.sinovac.com/?optionid=754&auto_id=834

Sinovac Biotech Ltd.(NasdaqGS:SVA) is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines for infectious diseases with significant unmet medical need.

25/12/2016

Sinovac Responds to Recent Report

BEIJING, China, December 23, 2016 -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today responded to a recent report regarding the allegations raised in a research report by Geoinvesting.

Sinovac’s Audit Committee has authorized the commencement of an internal investigation into the allegations made in the report. The Audit Committee has engaged Latham & Watkins as independent counsel to assist with the investigation.

Pending the outcome of the investigation, to the knowledge of Sinovac, no legal proceedings or government inquiries have been made against the Company or its chief executive officer Mr. Yin, based on any claims described in the report.

http://www.sinovac.com/?optionid=754&auto_id=831

Sinovac Biotech Ltd.(NasdaqGS:SVA) is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines for infectious diseases with significant unmet medical need.

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