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科兴控股因北京科兴少数股权股东的行为计划报废23价肺炎球菌多糖疫苗菌种并暂停生产现场检查准备
2018-05-01

 

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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.

 

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