Vaccine case fermentation: the real Jay bio GSP certificates were withdrawn Director vaccine _ news by control |

After each reporter yanyinchan

The afternoon of March 24, the Ministry of public security, the National Health Commission three ministries, the State food and Drug Administration today jointly held a press conference, informed of illegal investigations of vaccine treatment progress. Up to now, the illegal vaccines have been screened to verify each case down, all over the State in criminal cases, 69, involved 130 arrested.

Daily economic news reporter note to, previously national food drug regulatory General has announcement has 9 home drug wholesale Enterprise suspected fictional vaccine sales channel, may is caused involved vaccine into illegal channel of main responsibility who, which in new ban tone of Shandong real Jay biological technology Corporation (following referred to "real Jay biological") impressively in column, listed company Watson biological is holds its 85% equity.

Fujian, Shandong, according to food and Drug Administration disclosed that there are at present Jay bio GSP certificate has been revoked, aerospace Director Shen has been involved in Fujian police control. Analysts believe that the GSP certificate is withdrawn will make the real Jay bio-at least half a cessation of business activities, to apply for a certificate is also more difficult in the future, whose Jackie Watson bio revenues at around one-fourth per cent of total revenue.

Director Shen space controlled by the police

Watson bio-Chiang Kai-shek in operating a vaccine case in more deep.

The evening of March 21, the State food and Drug Administration issuing the Advisory, 9 drug wholesaler allegedly fictional vaccine sales channels, which included real Jay bio, whose outstanding stake held by Watson Bio Bio-85%.

March 23, Xinhua message said, Fujian food drug prison disclosure Fujian local involved illegal vaccine case of 3 name suspects has all was police control, online 1 people, line 2 people, by survey, online Shen Aerospace is shengtai (Putian) drug industry limited corporate representative, and Shandong food drug prison Council announcement of information consistent; line Chen Rongqiang, is Quanzhou Jinjiang people, and Shandong food drug prison Council announcement of information consistent; line Chen Jianglin for pseudonym, real name for Chanda, is Ningde Fu an people.

Jay bio's prospectus shows that at present a total of 5 Directors: Wang Wenhua (Chairman and Managing Director), Li yunchun (Managing Director, Chairman and CEO, Watson bio), Wang (Director, Chairman of Ningbo Puno), Yuan Yong (Director, Ning, Chairman of Chongqing times), Shenyang aerospace (Director and Deputy General Manager, St Putian Chairman).

Worth noting is that in Shandong Shandong, released by the food and Drug Administration vaccine launch list, already appeared in Putian, Fujian "Shenyang Aerospace" name.

The daily news reporter learned, Shenyang aerospace as well as real Jay bio-Director and Deputy General Manager duties, also is a licensed pharmacist and Deputy Chief physician, has served in Putian City, Putian City, epidemic prevention stations and health by the health authority.

Reporters had previously called shengtai (Putian) medicine, asked whether the Shenyang aerospace related to vaccine case in Shandong province, was told that directly ask the boss.

May 2015, Watson biological decisions in real circulation as the mainstay of its vaccine platform Kit integrate real Jay bio-Ningbo Puno, shengtai (Putian) and Chongqing times all the shares of the three companies. After the acquisition is completed, real Jay bio and all subsidiaries have 20 leading vaccine manufacturers at home and abroad signed product sales agreements, and 20 regional exclusive sales agent of the leading vaccine manufacturers.

On March 22, Watson bio-release suspension notice that confirmed real Kit bio for 2013 since the company acquired one of the four circuits of biological products companies, are now actively cooperate with the investigation and indeed Jie biological publishing companies are under regulatory investigation announcement.

GSP certificate is revoked

In addition to directors was controlled by the police, it is Jay bio-business also lost nearly half a year's eligibility.

On March 23, Shandong food drug announcement said the real Jay bio-serious violations of the medicine quality control regulation stipulates, according to the national Office for the medicine quality control certification regulations article 45th, revoked its certificate of medicine quality control specifications.

The night of March 24, Watson bio has also issued a notice.

The daily news reporter learned, GSP certification is the drug regulatory Department of medicine quality control of pharmaceutical trading enterprises as a means of conducting supervision and inspection, is code for quality management of pharmaceutical enterprises to implement the trading situation, evaluate the regulatory process and decide whether to issue a certificate. Drug-handling enterprises after GSP certificate is revoked, may not continue to engage in drug distribution activities be enterprises according to relevant regulations of the State of withdrawal of GSP certificates may be made again within six months after certification, still does not meet the requirements, the pharmaceutical business license has been revoked.

"GSP certificates of a pharmaceutical trading company can be said to be of survival, do not have this card, you cannot operate properly, income and I can't guarantee. "Gan Xiang pharmaceutical industry analyst said the real Jay biological impacts of very large.

Worthy of note is really Jay setback bio-business, first of all is the Watson bio. It was reported first half of 2013, 2014, 2015, real Jay bio revenue was 275 million Yuan, 481 million Yuan and 301 million Yuan, net profit is 36.0069 million Yuan, Yuan and 41.7463 million Yuan respectively, are Watson bio more affiliates in the net profits of the companies.

"The impact of vaccines in the country is very big, real hero of biological interest is also high, again applying for GSP certificate may be more difficult than ever. "Gan Xiang believes that rabies, pneumonia and other vaccine circulation this advantage is Jay creature, its market share in the future may be significantly changed.

Responsible editor: Chen yan SN225

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疫苗案发酵:实杰生物GSP证书被撤 董事被控制|疫苗_新闻资讯

　　◎每经记者 鄢银婵

　　3月24日下午，公安部、国家卫生计生委、国家食品药品监督管理总局三部委今日联合召开新闻发布会，通报非法经营疫苗案调查处置进展情况。截至目前，已对非法经营疫苗案涉及的上下线逐一进行了甄别查证，各地立刑事案件69起，抓获涉案人员130名。

　　《每日经济新闻》记者注意到，此前国家食品药品监管总局已公告有9家药品批发企业涉嫌虚构疫苗销售渠道，可能是造成涉案疫苗流入非法渠道的主要责任者，其中在新三板挂牌的山东实杰生物科技股份有限公司（以下简称“实杰生物”）赫然在列，上市公司沃森生物则持有其85%股权。

　　据福建、山东食药监局披露，目前实杰生物GSP证书已被撤销，涉案董事沈宇航则已被福建警方控制。分析认为，GSP证书被撤将令实杰生物至少半年时间停止经营活动，未来再申请证书也比较困难，而实杰生物的营收在沃森生物总营收中占比在四分之一左右。

　　董事沈宇航被警方控制

　　沃森生物在非法经营疫苗案中正愈陷愈深。

　　3月21日晚间，国家食药监局发布通报，有9家药品批发企业涉嫌虚构疫苗销售渠道，其中包括实杰生物，而实杰生物的85%股权由沃森生物持有。

　　3月23日，新华网消息称，福建食药监披露福建当地涉非法疫苗案的3名嫌疑人已全部被警方控制，上线1人，下线2人，经调查，上线沈宇航是圣泰(莆田)药业有限公司法人代表，与山东食药监局公告的信息一致;下线陈荣强，是泉州晋江人，与山东食药监局公告的信息一致;下线陈姜霖为化名，真实姓名为陈达，是宁德福安人。

　　而据实杰生物的招股说明书也显示，目前公司共有5名董事：王文华（董事长兼总经理）、李云春（董事、沃森生物董事长兼总裁）、王震（董事、宁波普诺董事长）、袁勇（董事、重庆倍宁董事长）、沈宇航（董事兼副总经理、圣泰莆田董事长）。

　　值得注意的是，在此前山东食药监局公布的山东疫苗案上线名单中，就已经出现福建莆田“沈宇航”的名字。

　　《每日经济新闻》记者了解到，沈宇航除了担任实杰生物董事兼副总经理职务外，还是一名执业药师、副主任医师，曾任职于莆田市卫生防疫站和莆田市卫生局卫生监督所。

　　记者此前曾致电圣泰（莆田）药业，询问沈宇航是否涉及山东疫苗案，被告知直接询问老板。

　　2015年5月，沃森生物决定以实杰生物为主体对旗下疫苗流通平台进行整合，实杰生物受让宁波普诺、圣泰（莆田）和重庆倍宁三家公司的全部股权。收购完成后，实杰生物及所有下属子公司已与国内外20家领先的疫苗生产厂家签订产品代理销售协议，并成为20家领先的疫苗生产企业的区域独家代理销售商。

　　3月22日下午，沃森生物发布停牌公告称，证实实杰生物为公司2013年以来收购的四家生物制品流通渠道公司之一，现正在积极配合调查；同时，实杰生物也发布了公司正在接受监管部门调查的公告。

　　GSP证书被撤销

　　除了董事被警方控制，实杰生物还失去近半年经营的资格。

　　3月23日，山东食药监发布公告表示，实杰生物严重违反《药品经营质量管理规范》规定，依据国家总局《药品经营质量管理规范认证管理办法》第四十五条规定，依法撤销其《药品经营质量管理规范认证证书》。

　　3月24日晚间，沃森生物也对此发布了公告说明。

　　《每日经济新闻》记者了解到，GSP认证是药品监督管理部门依法对药品经营企业药品经营质量管理进行监督检查的一种手段，是对药品经营企业实施《药品经营质量管理规范》情况的检查、评价并决定是否发给认证证书的监督管理过程。药品经营企业GSP认证证书被撤销后，不得继续从事药品经营活动；被撤销 GSP证书的企业按国家有关规定可在半年后再次申报认证，仍不符合要求的，将被吊销《药品经营许可证》。

　　“GSP证书对一家药品经营企业而言可以说是生死线，没有这个证，你就不能正常经营，收入也没法保障。”医药行业分析师甘翔表示，这对实杰生物造成的影响非常大。

　　值得注意的是，实杰生物经营受挫，首当其冲的便是沃森生物。据财报显示，2013年、2014年、2015年上半年，实杰生物营收分别为2.75亿元、4.81亿元及3.01亿元，净利润分别为3600.69万元、6368.69万元及4174.63万元，是沃森生物多个子公司中净利润较多的企业。

　　“此次疫苗案在全国造成的影响非常大，实杰生物所受到的关注度也很高，要再次申请获得GSP证书可能比以往还要难。”甘翔认为，在狂犬、肺炎等多个疫苗流通领域本占有优势的实杰生物，其未来的市场份额可能会大幅改变。

责任编辑：陈琰 SN225

文章关键词：
疫苗

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