"FDA certified" by the suspected "false statement" Investors sued Sea-Puri

For Hepalink, from "financial myth" to "false statement" seems only in one night, accompanied by its more than 5 billion yuan in excess fundraising, "FDA certification uniqueness" has become a gap in public opinion on its question.　　FDA is the U.S. Food and Drug Administration abbreviation, in the United States market for food, medicine, medical equipment, cosmetics, etc. are subject to FDA review certification. For investors, doubt and action are only one step.　　June 2, as a hepalink investor Ma Bin (alias), commissioned Beijing to ask Tian law firm Zhangyuanzhong lawyer, to the SFC, "request to investigate Shenzhen Hai-Pharmaceutical Co., Ltd. false statement of the" application. According to our law, the administrative penalty of the SFC is the prior procedure of the Investor's civil claim for the misrepresentation of the listed company, so the investor's action can be regarded as the first step of initiating the claim procedure.　　Zhangyuanzhong told reporters.　　As of press day, the SFC has not Ma Bin's application, but, according to the relevant procedures, Ma Bin application will be in two months to be seen. "Although the Hepalink 148 yuan history of the highest price from 211 institutions 91 times times the oversubscribed, there are multiple factors behind the institution's IPO, but this does not rule out that Ma Bin initiation of the claims process could trigger a series of follow-up actions that could bring considerable uncertainty to hepalink over the next few months.　　"A senior securities expert told the review.　　The focus of "whether the only" into "false statement" according to Zhangyuanzhong Lawyer's carding and summary, Hepalink in the prospectus six times that the company is "China's only FDA certified enterprises." In fact, the waves from the media to Hepalink called "FDA certification unique" Suspicion, although a number of domestic experts to the suspicion given the argument, but it seems that the authority of any argument can not exceed the FDA officials Rayleigh "testimony." "The second type of FDA license, which is the category of API products, is obtained by Shenzhen," says Riley. But this is not any form of certification, not to say that the company obtained FDA certification, the FDA does not give corporate certification. "The way to get permission is for the U.S. pharmaceutical companies that use the heparin produced by the company to submit a list of raw materials to the FDA, and the FDA will allow the U.S. pharmaceutical company to import raw materials from Hepalink after checking hepalink." So, to be more precise, the FDA's license to "direct the grantor" is actually the American pharmaceutical company, not Hepalink, Hepalink is just a licensed supplier of raw materials.　　"According to FDA's official statement: The FDA has been" certified "and has been" registered "in the FDA is completely different from the two concepts, because any company must first" register "before obtaining FDA certification, any enterprise can register, registration is only a procedure, and does not represent the FDA to the registered enterprises have any rights. "From the FDA's DMF (drug master FileThe library can see that the FDA licensing of China's heparin sodium raw materials enterprises are more than Hepalink family.　　"said Riley.　　Nevertheless, according to the May 14 Hepalink clarification announcement and May 17 Hepalink chairman Li Li's public explanation, still stressed that "the sea is still the only one in China through the U.S. FDA certified heparin sodium raw materials production enterprises." In the face of many questions, what is the reason for the company to adhere to the "FDA certification of the uniqueness of the" advantage?　　The fear of falling into the trap of being accused of "false statements", or of other reasons, seems to require an official reply from the FDA accreditation body.　　But as the case enters the formal process, the exact answer to the question of whether or not it is the only one has become necessary, since it is important to see whether it constitutes a "false statement" and whether it is necessary to compensate investors. "false statement" may cause legal liability in accordance with the Supreme People's Court of the People's Republic of China on the trial of civil compensation cases caused by false statements of the causal relationship of the case, "the plaintiff only need to prove that the false statement during the purchase of the securities associated with the false statement and thus caused losses, It can be presumed that there is a causal relationship between the false statement and the damage result.　　"This means that, for investors Ma Bin, as long as Hepalink's" FDA Certification uniqueness "advantage is overthrown, he can be in accordance with his own losses to claim hepalink compensation. Similarly, according to the provisions of the Supreme People's Court, "the false statement of the perpetrator in the securities exchange market to bear the scope of civil liability, the investors in the false statement of the actual losses." "Of course, such civil liability is not limited to the company itself." According to the provisions of China's securities law, the issuer and the listed company shall bear the liability for the loss of the investors in the securities transaction because of the false record, misleading statement or significant omission of the prospectus issued by the issuer and the listed company. "At the same time, the issuer, the director of the listed company, supervisors, senior managers and other directly responsible personnel, as well as sponsors and underwriting securities companies, shall bear joint and several liability for the issuer and the listed company, unless they can prove that they have no fault, the issuer, the controlling shareholder of the listed company and the actual controlling person have fault, The issuer and the listed company shall be jointly and severally liable for compensation. "And in respect of administrative liability," the issuer, listed company or other information disclosure obligation does not disclose information in accordance with the provisions, or the disclosure of information has false records, misleading statements or major omissions, ordered to correct, give warning, and sentenced to 300,000 yuan or more than 600,000 yuan below the fine. To give a warning to the supervisor and other persons directly responsible, and to impose a fine of less than 300,000 yuan of 30,000 yuan. "While this amount of punishment is nothing to a company that has already been overpaid, it is worth noting that credit and credibility have become increasingly important as Chinese companies accelerate the process of globalisation," he said. Enterprises eitherIntentionally or unintentionally, is the institutional turmoil or environmental dictates, the case is worth all enterprises to draw the training.　　And the value of investors Ma Bin and Zhangyuanzhong Lawyers is: they in the protection of the rights, the Chinese securities market will continue to be rigorous and efficient, the "disclosure, disclosure, or disclosure," the essence of the securities continue to be deeply rooted, this may be the case greater significance. Link link Hepalink mentioned "FDA certification uniqueness" six times in the publisher Overview: "Distributor is engaged in heparin sodium raw materials research, production and sales of High-tech Enterprises, is currently the domestic heparin pharmaceutical raw materials industry through the United States FDA certified enterprises, and through the EU CEP certification. "In the company's main business and changes," The following statement: "The company's main business is heparin sodium raw materials research, production and sales." At present, the company is the world's largest production and sales, but also the only U.S. FDA certification and the European Union CEP certified Heparin pharmaceutical raw materials manufacturing enterprises. "In the" domestic industry competition pattern "mentioned:" At this stage, China holds SFDA issued heparin API production approval number of enterprises have 24 (Source: SFDA website), but obtained FDA certification or the EU CEP certification of heparin raw materials production enterprises a small number, Changzhou thousand Red Biochemical Pharmaceutical Co., Ltd., Nanjing Kin-friend Biochemical Pharmaceutical Co., Ltd, Yantai Dong-cheng Biochemical Co., Ltd., Hebei Changshan Biochemical Co., Ltd. obtained the EU CEP certification, the company also obtained the United States FDA certification and the European Union CEP certification, And is the only one to obtain the United States FDA certification of heparin pharmaceutical raw materials production enterprises. "In the domestic industry competition status" mentioned: "The company in China's heparin industry exports ranked first in the list, is our only one through the U.S. FDA certification to the United States to export heparin sodium raw materials production enterprises." "In the domestic industry's main competitors," said: "The company is the only one through the FDA certification and through CEP certified heparin raw drug production enterprises." "In the international drug registration and certification advantage" mentioned: "The company has achieved the above two certification, but also is the domestic heparin sodium raw materials industry, the only one to obtain the U.S. FDA certification enterprises, compared with the domestic industry's main competitive enterprises, with prominent certification advantages, which for the company to further expand the share of the European and American markets laid the foundation. ”