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News Article | May 18, 2017
Site: www.businesswire.com

LOS ANGELES--(BUSINESS WIRE)--Goldberg Law PC, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Sinovac Biotech Ltd. (“Sinovac” or the “Company”) (Nasdaq: SVA). If you purchased or otherwise acquired Sinovac shares, and would like more information about the investigation, we encourage you to contact Michael Goldberg or Brian Schall, of Goldberg Law PC, 1999 Avenue of the Stars Suite 1100, Los Angeles, CA 90067, at 800-977-7401, to discuss your rights without cost to you. You can also reach us through the firm’s website at http://www.Goldberglawpc.com, or by email at info@goldberglawpc.com. The investigation focuses on whether Sinovac and certain of its officers and/or directors violated federal securities laws. On December 21, 2016, SeekingAlpha.com published an article revealing that the Company’s Chairman and CEO Weidong Ying paid bribes to the Deputy Director General of the Center for Drug Evaluation for the China Food and Drug Administration and his wife, in order to help advance drug applications and evaluations. On May 16, 2017, Sinovac announced that the U.S. Securities & Exchange Commission is conducting an enforcement investigation related to the bribery discussed in the article, and that the Company would not be able to timely file its annual financial results. If you have any questions concerning your legal rights, please immediately contact Goldberg Law PC at 800-977-7401, or visit our website at http://www.Goldberglawpc.com, or email us at info@goldberglawpc.com. Goldberg Law PC represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.


On December 21, 2016, SeekingAlpha.com reported that Sinovac's Chairman and Chief Executive Officer, Weidong Ying paid bribes to the Deputy Director General of the Center for Drug Evaluation for the China Food and Drug Administration and his wife, to help advance drug applications and evaluations. Then on May 16, 2017, Sinovac announced that the Securities Exchange Commission is investigating the Company for alleged bribery mentioned in SeekingAlpha's article, and that Sinovac would not be able to file its annual financial results on time. If you are aware of any facts relating to this investigation, or purchased shares of Sinovac, you can assist this investigation by visiting the firm's site: www.bgandg.com/sva. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484. Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique.  Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients.  In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration.   Attorney advertising. Prior results do not guarantee similar outcomes. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/shareholder-alert-bronstein-gewirtz--grossman-llc-announces-investigation-of-sinovac-biotech-ltd-sva-300460549.html


News Article | May 17, 2017
Site: www.nature.com

Those who submit faked clinical trial data might now go to jail — and in extreme circumstances, be executed — under a new interpretation of China’s criminal code, announced last month. The policy shift is one of a handful of measures that China is implementing both to speed up its notoriously slow drug-approval process and to keep dangerous and ineffective drugs off the market. This move “is the strongest signal yet, to all the drug developers, clinical-trial managers and principal investigators and physicians, that China is now very serious about clinical data”, says Dan Zhang, executive chairman of Beijing-based Fountain Medical Development, which helps companies to carry out clinical trials and itself stands to be held accountable by the policy change. A hint of the depth of the problem came after the China Food and Drug Administration (CFDA) in 2015 ordered companies to re-evaluate “the authenticity, integrity and compliance of clinical trial data” in pending applications for new drugs. The agency told them that if CFDA examiners later found violations, the companies would not be able to submit other drugs for approval. More than 80% of the applications were voluntarily withdrawn, according to CFDA documents. One-quarter of the remainder was subsequently rejected because of problems with authenticity. The new policy will broaden current laws to cover submissions of clinical-trial data, says Liu Ye, a lawyer dealing with medical issues at Haishang Law Firm in Shanghai. Manufacturing and selling counterfeit versions of drugs was already a crime, but the submission of fake data in the approval process was unregulated territory, says Su Ling, director of the Institute of Drug Regulatory Science at Shenyang Pharmaceutical University and a venture partner for the investment fund Lilly Asian Ventures. The new policy was approved by a court review committee on 10 April and will go into effect when published by the high court, expected within a few months. It will make those who submit faked clinical-trial data guilty under the same law as counterfeiting. Under that law, if the approved drug causes health problems, it can result in a 10-year prison term or the death penalty, in the case of severe or fatal consequences. Even if the drug is not approved and even if no one is harmed by an approved drug, those who break the law by submitting fake data may face three years in prison. The new policy also subjects those who submit fake clinical trial data to prosecution under a law that forbids bearing false testimony. The impact will depend on how the change is implemented, says Su. It still is not clear who among the large number of people involved in a trial would be held responsible for problematic data. Su also wonders how severe a judgment will be. “Will falsified data for one patient break the law, or would it have to be 10 or 100?” The first prosecution will clarify this, he says. “The government might make an example of someone.” Some doubt that anyone will be executed under the new policy, but others say it could happen. In 2007, China executed the former head of its drug agency for accepting bribes to approve medicines, some of which ended up killing people. “It’s a remote possibility, but if kids start taking bad vaccines, for example, and they die, I could see a real chance of this happening,” says Zhang. Liu, however, says that it might be difficult to enforce. “If intent cannot be proven, the crime will not hold. Proving intent is very challenging,” he says. Critics have long argued that the Chinese pharmaceutical industry is rife with problems. The flurry of application withdrawals last year happened for a variety of reasons, including poor documentation, “untruthful” data and neglect of standard protocols, according to a CFDA official. Publications from Chinese clinical hospitals tell a similar tale, says John Ioannidis, a researcher in health policy at Stanford University in California. They often fail to document whether trials are double-blinded, whether the study goals are achieved, whether informed consent and ethics approval had been given and whether the test and control groups had been randomly selected to decrease bias. Studies have also found that Chinese trials are much more likely to show a positive effect for a drug, even if the medicine had failed elsewhere. “Most of these problems are the result of people trying to cut corners in order to get papers published in better journals and reap the resulting benefits,” says Ioannidis. Su says the new policy will scare off many shams, whose applications clog up the approval process, and thus clear the way for valid drugs, which have been slow to get approval. There is typically a wait of four years or more for the CFDA to approve drugs that have already been approved in the United States or Europe. The CFDA has taken other steps to speed up the regulatory process and make it more rigorous. Between mid-2015 and the end of 2016, it quadrupled the number of staff by adding 450 new regulators, and it expects to add another 300 this year. And beginning in May, the Center for Drug Evaluation will be allowed to approve drugs to start clinical trials without getting a rubber stamp from the CFDA, its parent organization, which adds months to the process. Su even worries the efforts might “overheat”. People lacking drug development or regulatory experience could approve ineffective or even dangerous drugs, and that could be disastrous, he says.


NEW YORK, May 17, 2017 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, announces it is continuing to investigate potential securities claims on behalf of shareholders of Sinovac Biotech Ltd. (NASDAQ: SVA) resulting from allegations that Sinovac may have issued materially misleading business information to the investing public. On December 21, 2016, an article published on SeekingAlpha.com revealed that recently disclosed court documents show that Sinovac Chairman and CEO Weidong Ying paid bribes to the Deputy Director General of the Center for Drug Evaluation for the China Food and Drug Administration and his wife in order to help advance drug applications and evaluations. On May 16, 2017, Sinovac disclosed that the SEC staff is conducting an enforcement inquiry related to the matters discussed in the article.


NEW YORK--(BUSINESS WIRE)--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential securities fraud at Sinovac Biotech Ltd. (“Sinovac” or the “Company”) (NASDAQ:SVA). The investigation focuses on whether the Company and its executives violated federal securities laws. Specifically, on December 21, 2016, Seeking Alpha published an article stating that the Chairman and CEO of Sinovac, Weidong Ying, paid bribes to Yin Hongzhang, the Deputy Director General of the Center for Drug Evaluation for the China Food and Drug Administration, in order to help advance drug applications and evaluations. Furthermore, on May 16, 2017, the Company issued a press release and filed a Form 6-K with the Securities and Exchange Commission (“SEC”), disclosing, among other things, that the SEC issued a subpoena requesting documents relating to the allegations referenced in the Seeking Alpha article. As a result of these disclosures, Sinovac’s share price declined, causing harm to investors. If you invested in Sinovac stock or options and would like to discuss your legal rights, click here: www.faruqilaw.com/SVA. There is no cost or obligation to you. You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to rgonnello@faruqilaw.com. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.


LOS ANGELES--(BUSINESS WIRE)--Lundin Law PC, a shareholder rights firm, announces that it is investigating claims against Sinovac Biotech Ltd. (“Sinovac” or the “Company”) (Nasdaq: SVA) concerning possible violations of federal securities laws. To get more information about this investigation, please contact Brian Lundin, Esquire, of Lundin Law PC, at 888-713-1033, or by email at brian@lundinlawpc.com. On December 21, 2016, SeekingAlpha.com published an article revealing that Sinovac’s Chairman and CEO Weidong Ying paid bribes to the Deputy Director General of the Center for Drug Evaluation for the China Food and Drug Administration and his wife, in order to help advance drug applications and evaluations. On May 16, 2017, Sinovac announced that the SEC is conducting an enforcement inquiry related to the bribery discussed in the article, and that the Company would not be able to timely file its annual financial results. Lundin Law PC was founded by Brian Lundin, a securities litigator based in Los Angeles dedicated to upholding shareholders’ rights. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


News Article | May 29, 2017
Site: www.prweb.com

MediMergent announced today that its CEO, Sandra S. Garrett Ph.D., presented the company’s innovative “Voice of the Patient” software to the BigIdea CONNECTpreneur Forum. The sold-out event was attended by over 300 business leaders and investment groups . Dr. Garrett was among six corporate executives invited to present. “It was a great opportunity to present our platform to experts that could provide feedback on our product and services from multi-industry perspectives,” said Sandra S. Garrett, CEO MediMergent, LLC. “Our NMSOAP initiative enrolls patients at point of service, and creates a communication loop among patients, physicians and pharmacists that help track early warning signals related to medications. The majority of the audience is/was a patient and recognized how important it is for patients to know potential adverse effects of their medication and to be able to intervene before costly and dangerous events occur.” According to Sandra S. Garrett, the CONNECTpreneur Forum is the first of a series of industry events and private investor meetings that MediMergent plans to participate in over the next few months as it scales its business across thousands of pharmacies and physicians to enroll patients and collect real world evidence. About MediMergent, LLC MediMergent, LLC is a data collection, integration and analytics company co-founded by Sandra S. Garrett, CEO. or web-based devices, Under a Research Collaboration Agreement with the Center for Drug Evaluation Research (CDER) at the U.S. Food and Drug Administration (FDA), MediMergent established the National Medication Safety, Outcomes and Adherence Program (NMSOAP) to longitudinally assess safety, outcomes, and medication adherence using an innovative, prospective, evaluative approach towards recently approved drugs under real-world conditions. The result is the ability to collect health information directly from patients using the “Voice of the Patient” software without third party interpretation. This information is integrated with other sources of patient information including electronic medical records, pharmacy and claims data to create databases of real-world safety, clinical outcomes, medication compliance, REMS and comparative effectiveness data. About The BigIdea CONNECTpreneur Forum Big Idea CONNECTpreneur is a Community of over 3000 Business leaders, CEOs, Entrepreneurs, VCs and angels in the Mid-Atlantic Region. The Forum is a quarterly half-day event featuring networking, news-making speakers and a showcase of 7–8 exciting companies.


News Article | May 26, 2017
Site: www.businesswire.com

LOS ANGELES--(BUSINESS WIRE)--Goldberg Law PC, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Sinovac Biotech Ltd. (“Sinovac” or the “Company”) (Nasdaq: SVA). If you purchased or otherwise acquired Sinovac shares, and would like more information about the investigation, we encourage you to contact Michael Goldberg or Brian Schall, of Goldberg Law PC, 1999 Avenue of the Stars Suite 1100, Los Angeles, CA 90067, at 800-977-7401, to discuss your rights without cost to you. You can also reach us through the firm’s website at http://www.Goldberglawpc.com, or by email at info@goldberglawpc.com. The investigation focuses on whether Sinovac and certain of its officers and/or directors violated federal securities laws. On December 21, 2016, SeekingAlpha.com published an article revealing that the Company’s Chairman and CEO Weidong Ying paid bribes to the Deputy Director General of the Center for Drug Evaluation for the China Food and Drug Administration and his wife, in order to help advance drug applications and evaluations. On May 16, 2017, Sinovac announced that the U.S. Securities & Exchange Commission is conducting an enforcement investigation related to the bribery discussed in the article, and that the Company would not be able to timely file its annual financial results. If you have any questions concerning your legal rights, please immediately contact Goldberg Law PC at 800-977-7401, or visit our website at http://www.Goldberglawpc.com, or email us at info@goldberglawpc.com. Goldberg Law PC represents investors around the world, and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.


LOS ANGELES--(BUSINESS WIRE)--Goldberg Law PC, a national shareholder rights litigation firm, announces that it is investigating Sinovac Biotech Ltd. (“Sinovac” or the “Company”) (Nasdaq: SVA) concerning possible violations of federal securities laws. If you purchased or otherwise acquired Sinovac Biotech Ltd. shares and would like more information regarding the investigation, we encourage you to contact Michael Goldberg or Brian Schall, of Goldberg Law PC, 1999 Avenue of the Stars Suite 1100, Los Angeles, CA 90067, at 800-977-7401, to discuss your rights without cost to you. You can also reach us through the firm’s website at http://www.Goldberglawpc.com, or by email at info@goldberglawpc.com. On December 21, 2016, SeekingAlpha.com published an article revealing that according to a recent Beijing court judgment, Weidong Ying, Chairman and CEO of Sinovac, paid bribes to Yin Hongzhang, the Deputy Director General of the Center for Drug Evaluation for the China Food and Drug Administration, and his wife, in order to assist its vaccine clinical trial and approval. If you have any questions concerning your legal rights, please immediately contact Goldberg Law PC at 800-977-7401, or visit our website at http://www.Goldberglawpc.com, or email us at info@goldberglawpc.com. Goldberg Law PC represents shareholders around the world and specializes in securities class actions and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


TAIPEI, Taiwan, October 30, 2016 /PRNewswire/ -- TaiGen Biotechnology Co., Ltd. ("TaiGen") announced today that its wholly owned subsidiary, TaiGen Biopharmaceuticals Co. (Beijing), Ltd. has signed an agreement with YiChang HEC ChangJiang Pharmaceutical Co., Ltd ("HEC") to establish a new company ("Newco") in mainland China for the joint development, manufacturing, and commercialization of direct-acting antiviral agents (DAAs) for all-oral interferon-free treatments of chronic hepatitis C virus (HCV) infection in the Greater China region (mainland China, Taiwan, Hong Kong, and Macau). The Newco will be the first of its kind in a cross-strait partnership in the pharmaceutical industry. It also formalized the collaboration in the MOU signed in February 2016. Under the terms of the Agreement, the Newco will be capitalized at RMB 680 million (US$102 million). TaiGen will use the intellectual property rights of furaprevir (TG-2349) in Greater China as contribution in kind for 49% equity in the Newco. HEC will use the intellectual property rights of yimitasvir (DAG-181) in Greater China as contribution in kind and an additional cash investment in exchange for 51% equity in the Newco. TaiGen will be responsible for research, clinical development, and registration and HEC will be responsible for operation, manufacturing, sales and marketing of HCV treatment based on furaprevir and yimitasvir. Upon the establishment of the Newco, TaiGen and HEC will execute a separate share transfer agreement where TaiGen will receive from HEC a sum between US$20 to 40 million based on the Phase 2 clinical trial results. After the share transfer is complete, TaiGen will hold 40% equity and HEC 60% equity in the Newco. TaiGen's furaprevir, a HCV NS3 protease inhibitor, is completing a Phase 2 clinical trial in HCV genotype 1b patients in Taiwan. HEC's yimitasvir, an NS5a inhibitor, has completed in Phase 1 trial in mainland China. Both furaprevir and yimitasvir are DAAs, classified as Class 1.1 by CFDA, and were discovered and developed in-house by TaiGen and HEC respectively. According to the estimates from WHO and IMS, the number of HCV patients in mainland China ranges from 10-40 million making it the largest HCV market in the world. At present, less than 10% of the HCV patients are receiving treatment. This is due to low awareness of the disease and the severe and intolerable side effects of interferon-based treatment. Although all-oral interferon-free DAA-based HCV regiments are already available in many countries, none of these are currently approved in mainland China. To expedite the approval and availability of the revolutionary treatment, China's Center for Drug Evaluation has begun to grant priority review status to HCV drugs in development. Furaprevir was granted priority review in April 2016 and TaiGen is the only Taiwanese firm among the seven companies that receive priority review. Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen said "Mainland China remains the largest untapped HCV market. We are confident that combining both drugs and company expertise will accelerate the development of our DAA regiment and become a formidable competitor in the Greater China HCV market. This partnership with HEC will be another significant milestone in TaiGen's history and take TaiGen to the next level." Mr. Show-Chung Ho, Chairman of TaiGen's Steering Committee commented, "TaiGen has a successful track record in clinical development and obtaining market approval in mainland China. HEC has the integrated marketing and distribution channels. The synergy that the two companies and their drugs create will bring tremendous benefits to the HCV patients in this region." About YiChang HEC ChangJiang Pharmaceutical YiChang HEC ChangJiang Pharmaceutical, a public listed company in the Hong Kong Stock Exchange (1558.HK), focuses on the development, manufacturing and sales of pharmaceutical products in viral infections, endocrine, metabolic and cardiovascular diseases. HEC's leading product, Kewei (oseltamivir phosphate) is the No. 1 selling influenza drug in China from 2013 to 2015. YiChang HEC is part of HEC Pharmaceutical Group. Its products are exported overseas to the US, Japan, Germany and Australia. HEC Pharmaceutical Group is part of the HEC Group with businesses in materials, healthcare, cosmetics, tourism, and hospitality. About TaiGen Biotechnology TaiGen Biotechnology, a public listed company in Taipei Exchange (4157.TWO), is a leading research-based biotechnology company in Taiwan. TaiGen's pipeline includes other in-house discovered and developed new chemical entities: Taigexyn®, a novel antibiotic, is one of the first NCEs developed by a Taiwanese company that received market approval and launched in Taiwan and mainland China. Burixafor, a chemokine receptor antagonist, is in Phase 2 clinical development for stem cell transplantation and chemosensitization in the US and mainland China. For more information please contact: Peter W. Tsao, PhD, Vice President Corporate Development Tel: +886-2-8177-7072 ptsao@taigenbiotech.com.tw To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/taigen-biotechnology-to-establish-a-new-company-with-hec-pharmaceutical-in-china-for-treatment-of-chronic-hepatitis-c-300353821.html

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