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Dong Y.-H.,National Taiwan University | Lin H.-H.,National Taiwan University | Shau W.-Y.,Center for Drug Evaluation | Wu Y.-C.,National Taiwan University | And 3 more authors.
Thorax | Year: 2013

Background: The active-treatment comparative safety information for all inhaled medications in patients with chronic obstructive pulmonary disease (COPD) is limited. We aimed to compare the risk of overall and cardiovascular death for inhaled medications in patients with COPD. Methods: Through systematic database searching, we identified randomised controlled trials of tiotropium Soft Mist Inhaler, tiotropium HandiHaler, long-acting β2 agonists (LABAs), inhaled corticosteroids (ICS), and LABA-ICS combination with at least a 6-month treatment duration. Direct comparison and mixed treatment comparison (MTC) meta-analyses were conducted to estimate the pooled ORs of death for each comparison. Results: 42 trials with 52 516 subjects were included. The MTC meta-analysis with the fixed effect model indicated tiotropium Soft Mist Inhaler was associated with an universally increased risk of overall death compared with placebo (OR 1.51; 95% CI 1.06 to 2.19), tiotropium HandiHaler (OR 1.65; 95% CI 1.13 to 2.43), LABA (OR 1.63; 95% CI 1.10 to 2.44) and LABA-ICS (OR 1.90; 95% CI 1.28 to 2.86). The risk was more evident for cardiovascular death, in patients with severe COPD, and at a higher daily dose. LABA-ICS was associated with the lowest risk of death among all treatments. No excess risk was noted for tiotropium HandiHaler or LABA. The results were similar for MTC and direct comparison meta-analyses, with less precision in the random effects model. Conclusion: Our study provided a comparative safety spectrum for each category of inhaled medications. Tiotropium Soft Mist Inhaler had a higher risk of mortality and should be used with caution.

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 via email at brian@lundinlawpc.com. On December 21, 2016, SeekingAlpha.com released an article stating 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, as well as his wife, with the intention of assisting its vaccine clinical trial and approval. 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.

LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”) announces an investigation on behalf of Sinovac Biotech Ltd. (“Sinovac” or the “Company”) (NASDAQ: SVA) investors concerning the Company and its officers’ possible violations of federal securities laws. GPM is preparing a lawsuit on behalf of Sinovac investors. Sinovac is a biopharmaceutical company that engages in the research, development, manufacture and commercialization of vaccines against hepatitis A, hepatitis B, seasonal influenza, H5N1 and H1N1 pandemic influenza and mumps in the People's Republic of China. On December 21, 2016, media outlet SeekingAlpha issued a report disclosing that Sinovac’s Chairman and CEO, Weidong Ying, had paid bribes to Yin Hongzhang, the Deputy Director General of the Center for Drug Evaluation for the China Food and Drug Administration, to help procure and pass drug applications and evaluations. If you purchased Sinovac securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Lesley Portnoy, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to shareholders@glancylaw.com, or visit our website at http://www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces it is investigating 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 according to a recent Beijing court judgment, 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, and his wife, in order to help advance drug applications and evaluations. Rosen Law Firm is preparing a class action lawsuit to recover losses suffered by Sinovac investors. If you purchased shares of Sinovac, please visit the firm’s website at http://www.rosenlegal.com/cases-1015.html for more information. You may also contact Phillip Kim or Kevin Chan of Rosen Law Firm toll free at 866-767-3653 or via email at pkim@rosenlegal.com or kchan@rosenlegal.com. Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm. Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.

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

Tao Q.,Sun Yat Sen University | Chen J.-M.,Sun Yat Sen University | Ma L.,Center for Drug Evaluation | Lu T.-B.,Sun Yat Sen University
Crystal Growth and Design | Year: 2012

One phenazopyridine monohydrate (1•H 2O), one cocrystal of phenazopyridine with phthalimide (2), and three salts of phenazopyridine with benzoic acid (3), 4-hydroxyphenylacetic acid (4), and scaaharin (5) were synthesized, and their structures were determined by single crystal X-ray diffraction. The results of dissolution experiments indicate that the solubility of phenazopyridine can be enhanced after the formations of cocrystal and salts, in which the apparent solubility value of 5is approximately 9 times as large as that of phenazopyridine in water, and the apparent solubility value of 4 is approximately 10 times as large as that of phenazopyridine hydrochloride (1•HCl) in 0.1 M HCl aqueous solution. The results of the stability study demonstrate that 2-5 are less hygroscopic than 1•H 2O and 1•HCl at both 85% and 98% RH. © 2012 American Chemical Society.

Chuang T.-L.,National Taiwan University | Wei S.-C.,National Taiwan University | Lee S.-Y.,Center for Drug Evaluation | Lin C.-W.,National Taiwan University
Biosensors and Bioelectronics | Year: 2012

In this study, we report a simple, low-cost surface plasmon resonance (SPR)-sensing cartridge based on a loop-mediated isothermal amplification (LAMP) method for the on-site detection of the hepatitis B virus (HBV). For LAMP detection, a SPR based LAMP sensing system (SPRLAMP) was constructed, including a novel SPRLAMP sensing cartridge integrating a polymethyl methacrylate (PMMA) micro-reactor with a polycarbonate (PC)-based prism coated with a 50. nm Au film.First, we found that the change of refractive index of the bulk solution was approximately 0.0011 refractive index (RI) units after LAMP reaction. The PC-based prism's linearity and thermal responses were compared to those of a traditional glass prism to show that a PC-based prism can be used for SPR measurement. Finally, the HBV template mixed in the 10μl LAMP solution could be detected by SPRLAMP system in 17min even at the detection-limited concentration of 2fg/ml. We also analyzed the correlation coefficients between the initial concentrations of HBV DNA templates and the system response (ΔRU) at varying amplification times to establish an optimal amplification time endpoint of 25min (R 2=0.98). In conclusion, the LAMP reaction could be detected with the SPRLAMP sensing cartridge based on direct sensing of the bulk refractive index. © 2011.

Chen Z.,Center for Drug Evaluation
Chinese Journal of New Drugs | Year: 2014

In the past 10 years, technical requirements with respect to chemistry, manufacturing & control (CMC) for registration of chemical drugs have been established systematically in China. At present, CMC technical requirements are being improved based on science and risk principles in order to make these requirements more in line with the rules of drug research & development as well as international standards. In this article, we reviewed briefly the progress history of CMC technical requirements for registration of chemical drugs in China, and summarized the current basic considerations for improving CMC technical requirements, i.e. systematic quality control, phases of CMC development and linkage in quality. Moreover, we put forward the developing prospects of CMC technical requirements in China.

Yang J.,China Pharmaceutical University | Lu Y.,China Pharmaceutical University | Yang J.,Center for Drug Evaluation | Zhang H.,Jiangsu University
Clinical Pharmacokinetics | Year: 2013

Background and Objectives: Many attempts have been made to predict the warfarin maintenance dose in patients beginning warfarin therapy using a descriptive model based on multiple linear regression. Here we report the first attempt to develop a comprehensive mechanistic model integrating in vitro-in vivo extrapolation (IVIVE) with a pharmacokinetic-pharmacodynamic model to predict the warfarin maintenance dose in Han Chinese patients. The model incorporates demographic factors [sex, age, body weight (BW)] and the genetic polymorphisms of cytochrome P450 (CYP) 2C9 (CYP2C9) and vitamin K epoxide reductase complex subunit 1 (VKORC1). Methods: Information on the various factors, mean warfarin daily dose and International Normalized Ratio (INR) was available for a cohort of 197 Han Chinese patients. Based on in vitro enzyme kinetic parameters for S-warfarin metabolism, demographic data for Han Chinese and some scaling factors, the S-warfarin clearance (CL) was predicted for patients in the cohort with different CYP2C9 genotypes using IVIVE. The plasma concentration of S-warfarin after a single oral dose was simulated using a one-compartment pharmacokinetic model with first-order absorption and a lag time and was combined with a mechanistic coagulation model to simulate the INR response. The warfarin maintenance dose was then predicted based on the demographic data and genotypes of CYP2C9 and VKORC1 for each patient and using the observed steady-state INR (INRss) as a target value. Finally, sensitivity analysis was carried out to determine which factor(s) affect the warfarin maintenance dose most strongly. Results: The predictive performance of this mechanistic model is not inferior to that of our previous descriptive model. There were significant differences in the mean warfarin daily dose in patients with different CYP2C9 and VKORC1 genotypes. Using IVIVE, the predicted mean CL of S-warfarin for patients with CYP2C9*1/*3 (0.092 l/h, n = 11) was 57 % less than for those with wild-type*1/*1 (0.215 l/h, n = 186). In addition,*1/*1 patients needed about 1 week to reach steady state, whereas*1/*3 patients needed about 2 weeks. In terms of the predicted INRss values, only ten patients had INRss values outside the expected therapeutic range (1.5-2.8). To evaluate our mechanistic model, we predicted the warfarin maintenance dose for 183 patients and explained 42 % of its variation, which is comparable to our previous prediction using a descriptive model based on multiple linear regression. The mean predicted/observed warfarin doses (mg/day) for different combinations of CYP2C9 and VKORC1 genotypes were 1.54/3.75 (n = 1) for*1/*1 and GG, 3.33/3.66 (n = 36) for*1/*1 and AG, 2.31/2.41 (n = 136) for*1/*1 and AA, and 1.56/1.69 (n = 10) for*1/*3 and AA, respectively. Sensitivity analysis indicated BW and genetic polymorphisms of CYP2C9 and VKORC1 were important factors affecting the warfarin maintenance dose in the study population. Conclusion: The mechanistic model reported is the first to integrate IVIVE with a pharmacokinetic-pharmacodynamic model to describe the association of the warfarin maintenance dose with sex, age, BW and the genotypes of CYP2C9 and VKORC1. The model was effective in predicting S-warfarin clearance and in simulating its plasma concentration-time curve in a cohort of Han Chinese patients. In addition, the model accurately predicted the INR response and warfarin maintenance dose in a cohort of Han Chinese patients. © 2013 Springer International Publishing Switzerland.

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