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You are here: Home » Trials & Approvals

Trials & Approvals

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Updates on new clinical tirals being performed in China, trial updates and drug approvals...

Recent Articles

  Zensun Announces Positive Data from Phase II Trials of Neucardin
May 23, 2013
Zensun Sci & Tech, Ltd., a Shanghai-San Diego biopharma, reported positive results from four Phase II trials of its lead drug candidate, Neucardin™, a treatment for heart failure. Because of the successful tests, Zensun has filed with the CFDA for accelerated approval of the drug. Last week, SciClone announced it has in-licensed the China rights to Neucardin. More details....

Stock Symbol: (NSDQ: SCLN)

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  CFDA Approves Clinical Trials for Novel China AIDS Treatment
May 22, 2013
A novel treatment for AIDS, developed in the Zhengzhou University labs of Junbiao Chang, PhD, has been approved by the CFDA for human trials. The molecule, which has been in development for ten years, is a reverse transcriptase (RT) inhibito, called Azi Fu (Azvudine). According to Dr. Chang, Azi Fu is more effective at blocking the mutated forms of the virus than currently available treatments. He also believes the molecule has the potential to lower treatment costs. More details....

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  Injex Pharma Given China Approval for Needle-Free Delivery Device
Apr 17, 2013
Injex Pharma of Germany was granted SFDA approval to market its INJEX30 needle-free injection system in China. Injex said its exclusive China distributor, Hangzhou Hema Medical Equipment Co., helped with the one and one-half year registration process, which it described as “arduous.” Injex will sell the product as a needle-free delivery system for insulin. More details....

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  Shenzhen Chipscreen Reports Phase II Success of Cancer Drug
Apr 16, 2013
Shenzhen Chipscreen Biosciences announced that Chidamide (Epidaza®) met its primary endpoint in a Phase II trial, which was conducted in China patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The objective response rate was at least 27%, the agreed-upon goal. Chipscreen is developing the drug under an SFDA-approved accelerated review. The company will release more data at the ASCO conference in June. More details....

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  Furui Subsidiary Receives US Approval for Liver Testing Device
Apr 16, 2013
Echosens™ has been given FDA 510(k) approval to market its FibroScan® device in the US. Echosens, a French company, is wholly owned by Inner Mongolia Furui Medical Science Co. FibroScan is a noninvasive device that tests for liver fibrosis. It uses an ultrasound machine and a technology called transient elastography. The device has been marketed in Europe since 2003; the US is the last major country to approve FibroScan. More details....

Stock Symbol: (SHE: 300049)

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  China’s SFDA Ready to Fast-Track Approvals of Peramivir, a Flu Treatment
Apr 8, 2013
In the wake of the growing bird flu outbreak, China’s SFDA will fast-track approvals of a flu treatment – not a vaccine – known as peramivir (peramivir sodium chloride injection). The drug is a neuraminidase inhibitor, which works by preventing the virus from moving from an infected cell to infect other cells. Guangzhou Nanxin Pharma has been approved to produce the medicine, and it expects to begin distributing the drug in 30 days. Other China pharmas have also filed for approval to make the drug or conduct human clinical trials. More details....

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  Agenix to File for Clinical Trial of Hepatitis B Drug by June
Mar 29, 2013
The Australia-headquartered biopharma Agenix now expects to file a China clinical trial application for its hepatitis B drug candidate, AGX-1009, with the SFDA by June of this year. Agenix hopes to begin a Phase I trial of AGX-1009 in the first half of 2014. Agenix will position the drug as a low-cost, once-daily treatment for hepatitis B patients who have developed resistance to other treatments. More details....

Stock Symbol: (ASX: AGX)

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  Life Technologies Gene Sequencer SFDA Approved for Diagnostic Use
Mar 28, 2013
Life Technologies has been granted SFDA approval for diagnostic use of its Applied Biosystems 3500xL Dx Genetic Analyzer. The company’s JV with Daan Gene is developing 10 assays for use on the machine. Life Tech called the approval a “major extension” of its ability to serve the clinical market in China with machines based on Sanger-method sequencing. More details....

Stock Symbol: (NSDQ: LIFE)

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  Cellular Biomedicine Starts China Trial of Liver Cancer Treatment
Mar 25, 2013
Cellular Biomedicine Group has started a clinical trial in China of an innovative personalized treatment for liver cancer. Through a collaboration with Shanghai's PLA 85 Hospital, the company will test its TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy in patients with hepatocellular carcinoma (HCC). CBMG has facilities in Shanghai and WuXi, though its headquarters are in Palo Alto, California. More details....

Stock Symbol: (OTCQB: CBMG)

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  Amoy Diagnostics Approved to Market IVD for Lung Cancer
Mar 21, 2013
Amoy Diagnostics, a Xiamen maker of in vitro diagnostics, was given SFDA permission to market its EML4-ALK Fusion Gene Detection Kit in China. The assay detects 21 different fusion products from rearrangements of the EML4 and ALK genes. The activity of the EML4-ALK fusion oncogene, a recently discovered molecular target in non-small-cell lung cancer (NSCLC), can be inhibited by small-molecule inhibitors such as Xalkori from Pfizer. More details....

Stock Symbol: (NYSE: PFE)

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