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You are here: Home » Trials & Approvals

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

Recent Articles

Lotus Pharma Starts China Clinical Trial of Asthma Drug Aug 26, 2010: Lotus Pharmaceuticals has begun a Phase I trial of R-Bambuterol®, an asthma treatment. The company said preclinical studies of R-Bambuterol showed efficacy but lower toxicity than Bambuterol, which can cause liver and cardiovascular side effects. Bambuterol is already commercially available in China. More details....

Stock Symbol: (OTCBB: LTUS)

Aoxing Receives Approval for Trial of Drug Dependence Therapy Aug 25, 2010: Aoxing Pharmaceutical has been given SFDA approval to begin a clinical trial of buprenorphine/naloxone sublingual tablets as a maintenance therapy for opioid addiction. Aoxing plans to start the trial of the therapy, which is not yet available in China, later this year. The test will be completed in mid-2011 and, if all goes well, it will launch in mid-2012. More details....

Stock Symbol: (NYSE Amex: AXN)

Hepatitis E Vaccine from Xiamen Innovax Passes Phase III Test Aug 24, 2010: A hepatitis E vaccine developed by Xiamen Innovax Biotech was effective in a large-scale Phase III trial, according to data published in The Lancet. The trial enrolled more than 112,000 people between the ages of 16 and 65. Further studies are needed to determine the vaccine's safety in pregnant women and the duration of its efficacy. More details....

Jiangbo Predicts $8-$12 Million First Year Sales of Hypertension Drug Aug 17, 2010: Jiangbo Pharmaceuticals has received approval from the Shandong Food and Drug Administration to start selling a treatment for high blood pressure, Felodipine sustained release tablets. The company expects to sell $8 million to $12 million of the drug in the first 12 months at a 70% gross margin. More details...

Stock Symbol: (NSDQ: JGBO)

Simcere Given SFDA Approval of Anti-Nausea Drug Aug 12, 2010: Simcere Pharmaceutical Group (先声药业) reported that its China subsidiary, Simcere Dongyuan Pharmaceutical Co., was granted SFDA approval to manufacture and market Palonosetron material and injections. Palonosetron is given to prevent the nausea and vomiting side effects of chemotherapy. Simcere, which focuses on branded generics, already markets four other drugs that treat cancer. More details...

Stock Symbol: (NYSE: SCR)

Tasly to Start Phase III Trial of TCM Angina Treatment in US Aug 9, 2010: Tianjin Tasly Pharmaceutical said its patented TCM treatment for angina, Compound Danshen Dripping Pills, posted positive results in a Phase II trial conducted in the US. The FDA has also given its go-ahead to move the drug into Phase III trials, according to Tasly. Assuming a positive outcome for the trial, the company hopes to launch the drug in the US as early as 2013. Tasly said Danshen is the first TCM drug approved by the FDA for Phase III trials. More details....

Stock Symbol: (SHEX: 600535)

SFDA Approves Rasilez, a Novartis Hypertension Drug Jul 21, 2010: Novartis reported the SFDA has approved China use of Rasilez® (aliskiren), a treatment for high blood pressure. A first-in-class direct renin inhibitor, Renin is part of the renin-angiotensin-aldosterone system that narrows blood vessels and helps regulate blood pressure. It is approved for use alone or in combination with other hypertensives. More details....

Stock Symbol: (NYSE: NVS)

Stallergenes Reports Successful Asthma Trial in China Jun 25, 2010: Stallergenes S.A. announced positive results from a China Phase III clinical trial that tested Staloral® 300 in adult patients with asthma triggered by dust mites. The French company will use the results to support an application for SFDA approval of its drug, a sublingual immunotherapy. It will also conduct a similar trial of another drug, Actair®, in a slightly different population: patients whose rhinitis is triggered by dust mites. More details...

Kun Run Biotech OK’d to Produce Hepatitis B Drug Jun 17, 2010: Kun Run Biotechnology, a China manufacturer of peptide-based and small molecule drugs, received SFDA manufacturing approval for Entecavir, an oral treatment for hepatitis B. Entecavir inhibits reverse transcription, DNA replication and transcription in the viral replication process. Baraclude, which is Bristol-Myers Squibb’s (NYSE: BMS) version of the drug, was approved by the US FDA in 2005 for hepatitis B treatment. More details...

Stock Symbol: (OTCBB: KURU)

SFDA Approves China Medical Technologies’ HPV Test Jun 9, 2010: China Medical Technologies (中国医疗技术公司) reported that its SPR-based HPV-DNA chip has been approved by the SFDA. The fully automated machine is capable of identifying the 16 high-risk HPV subtypes and 8 low-risk variations as well as viral load. Human papillomavirus is a common virus that can lead to warts as well as cervical cancer. More details...

Stock Symbol: (NSDQ: CMED)