Trials & Approvals

OrbusNeich Begins China Clinical Trial of Bio-Engineered Stent Feb 12, 2010: OrbusNeich has enrolled the first patient in a China clinical trial of its Genous Bio-engineered R stent. The stent, which has been available in Europe since 2005, is coated with an antibody that captures a patient’s endothelial progenitor cells from the bloodstream. The company says the cells promote rapid healing of the blood vessel’s lining, helping to protect against thrombus and to minimize restenosis. More details...

Simcere Given OK by SFDA for Flu Drug Relenza Feb 11, 2010: Simcere Pharma (先声药业) reported it has received SFDA approval to manufacture and market Relenza (zanamivir), the flu treatment developed by GlaxoSmithKline (NYSE: GSK). Relenza, an inhaled neuraminidase inhibitor, is one of only two approved drugs for treating H1N1 flu. Simcere holds an exclusive license for Relenza in China. More details...

Stock Symbol: (NYSE: SCR)

NeoStem’s Eyre Subsidiary Approved to Use New Manufacturing Facility Feb 1, 2010: NeoStem reported its China subsidiary, Suzhou Erye Pharma, was approved by the SFDA to begin manufacturing two penicillin products at the company’s new facility. The new plant will allow Eyre to increase production of solvent crystallization sterile penicillin by 50% and freeze-dried raw sterile penicillin by 100%. In the past, these two products have generated 20% of Erye's revenues. More details...

Stock Symbol: (NYSE Amex: NBS)

Novo Nordisk Awaits China Approval of Type 2 Diabetes Treatment Jan 29, 2010: Novo Nordisk reported that Victoza®, its once-daily human glucagon-like peptide-1 (GLP-1) analog for type 2 diabetes, was submitted to the SFDA in August of last year. The news came as Novo Nordisk celebrated approval of the product in the US and Japan this week. It has been marketed in Europe since last summer. More details...

Stock Symbol: (NYSE: NVO)

Bayer Schering to Conduct Phase IV Hypertension trial in China Jan 27, 2010: Bayer Schering Pharma announced it is beginning a Phase IV trial among an Asia Pacific population that combines two blood pressure medications: Adalat, Bayer Schering’s calcium channel blocker (CCB), and valsartan, an angiotensin receptor blocker (ARB) marketed by Novartis under the name Diovan. The goal is to produce lower blood pressure readings than a high dose of valsartan alone. More details...

Stock Symbol: (NYSE: NVS)

China Aoxing Completes Trial of Pain Drug Jan 25, 2010: China Aoxing Pharmaceutical Company has completed its Phase III trial of Tilidine tablets, a synthetic oral narcotic drug that treats acute and chronic moderate to severe pain, including post-operative and cancer pain. The drug, which is not currently available in China, is a Class III New Medicine that will enjoy at least four years of market exclusivity protection, post-approval. More details...

Stock Symbol: (OTCBB: CAXG)

NeoStem Receives SFDA Approval for Proton Pump Inhibitor Jan 25, 2010: NeoStem, Inc. said its China subsidiary, Suzhou Erye Pharmaceutical, was granted SFDA approval for omeprazole 20mg capsules. Omeprazole is a proton pump inhibitor prescribed to treat peptic ulcer disease and gastroesophageal reflux disease. The drug is on China's National Medical Reimbursement Insurance List, making it eligible for insurance reimbursement. More details...

Stock Symbol: (NYSE Amex: NBS)

Sinobiopharma to Launch ACE Inhibitor Jan 25, 2010: Sinobiopharma reported that its production facility for a capsule form of Perindopril, an ACE inhibitor used to treat high blood pressure, received production approval from the SFDA. The company can now launch the product, which was granted SFDA approval in April 2009. Sinobiopharma will market the product under the name YiTai. It is the first capsule form of Perindopril available in China. More details...

Stock Symbol: (OTCBB: SNBP)

China Pharma Holdings Seeks Approval of Generic Hypertension Drug Jan 22, 2010: China Pharma Holdings reported that its clinical trials for a generic version of Candesartan, an anti-hypertension drug, have been completed successfully, and China Pharma has submitted a generic drug production application for Candesartan to the SFDA. Candesartan Cilexetil is a prodrug of Candesartan, which allows the product to be administered orally and also means that it remains effective for a full day. More details...

Stock Symbol: (NYSE: CPHI)

3SBio Files to Begin Trial of Anemia Drug Jan 8, 2010: 3SBio Inc. applied to the SFDA to begin a registrational clinical trial for Feraheme™ (ferumoxytol) Injection, an IV treatment for iron deficiency anemia in patients with chronic kidney disease. 3SBio licensed the China rights for the drug from AMAG Pharmaceuticals last May, shortly before AMAG was granted approval for the product by the US FDA. More details...

Stock Symbols: (NSDQ: SSRX) (NSDQ: AMAG)