Beijing SL Pharmaceutical Co. Ltd. received SFDA approval to begin producing a hepatitis drug and a second SFDA authorization to begin clinical trials of drug for male infertility. Adefovir dipivoxil, the drug newly approved for marketing, is aimed at hepatitis B. SL Pharma’s male infertility product is thought to be modafinil, the stimulant drug that is marketed as Provigil by Cephalon. More details...

Stock Symbols: (SZSE: 002038) (NSDQ: CEPH)

Tianyin Pharmaceutical, Co. was given SFDA approval for a generic version of a statin drug, simvastatin tablets. Simvastatin was developed by Merck, which markets the drug as Zocor. The US patent for the drug expired in 2006. Simvastatin is used to control hypercholesterolemia and treat coronary heart diseases, the only statin approved by the SFDA for these conditions. Tianyin has the ability to produce $2 million of the drug annually. More details...

Stock Symbols: (OTCBB: TYNP) (NYSE: MRK)

CompuMed, Inc. received approval from the SFDA to market its OsteoGram software system in China for screening, diagnosing and monitoring of osteoporosis. CompuMed said it would work with China digital x-ray OEMs to market its product. OsteoGram is a software system that is used with ordinary digital (that is, filmless) x-ray equipment. More details...

Stock Symbol: (OTCBB: CMPD)

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals were awarded SFDA approval for Nexavar® (sorafenib) tablets, a treatment for unresectable or metastatic hepatocellular carcinoma (HCC), or liver cancer. The approval was based on two international Phase III trials that showed Nexavar improved overall survival in liver cancer patients. More details...

Stock Symbol: (NYSE: ONYX)

Genesis Pharmaceuticals Enterprises was granted SFDA approval for Radix Isatidis Dispersible Tablets. Radix Isatidis is a very popular traditional Chinese medicine used to treat the flu, though it was previously available only as a powder, which is dissolved in hot water. The Genesis formulation is the only dispersible tablet available. As a whole, Radix Isatidis is a $1.4 billion market annually. Genesis forecasts that it will manufacture and sell somewhere between $4 million and $10 million of its product in the next fiscal year (which ends June 30, 2009). More details...

Stock Symbol: (OTCBB: GTEC)

Abraxis BioScience, Inc. (NSDQ: ABII) received SFDA approval for ABRAXANE® Paclitaxel for Injection (Albumin Bound) as a breast cancer treatment. The approval was based on trials conducted in the US and in China. ABRAXANE is a protein-bound chemotherapy, combining paclitaxel and albumin to deliver the drug. Because the delivery mechanism does not require solvents, a 49% higher dose of the active ingredient, paclitaxel, can be given without causing safety issues. More details...

Stock Symbol: (NSDQ: ABII) (NYSE: AZN)

China Sky One Medical reported that it has 11 new drugs in clinical trials, seven of them administered by injection. The clinical trials are expected to be underway for six months. Assuming the trials are successful, China Sky One projects it will submit the drugs for SFDA approval in early 2009. China Sky One has traditionally emphasized externally administered products (patches and ointments), but it has been building up its product portfolio by acquiring other companies. More details...

Stock Symbol: (AMEX: CSY)

China Sky One Medical, Inc. received production approval for three injected products, including a propyl gallate injection for the treatment of acute cerebral infarction, coronary heart disease, thrombosis, dysmenorrheal and nephropathy. China Sky One expects to launch its propyl gallate injection product in August. The company projects that it will produce Q4 revenues of $3 million. More details...

Stock Symbol: (AMEX: CSY)

Helicon Group Limited (ASX: HCG) of Australia received SFDA approval for ReCell®, a skin regeneration concept and device. Before the device can be imported to China, however, Helicon and the SFDA must resolve some importation issues because the device contains trypsin. ReCell treats burns and small wounds. It can also be used for cosmetic surgery, repairing scars. The device harvests a patient’s own skin cells to treat the wounds, improving the color match with a patient’s skin and eliminating tissue rejection. More details...

Chindex International received SFDA approval for two medical devices: the daVinci S Surgical System and the AlexLaser. Although Chindex was pleased to receive the approvals, its announcement was full of complaints about the length of time required for the SFDA to process the applications. More details...

Stock Symbols: (NSDQ: CHDX) (NSDQ: ISRG) (NSDQ: CLZR)