BMP Sunstone Corporation said its Clinical Trial Application for Enablex® (Darifenacin) was accepted by the SFDA, allowing the company to begin clinical trials of the treatment for overactive bladder (OAB). BMP will start human trials in the first half of 2009 and expects that approval will follow sometime in 2011. Novartis, which owns Enablex, signed an agreement with BMP Sunstone in November 2007, authorizing the company to seek marketing approval for the drug. If the drug is approved for use in China, BMP Sunstone will have ten years of marketing exclusivity for Enablex. More details...

Stock Symbols: (NSDQ: BJGP) (NYSE: NVS) (NYSE: PFE) 

Takara Bio Inc. of Japan has begun a collaboration with Tianjin Cancer Institute & Hospital, Tianjin Medical University, under which Tianjin Cancer Institute & Hospital has initiated clinical research of a cancer immunotherapy developed by Takara. The new immunotherapy uses RetroNectin®, Takara’s proprietary recombinant human fibronectin, to expand T-cells. More details...

Stock Symbol: (TSE: 4974)

China Biologic Products, Inc. received SFDA approval to start the production of Cryoprecipitate, a frozen blood product prepared from plasma, and also to begin a clinical trial of Human Prothrombin Complex, a new offering. China Biologic bases its business on plasma-derived biopharmaceuticals. Its human albumin products are used to increase blood volume and its immunoglobulin products treat and prevent diseases. More details...

Stock Symbol: (OTCBB: CBPO)

Frontier Biotechnologies Co. of Chongqing has received SFDA approval to begin a Phase I trial of HIV drug, Albuvirtide, a member of the viral entry inhibitor class of HIV/AIDS drugs. Albuvirtide targets gp-41, a viral protein that serves as a portal of entry by HIV into healthy (CD4+) T cells. The Phase I trial, which will be conducted in Beijing, will evaluate the tolerability, pharmacokinetics, and antiviral activity of Albuvirtide in HIV-infected patients. More details...

Sinovac Biotech Ltd. received approval from the SFDA for Panflu, a vaccine for H5N1 pandemic avian flu. Panflu is a whole viron inactivated vaccine, the only avian flu vaccine thus far to be granted approval in any country. Sinovac said the vaccine was approved only for stockpiling in the national program and would not be marketed to the general population. More details...

Stock Symbol: (AMEX:SVA)

Oculus Innovative Sciences (NSDQ: OCLS) has received an approval from the SFDA of its Microcyn® Technology for treatment of several acute and chronic wounds including ulcers, cuts, contusions and burns. Microcyn is a super-oxygenated form of water that is not toxic, but highly effective against bacteria, viruses, mold and spores. Microcyn combines its anti-infective properties with the ability to promote wound healing. More details...

Stock Symbol: (NSDQ: OCLS)

China Medical Technologies, Inc. was awarded the Conformité Européenne Mark (CE Mark) for two semi-automatic ECLIA analyzers and 15 reagents, including reagents for thyroid disorders, diabetes and tumor markers. The CE Mark indicates the product meets the provisions of the In-Vitro Diagnostic Directive (IVDD) of the European Union. More details...

Stock Symbol: (NSDQ: CMED)

Tianyin Pharmaceutical, Co., Inc. continues the rapid pace of its news flow with an announcement that the SFDA approved the company’s generic form of antibiotic medicine Azithromycin Dispersible Tablets. For Tianyin, the approval was the first the company has received from the SFDA, and the drug will become the third Western-style drug in the portfolio. Most of Tianyin’s products are traditional Chinese medicines. To further diversify its product line, Tianyin has another 10 products awaiting SFDA approval. More details...

Stock Symbol: (OTCBB: TYNP) (NYSE: PFE)

Pharmaxis, an Australian biotech focusing on respiratory and autoimmune diseases, said the SFDA accepted for review its application for a clinical trial of Bronchitol™, a treatment for bronchiectasis. The clinical goal of Bronchitol™ is to help patients clear mucus from their lungs by promoting salt and water movement through airway cells. Bronchitol™ is administered twice daily by inhalation. More details...

Stock Symbol: (ASX: PXS; NSDQ: PXSL)

SurExam Life Science & Technology (Shenzhen) Co. has been granted the right to develop a test for early stage ovarian cancer in China that was discovered at Yale School of Medicine. Dr. Jiasen Xu, chief executive officer of SurExam, is a graduate of Yale. The new test uses proteins that the body produces in response to a tumor, along with the tumor proteins, which gives the test the ability to detect both early- and late-stage ovarian cancer with a 99% accuracy. More details...