Trials & Approvals - ChinaBio® Today

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Frontage Labs Completes US Phase I Trial for China TCM Company Feb 1, 2012: Frontage Laboratories announced its US facility has finished a Phase I dose-escalation trial of a botanical drug for a China client. The test will be used to support a request for FDA approval of the drug. One year ago, Frontage announced a $50 million strategic collaboration with Yabao Pharma of Beijing. The two companies planned to develop sustained release delivery for more than 20 drug products for use in the US and Europe. This drug being tested may be part of that deal. More details....

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Syneron Announces SFDA Approval for Five Aesthetic Machines Jan 25, 2012: Syneron Medical, an Israeli company that makes aesthetic devices, received SFDA approval for five of the company’s products: eLaser, eLight, eMatrix, eMax and VelaShape systems. The company said the approvals constituted a “significant” expansion of its China product offerings. Syneron began marketing its products in China in 2008. More details....

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Novartis Announces China Launch for Lucentis and Galvus Jan 18, 2012: Novartis received SFDA approval to sell Lucentis (ranibizumab) in China. Lucentis is a treatment for wet (neovascular) age-related macular degeneration (AMD), which causes blindness and vision loss, usually in people over 50. The company also announced the China launch of Galvus (vildagliptin), an oral diabetes treatment. Galvus is a dipeptidyl peptidase IV (DPP-IV) inhibitor indicated for people with diabetes 2. More details....

Stock Symbol: (NYSE: NVS)

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Xiamen Innovax Biotech Gains Approval for Hepatitis E Vaccine Jan 17, 2012: A hepatitis E vaccine developed by Xiamen Innovax Biotech was granted SFDA approval – the first vaccine approved for hepatitis E anywhere in the world. Innovax worked with researchers at Xiamen University for 14 years to develop the product, which has been supported by grants under China’s 863 Program since 2005. The vaccine was tested in a 100,000 person Phase III trial, whose results were published in The Lancet last year. More details....

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China Kanghui Granted FDA Approval for Two Joint Replacements Jan 6, 2012: China Kanghui Holdings, an orthopedic medical device maker based in Changzhou, said its wholly owned subsidiary, TGM Medical, received approvals from the FDA to market in the US two joint replacement systems: the Helicon™ Hip System and the Milestone Knee System, along with related surgical instruments. More details....

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Hengrui Gains FDA Approval for Cancer Drug Dec 20, 2011: Jiangsu Hengrui Medicine has been granted FDA approval for Irinotecan, an anti-cancer drug that is usually prescribed as part of a drug cocktail for colon cancer. According to Hengrui, the approval is the first given to a China company for an injected drug. The company said it plans to use the experience of its first FDA approval to accelerate plans for US and European acceptance of other drugs in its portfolio. More details....

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LDR Given China Approval for Two Medical Devices Dec 2, 2011: LDR, a medical device company headquartered in Texas, received SFDA approval to market two spinal device systems in China: the ROI-C® Cervical Cage and the ROI-A® ALIF Cage. LDR has been selling its artificial discs in China since 2009. The company has offices in Beijing and Shanghai. More details....

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Haibin Pharma Announces European Approval for Bulk Antibiotic Dec 2, 2011: Shenzhen Haibin Pharma received a EU-GMP certificate from Germany allowing it to sell its meropenem bulk drug in Europe. Meropenem is a broad spectrum antibiotic. Haibin said it is the first China company to be granted European approval for meopenem bulk medicine. Currently, Haibin supplies almost 50% of China’s meropenem needs, and it exports to many areas of the world as well. Haibin is a subsidiary of Joincare Pharma. More details....

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Regeneron/Bayer Start China Trial of Wet AMD Drug Nov 28, 2011: Regeneron Pharma and Bayer have begun a China Phase III trial of Eylea™ (aflibercept) Injection, a treatment for neovascular age-related macular degeneration (wet AMD). Earlier this month, Eylea was granted FDA approval for this indication in the US. More details....

Stock Symbol: (NSDQ: REGN) (XETRA: BAY)

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Tasly Pharma Selects ICON for Global Phase III Trial of TCM Heart Drug Nov 21, 2011: Tasly Pharmaceuticals has chosen ICON, the Dublin-based CRO, to conduct a global Phase III trial of Tasly’s oral TCM treatment for angina. The drug, known alternately as T89, Dantonic® and Cardiotonic, could be the first TCM to win FDA approval in the US. In June of this year, Tasly announced it would invest $40 million into a US facility to support Dantonic. More details....

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