Beijing Mefuvir Medicinal Technology in-licensed from Medivir of Sweden the Asian rights (ex-Japan) to an HIV nucleoside reverse transcriptase inhibitor that has already completed Phase II tests. MIV-310 is administered in addition to AZT to HIV patients who have drug-resistant strains of the disease. In its Phase II tests, MIV-310 displayed a synergistic effect with AZT against HIV and antagonistic toxicity. Beijing Mefuvir will be responsible for obtaining approval of the drug in China. In December 2006, Medivir out-licensed the rights to MIV-310 to Presidio Pharma of San Francisco, but Presidio returned the prospective drug to Medivir, giving Medivir the opportunity to re-license it to Beijing Mefuvir. Beijing Mefurvir is a subsidiary of Tianjin Human-Care Latex, a condom maker. Financial details were not disclosed.

In other news last week, Vital Therapies, Inc. (VTI) talked to ChinaBio® Today about its liver treatment device, the ELAD® (Extracorporeal Liver Assist Device) System, which incorporates C3A cells that mimic liver function (see story). VTI decided to seek approval of the device in China first because they were invited into China by leading hepatologists who face a very high incidence of liver disease. In November, VTI announced it had concluded a pivotal trial of the ELAD® early because the interim results were so compelling. The company has submitted its request for market approval to the SFDA and is now awaiting its decision.

MPI Research of Mattawan, Michigan (USA) formed a joint venture CRO with Shanghai Medicilon (see story). The purpose of the new enterprise will be to conduct preclinical trial work that meets the standards of the FDA and other international regulatory bodies. Both parent CROs specialize in preclinical work. MPI brings to the table its expertise in FDA-compliant pre-clinical studies while Shanghai Medicilon will provide the staffing for the new enterprise and add its experience in China.

Lee’s Pharmaceutical Ltd. (HK: 8221) of Hong Kong in-licensed two compounds from Novelos Therapeutics, one for cancer and the other for hepatitis (see story). Lee’s Pharma will be responsible for all clinical development, regulatory filings and commercialization of the compounds in China. Originally developed in Russia, the two compounds have been administered to over 10,000 patients. Novelos bought the ex-Russia rights to the drugs.

On the regulatory front last week, Merck (NYSE: MRK) withdrew over 100,000 vials of a childhood vaccine from China, part of a larger worldwide recall of the vaccine (see story). The vaccine, known as Hib, is administered to children under the age of five to protect them from meningitis, pneumonia and other infections. Merck admitted that the vaccine had become contaminated at the factory. Although China officials maintained that all imported drugs are subjected to safety tests, one case of an adverse drug reaction has appeared in China. The incident showed that imported drugs can cause a problem in China, just as they have in the West.


Disclosure: none.