Friday, November 7, 2014
Sinovac Biotech, a provider of biopharmaceutical products in China, has announced that Phase III clinical trial results for its proprietary Enterovirus 71 (EV71) vaccine have been published online in the February 27 issue of TheNew England Journal of Medicine (NEJM). The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease (HFMD), or herpangina, was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac’s vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities.
Cytori Therapeutics and Lorem Vascular, a Beijing-based provider of cardiovascular care, have announced a partnership to commercialize Cytori Cell Therapy for the cardiovascular, renal and diabetes markets in China, Hong Kong, Malaysia, Singapore and Australia. Cytori Cell Therapy is derived from the company’s Celution System, which enables access to a patient’s own adipose-derived regenerative cells (ADRCs) at the point of care.
Hutchison MediPharma (HMP), an R&D company majority owned by Chi-Med, has entered a licensing, co-development and commercialization agreement in China with Eli Lilly for Fruquintinib (HMPL-013), a targeted oncology therapy for the potential treatment of various types of solid tumors. Fruquintinib, a selective inhibitor of the Vascular Endothelial Growth Factor (“VEGF”) receptor tyrosine kinases, was discovered by HMP and currently is in phase II testing in China.
Japan-based pharmaceutical company Daiichi Sankyo is expanding its use of Medidata Solutions‘ cloud-based platform to support clinical trials conducted by its division in China, an investment expected to streamline trial activities, improve the efficiency of data capture and increase the productivity of site users and clinical monitors. Daiichi Sankyo will bring Medidata’s applications for electronic data capture, clinical data management and randomization and trial supply management to its expanding clinical work in China.
Raleigh, N.C.-based INC Research, a therapeutically focused global CRO, has established INC Research Japan KK, with the opening of locations in Osaka and the Shinagawa ward in Tokyo. The new operations provide INC Research’s global drug development customers access to an increasingly significant market and further expand its presence in the Asia-Pacific region.
Ascendancy Healthcare, dedicated to the commercialization of therapeutic products to meet unmet medical needs in China and other high-growth Asian markets, has announced a multi-year collaboration with Quintiles, a provider of biopharmaceutical development and commercial outsourcing services.
Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there is an unmet medical need, has announced a personalized medicine collaboration with SciClone Pharmaceuticals in the company’s oral mucositis clinical program with SGX942. Soligenix will receive access to SciClone’s oral mucositis clinical and regulatory data library in exchange for commercialization rights in China, including Hong Kong and Macau.