SHANGHAI – The Beijing-based oncology company Beigene Co. Ltd. continuing its string of upbeat news, announcing the first human dosing of its programmed death-1 (PD-1) antibody, BGB-A317, in Australia.
Hanmi Pharmaceutical Co. Ltd., of Seoul, Korea, presented interim results of the phase I/II domestic trial of HM61713, an orally active epidermal growth factor receptor (EGFR) mutant selective inhibitor, in T790M mutation-positive non-small-cell lung cancer patients. Daily single administration of HM61713 800 mg showed 95.2 percent disease control rate (DCR) in 59 of 62 patients with T790M-positive mutation who developed resistance to previous EGFR tyrosine kinase inhibition.
TOKYO – A new initiative in Japan aims to bring together the research resources of multiple stakeholders, including a handful of multinational biotech companies, to bear on the fight against some insidious neglected diseases.
HONG KONG – New RNA-based switching biotechnology that detects and sorts cells derived from induced human pluripotent (iPS) cells using microRNAs (miRNAs) will enable production of purer cell populations with potentially better therapeutic outcomes, a study by Japanese researchers at the Center for iPS Cell Research and Application (CiRA) at Kyoto University has found.
HONG KONG – Biotech and medtech companies operating in China now have to pay more attention to the cost of regulatory approvals after the national regulator drastically raised registration application fees for both clinical trials and marketing approvals.
HONG KONG – In a move that sent its stock down more than 3 percent Tuesday, Hong Kong-listed Chinese pharmaceutical company Luye Pharma Group (HK:2186) terminated a billion-dollar acquisition deal.
R-Tech Ueno Ltd., of Tokyo, reported that the phase I single-dose study for its anti-inflammatory and immunomodulatory agent, RTU-1096, has been completed, confirming safety and tolerability of the drug up to the highest dose.
SHANGHAI – Sciclone Pharmaceuticals Inc., a Foster City, Calif.-based company that brings specialty therapeutics to the China market, has secured a deal for China (including Hong Kong, Macau, Taiwan and Vietnam) with Theravance Biopharma Inc., for Vibativ (telavancin), a lipoglycopeptide antibiotic that addresses difficult-to-treat hospital-acquired infections and ventilator-assisted infections.