Living Cell Technologies Ltd., of Sydney, said 81 weeks after treatment all four patients who took part in the phase I/IIa trial of Parkinson's disease cell therapy candidate Ntcell showed reversal of the progression of disease, as measured by the Unified Parkinson's Disease Rating Scale. All four patients remain well and there are no safety concerns. Read More
HONG KONG – Aiming to address a perceived disparity in the quality of manufacturing of drugs for the China market, the CFDA is ramping up its focus on offshore drug manufacturers. The regulator last year stepped up the number of overseas good manufacturing practice (GMP) inspections it carried out, while domestically, it put more of the onus on companies to police themselves. Read More
SAN FRANCISCO – The global markets track during last week's BIO International Convention drew a number of attendees seeking to hear more about the promising China market and its changing regulations. Read More
HONG KONG – Catching up with international markets, China is unbinding its drug manufacturing licensing regime from the marketing authorization in a move aimed at revolutionizing the country's drug development space. Read More
SHANGHAI – Shenyang Sunshine Pharmaceutical Co. Ltd. (3SBio), a revenue-generating biotech with products in China, has decided to try its hand at the hottest category in immuno-oncology. The company will be responsible for developing three chimeric antigen receptor T cell (CAR T) candidates in Greater China (including Macao and Hong Kong) originally discovered by TNK Therapeutics Inc. (TNK), of San Diego. TNK, a cellular therapy company, is a subsidiary of Nasdaq-listed Sorrento Therapeutics Inc. (SRNE). Read More