SHANGHAI – The CFDA recently released "Guiding Principles for the Research and Evaluation of Cell Therapy Products" for trial implementation. This hotly anticipated move now adds cell therapies – such as stem cells and chimeric antigen receptor (CAR T) therapies – under the umbrella of CFDA reforms that are aligning China's drug regulations with global drug markets. The guidelines set out standards for the approval of clinical trials for cell therapies and opens the door to a viable path to commercialization of cell therapies to be regulated by the CFDA, much like other new drugs.
SHANGHAI – Xinogen (Hong Kong) Pharma Co. Ltd., a subsidiary of Beijing Shenogen Pharmaceuticals Group, has negotiated a deal with Angiochem Inc., of Montreal, to develop and sell ANG-1005, a paclitaxel-peptide drug conjugate for the treatment of leptomeningeal carcinomatosis from breast cancer. The deal gives Xinogen rights for greater China.
SHANGHAI – Zai Labs Ltd., of Shanghai, nabbed greater China rights for FPA-144, a first-in-class fibroblast growth factor (FGF) monoclonal antibody for gastric and gastroesophageal junction cancer being developed globally by Five Prime Therapeutics Inc., of San Francisco.
SHANGHAI – Nanjing-based Legend Biotechnology Corp. has partnered with Janssen Biotech Inc., a subsidiary of Johnson & Johnson, to develop in CAR-B38M, a promising chimeric antigen receptor T-cell (CAR T) therapy for multiple myeloma that targets B-cell maturation antigen (BCMA).
SHANGHAI – Nanjing-based Legend Biotechnology Corp. has partnered with Janssen Biotech Inc., a subsidiary of Johnson & Johnson, to develop in CAR-B38M, a promising chimeric antigen receptor T cell (CAR T) therapy for multiple myeloma that targets B-cell maturation antigen (BCMA).
SHANGHAI – Zai Labs Ltd., of Shanghai, nabbed Greater China rights for FPA144, a first-in-class fibroblast growth factor (FGF) monoclonal antibody for gastric and gastro-esophageal junction cancer being developed globally by Five Prime Therapeutics Inc., of San Francisco.
SHANGHAI – When Beyondspring Pharmaceuticals Inc., a clinical-stage immuno-oncology biopharma started its U.S.-China development strategy for lead candidate plinabulin, getting a first-in-class drug past China's regulators was an unwieldy prospect, often taking years longer than the U.S. But after China's most recent round of regulatory reforms, things are looking up considerably.
SHANGHAI – When Beyondspring Pharmaceuticals Inc., a clinical-stage immuno-oncology biopharma started its U.S.-China development strategy for lead candidate plinabulin, getting a first-in-class drug past China's regulators was an unwieldy prospect, often taking years longer than the U.S. But after China's most recent round of regulatory reforms, things are looking up considerably. (See BioWorld Today, March 18, 2015.)
SHANGHAI – Shanghai-based Ark Biosciences Inc., a virtual biotech, and the California Institute of Biomedical Research (Calibr), of La Jolla, an affiliate of The Scripps Research Institute (TSRI), one of the world's largest private biomedical research institutes, have partnered to develop preclinical assets for chronic obstructive pulmonary disease (COPD).
SHANGHAI – Shanghai-based Ark Biosciences Inc., a virtual biotech, and the California Institute of Biomedical Research (Calibr), of La Jolla, an affiliate of The Scripps Research Institute (TSRI), one of the world's largest private biomedical research institutes, have partnered to develop preclinical assets for chronic obstructive pulmonary disease (COPD).
