Vaxxas Pty. Ltd. and the Coalition for Epidemic Preparedness Innovations are progressing heat-stable, dried-formulation mRNA vaccines using Vaxxas’ needle-free high-density microarray patch.
George Medicines, a new spinout from Australia’s George Institute for Global Health, could offer patients better control of their blood pressure as well as fewer side effects thanks to an ultra-low-dose triple combination. A polypill that combines multiple medicines into a single tablet, GMRx2 was developed out of a 20-year research program at The George Institute for Global Health. The single pill is a combination of three best-in-class medicines: telmisartan, amlodipine and indapamide.
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
Marking the second global approval after Japan, the U.S. FDA has approved Datroway (datopotamab deruxtecan), a trophoblast cell surface antigen 2-directed antibody-drug conjugate (ADC) from Daiichi Sankyo Co. Ltd. and Astrazeneca plc, for treating adults with hormone receptor-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
In another Chinese newco out-licensing deal, Innocare Pharma Ltd. and Keymed Biosciences Co. Ltd. out-licensed their co-developed CD20×CD3 bispecific antibody (ICP-B02/CM355) to startup Prolium Bioscience Inc. in a deal worth up to $520 million.
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
Mountainfield Venture Partners and Chengdu, China-based Keymed Biosciences Co. Ltd have partnered to form San Diego-based Timberlyne Therapeutics, which will progress Keymed’s CD-38 monoclonal antibody globally excluding China.
Wuxi Biologics Co. Ltd. is licensing a preclinical trispecific T-cell engager to Candid Therapeutics Inc. in a deal worth up to $925 million plus royalties.
