As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
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.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, Bioarctic, Daiichi Sankyo, Eisai, Hutchmed, Innovent.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Bio-Thera Solutions, Hengrui, Kailera, Zai Lab.
According to the World Health Organization (WHO), multidrug-resistant pathogens caused over 1.27 million deaths worldwide in 2020. And figures are rising, with projections pointing to antimicrobial resistance surpassing cancer as the leading cause of death by 2050. Now, researchers at the HUN-REN Biological Research Center have unveiled the role of pre-existing genetic variabilities and specific cross-resistance patterns among several antibiotics designed to combat gram-positive bacteria.
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.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Genfleet, Handa, Imaginab, Nanocopoeia, Orna, Simnova, Telix, Verastem Oncology.
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