CSPC Pharmaceutical Group Ltd.’s SYS-6011 has been cleared by China’s National Medical Products Administration (NMPA) to enter clinical trials in China for solid tumors.
Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022.
Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022.
Researchers from Generate Biomedicines Inc. have detailed the discovery and preclinical characterization of GB-0669, a spike S2-targeted monoclonal antibody (MAb) being developed for the prophylaxis of SARS-CoV-2 infection. Machine learning models were used to identify MAbs targeting the conserved S2 stem helix and RBD class IV region of spike.
Salipro Biotech AB and Icosagen AS have entered into a multitarget antibody research agreement for the discovery and characterization of monoclonal antibodies against several challenging membrane proteins.
Aerium Therapeutics Inc. has licensed and commenced development of three monoclonal antibodies (MAbs) with broad and potent activity against the predominant variants of SARS-CoV-2, including those containing the F456L mutation, such as EG.5.1. These antibodies could provide an option to protect immunocompromised populations from severe COVID-19.
The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response, has awarded Vir Biotechnology Inc. approximately $50 million in new funding to advance the development of novel monoclonal antibody (MAb) candidates and delivery solutions to widen the applicability of MAbs in COVID-19 and in pandemic preparedness and response.
Pharmabcine Inc. has received approval from the human research ethics committee (HREC) in Australia for a phase Ia/b trial of PMC-309, a monoclonal antibody against the human V-domain Ig suppressor of T-cell activation (VISTA) ligand.
The FDA has cleared an IND application for ADEL-Y01, being jointly developed by Oscotec Inc. and Adel Inc., for the treatment of Alzheimer’s disease. A phase Ia/b study will include healthy volunteers, and participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.
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