Shanghai Henlius Biotech Inc.’s HLX-48 for injection has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The first-in-human phase I study in Australia will evaluate HLX-48 in patients with advanced or metastatic solid tumors.
Shanghai Henlius Biotech Inc. has announced acceptance of IND applications by China’s National Medical Products Administration (NMPA) for three differentiated candidates for the treatment of solid tumors.