Hanchorbio Inc. and Shanghai Henlius Biotech Inc. have entered into a strategic framework agreement for collaboration to combine Hanchorbio’s protein engineering expertise and proprietary Fc-based designer biologics (FBDB) technology platform with Henlius’ integrated product development and commercialization capabilities.
Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.
Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.
Shanghai Henlius Biotech Inc. scored NMPA approval for its self-developed anti-PD-1 monoclonal antibody Hansizhuang (serplulimab). It can be used for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide.
China's National Medical Products Administration (NMPA) has cleared an IND application for a clinical trial of Shanghai Henlius Biotech Inc.'s HLX-60 for the treatment of solid tumors and lymphomas.
Shanghai Henlius Biotech Inc. has inked a deal to acquire greater China rights for two cancer-focused bifunctional sialidase programs from Palleon Pharmaceuticals Inc. In return, Palleon will receive an unspecified up-front payment and is eligible for up to $196.5 million in milestone payments.
Shanghai Henlius Biotech Inc. has inked a deal to acquire greater China rights for two cancer-focused bifunctional sialidase programs from Palleon Pharmaceuticals Inc. In return, Palleon will receive an unspecified up-front payment and is eligible for up to $196.5 million in milestone payments.
Shanghai Henlius Biotech Inc. signed an exclusive licensing deal with Organon LLC under which Organon will in-license rights for two of Henlius’ internally developed biosimilar candidates for global commercialization, excluding China, Hong Kong, Macau and Taiwan.
