Wuhan YZY Biopharma Co. Ltd. is out-licensing lead candidate M-701, a CD3/EpCAM bispecific antibody, to Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ) for China rights in a deal worth up to $143 million. Under the deal, Sino Biopharmaceutical Ltd. subsidiary CTTQ is granted an exclusive license to develop, register, manufacture and commercialize M-701 within mainland China.
China’s National Medical Products Administration wrapped up a revision of its device classification procedures, providing entries into one of the world’s largest markets a mechanism for obtaining means for determining the risk of a novel device type.
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
Jiangsu Alphamab Biopharmaceuticals Co. Ltd. is out-licensing its anti-HER2 bispecific antibody-drug conjugate, JSKN-003, to JMT-Bio Technology Co. for China rights in a deal worth up to ¥3.08 billion (US$439 million) plus sales royalties.
Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
Jiangsu Alphamab Biopharmaceuticals Co. Ltd. is out-licensing its anti-HER2 bispecific antibody-drug conjugate, JSKN-003, to JMT-Bio Technology Co. for China rights in a deal worth up to ¥3.08 billion (US$439 million) plus sales royalties.
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
Innovent Biologics Inc. unveiled for the first time safety and efficacy data of IBI-354, an HER2 monoclonal antibody-camptothecin derivative conjugate that shows promising efficacy signals across a range of advanced solid tumors, during the European Society of Medical Oncology (ESMO) 2024 Congress. An HER2-targeted antibody-drug conjugate developed using Innovent's topoisomerase inhibitor NT3 platform, IBI-354 combines a hydrophilic linker design with a hydrophobic payload to enhance the bystander effect, targeting adjacent antigen-low or negative tumor cells.
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