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CDE Launches Trial Procedures for Adding Pediatric Information to Drug Inserts
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The Center for Drug Evaluation (CDE) has released the “Work Procedures for Adding Children’s Drug Information to the Listed Drugs’ Package Insert (Trial),” which is effective immediately. This document is designed to provide a framework for qualified pediatric-related medical institutions, societies, and industry associations to propose the inclusion of children’s…
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Sino Biopharmaceutical’s F-star Therapeutics Inks Third Licensing Deal with Takeda for Immunotherapies
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a third licensing agreement between its subsidiary, F-star Therapeutics Inc., (NASDAQ: FSTX), and Japan-based Takeda Pharmaceutical Co., Ltd. The agreement facilitates the utilization of F-star’s proprietary wholly human Fcab and tetravalent mAb2 platforms to develop next-generation multi-specific immunotherapies targeting cancer. Joint Research and…
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3SBio Inc. Receives NMPA Approval for Nalfurafine Tablets to Treat Hemodialysis-Related Pruritus
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China-based 3SBio Inc. (HKG: 1530) has announced receiving marketing approval from the National Medical Products Administration (NMPA) in China for its nalfurafine orally disintegrating tablets. The drug is used to improve pruritus in hemodialysis patients in situations where existing treatment efficacy is not ideal. This marks the first and only…
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Tot Biopharmaceutical and GL-Biotech Collaborate on DisacLink Technology for ADC Advancements
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China-based Tot Biopharma International Co., Ltd (HKG: 1875) has announced a strategic partnership with compatriot firm GL-Biotech in relation to GL-Biotech’s proprietary DisacLink technology. The collaboration aims to achieve technological breakthroughs, jointly develop, improve, and commercialize fixed-point conjugate technology, with both parties engaging in extensive commercial cooperation for the external…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Esflurbiprofen Patch Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its esflurbiprofen patch, a generic version of Japan firm Taisho Pharmaceutical’s Loqoa tape. The intended indication for the patch…
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Biocytogen Pharmaceuticals Enters Antibody License Agreement with Pheon Therapeutics for ADC Development
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced an antibody license agreement with Pheon Therapeutics (Pheon), a leading UK-based antibody-drug conjugate (ADC) specialist developing next-generation ADCs for a wide range of hard-to-treat cancers. According to the agreement, Pheon will develop and commercialize an antibody developed using Biocytogen’s proprietary…
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Nanjing Kati Medical and Leman Biotech Partner to Advance Immune Metabolism Reprogramming in CAR-T Therapy
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Nanjing Kati Medical Technology Co., Ltd, a China-based company, has entered into a partnership with Leman Biotech Co., Ltd, a clinical-stage immune-metabolism drug developer based in Shenzhen. The collaboration aims to explore the application and translation capabilities of immune metabolism reprogramming technology (Meta 10) in solid tumor CAR-T therapy, with…
