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Sep 1Tue
  1. aacrjournals.org61

    First CAR T-Cell Therapy Approved for Solid Tumors

    China has approved satricabtagene autoleucel (satri-cel), the first CAR T-cell therapy for solid tumors, for patients with claudin 18.2-positive, HER2-negative gastric or gastro-esophageal junction cancer. The approval is based on a phase II trial showing improved progression-free and overall survival. Scientists welcome the decision but say more research is needed to improve CAR T-cell effectiveness against solid tumors.

    Why it matters: First regulatory approval of a CAR T-cell therapy for a solid tumor indication.

Aug 14Fri
  1. FierceBiotech49

    After 2 undisclosed gene therapy deaths, can China’s alternative regulatory path still be trusted?

    Two patient deaths after high-dose gene therapies delivered by viral vectors have drawn international scrutiny of China's investigator-initiated trial (IIT) framework. Both cases involved severe immune reactions, and neither death was disclosed, pointing to gaps in oversight and transparency. The failures raise questions about whether the alternative regulatory path can be trusted.

  2. BioCentury40

    Global drugs that made the grade in China in 2025

    China's NMPA approved 60 drugs and vaccines in 2025 that were already marketed abroad, with a median first-approval year of 2019. Merck & Co. holds marketing authorizations for five of the 60 products, including two vaccines, the most among importers. Most other multi-product sponsors are large multinational pharmas, with Almirall and UCB the two specialty European companies included.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org