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Explore the latest developments in cellular research, including stem cell therapy, regenerative medicine, and innovative approaches to treating diseases at the cellular level.

Pr News Wire

CARsgen’s Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA

SHANGHAI, March 2, 2025 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to satricabtagene autoleucel (“satri-cel”, CT041) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction cancer (G/GEJ) in patients who have failed at least two prior lines of therapy.

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Target Edonc

The Targeted Pulse: Discover the FDA’s Holiday Moves For Solid Tumors, Gastric, and GEJ Cancers

The subcutaneous formulation of nivolumab (Opdivo Qvantig) received FDA approval for all previously approved adult solid tumor indications as monotherapy, maintenance therapy, or in combination with chemotherapy or cabozantinib (Cabometyx). Data from the phase 3 CheckMate-67T study (NCT04810078) provided support for this approval. In the trial, subcutaneous nivolumab was compared with its intravenous formulation.

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ASTRO

China’s National Medical Products Administration (NMPA) Approves VYLOY™ (zolbetuximab) for First-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

OKYO, Jan. 5, 2025 /PRNewswire/ — Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved VYLOY™ (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.

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