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Jiangsu Huayi Technology develops, manufactures, and distributes high-quality radiopharmaceutical products including PET/SPECT tracers and precursors. The company has achieved regulatory milestones such as GMP certification in China and FDA DMF acceptance for certain products. Its pipeline includes approved diagnostic agents as well as candidates in clinical development targeting oncology indications. It also provides CDMO services globally.
The company’s subsidiary, Huayi Isotopes Co., supplies stable isotopes and precursor chemicals worldwide. In addition to its pharmaceutical activities, it manufactures sterile packaging solutions such as glass vials used by the pharma industry.
Clinical highlights include approval of a lung cancer imaging agent (99mTc‐3PRGD2) in Switzerland/NDA status elsewhere; peptide-based precursors like DOTATATE ACETATE have received US FDA DMF acceptance.
The company operates multiple manufacturing sites across China with a focus on nuclear medicine supply chain integration.
Pipeline breadth appears moderate with at least three clinical-stage programs plus commercialized products.
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