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Efung News | First and Only in China! New Radiomedicine's Germanium-Gallium Generator Completes FDA DMF Filing

Date: 2026-10-14
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On October 14, according to the latest List of Drug Master Files (DMFs) 3rd Quarter 2026 published by the U.S. Food and Drug Administration (FDA), the JiaLin® Germanium-Gallium Generator independently developed by Chengdu New Radiomedicine Technology Co., Ltd. has officially completed its Drug Master File (DMF) filing, with the status marked as Active and DMF number 44330.

Completion of an FDA DMF filing is a prerequisite for pharmaceutical companies (NDA/ANDA/IND applicants) to reference an upstream product. Currently, only four Germanium-Gallium Generators have completed FDA DMF filings and remain in Active status, three of which are held by overseas companies (Eckert & Ziegler, IRE ELiT, and Curium). As the first and only Germanium-Gallium Generator in China to enter the DMF system, the JiaLin® Germanium-Gallium Generator not only means that the company's DMF can be referenced and linked by radiopharmaceutical companies to support their FDA drug registration applications, but also provides global customers with a compliant, stable, and traceable upstream source of radionuclides. This marks a substantial leap for domestically produced Germanium-Gallium Generators from "product going global" to "registration-compliant going global."

Efung Capital participated in New Radiomedicine's financing rounds in February and April 2026. The Series E round in April raised RMB 1 billion, setting a new record for a single financing round in China's radiopharmaceutical sector. Yifeng Capital will continue to focus on opportunities across the entire radiopharmaceutical value chain, from upstream radionuclide supply to downstream drug development, providing upstream infrastructure support for Chinese radiopharmaceutical companies to compete globally.

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